FDA Device recall Z-1514-2025
PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1 by Ethicon Endo Surgery, citing identified curing issues with the silicone during the needles manufacturing process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1514-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-07 |
| Published | 2025-04-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ethicon Endo Surgery |
| Distribution | US |
Product
PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
Reason
Identified curing issues with the silicone during the needles manufacturing process.
Identifiers
| code_info | Product Code: Z127H-50; GMDN: 16584; UDI-DI: 10705031060227; Lot number: 104BQC; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1514-2025%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.