Official recall notice

FDA DeviceClass IINotable

GYN Laparoscopy/Laparotomy Recall (Oct 2026) – AVID Medical

Product: GYN LAPAROSCOPY/LAPAROTOMY; Model/Item Number (Kit): 1. WRNM002-15, 2. FBCH108-03;

Recall date
2026-10-14
FDA class
Class II

Why it was recalled

Hazard

Product may be potentially contaminated with a lubricant used during the manufacturing process.

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Product description

Product may be potentially contaminated with a lubricant used during the manufacturing process.

Affected products

1. Model/Item Number (Kit): WRNM002-15; UDI-DI: 10809160487181; Kit Lot Numbers: 1666722; 2. Model/Item Number (Kit): FBCH108-03; UDI-DI: 10809160399781; Kit Lot Numbers: 1659079, 1696378; Recalled Supplier Component (in kit): A942216; Recalled Supplier Lot Number (in kit): NGKU3975, NGKU2887;

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