FDA Device recall Z-1383-2022
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
- FDA Device
- Class II
- terminated
- Published 2022-07-20
On 2022-07-20 the FDA classified a Class II recall of AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle by Aesculap Implant Systems, citing needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1383-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-25 |
| Published | 2022-07-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aesculap Implant Systems |
| Distribution | AK, TX |
Product
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Reason
Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
Identifiers
| code_info | UDI-DI (GTIN): 04046955063277 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1383-2022%22
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