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

Recall date

September 25, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0319-2025

FDA classification

Class II

Brand / firm

Ethicon, Inc.

Sold / distributed

International distribution to the country of China.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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