FDA Device recall Z-3245-2024
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
- FDA Device
- Class II
- ongoing
- Published 2024-10-02
On 2024-10-02 the FDA classified a Class II recall of LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01 by Waldemar Link And Kg Hq, citing 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 th….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3245-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-11 |
| Published | 2024-10-02 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Waldemar Link And Kg Hq |
| Distribution | US |
Product
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Reason
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.
Identifiers
| code_info | UDI-DI: 04026575215539; Lot Codes: C204156; C219063; C219064; C233033; C233034; C332135 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3245-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.