Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PDS II (polydioxanone) Suture Recalled by Ethicon, Inc. Due to Product may contain the incorrect material which could...

Date: August 8, 2022
Company: Ethicon, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Ethicon, Inc. directly.

Affected Products

PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles

Quantity: 88 boxes (1056 ea)

Why Was This Recalled?

Product may contain the incorrect material which could impact treatment.

Where Was This Sold?

Distribution in Japan only

About Ethicon, Inc.

Ethicon, Inc. has 69 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report