PDS¿PLUS¿VIO¿30IN — Class II medical device recall Z-1513-2025
Ongoing recall by Ethicon Endo Surgery, LLC, reported 2025-04-09, distributed nationwide. Identified curing issues with the silicone during the needles manufacturing process.
| Recall number | Z-1513-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon Endo Surgery, LLC, Guaynabo, PR, United States |
| Recall initiated | 2025-03-07 |
| Classified | 2025-04-03 |
| Reported by FDA | 2025-04-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, BR, CA, CL, CN, DE, ES, IL, IN, JP, LT, MX, NL, NO, NZ, PA, SG, TW, UY |
| Quantity | 792 units |
| UPC / GTIN / UDI-DI | 10705031047907 |
| Lot numbers | 104M7E |
Product
PDS¿PLUS¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1¿MP
Reason for recall
Identified curing issues with the silicone during the needles manufacturing process.
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-1513-2025. 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.