DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold… — Class II medical device recall Z-2534-2020
Terminated recall by Dufner Instrumente GmbH, reported 2020-07-15, distributed in IL. Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewin
| Recall number | Z-2534-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dufner Instrumente GmbH, Tuttlingen, Germany |
| Recall initiated | 2020-06-03 |
| Classified | 2020-07-07 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2021-01-21 |
| Distributed | IL |
| Quantity | 30 units |
| Reason classes | device malfunction |
| Lot numbers | 8170368, 8180673 |
Product
DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23
Reason for recall
Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury
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-2534-2020. 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.