Class II — ETHICON, LLC
| Recalling firm | ETHICON, LLC |
|---|---|
| Registered facility | ETHICON, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential for barb non-engagement. |
| 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. |
| Quantity | 516 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AR, AZ, CA, IL, IN, KS, MA, MD, MI, MO, MN, NC, NH, NM, TX, VA, WA, WI and the countries of Singapore and Malaysia. |
| Initiated | 2025-08-15 |
| Classified | 2025-09-19 |
| Recall number | Z-2605-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ETHICON, LLC (Z-2605-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97471/
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