FDA Device recall Z-1096-2025
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approxima…
- FDA Device
- Class II
- ongoing
- Published 2025-02-12
On 2025-02-12 the FDA classified a Class II recall of PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approxima… by Ethicon, citing sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could int….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1096-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-20 |
| Published | 2025-02-12 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ethicon |
| Distribution | US |
Product
PROLENE Polypropylene Suture, REF: EH7585H, 8706H, 8833H, 8963H, 8935H PROLENE Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurosurgical procedures.
Reason
Sutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to breach in sterility, could introduce pathogens to the patient and cause infection.
Identifiers
| code_info | REF/UDI-DI-GTIN/Lot(expiration): EH7585H/10705031097254/103DQR(8/31/2029); 8706H/10705031019430/103E22(8/31/2029), 103…REF/UDI-DI-GTIN/Lot(expiration): EH7585H/10705031097254/103DQR(8/31/2029); 8706H/10705031019430/103E22(8/31/2029), 103EMJ(8/31/2029); 8833H/10705031021037/103HC4(8/31/2029); 8963H/10705031091931/103E8Z(8/31/2029); 8935H/10705031022089/103HBP(8/31/2029) |
|---|
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
- PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture, 1X18" TF-5, Product Code: N271H
FDA Device · Class II · 2026-10-21 · Ethicon - 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 · 2025-10-01 · 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 - 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-1096-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.