STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device — Class II medical device recall Z-2605-2025
Ongoing recall by ETHICON, LLC, reported 2025-10-01, distributed nationwide. Potential for barb non-engagement.
| Recall number | Z-2605-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ETHICON, LLC, Guaynabo, PR, United States |
| Recall initiated | 2025-08-15 |
| Classified | 2025-09-19 |
| Reported by FDA | 2025-10-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | MY, SG |
| Quantity | 516 units |
| UPC / GTIN / UDI-DI | 10705031464568, 30705031464562 |
| Lot numbers | 104DBB |
Product
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Code: SXPP2B400-11.
Reason for recall
Potential for barb non-engagement.
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-2605-2025. 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.