Coated VICRYL Polyglactin 910 Suture VIO 36IN — Class II medical device recall Z-0319-2025
Ongoing recall by Ethicon, Inc., reported 2024-11-13. Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from t
| Recall number | Z-0319-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Raritan, NJ, United States |
| Recall initiated | 2024-09-25 |
| Classified | 2024-11-07 |
| Reported by FDA | 2024-11-13 |
| Countries outside the US | CN |
| Quantity | 31,032 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10705031237308, 30705031237302 |
| Lot numbers | QP2AJM |
Product
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Reason for recall
Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
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-0319-2025. 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.