FLEX — Class II medical device recall Z-1422-2023
Ongoing recall by Richard Wolf GmbH, reported 2023-05-03, distributed nationwide. Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition,
| Recall number | Z-1422-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Richard Wolf GmbH, Knittlingen, N/A, Germany |
| Recall initiated | 2023-03-24 |
| Classified | 2023-04-24 |
| Reported by FDA | 2023-05-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BE, BR, CA, CL, CZ, DE, DK, EC, ES, FI, FR, GR, HK, HR, IE, IN, IT, JO, JP, KR, KW, LT, MX, NL, NO, NZ, OM, PK, PL, PT, QA, RO, RS, SA, SI, SK, TH, TR |
| Quantity | 838 units |
| UPC / GTIN / UDI-DI | 04055207009574 |
| Lot numbers | 4500334002, 4500334737, 4500336245, 4500338447, 4500341314, 4500345769, 4500347760, 4500350415, 4500353558, 4500356582, 4500359201, 4500363096, 4500363662, 4500367397, 4500369724, 4500371834, 4500374645, 4500377299 |
Product
FLEX. GRASP. FORCEPS 5FR WL 550MM, Product Number 828.051
Reason for recall
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
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-1422-2023. 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.