FDA Device recall Z-2605-2025
STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Cod…
- FDA Device
- Class II
- ongoing
- Published 2025-10-01
On 2025-10-01 the FDA classified a Class II recall of STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device, SFX SPI PDS+ BI VIO 14X14IN(36X36CM) USP1(M4) D/A MO-4. Product Cod… by Ethicon, citing potential for barb non-engagement.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2605-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-08-15 |
| Published | 2025-10-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ethicon |
| Distribution | US |
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
Potential for barb non-engagement.
Identifiers
| code_info | Product Code: SXPP2B400-11. GTIN: 10705031464568 (each), 30705031464562 (box of 12). Lot Number: 104DBB. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Ethicon
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FDA Device · Class II · 2026-10-21 · Ethicon - PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H
FDA Device · Class II · 2025-02-12 · Ethicon - ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
FDA Device · Class II · 2025-02-12 · Ethicon - PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approxima…
FDA Device · Class II · 2025-02-12 · Ethicon - MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximation and/or ligation…
FDA Device · Class II · 2024-11-27 · Ethicon
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2605-2025%22
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