ESG PK CUTTING FORCEPS — Class II medical device recall Z-1167-2024
Ongoing recall by Olympus Corporation of the Americas, reported 2024-02-28, distributed nationwide. The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the proced
| Recall number | Z-1167-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2023-12-15 |
| Classified | 2024-02-20 |
| Reported by FDA | 2024-02-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, DE, KR, MX, SG |
| Quantity | 11,123 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00821925035867 |
| Lot numbers | FR207935, FR212413, FR212735, FR215061, FR216817, FR220525, FR222456, FR227254, FR227774, FR227781, FR232882, FR234845, FR240430, FR246627, FR247039, FR247614, FR248008, FR248312, FR255679, FR258486, FR259544, FR261738, FR263183, FR263244, FR263636, FR269267, FR269269, FR269280, FR276278, FR279625, FR279658, FR279757, FR286369, FR287112, FR287114, FR297022, FR301062, FR303799, FR303864, FR313639 and 20 more |
| Model numbers | PK-CF0533 |
Product
ESG PK CUTTING FORCEPS, 5MM, 33CM
Reason for recall
The jaw may fracture prior to the procedure during the inspection instructed per the IFU, or during the procedure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1167-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.