# FDA recall Z-2148-2024

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

## 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 .

## 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-2148-2024
- **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-2148-2024

## Citation

> AI Analytics. FDA recall Z-2148-2024. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-2148-2024. Source: US FDA. Licensed CC0.

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