Class II

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

Ethicon, Inc. · September 25, 2024

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.

Quantity Affected

31,032 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0319-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.