LINK Universal Handle — Class II medical device recall Z-3245-2024
Ongoing recall by Waldemar Link GmbH & Co. KG (Corp. Hq.), reported 2024-10-02, distributed nationwide. Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate
| Recall number | Z-3245-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Waldemar Link GmbH & Co. KG (Corp. Hq.), Hamburg, Germany |
| Recall initiated | 2024-09-11 |
| Classified | 2024-09-24 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 32 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 04026575215539 |
| Lot numbers | C204156, C219063, C219064, C233033, C233034, C332135 |
| Model numbers | 130-394/01 |
Product
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Reason for recall
Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle.
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-3245-2024. 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.