MB215R — Class II medical device recall Z-0867-2024
Ongoing recall by Aesculap Inc, reported 2024-02-07, distributed nationwide. Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R duri
| Recall number | Z-0867-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap Inc, Center Valley, PA, United States |
| Recall initiated | 2023-12-29 |
| Classified | 2024-01-31 |
| Reported by FDA | 2024-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 60 |
| UPC / GTIN / UDI-DI | 04046955075379 |
Product
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
Reason for recall
Needle Holder MB215R was inadvertently distributed as MB362R. Similarly, MB362R was distributed as MB215R during the affected distribution date range. The issue may lead to a short delay in procedure.
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-0867-2024. 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.