# FDA recall Z-0319-2025

> **Ethicon, Inc.** · Class II · device recall initiated 2024-09-25.

## Product

Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

## Reason for recall

Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.

## Distribution

International distribution to the country of China.

## Key facts

- **Recall number:** Z-0319-2025
- **Recalling firm:** Ethicon, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-25
- **Report date:** 2024-11-13

- **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-0319-2025

## Citation

> AI Analytics. FDA recall Z-0319-2025. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-0319-2025. Source: US FDA. Licensed CC0.

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