# FDA recall Z-2146-2024

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

## Product

PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.  PRODUCT CODE:		  D6261		  Z117H		  Z149H		  Z259H		  Z305H		  Z320H

## 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-2146-2024
- **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-2146-2024

## Citation

> AI Analytics. FDA recall Z-2146-2024. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/Z-2146-2024. Source: US FDA. Licensed CC0.

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