FDA Device recall Z-1516-2025
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
- FDA Device
- Class II
- ongoing
- Published 2025-04-09
On 2025-04-09 the FDA classified a Class II recall of ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH 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-1516-2025 |
| 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
ETHIBOND EXCEL GRN 36IN(90CM) USP2-0(M3) D/A MH
Reason
Identified curing issues with the silicone during the needles manufacturing process.
Identifiers
| code_info | Product Code: X843H-56; GMDN: 13906; UDI-DI: 10705031058088; Lot number: 10489X ; |
|---|
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-1516-2025%22
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