fda
3 records
FDA Device Recall: Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
2025-08-20
Class III — Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit ...
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FDA Device Recall: ZVU Functional GI Software, REF: ZVU-3
2023-09-13
Class III — GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.
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FDA Device Recall: Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 E
2022-09-28
Class II — M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling...
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