Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) Recalled by Ethicon, Inc. Due to Suture breakage during intra-operative use could result 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¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H
Quantity: 1,656 eaches (OUS only)
Why Was This Recalled?
Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved
Where Was This Sold?
International distribution in the countries of United Kingdom, Ireland and Turkey.
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