Ethicon, Inc.: Device Recall

Recall #Z-0319-2025 · 09/25/2024

Class II: Risk

Recall Details

Recall Number: Z-0319-2025
Classification: Class II
Product Type: Device
Recalling Firm: Ethicon, Inc.
Status: Ongoing
Date Initiated: 09/25/2024
Location: Raritan, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 31,032 units

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.

Product Description

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

Distribution Pattern

International distribution to the country of China.

Other Recalls by Ethicon, Inc.

Class II: Risk 10/08/2024

Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
Class II: Risk 05/10/2024

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II: Risk 05/10/2024

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II: Risk 05/10/2024

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Class II: Risk 05/10/2024

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

View all recalls by Ethicon, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.