chicago_biz
10 records
co_sos
2 records
Department of Justice
1 records
DOJ: Cook Sentenced To 36 Months In Prison In Connection With Mortgage Fraud Scheme
2015-03-12
Ordered to Pay Almost $2 million in Restitution; Victims of Scheme Include Students and Mortgage Lenders SALT LAKE CITY – Keith Nelson Cook, age 57, of Emmett, Idaho, who pleaded guilty in March to th...
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epa_echo
1 records
fda
285 records
FDA Recall: Cook Incorporated — Class II
20260415
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Product: COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-...
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FDA Recall: Cook Incorporated — Class II
20260415
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Product: Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Num...
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FDA Recall: Cook Incorporated — Class II
20260415
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | Product: COOK MEDICAL Cook¿ Strange Bile Duct Stone Exploration Set: Reference Part Number...
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FDA Recall: Cook Incorporated — Class II
20250528
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath. | Product: Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) R...
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FDA Device Recall: Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18
2025-12-31
Class II — Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not ...
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FDA Device Recall: R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100;
2025-12-31
Class II — Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not ...
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FDA Device Recall: Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.
2025-05-28
Class II — Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
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FDA Device Recall: Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.
2025-05-28
Class II — Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
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FDA Device Recall: Tornado Embolization Microcoil, intended for embolization of selective vessel su
2025-05-21
Class II — Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
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FDA Recall: Cook Incorporated — Class II
20241016
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the | Product: Check-Flo Performer Introducer Set, Re...
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FDA Device Recall: Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers
2024-11-20
Class II — Affected device lots have labels that state the incorrect expiration dates.
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FDA Device Recall: Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order
2024-10-16
Class II — Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
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FDA Device Recall: Peel-Away Introducer - Intended for the percutaneous introduction of balloon, el
2024-04-24
Class II — Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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FDA Device Recall: Dilator - Intended to be used for dilating puncture sites or catheter tracts for
2024-04-24
Class II — Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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FDA Device Recall: Entuit Secure Adjustable Gastrointestinal Suture Anchor Set - Intended for ancho
2024-04-24
Class II — Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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FDA Device Recall: Yueh Centesis Disposable Catheter Needle - Intended for use in percutaneous flui
2024-04-24
Class II — Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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FDA Device Recall: Trocar Needle - Used for dilating puncture sites or catheter tracts for percutan
2024-04-24
Class II — Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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FDA Device Recall: Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for
2024-04-24
Class II — Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
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FDA Recall: Cook Incorporated — Class I
20230517
There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circu | Product: Blue Rhino G2-Multi Percutaneous Trach...
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FDA Device Recall: Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Reference Part Nu
2023-05-17
Class I — There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This res...
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FDA Device Recall: Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Num
2023-05-17
Class I — There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This res...
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FDA Recall: Cook Incorporated — Class II
20221005
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the ste | Product: Fixed Core Wire Guide (Safe-T-J Curved...
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FDA Recall: Cook Incorporated — Class II
20221005
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the ste | Product: Heavy Double Flexible Tipped Wire Guid...
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FDA Recall: Cook Incorporated — Class II
20221005
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the ste | Product: Vinyl Connecting Tube, Connecting Tube...
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FDA Recall: Cook Incorporated — Class II
20221005
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the ste | Product: Newton Wire Guide (LT Taper/10cm Dista...
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FDA Recall: Cook Incorporated — Class II
20221005
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the ste | Product: Bentson Plus Wire Guide (Extra Body/20...
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FDA Recall: Cook Incorporated — Class II
20220921
Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the de | Product: Roadrunner UniGlide Hydrophilic Wire G...
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FDA Recall: Cook Incorporated — Class II
20220615
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. | Product: Nester Embolization Microcoil RPN GPN M...
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FDA Device Recall: Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN:
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN:
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30-ST
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Part
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip),
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RL
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1.5-
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part Numb
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G021
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/G
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Numb
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-3
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Refe
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN THSF-
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number/GP
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Part N
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF-18
2022-10-05
Class II — Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compr...
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FDA Device Recall: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS
2022-09-21
Class II — Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
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FDA Device Recall: Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180
2022-09-21
Class II — Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
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FDA Device Recall: Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180
2022-09-21
Class II — Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
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FDA Device Recall: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-
2022-09-21
Class II — Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
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FDA Device Recall: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-
2022-09-21
Class II — Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
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FDA Device Recall: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-
2022-09-21
Class II — Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
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FDA Device Recall: Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180
2022-09-21
Class II — Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
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FDA Device Recall: Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-3
2022-09-21
Class II — Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
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FDA Device Recall: Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PM
2022-07-20
Class II — The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a de...
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FDA Device Recall: Nester Embolization Microcoil RPN GPN M
2022-06-15
Class II — The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
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FDA Device Recall: Tornado Embolization Microcoil, RPN
2022-06-15
Class II — The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
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FDA Device Recall: Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-
2022-06-15
Class II — The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
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FDA Recall: Cook Inc. — Class II
20211110
Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal | Product: Flexor Check-Flo Introducer - Raabe Mo...
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FDA Device Recall: Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigi
2021-12-29
Class II — Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used...
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FDA Device Recall: Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-7.0-18/38-45-
2021-12-22
Class II — Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa
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FDA Device Recall: Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261. Coaxi
2021-11-24
Class II — Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges fro...
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FDA Device Recall: Transseptal Needle, Trocar. RPN TSNC-18-71.0, TSNC-19-56.0. GPN G02364, G02365.
2021-11-24
Class II — Transseptal needles may contain rust on the interior and/or exterior of the needle, which may not be detected by the user. Potential adverse events if an affected product is used ranges fro...
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FDA Device Recall: Flexor Check-Flo Introducer - Raabe Modification, Introducer Set, RPN KCFW-5.0-3
2021-11-10
Class II — Affected lots may be manufactured incorrectly with the radiopaque marker band located just below the Check-Flo proximal fitting instead of the distal tip. The issue may not be identified un...
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FDA Device Recall: Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retr
2021-02-17
Class II — Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
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FDA Recall: Cook Inc. — Class I
20201230
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in l | Product: Flexor Check-Flo Introducer, RPN KCFW-...
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FDA Recall: Cook Inc. — Class I
20201230
There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in l | Product: Flexor Check-Flo Introducer, RPN KCFW-...
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FDA Recall: Cook Inc. — Class II
20200212
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient inst | Product: Universa Firm Ureteral Stent, Global P...
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FDA Recall: Cook Inc. — Class II
20200212
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient inst | Product: PTFE Wire Guide, Guidewire, Global Pro...
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FDA Recall: Cook Inc. — Class II
20200212
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient inst | Product: Angled Tip Ureteral Catheter Set with ...
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FDA Recall: Cook Inc. — Class II
20200212
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient inst | Product: Bander Ureteral Diversion Open-End Ste...
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FDA Recall: Cook Inc. — Class II
20200212
The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient inst | Product: Urethral Dilation Balloon Catheter wit...
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FDA Recall: Cook Inc. — Class II
20200122
Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembl | Product: Dawson-Mueller Drainage Catheter, Mult...
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FDA Device Recall: Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL0-HC, Order Number G5623
2020-12-30
Class I — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The pote...
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FDA Device Recall: Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL0-HC, Order Number G5623
2020-12-30
Class I — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The pote...
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FDA Device Recall: Flexor Check-Flo Introducer, RPN KCFW-6.0-35-55-RB-HFANL1-HC, Order Number G5623
2020-12-30
Class I — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The pote...
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FDA Device Recall: Flexor Check-Flo Introducer, RPN KCFW-5.0-35-70-RB-HFANL0-HC, Order Number G5622
2020-12-30
Class I — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The pote...
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FDA Device Recall: Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL0-HC, Order Number G5622
2020-12-30
Class I — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The pote...
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FDA Device Recall: Flexor Check-Flo Introducer, RPN KCFW-4.0-35-55-RB-HFANL0-HC, Order Number G5622
2020-12-30
Class I — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The pote...
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FDA Device Recall: Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select), RPN KSAW-5.0-38-90-RB-S
2020-12-30
Class I — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The pote...
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FDA Device Recall: Flexor Check-Flo Introducer, RPN KCFW-8.0-35-55-RB-HFANL1-HC, Order Number G4904
2020-12-30
Class I — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The pote...
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FDA Device Recall: Flexor Check-Flo Introducer, RPN KCFW-7.0-35-70-RB-HFANL1-HC, Order Number G5622
2020-12-30
Class I — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The pote...
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FDA Device Recall: Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL1-HC, Order Number G5622
2020-12-30
Class I — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The pote...
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FDA Device Recall: Flexor Check-Flo Introducer, RPN KCFW-6.0-35-70-RB-HFANL0-HC, Order Number G5622
2020-12-30
Class I — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The pote...
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FDA Device Recall: Flexor Check-Flo Introducer, RPN KCFW-8.0-35-70-RB-HFANL1-HC, Order Number G5622
2020-12-30
Class I — There is an increased likelihood of the introducer sheath separating at the proximal bond site. If separation occurs during use, it could result in life-threatening adverse events. The pote...
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FDA Device Recall: Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wi
2020-11-11
Class I — Affected product was dropped during manufacturing, which may result in a bent wire guide and/or the presence of loose foreign matter on the wire guide.
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FDA Device Recall: Zenith Alpha Abdominal Endovascular Graft - Distributed OUS only. Indicated for
2020-09-23
Class II — May contain excess glue within the handle of the delivery system, resulting in an inability to fully deploy the graft via the standard method or troubleshooting deployment method provided ...
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FDA Device Recall: Pressure Monitoring Set, C-PMS, G02838
2020-06-10
Class II — The Pressure Monitoring Set and Tray may contain excess coating material on the outside and/or interior of the needle component which could cause occlusion.
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FDA Device Recall: Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Angled Tip Ureteral Catheter Set with Bentson PTFE Wire Guide, Ureteral Catheter
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Kwart Retro-Inject Ureteral Stent Set, Global Product No. G15016 G14836 G1488
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Wire Guide, Guidewire, Global Product Number G14326
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Urethral Dilator Set, Global Product No. G14185
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Angled Tip Ureteral Catheter Set, Ureteral Catheter, Global Product No. G14598
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: C-Flex Double Pigtail Ureteral Stent Set, Global Product No. G14364 G14365 G14
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G1489
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937
2020-02-12
Class II — The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
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FDA Device Recall: Dawson-Mueller Drainage Catheter, Multipurpose Drainage Catheter, RPN UL T6.3-35
2020-01-22
Class II — Specific lots of the Dawson-Mueller Drainage Catheter were not manufactured to specification, which could lead to leakage from the Mac-Loc hub assembly.
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FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
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FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
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FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
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FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
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FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
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FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
View Source
FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
View Source
FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
View Source
FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
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FDA Recall: Cook Inc. — Class II
20191127
Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events | Product: Guardia Access Nano Embryo Transfer Ca...
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FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
View Source
FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
View Source
FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
View Source
FDA Recall: Cook Inc. — Class II
20191127
The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters. | Product: Torcon NB Advantage Catheters - Product Usage: I...
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FDA Recall: Cook Inc. — Class II
20190612
Affected products may have been manufactured with the catheter distal end hole too small | Product: Thoracentesis Set, RPN C-THS-850, Order # G03286
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FDA Recall: Cook Inc. — Class II
20190612
Affected products may have been manufactured with the catheter distal end hole too small | Product: Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030
View Source
FDA Recall: Cook Inc. — Class II
20190529
Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for st | Product: Cook Kwart Retro-Inject Ureteral Stent...
View Source
FDA Recall: Cook Inc. — Class II
20190529
Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for st | Product: Cook Salle Intraoperative Pyeloplasty ...
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FDA Device Recall: CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 F
2019-12-18
Class I — A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 ...
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FDA Device Recall: CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577
2019-12-18
Class I — A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 ...
View Source
FDA Device Recall: CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583
2019-12-18
Class I — A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 ...
View Source
FDA Device Recall: CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 Fo
2019-12-18
Class I — A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4 ...
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Guardia Access Nano Embryo Transfer Catheter is use for transferring IVF embryos
2019-11-27
Class II — Bent transfer catheter tips may cause difficulty or inability in inserting the transfer catheter into the guiding catheter. Potential adverse events that may occur if an affected product i...
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FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Produ
2019-11-27
Class II — Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Torcon NB Advantage Catheters - Product Usage: Intended for use in the periphera
2019-11-27
Class II — The potential compromise of the sterility of products from an undersealed chevron in the packaging pouches of Torcon NB Advantage Catheters.
View Source
FDA Device Recall: Neff Percutaneous Access Set, Catalog Number NPAS-100-RH-NT
2019-06-19
Class II — The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product.
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FDA Device Recall: Thoracentesis Set, RPN C-THS-850, Order # G03286
2019-06-12
Class II — Affected products may have been manufactured with the catheter distal end hole too small
View Source
FDA Device Recall: Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030
2019-06-12
Class II — Affected products may have been manufactured with the catheter distal end hole too small
View Source
FDA Device Recall: Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
2019-06-12
Class II — Affected products may have been manufactured with the catheter distal end hole too small
View Source
FDA Device Recall: Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284
2019-06-12
Class II — Affected products may have been manufactured with the catheter distal end hole too small
View Source
FDA Device Recall: Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 F
2019-05-29
Class II — Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
View Source
FDA Device Recall: Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4
2019-05-29
Class II — Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting.
View Source
FDA Device Recall: Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. Fo
2019-03-20
Class I — The products were manufactured without a back bevel on the needle tip. This could cause damage to the inside of the introducer during needle insertion.
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FDA Device Recall: Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-3, Ord
2019-03-06
Class II — There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
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FDA Device Recall: Entuit Secure Gastrointestinal Suture Anchor Set, Catalog Number GIAS-SRM-2, Ord
2019-03-06
Class II — There is a potential for difficulty in sliding down the retention mechanism on the sets manufactured with a specific extension spring lot.
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FDA Device Recall: Check-Flo Performer Introducer, Catalog Number RCFW-5.0-25-45-RB-CHB, GPN G11571
2019-02-27
Class II — The products were manufactured with longer than specified sheaths.
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FDA Recall: Cook Inc. — Class II
20180509
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Ins | Product: StoneBreaker Exhaust Cap, Catalog numb...
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FDA Recall: Cook Inc. — Class II
20180509
The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Ins | Product: StoneBreaker Single Use Probe, Catalog...
View Source
FDA Recall: Cook Inc. — Class II
20180425
Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operat | Product: Cook Vacuum Pump ( Cook Aspiration Uni...
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FDA Recall: Cook Inc. — Class II
20180404
Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events | Product: Norm-Ject Tuberkulin Syringe, Catalog ...
View Source
FDA Recall: Cook Inc. — Class II
20180321
Label does not state that the product is heparin-coated. | Product: Coons Interventional Wire Guide
View Source
FDA Recall: Cook Inc. — Class II
20180321
Label does not state that the product is heparin-coated. | Product: Movable Core Wire Guide
View Source
FDA Recall: Cook Inc. — Class II
20180321
Label does not state that the product is heparin-coated. | Product: Amplatz Extra Stiff Wire Guide
View Source
FDA Recall: Cook Inc. — Class II
20180321
Label does not state that the product is heparin-coated. | Product: Amplatz Ultra Stiff Wire Guide
View Source
FDA Recall: Cook Inc. — Class II
20180321
Label does not state that the product is heparin-coated. | Product: Bentson Cerebral Wire Guide
View Source
FDA Recall: Cook Inc. — Class II
20180307
Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder. | Product: Mallinckrodt Institute Percutaneous Gastrostomy Set Product Us...
View Source
FDA Recall: Cook Inc. — Class II
20180221
Central venous catheters may not fit over guide wire potentially causing procedure delay. | Product: Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UTLMY-501J-CCT Pro...
View Source
FDA Device Recall: Connecting Tube - Female to Male Luer Lock, HPCT8.8-60-M-FM-BNS Product Usage
2018-05-16
Class II — Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
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FDA Device Recall: Connecting Tube - Female to Male Luer Lock, HPCT8.8-100-M-FM Product Usage:
2018-05-16
Class II — Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
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FDA Device Recall: Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: T
2018-05-16
Class II — Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
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FDA Device Recall: Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: T
2018-05-16
Class II — Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube.
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FDA Device Recall: StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002
2018-05-09
Class II — The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
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FDA Device Recall: StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016
2018-05-09
Class II — The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
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FDA Device Recall: StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00
2018-05-09
Class II — The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
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FDA Device Recall: StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(
2018-05-09
Class II — The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
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FDA Device Recall: Advance¿ 35LP Low-Profile PTA Balloon Dilatation Catheter; Catalog numbers: PTA5
2018-05-02
Class II — Incorrect product labeling. Product labeled as 6mm x 2cm balloon are packaged with a 4mm x 4 cm balloon label and vice-versa.
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FDA Device Recall: Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended
2018-04-25
Class II — Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user...
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FDA Device Recall: MINC Benchtop Incubator (Mini Incubator) catalog (K-MINC-1000) G20079 is a micr
2018-04-25
Class II — The temperature of the incubation lids of the MINC Bench top Incubators may become too high or too low for proper gamete/embryo incubation due to fatigue failure of the flat flex lid heater...
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FDA Device Recall: Norm-Ject Tuberkulin Syringe, Catalog Number: K-ATS-1000, Global Product Number:
2018-04-04
Class II — Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and...
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FDA Device Recall: Echosight Jansen-Anderson Intratubal Transfer Set, Catalog Number: K-J-JITS-5729
2018-04-04
Class II — Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and...
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FDA Device Recall: 1. SMS Embryo Transfer Set, Catalog Number: K-J-SMS-571800, Global Product Numbe
2018-04-04
Class II — Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and...
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FDA Device Recall: Marrs Laparoscopic GIFT Catheters, Catalog Number:K-J-MLC-503000, Global Product
2018-04-04
Class II — Certain lots of in vitro fertilization (IVF) products were distributed without completed finished device quality testing with potential adverse events that may include nonviable gametes and...
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FDA Device Recall: Coons Interventional Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Movable Core Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Amplatz Extra Stiff Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Amplatz Ultra Stiff Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Bentson Cerebral Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Femoral Artery Pressure Monitoring Set
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Reuter Tip Deflecting Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Amplatz Stiff Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Double Flexible Tipped Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Left Atrial Catheter Set
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Bentson Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Amplatz Extra Stiff Whisker Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Central Venous Catheter Tray
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Fixed Core Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Bentson Plus Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Disposable Reuter Tip Deflecting Wire Guide
2018-03-21
Class II — Label does not state that the product is heparin-coated.
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FDA Device Recall: Mallinckrodt Institute Percutaneous Gastrostomy Set Product Usage: Intende
2018-03-07
Class II — Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
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FDA Device Recall: Percutaneous Gastrojejunostomy Set Product Usage: Intended for the percuta
2018-03-07
Class II — Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
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FDA Device Recall: Wills-Oglesby Percutaneous Gastrostomy Set Product Usage: Intended for the per
2018-03-07
Class II — Cook has identified that the affected lots may contain wire guides that were loaded backwards into the wire guide holder.
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FDA Device Recall: Central Venous Tray Triple Lumen Polyurethane Catheter, Catalog Identifier: C-UT
2018-02-21
Class II — Central venous catheters may not fit over guide wire potentially causing procedure delay.
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FDA Device Recall: Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Id
2018-02-21
Class II — Central venous catheters may not fit over guide wire potentially causing procedure delay.
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FDA Recall: Cook Inc. — Class II
20170621
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products | Product: Clarke-Reich Laparoscopic Knot Pusher
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FDA Recall: Cook Inc. — Class II
20170621
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products | Product: Stamey Needle
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FDA Recall: Cook Inc. — Class II
20170614
COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed informatio | Product: Willscher Vas Reapproximator Set, Surg...
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FDA Recall: Cook Inc. — Class II
20170308
Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss assoc | Product: Micropuncture Check-Flo Performer Intr...
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FDA Device Recall: Clarke-Reich Laparoscopic Knot Pusher
2017-06-21
Class II — reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
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FDA Device Recall: Stamey Needle
2017-06-21
Class II — reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
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FDA Device Recall: Endoscopic Introducer/Extractor
2017-06-21
Class II — reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
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FDA Device Recall: Pereyra-Raz Ligature Carrier
2017-06-21
Class II — reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
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FDA Device Recall: OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide g
2017-06-21
Class II — Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently detai...
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FDA Device Recall: Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas i
2017-06-21
Class II — Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization...
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FDA Device Recall: Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by et
2017-06-14
Class II — COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and s...
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FDA Device Recall: LapSac Introducer, Supplied sterilized by ethylene oxide gas in peel-open packag
2017-06-14
Class II — COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and s...
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FDA Device Recall: Willscher Vas Reapproximator Plate, Surgical Instrument, Supplied sterilized by
2017-06-14
Class II — COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and s...
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FDA Device Recall: Micropuncture Check-Flo Performer Introducer Set, Individual product is packaged
2017-03-08
Class II — Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could resu...
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FDA Device Recall: TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film
2017-03-08
Class II — Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could resu...
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FDA Device Recall: Check-Flo Hemostasis Assembly, Individual product is packaged in a Tyvek-film st
2017-03-08
Class II — Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could resu...
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FDA Device Recall: Check-Flo Performer Introducer, Individual product is packaged in a Tyvek-film s
2017-03-08
Class II — Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could resu...
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FDA Device Recall: Check-Flo Performer Introducer Set, Individual product is packaged in a Tyvek-fi
2017-03-08
Class II — Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could resu...
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FDA Recall: Cook Inc. — Class II
20160302
Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. | Product: Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC In...
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FDA Device Recall: Neff DAgostino Percutaneous Access Set Accessories, Catheter Intended for sing
2016-08-31
Class II — Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segme...
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FDA Device Recall: Aprima Access Nonvascular Introducer Set Accessories, Catheter Intended for si
2016-08-31
Class II — Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segme...
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FDA Device Recall: Shuttle Select Slip-Cath Catheter, Intravascular, Diagnostic The catheters are
2016-08-31
Class II — Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segme...
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FDA Device Recall: Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnos
2016-08-31
Class II — Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segme...
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FDA Device Recall: FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Ute
2016-08-31
Class II — Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segme...
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FDA Device Recall: Beacon Tip Torcon NB Advantage Catheter Catheter, Intravascular, Diagnostic
2016-08-31
Class II — Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segme...
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FDA Device Recall: Kopans Breast Lesion Localization Needle The Kopans Breast Lesion Localization
2016-03-09
Class II — Product potentially exposed to body fluids during processing. Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, ...
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FDA Device Recall: Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB
2016-03-02
Class II — Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
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FDA Device Recall: Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays ar
2016-03-02
Class I — A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segme...
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FDA Device Recall: Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiogr
2016-03-02
Class I — Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood f...
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FDA Device Recall: VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access and d
2015-12-23
Class II — Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricular Drainage Catheter Set due to the device being sterilized twice, which may result in the m...
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FDA Device Recall: Cook Medical CXI Support Catheter 2.6FR curved catheter and 4.0FR straight cath
2015-11-18
Class II — Cook Medical has received six product complaints associated with reports of the 2.6FR curved catheter being mixed with the 4.0FR straight catheter and vice versa. Investigation revealed the...
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FDA Device Recall: Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. For
2015-08-12
Class I — Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood ...
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FDA Device Recall: Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiograp
2015-08-12
Class I — Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood ...
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FDA Device Recall: Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use in a
2015-08-12
Class I — Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood ...
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FDA Device Recall: Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugul
2015-07-29
Class II — Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long.
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FDA Device Recall: LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgic
2015-07-01
Class II — Includes Information not stated in the intended use.
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FDA Device Recall: CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-fil
2014-09-03
Class I — This remedial action is the result of six product complaints associated with separation of the snare from the distal tip of the wire.
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FDA Recall: Cook, Inc. — Class I
20130522
Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving frac | Product: Zilver¿ PTX¿ Drug-Eluting Peripheral S...
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FDA Device Recall: Zilver¿ PTX¿ Drug-Eluting Peripheral Stent - 6 mm X 80mm; 125 cm, Rx, Sterile
2013-05-22
Class I — Cook Medical has received a small number of complaints related to the delivery system for the Zilver PTX Drug-Eluting Peripheral Stent involving fractures of the delivery system inner cathe...
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lobbying
1 records
Lobbying Firm: THE COOK GROUP INC.
Registered lobbying firm — Arlington, VA — Medical device manufacturer.
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nppes
1 records
ny_corps
4 records
NY Corp: COOK LLC
2025-10-06
DOMESTIC LIMITED LIABILITY COMPANY | County: Kings | Jurisdiction: New York
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NY Corp: COOK HOLDINGS, LLC
2012-10-03
DOMESTIC LIMITED LIABILITY COMPANY | County: Niagara | Jurisdiction: New York
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NY Corp: THE COOK GROUP LLC
1999-10-13
DOMESTIC LIMITED LIABILITY COMPANY | County: New York | Jurisdiction: New York
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NY Corp: COOK ASSOCIATES, LLC
1998-10-28
DOMESTIC LIMITED LIABILITY COMPANY | County: Westchester | Jurisdiction: New York
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