MONOCRYL Plus Antibacterial — Class II medical device recall Z-2149-2024
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-2149-2024 |
|---|---|
| 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 | 287,892 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10705031046337, 10705031046405, 10705031046429, 10705031046481, 10705031046498, 10705031046504, 10705031046511, 10705031046634, 10705031046757, 10705031046795, 10705031046863, 10705031121393, 10705031121423, 10705031121430, 10705031121997, 10705031122000, 10705031122314, 10705031122338, 10705031148116 |
| Lot numbers | MCP266H |
Product
MONOCRYL Plus Antibacterial (poliglecaprone 25) Suture - Intended for use in general soft tissue approximation and/or ligation where an absorbable material is indicated. PRODUCT CODE: MCP266H13 MCP3200H16 MCP3212H16 MCP3213H16 MCP340H13 MCP345H13 MCP416H14 MCP417H14 MCP426H13 MCP427H13 MCP4423H16 MCP4424H14 MCP442H14 MCP496H16 MCP497H16 MCP604H13 MCP936H13 MCP945H14 MCPB346H13
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-2149-2024. 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.