MONOCRYL — Class II medical device recall Z-2148-2024
Ongoing recall by Ethicon, Inc., reported 2024-06-26, distributed nationwide. Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromis
| Recall number | Z-2148-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ethicon, Inc., Raritan, NJ, United States |
| Recall initiated | 2024-05-10 |
| Classified | 2024-06-14 |
| Reported by FDA | 2024-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 306,000 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10705031058729, 10705031058897, 10705031059047, 10705031059092, 10705031059122, 10705031059146, 10705031059153, 10705031059245, 10705031059894, 10705031059917, 10705031059962, 10705031112674, 30705031059133 |
| Lot numbers | Y315H |
Product
MONOCRYL (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated PRODUCT CODE: Y315H Y345H Y359H Y398H Y416H Y417H Y426H Y427H Y935H Y936H Y945H
Reason for recall
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2148-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.