FDAFDA · Food and drugs·Recall number Z-1167-2024
ESG PK CUTTING FORCEPS, 5MM, 33CM
Published February 28, 2024 · Recall initiated: December 15, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Olympus Corporation of the Americas
- Distributor
- Worldwide distribution - US Nationwide and the countries of Australia, Canada, Germany, Mexico, P.R. China, Singapore, South Korea.
- Lot
- Model: PK-CF0533; UDI DI: 00821925035867; Lot Numbers: FR258486, FR261738, FR259544, FR263183, FR276278, FR279757, FR279625, FR279658, FR286369, FR287112, FR374622, FR207935, FR212413, FR212735, FR215061, FR216817, FR220525, FR222456, FR227254, FR227774, FR227781, FR232882, FR234845, FR247614, FR240430, FR246627, FR247039, FR248008, FR255679, FR248312, FR263636, FR263244, FR269280, FR269267, FR269269, FR287114, FR303799, FR297022, FR301062, PWO-308561, PWO-308562, PWO-308563, PWO-308560, PWO-308567, PWO-308566, PWO-308565, FR303864, FR313639, FR316869, FR319703, FR316872, FR327890, PWO-308972, FR335984, FR335990, FR337947, FR373912, FR401646, FR379790, FR347006;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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