FDA Device recall Z-0319-2025
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
- FDA Device
- Class II
- ongoing
- Published 2024-11-13
On 2024-11-13 the FDA classified a Class II recall of Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H by Ethicon, citing complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the pac….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0319-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-25 |
| Published | 2024-11-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ethicon |
| Distribution | n/a |
Product
Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H
Reason
Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
Identifiers
| code_info | UDI-DI: 10705031237308 (each); 30705031237302 (box); Lot Number: QP2AJM |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class II · 2025-02-12 · Ethicon
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0319-2025%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.