Ethicon PDS Plus Suture Recall: Risk of Breakage During Surgery
Ethicon recalls PDS Plus antibacterial sutures that may break during surgery, risking poor tissue repair. Affected products include specific sizes and lot numbers. Consumers should contact Ethicon for details.
Lower-risk recall
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
Contact the company
What happened, in plain English
Ethicon is recalling antibacterial sutures that could break during surgery, potentially leading to poor wound healing. This recall affects specific product sizes and lot numbers sold to medical professionals. Read more at govinfonow.com/recall/58628-ethicon-pds-plus-suture-recall-risk-of-breakage-during-surgery.
Source Summary by GovInfoNow · govinfonow.com/recall/58628-ethicon-pds-plus-suture-recall-risk-of-breakage-during-surgery · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1571-2023
Cite this page
“Ethicon PDS Plus Suture Recall: Risk of Breakage During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58628-ethicon-pds-plus-suture-recall-risk-of-breakage-during-surgery. Based on FDA recall #Z-1571-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1571-2023%22&limit=1).
Why it’s dangerous
The suture may break during surgical procedures, which could prevent proper tissue repair or ligation. This risk occurs when the suture is used in delicate areas like pediatric cardiovascular tissue.
Who’s affected
Medical professionals using the suture for surgery are most at risk. The recall targets specific product sizes and lot numbers sold to hospitals and clinics.
How to tell if you have this one
Check for the product code PDP9625H or lot number SCMAZH. The suture is sold in boxes of 36 units with specific size and model numbers.
- Brand
Ethicon- Product
PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use- Category
Medical device
What to do — step by step
Contact Ethicon
Reach out to Ethicon directly for specific product details and instructions.
How this recall unfolded
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest medical device recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1571-2023 (March 31, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1571-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.