Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PDS II (polydioxanone) Suture - Intended for use in general Recalled by Ethicon, Inc. Due to Issue on a specific packaging machine resulted in...
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 - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H
Quantity: 56952 units
Why Was This Recalled?
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ethicon, Inc.
Ethicon, Inc. has 69 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report