fda
313 records
FDA Recall: Olympus Corporation of the Americas — Class II
20260429
Potential for detachment of a distal tip component of the device during use. | Product: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
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FDA Recall: Olympus Corporation of the Americas — Class II
20260429
XXX | Product: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2115.
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FDA Recall: Olympus Corporation of the Americas — Class II
20260401
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds | Product: Brand Name: Olympus PKS Cutting Forcep...
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FDA Recall: Olympus Corporation of the Americas — Class II
20260311
Potential for rubber fragment detachment during use. | Product: Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has
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FDA Recall: Olympus Corporation of the Americas — Class II
20260311
Potential for rubber fragment detachment during use. | Product: Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 h
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FDA Recall: Olympus Corporation of the Americas — Class II
20260304
Complaints of the ceramic tip of the resection sheath breaking have been received. | Product: Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological appl
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FDA Recall: Olympus Corporation of the Americas — Class II
20260225
Firm is initiating a removal due to continued reports of adverse events. | Product: Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
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FDA Recall: Olympus Corporation of the Americas — Class II
20260225
Firm is initiating a removal due to continued reports of adverse events. | Product: Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
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FDA Recall: Olympus Corporation of the Americas — Class II
20260211
Devices which did not undergo thermoforming could deform and lose performance. | Product: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Desc
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FDA Recall: Olympus Corporation of the Americas — Class II
20260211
Devices which did not undergo thermoforming could deform and lose performance. | Product: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product De
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FDA Recall: Olympus Corporation of the Americas — Class II
20260211
Devices which did not undergo thermoforming could deform and lose performance. | Product: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software V
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FDA Recall: Olympus Corporation of the Americas — Class II
20260211
Devices which did not undergo thermoforming could deform and lose performance. | Product: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software V
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FDA Device Recall: Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLT
2026-04-08
Class II — Following a complaint investigation, Olympus identified a potential defect in the 24V power supply module in some SOLTIVE laser units which may cause the system to become inoperable. Additi...
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FDA Device Recall: Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting For
2026-04-01
Class II — Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw...
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FDA Device Recall: Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
2026-04-01
Class II — The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
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FDA Device Recall: Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutt
2026-04-01
Class II — Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw...
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FDA Device Recall: Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
2026-04-01
Class II — The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
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FDA Device Recall: Brand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting Force
2026-04-01
Class II — Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw...
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FDA Device Recall: Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
2026-04-01
Class II — The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
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FDA Device Recall: Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
2026-04-01
Class II — The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
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FDA Device Recall: Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: E
2026-04-01
Class II — Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw...
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FDA Device Recall: Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box
2026-03-11
Class II — Potential for rubber fragment detachment during use.
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FDA Device Recall: Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per bo
2026-03-11
Class II — Potential for rubber fragment detachment during use.
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FDA Device Recall: Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithot
2026-03-11
Class II — Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or genera...
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FDA Device Recall: Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatmen
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T.
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urolo
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T.
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Res
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. R
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecol
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applica
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment i
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Rese
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatm
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and trea
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urolog
2026-03-04
Class II — Complaints of the ceramic tip of the resection sheath breaking have been received.
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FDA Device Recall: Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
2026-02-25
Class II — Firm is initiating a removal due to continued reports of adverse events.
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FDA Device Recall: Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
2026-02-25
Class II — Firm is initiating a removal due to continued reports of adverse events.
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FDA Device Recall: Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
2026-02-25
Class II — Firm is initiating a removal due to continued reports of adverse events.
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FDA Device Recall: Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflat
2026-02-25
Class I — Issue with software algorithm which may lead to overpressure events.
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FDA Device Recall: Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip
2026-02-25
Class II — Firm is initiating a removal due to continued reports of adverse events.
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FDA Device Recall: Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insuffla
2026-02-25
Class I — Issue with software algorithm which may lead to overpressure events.
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FDA Device Recall: Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
2026-02-25
Class II — Firm is initiating a removal due to continued reports of adverse events.
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FDA Device Recall: Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
2026-02-25
Class II — Firm is initiating a removal due to continued reports of adverse events.
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FDA Device Recall: Olympus Thunderbeat 5 mm, 10 cm, Inline Grip
2026-02-25
Class II — Firm is initiating a removal due to continued reports of adverse events.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V41
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V41
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V43
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V41
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use E
2026-02-11
Class II — A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Device Recall: Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Singl
2026-02-11
Class II — A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
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FDA Device Recall: Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411
2026-02-11
Class II — Devices which did not undergo thermoforming could deform and lose performance.
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FDA Recall: Olympus Corporation of the Americas — Class II
20251119
The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition | Product: Brand Name: Lithotriptor, Ultrasonic ...
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FDA Recall: Olympus Corporation of the Americas — Class I
20251022
Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma c | Product: EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS B...
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FDA Recall: Olympus Corporation of the Americas — Class II
20250827
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of | Product: Electrosurgical, Cutting and Coagulati...
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FDA Recall: Olympus Corporation of the Americas — Class II
20250129
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment. | Product: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Product...
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FDA Recall: Olympus Corporation of the Americas — Class I
20250122
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and d | Product: Olympus MAJ-891 Forceps/Irrigation Plu...
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FDA Device Recall: Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/
2025-12-03
Class I — Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
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FDA Device Recall: Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Prod
2025-11-26
Class II — Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other com...
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FDA Device Recall: Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Trans
2025-11-19
Class II — The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece ...
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FDA Device Recall: Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product
2025-11-19
Class II — Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
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FDA Device Recall: EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: BRONCHOVIDEOSCOPE OLYMPUS BF-H1100
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
2025-10-22
Class I — Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy e...
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FDA Device Recall: ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. T
2025-09-17
Class I — Potential for undetected, deformed a-traumatic tips.
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FDA Device Recall: Electrosurgical, Cutting and Coagulation and Accessories. Electrosurgical Genera
2025-08-27
Class II — Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops...
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FDA Device Recall: Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessori
2025-07-30
Class II — Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
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FDA Device Recall: Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Elli
2025-07-30
Class II — Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
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FDA Device Recall: Cone with Male Tubing, Non-Locking, Ellik Evacuator. Model Number: 191-NRS.
2025-07-30
Class II — Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
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FDA Device Recall: Glass Body For 194 Ellik Evacuator. Model Number: 190A. The Ellik Evacuator
2025-07-30
Class II — Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
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FDA Device Recall: Ellik Latex Bulb, Ellik Evacuator. Model Number: 194-2. The Ellik Evacuator
2025-07-30
Class II — Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
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FDA Device Recall: Brand Name: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed
2025-06-18
Class II — Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contribu...
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FDA Device Recall: Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
2025-06-11
Class II — Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a p...
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FDA Device Recall: Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPu
2025-05-07
Class II — Preset treatment parameters are not consistently being used in accordance with the IFU.
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FDA Device Recall: Olympus Single Use Guide Sheath Kits with the following product descriptions and
2025-02-19
Class I — Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
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FDA Device Recall: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Prod
2025-01-29
Class II — The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
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FDA Device Recall: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Prod
2025-01-29
Class II — The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
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FDA Device Recall: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Prod
2025-01-29
Class II — The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
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FDA Device Recall: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Prod
2025-01-29
Class II — The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
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FDA Device Recall: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Prod
2025-01-29
Class II — The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
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FDA Device Recall: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Prod
2025-01-29
Class II — The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
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FDA Device Recall: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Prod
2025-01-29
Class II — The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
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FDA Device Recall: Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument Prod
2025-01-29
Class II — The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
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FDA Device Recall: Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: M
2025-01-22
Class I — Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
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FDA Recall: Olympus Corporation of the Americas — Class II
20241120
Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for | Product: Brand Name: Olympus Product Name: Cys...
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FDA Recall: Olympus Corporation of the Americas — Class II
20241106
There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-4 | Product: Olympus Electrosurgical Generator, Mod...
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FDA Recall: Olympus Corporation of the Americas — Class II
20241023
Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply | Product: EVIS EXERA III Video System Center Mod...
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FDA Recall: Olympus Corporation of the Americas — Class II
20240814
Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach | Product: The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm can...
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FDA Recall: Olympus Corporation of the Americas — Class II
20240306
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vib | Product: Colonoscope, Model Number PCF-H190DL.
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FDA Recall: Olympus Corporation of the Americas — Class II
20240306
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vib | Product: Colonoscope, Model Number CF-Q180AL.
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FDA Recall: Olympus Corporation of the Americas — Class II
20240306
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vib | Product: Colonoscope, Model Number CF-H180AL.
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FDA Recall: Olympus Corporation of the Americas — Class II
20240214
The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12 | Product: Olympus/Gyrus Paparrela-Type Vent Tube...
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FDA Recall: Olympus Corporation of the Americas — Class II
20240207
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patie | Product: EZDilate Wire Guided Balloon 6-7-8. in...
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FDA Recall: Olympus Corporation of the Americas — Class II
20240207
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patie | Product: EZDilate Wire Guided Balloon 16-17-18....
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FDA Recall: Olympus Corporation of the Americas — Class II
20240207
Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patie | Product: EZDilate Fixed Wire Balloon 6-7-8. Ind...
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FDA Recall: Olympus Corporation of the Americas — Class II
20240124
Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Followi | Product: SOLTIVE SuperPulsed Laser Fibers Mode...
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FDA Recall: Olympus Corporation of the Americas — Class II
20240124
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization | Product: Soltive SuperPulsed Laser System TFL F...
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FDA Recall: Olympus Corporation of the Americas — Class II
20240117
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are re | Product: OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEO...
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FDA Device Recall: Duravent Silicone Ventilation Tube. Model Number: 240075.
2024-12-25
Class II — Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation ...
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FDA Device Recall: Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name:
2024-11-27
Class II — To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when com...
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FDA Device Recall: Brand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number
2024-11-20
Class II — Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser pr...
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FDA Device Recall: Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheat
2024-11-20
Class II — Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during s...
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FDA Device Recall: Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
2024-11-06
Class II — There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
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FDA Device Recall: Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
2024-11-06
Class II — During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
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FDA Device Recall: EZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 ye
2024-10-30
Class II — Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is co...
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FDA Device Recall: Olympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
2024-10-30
Class II — It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
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FDA Device Recall: Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection,
2024-10-30
Class II — The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an inco...
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FDA Device Recall: EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with
2024-10-23
Class II — Certain serial numbers of the CV-190 do not start up properly because parts that deviated from the specification were assembled into the power supply unit.
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FDA Device Recall: Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscopes
2024-09-18
Class II — Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in acc...
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FDA Device Recall: The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or
2024-08-14
Class II — Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
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FDA Device Recall: Soltive Premium SuperPulsed Laser System, Model TFL-PLS
2024-08-14
Class II — Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
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FDA Device Recall: The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or
2024-08-14
Class II — Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
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FDA Device Recall: EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuite 4
2024-07-10
Class II — A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical cur...
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FDA Device Recall: POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated
2024-05-08
Class II — Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on the generator screen, and no ...
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FDA Device Recall: Insufflation unit, UHI-4.
2024-04-03
Class II — Olympus has become aware of an increased trend of both repairs and customer complaints reporting "UHI-4 stopping air supply due to the front panel LED turning off".
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FDA Device Recall: SOLTIVE Pro SuperPulsed Laser (TFL-SLS )
2024-04-03
Class II — A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
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FDA Device Recall: InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures a
2024-04-03
Class II — Japanese IFU version had slightly different language and illustrations from the English IFU, which could contribute to the tip and plate falling off. In order to maintain consistency global...
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FDA Device Recall: SOLTIVE Premium SuperPulsed Laser (TFL-PLS )
2024-04-03
Class II — A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
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FDA Device Recall: Colonoscope, Model Number PCF-H190DL.
2024-03-06
Class II — Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or s...
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FDA Device Recall: Colonoscope, Model Number CF-Q180AL.
2024-03-06
Class II — Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or s...
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FDA Device Recall: Colonoscope, Model Number CF-H180AL.
2024-03-06
Class II — Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or s...
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FDA Device Recall: Colonoscope, Model Number PCF-H180AL.
2024-03-06
Class II — Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or s...
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FDA Device Recall: Colonoscope, Model Number CF-HQ190L.
2024-03-06
Class II — Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or s...
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FDA Device Recall: Colonoscope, Model Number PCF-Q180AL.
2024-03-06
Class II — Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or s...
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FDA Device Recall: Colonoscope, Model Number CF-HQ190I.
2024-03-06
Class II — Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or s...
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FDA Device Recall: Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF
2024-02-21
Class II — Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due...
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FDA Device Recall: Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate t
2024-02-14
Class II — The expiration date is missing from the primary (inner) packaging. The secondary (outer) box label correctly states the expiration date of February 12, 2033, for this lot
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FDA Device Recall: Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used w
2024-02-14
Class II — Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used for reprocessing. This may expose a patient to a potentially contaminated device, presenting a...
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FDA Device Recall: EZDilate Wire Guided Balloon 6-7-8. indicated for endoscopic dilation of strict
2024-02-07
Class II — Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
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FDA Device Recall: EZDilate Wire Guided Balloon 16-17-18. Indicated for endoscopic dilation of str
2024-02-07
Class II — Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
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FDA Device Recall: EZDilate Fixed Wire Balloon 6-7-8. Indicated for endoscopic dilation of strictur
2024-02-07
Class II — Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
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FDA Device Recall: EZDilate Fixed Wire Balloon 13.5-14.5-15.5. Indicated for endoscopic dilation of
2024-02-07
Class II — Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
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FDA Device Recall: EZDilate Fixed Wire Balloon 18-19-20. Indicated for endoscopic dilation of stric
2024-02-07
Class II — Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
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FDA Device Recall: EZDilate Wire Guided Balloon 8.5-9.5-10.5. indicated for endoscopic dilation of
2024-02-07
Class II — Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
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FDA Device Recall: EZDilate Wire Guided Balloon 11-12-13. Indicated for endoscopic dilation of str
2024-02-07
Class II — Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
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FDA Device Recall: EZDilate Fixed Wire Balloon 8.5-9.5-10.5. Indicated for endoscopic dilation of s
2024-02-07
Class II — Product balloon issues: inflating, deflating and/or retrieving the devices; reports of bursting and leaking and events involving foreign body in patient and prolonged procedure.
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FDA Device Recall: SOLTIVE SuperPulsed Laser Fibers Model Numbers TFL-FBX150S, TFL-FBX200S, TFL-FB
2024-01-24
Class II — Olympus identified inconsistencies in the Instructions for Use regarding cleaning the fiber tip and fiber cleaving and stripping instructions. Following the current instructions presents th...
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FDA Device Recall: Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, T
2024-01-24
Class II — The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fibe...
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FDA Device Recall: OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-
2024-01-17
Class II — Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of t...
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FDA Device Recall: OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (10 mm diameter) Model: LTF-S190-
2024-01-17
Class II — Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of t...
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FDA Recall: Olympus Corporation of the Americas — Class I
20231115
There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the | Product: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMP...
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FDA Recall: Olympus Corporation of the Americas — Class II
20231115
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel. | Product: EVIS EXERA III Gastrointestinal Videoscope
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FDA Recall: Olympus Corporation of the Americas — Class I
20231025
There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. Thes | Product: Olympus High-Flow Insufflation Unit, M...
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FDA Recall: Olympus Corporation of the Americas — Class II
20231011
Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navi | Product: Veran : Endobronchial Always on Track ...
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FDA Recall: Olympus Corporation of the Americas — Class II
20230906
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. | Product: Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
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FDA Recall: Olympus Corporation of the Americas — Class II
20230906
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. | Product: Olympus Bronchovideoscope, Models BF-3C160.
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FDA Recall: Olympus Corporation of the Americas — Class II
20230906
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large. | Product: Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
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FDA Recall: Olympus Corporation of the Americas — Class II
20230830
The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated aut | Product: The Air/Water Valve is provided/used w...
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FDA Recall: Olympus Corporation of the Americas — Class II
20230809
Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to | Product: Always-On Tip Tracked Instruments (SPi...
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FDA Recall: Olympus Corporation of the Americas — Class I
20230726
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. | Product: Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
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FDA Recall: Olympus Corporation of the Americas — Class I
20230726
There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope. | Product: Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF...
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FDA Device Recall: TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP, Model Number: LF-GP
2023-12-20
Class II — Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
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FDA Device Recall: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
2023-11-15
Class I — There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close t...
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FDA Device Recall: EVIS EXERA III Gastrointestinal Videoscope
2023-11-15
Class II — Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
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FDA Device Recall: EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
2023-11-15
Class I — There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close t...
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FDA Device Recall: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P
2023-11-15
Class I — There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close t...
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FDA Device Recall: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ18
2023-11-15
Class I — There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close t...
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FDA Device Recall: EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and
2023-11-15
Class I — There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close t...
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FDA Device Recall: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
2023-11-15
Class I — There is a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen [and/or] the electrode section of the electrosurgical accessory is too close t...
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FDA Device Recall: Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
2023-10-25
Class I — There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over in...
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FDA Device Recall: THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S. Model: TB-0535FCS Indicate
2023-10-18
Class II — Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery
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FDA Device Recall: Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12mm
2023-10-11
Class II — Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to d...
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FDA Device Recall: Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Univers
2023-10-11
Class II — Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to d...
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FDA Device Recall: Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigatio
2023-10-11
Class II — Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to d...
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FDA Device Recall: Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 20cm
2023-10-11
Class II — Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN Planning Laptop Workstation, and all associated navigation instruments) manufacturing to d...
View Source
FDA Device Recall: Olympus Bronchovideoscope, Models BF-3C40 & BF-N20.
2023-09-06
Class II — Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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FDA Device Recall: Olympus Bronchovideoscope, Models BF-3C160.
2023-09-06
Class II — Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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FDA Device Recall: Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
2023-09-06
Class II — Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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FDA Device Recall: Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, B
2023-09-06
Class II — Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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FDA Device Recall: Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60.
2023-09-06
Class II — Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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FDA Device Recall: Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
2023-09-06
Class II — Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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FDA Device Recall: Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.
2023-09-06
Class II — Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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FDA Device Recall: Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
2023-09-06
Class II — Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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FDA Device Recall: Visera Hysterovideoscope Olympus HYF Type V
2023-09-06
Class II — IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
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FDA Device Recall: Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
2023-09-06
Class II — Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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FDA Device Recall: Olympus Bronchovideoscope, Model BF-Q180-AC
2023-09-06
Class II — Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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FDA Device Recall: Olympus Bronchovideoscope, Models BF-MP190F.
2023-09-06
Class II — Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
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FDA Device Recall: EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
2023-09-06
Class II — Recent reports of patient infection.
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FDA Device Recall: The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC
2023-08-30
Class II — The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympu...
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FDA Device Recall: HF Resection Electrodes - HF resection electrodes are part of a resectoscope sys
2023-08-23
Class II — Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end of the HF resection electrode broke after getting in contact with metal objects, such as ot...
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FDA Device Recall: UroPass Ureteral Access Sheaths, 5 pieces/box
2023-08-23
Class II — Dilator tips may break in the package and in patients during surgical procedures.
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FDA Device Recall: Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light So
2023-08-16
Class II — Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the followi...
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FDA Device Recall: Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinf
2023-08-16
Class II — Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the followi...
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FDA Device Recall: Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disin
2023-08-16
Class II — Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the followi...
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FDA Device Recall: Always-On Tip Tracked Instruments (SPiN Drive instruments) Triple Needle Brush,
2023-08-09
Class II — Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. T...
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FDA Device Recall: Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8mm OD, Se
2023-08-09
Class II — Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. T...
View Source
FDA Device Recall: Always-On Tip Tracked Instruments (SPiN Drive¿ instruments) Brush, 15mm L, 1.8mm
2023-08-09
Class II — Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. T...
View Source
FDA Device Recall: Always-On Tip Tracked Instruments (SPiN Drive instruments) Forceps, 1.8 mm OD, O
2023-08-09
Class II — Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. T...
View Source
FDA Device Recall: Always-On Tip Tracked Instruments (SPiN Drive instruments) 21ga ANSO Cytology Ne
2023-08-09
Class II — Electromagnetic (EM) sensor tracking malfunction impacts the use of navigation functionality during endobronchial procedures and prompts the system to report a coil break warning message. T...
View Source
FDA Device Recall: Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2
2023-07-26
Class I — There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
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FDA Device Recall: Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q190
2023-07-26
Class I — There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
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FDA Device Recall: Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170
2023-07-26
Class I — There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
View Source
FDA Device Recall: Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160
2023-07-26
Class I — There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
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FDA Device Recall: Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60, B
2023-07-26
Class I — There have been complaints of endobronchial combustion during therapeutic laser procedures with the bronchoscope.
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FDA Device Recall: Single Use Repositionable Clip QUICKCLIP PRO 165 CM 10/BX- Intended for hemostat
2023-06-28
Class II — Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially ca...
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FDA Device Recall: Single Use Repositionable Clip QUICKCLIP PRO 165CM 5/BX- Intended for hemostatic
2023-06-28
Class II — Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially ca...
View Source
FDA Device Recall: Single Use Repositionable Clip QUICKCLIP PRO 230 CM 10/BX- Intended for hemostat
2023-06-28
Class II — Complaints on clip deployment occurring during clinical procedures, leading to hazardous situations where clips fail to achieve their expected function or deploy incorrectly, potentially ca...
View Source
FDA Device Recall: ViziShot 2 Single Use Aspiration Needle, 21G- To be used with ultrasound endosco
2023-05-31
Class III — Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advan...
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FDA Device Recall: To be used with ultrasound endoscopes for ultrasound guided fine needle aspirati
2023-05-31
Class III — Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advan...
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FDA Device Recall: EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the
2023-02-22
Class II — A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial...
View Source
FDA Recall: Olympus Corporation of the Americas — Class II
20220629
Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last rep | Product: EVIS EXERA II Gastrointestinal Videosc...
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FDA Recall: Olympus Corporation of the Americas — Class II
20220518
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing step | Product: BF-3C160: EVIS EXERA Bronchovideoscope
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FDA Device Recall: Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspi
2022-10-19
Class II — Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of accessories which are not listed in the IFU. There have been reported adverse events involving th...
View Source
FDA Device Recall: Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Mod
2022-10-05
Class II — An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay o...
View Source
FDA Device Recall: ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
2022-08-17
Class II — Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic co...
View Source
FDA Device Recall: EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper dig
2022-06-29
Class II — Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber ...
View Source
FDA Device Recall: Colonovideoscope Model CF-H180AL
2022-06-29
Class II — A (Camera unit) CCD intended for a different model of colonoscope may have been installed in the CF-H180AL, viewing angle would be narrower than a normal CF-H180AL and the use of EndoTherap...
View Source
FDA Device Recall: Olympus URETERO-RENO FIBERSCOPE Model: URF-P6R
2022-06-22
Class II — Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision a...
View Source
FDA Device Recall: Olympus DISPOSABLE GRASPING FORCEPS, FG-51D
2022-06-01
Class II — Forceps do not comply with Olympus standards for the amount of force required to open and close the forceps
View Source
FDA Device Recall: BF-3C160: EVIS EXERA Bronchovideoscope
2022-05-18
Class II — Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a ...
View Source
FDA Device Recall: BF-MP160F: EVIS EXERA Bronchofibervideoscope
2022-05-18
Class II — Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a ...
View Source
FDA Device Recall: BF-MP60: OES Bronchofiberscope
2022-05-18
Class II — Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a ...
View Source
FDA Device Recall: BF-1TQ180: EVIS EXERA II Bronchovideoscope
2022-05-18
Class II — Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a ...
View Source
FDA Device Recall: Ultrasonic Gastrovideoscope, GF-UC140P-AL5. Intended for endoscopic real-time ul
2022-05-11
Class II — GF-UC140P-AL5 is no longer a compatible endoscope for reprocessing in the OER-Pro and presents an infection control risk to patients
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FDA Device Recall: Spiration Valve System (SVS) Valve in Cartridge -A one-way endobronchial valves
2022-02-09
Class II — Mislabeled Patient Charge Label indicating model number SVS-V7-00 (7mm) instead of SVS-V9-00 (9mm)
View Source
FDA Recall: Olympus Corporation of the Americas — Class II
20211222
Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid in | Product: EVIS EXERA II DUODENOVIDEOSCOPE OLYMPU...
View Source
FDA Recall: Olympus Corporation of the Americas — Class II
20211103
Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deplo | Product: ASC PneumoLiner device, Part No. WA905...
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FDA Recall: Olympus Corporation of the Americas — Class II
20210331
Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duod | Product: Duodenoscope and accessories, flexible...
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FDA Device Recall: EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF-Q180V Model Number: TJF-Q180V
2021-12-22
Class II — Use of a TJF-Q180V with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can pres...
View Source
FDA Device Recall: ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner d
2021-11-03
Class II — Due to manufacturing error, the Pneumoliner Bag Distal Tab that exits the Introducer shaft is in the wrong orientation. This results in the user deploying the bag upside down, which will ma...
View Source
FDA Device Recall: BF-XP60 OES Bronchofiberscope, Model No. BF-XP60
2021-10-06
Class II — The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
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FDA Device Recall: BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
2021-10-06
Class II — The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
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FDA Device Recall: BF-3C40 OES Bronchofiberscope, Model No. BF-3C40
2021-10-06
Class II — The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
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FDA Device Recall: BF-XT160 EVIS EXERA Bronchovideoscope, Model No. BF-XT160
2021-10-06
Class II — The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
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FDA Device Recall: BF-1T60 OES Bronchofiberscope, Model No. BF-1T60
2021-10-06
Class II — The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
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FDA Device Recall: BF-N20 OES Bronchofiberscope, Model No. BF-N20
2021-10-06
Class II — The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
View Source
FDA Device Recall: EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
2021-09-29
Class II — A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection con...
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FDA Device Recall: Arc Endocuff Vision as follows: ARV110 ENDOCUFF-V M BLUE PK8, Part Number: E0
2021-09-15
Class II — Packaging seal defect may allow a breach of the package sterile barrier and result in patient infection.
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FDA Device Recall: Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olymp
2021-03-31
Class II — Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (m...
View Source
FDA Recall: Olympus Corporation of the Americas — Class II
20201209
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk | Product: Olympus Ultrasound Endoscope, Model nu...
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FDA Recall: Olympus Corporation of the Americas — Class II
20201209
A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk | Product: Olympus Ultrasound Endoscope, Model nu...
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FDA Recall: Olympus Corporation of the Americas — Class II
20200826
Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was | Product: Smart Stapes Protheses Piston 0.6mm X...
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FDA Recall: Olympus Corporation of the Americas — Class II
20200429
There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manua | Product: Olympus Pleuravideoscope, Model LTF-16...
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FDA Device Recall: Olympus Ultrasound Endoscope, Model number: GF-UCT140P-AL5 - Product Usage: used
2020-12-09
Class II — A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
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FDA Device Recall: Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used
2020-12-09
Class II — A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
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FDA Device Recall: Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used f
2020-12-09
Class II — A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
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FDA Device Recall: Olympus Ultrasound Endoscope, Model number :GF-UM20 - Product Usage: used with o
2020-12-09
Class II — A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
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FDA Device Recall: Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with
2020-12-09
Class II — A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
View Source
FDA Device Recall: Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with
2020-12-09
Class II — A new inspection step was added to the cleaning and disinfection section of the Instructions For Use (IFU) for this device in order to reduce the risk of causing patient infections.
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FDA Device Recall: Olympus CHF-CB30S Choledoscope Intended Use: The device was designed to be u
2020-10-28
Class II — The CHF-CB30S Device did not have a 510(k) clearance. Additionally, the device has been associated with breakage of the insertion section and protrusion of metal parts, as well as breakage ...
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FDA Device Recall: Olympus Medical Systems Corporation (OMSC) Evis Exera II Bronchovideoscope Olymp
2020-10-07
Class II — The BF-Q180 bronchoscope is being recalled because it does not have a 510(k) clearance, and the device is associated with a higher rate of patient infections than other comparable OMSC bron...
View Source
FDA Device Recall: Smart Stapes Protheses Piston 0.6mm X 4.25 mm- Partial Ossicular Replacement
2020-08-26
Class II — Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image b...
View Source
FDA Device Recall: OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
2020-06-10
Class II — A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
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FDA Device Recall: Olympus Pleuravideoscope, Model LTF-160
2020-04-29
Class II — There was no data to validate that the identified endo-therapy devices were compatible with certain pleuravideoscope models. Updated Operations Manuals are being provided.
View Source
FDA Device Recall: Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Produ
2019-10-23
Class II — Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate
View Source
FDA Device Recall: Olympus PCF-Q180AC Video Colonoscope - Product Usage: These endoscopes are inten
2019-03-20
Class II — The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the...
View Source
FDA Device Recall: Olympus TJF-Q180V Duodenoscope - Product Usage: These endoscopes are intended fo
2019-03-20
Class II — The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the...
View Source
FDA Recall: Olympus Corporation of the Americas — Class II
20181010
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead | Product: Bronchovideoscope BF-XP160F
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FDA Recall: Olympus Corporation of the Americas — Class II
20181010
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead | Product: Rhino Laryngo scope ENF-VT2
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FDA Recall: Olympus Corporation of the Americas — Class II
20181010
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead | Product: Bronchovideoscope BF-240
View Source
FDA Device Recall: Bronchovideoscope BF-XP160F
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Rhino Laryngo scope ENF-VT2
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Bronchovideoscope BF-240
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Ultrasonic Bronchoscope BF-UC160F-OL8
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Bronchofiberscope F-1T160
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Bronchovideoscope F-1TQ180
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Bronchovideoscope BF-P240
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Bronchovideoscope BF-XT160
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Bronchofibercope BF-6C240
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Bronchovideoscope BF-Q180
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Bronchovideoscope BF-Q180-AC
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Bronchofiberscope BF-XP40
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
View Source
FDA Device Recall: Bronchofiberscope BF-XP60
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
View Source
FDA Device Recall: Bronchovideoscope BF-160
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
View Source
FDA Device Recall: Bronchofiberscope BF-XT40
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Airway Mobilescope MAF-TM
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Bronchovideoscope BF-1T60
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
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FDA Device Recall: Bronchofiberscope BF-P60
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
View Source
FDA Device Recall: Bronchovideoscope BF-3C40
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
View Source
FDA Device Recall: Bronchovideoscope BF-MP160F
2018-10-10
Class II — The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel...
View Source
FDA Device Recall: Uretero-reno videoscope URF-V2 Uretero-reno videoscope URF-V2R
2018-08-01
Class II — Potential breakage of the endoscope s insertion tube bending section during surgical procedures
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FDA Device Recall: Uretero-reno fiberscope URF-P6RP6
2018-08-01
Class II — Breakage of the endoscope's insertion tube bending section during surgical procedures.
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FDA Device Recall: Uretero-reno fiberscope URF-P6
2018-08-01
Class II — Breakage of the endoscope's insertion tube bending section during surgical procedures.
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FDA Device Recall: Olympus JF-140F duodenoscopes (Model NumberJF-140F)
2018-06-27
Class II — Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infectio...
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FDA Device Recall: A20975A "Working insert, with ramp, one way" (Lots 13ZW to 172W; A20976A "Bridge
2018-03-07
Class II — Olympus has received complaints about fragments of adhesive which detached from inside the working channel of the referenced products. Cracking, chipping, missing pieces, and delamination o...
View Source
FDA Device Recall: Uretero-reno videoscope URF-V2 and URF-V2R endoscope and accessories The URF-
2017-03-08
Class II — Olympus has received complaints regarding the breakage of the endoscope's insertion tube bending section during surgical procedures. Some of these complaints are associated with tissue tra...
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FDA Device Recall: URF-P6 Uretero-reno fiberscope and URF-P6R Uretero-reno fiberscope
2017-03-08
Class II — Olympus is recalling the URF-P6/P6R endoscopes due to a similar device (URF-V2/V2R endoscopes) but not identical, where adverse event complaints associated with tissue trauma, perforation a...
View Source
FDA Device Recall: HF Cable WA00014A, Endoscopic electrosurgical unit and accessories
2016-12-21
Class II — Software malfunction that results in incorrect generation or display of error codes.
View Source
FDA Device Recall: OER-Pro Endoscope Reprocessor, Endoscope washer/disinfector
2016-10-26
Class II — New warning requiring Users to conduct duodenoscope precleaning and manual cleaning even when using an Automated Endoscope Reprocessor (AER) that has instructions that may indicate a user c...
View Source
FDA Device Recall: EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an Olympus vide
2016-06-08
Class II — New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new ...
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FDA Device Recall: Olympus ENDOEYE HD II Video Telescopes. Models WA50040A ENDOEYE HD II, 10 mm, 0
2015-12-16
Class II — A damaged temperature sensor at the ENDOEYE tip caused the distal end to become abnormally hot. Excessive heating of the ENDOEYE distal end could result in patient or user injury.
View Source
FDA Device Recall: MAJ-1606 Instrument Channel Adaptor; a single use adapter which enables a connec
2015-10-14
Class II — small puncture marks in a sterile package for an accessory to an Olympus device
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ny_corps
1 records
NY Corp: OLYMPUS CORPORATION OF THE AMERICAS
1990-06-21
DOMESTIC BUSINESS CORPORATION | County: Suffolk | Jurisdiction:
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