FDA Device recall Z-1515-2025
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM 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-1515-2025 |
| 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
PROLENE BLU 18IN(45CM) USP6-0(M0.7) S/A P-1 PRM
Reason
Identified curing issues with the silicone during the needles manufacturing process.
Identifiers
| code_info | Product Code: (1) 8706H-15, (2) 8711H-16; GMDN: 13909; UDI-DI: (1) 10705031019430, (2) 10705031019560; Lot number: 104E…Product Code: (1) 8706H-15, (2) 8711H-16; GMDN: 13909; UDI-DI: (1) 10705031019430, (2) 10705031019560; Lot number: 104E88, 104E89, 1047TZ, 104BQ0, 104DA2, 104JAR, 104JPJ, 104SES, 104KHD, 104SER; |
|---|
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-1515-2025%22
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