# FDA recall Z-2149-2024

> **Ethicon, Inc.** · Class II · device recall initiated 2024-05-10.

## 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 .

## Distribution

Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.

## Key facts

- **Recall number:** Z-2149-2024
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-10
- **Report date:** 2024-06-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Raritan, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2149-2024

## Citation

> AI Analytics. FDA recall Z-2149-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2149-2024. Source: US FDA. Licensed CC0.

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