Ethicon recalls specific PDS Plus Antibacterial sutures due to weak tensile strength. Affected products may break during surgery, risking complications. Consumers should check product numbers and contact Ethicon for details.
Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Sutures from this lot did not meet tensile strength requirement.
Ethicon is recalling certain PDS Plus Antibacterial sutures because some in the affected lots did not meet the required tensile strength. This could cause sutures to break during surgery, potentially leading to complications for patients.
The recalled sutures failed internal tensile strength tests, meaning they could break more easily than required during surgical procedures. This risk is specific to the affected product lots and does not apply to all sutures.
Medical professionals and surgical teams who use the recalled sutures are most at risk. Patients undergoing surgery with these sutures may face complications if the suture breaks.
Check for product numbers starting with PDP072H40, PDP259H50, or other listed numbers. Also look for lot numbers like RLMCKU, RLMEAL, or RLMDST on the packaging.
Identify if your suture has a product number listed in the recall notice, such as PDP072H40 or PDP259H50.
Reach out to Ethicon directly for further assistance or to confirm if your suture is affected.
Internal testing found that some PDS Plus Antibacterial sutures in this lot did not meet the required tensile strength.
Check for product numbers like PDP072H40, PDP259H50, or lot numbers such as RLMCKU, RLMEAL, or RLMDST on the packaging.
Contact Ethicon directly to confirm if your suture is affected and for further instructions.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-2616-2023 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-2616-2023 from Ethicon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.