# FDA recall Z-2144-2024

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

## Product

VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissues.  PRODUCT CODE:		  J214H		  J218H		  J258H		  J268H		  J269H		  J327H		  J344H		  J345H		  J370H		  J416H		  J417H		  J426H		  		  J427H		  J458H		  J493H		  J603H		  J699H		  J936H		  J978H

## 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-2144-2024
- **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-2144-2024

## Citation

> AI Analytics. FDA recall Z-2144-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2144-2024. Source: US FDA. Licensed CC0.

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