AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM — Class II medical device recall Z-1383-2022
Terminated recall by Aesculap Implant Systems LLC, reported 2022-07-20, distributed in AK, TX. Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
| Recall number | Z-1383-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Implant Systems LLC, Center Valley, PA, United States |
| Recall initiated | 2019-09-25 |
| Classified | 2022-07-13 |
| Reported by FDA | 2022-07-20 |
| Terminated | 2024-04-01 |
| Distributed | AK, TX |
| Quantity | 7 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 04046955063277 |
Product
AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Reason for recall
Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
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-1383-2022. 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.