Ethicon recalls specific PDSII VIO 30IN (75CM) sutures due to silicone curing issues during manufacturing. Affected products have unique identifiers; contact Ethicon for details.
Identified curing issues with the silicone during the needles manufacturing process.
Ethicon is recalling a specific type of surgical suture (PDSII VIO 30IN) because of potential silicone curing problems during production. This could affect the suture's safety and performance during medical procedures.
The suture's silicone may not cure properly during manufacturing, which could lead to structural weaknesses. This might cause the suture to fail during use, potentially causing complications in medical procedures.
Surgical professionals and patients who use the recalled suture product are affected. The risk is highest for those using the suture in procedures where the silicone integrity is critical.
Check for the product code Z127H-50, GMDN 16584, or UDI-DI 10705031060227 on the packaging. The lot number 104BQC is also associated with this recall.
Look for the product code Z127H-50, GMDN 16584, or UDI-DI 10705031060227 on the packaging.
The recall indicates potential curing issues, but the official notice does not specify if the suture is safe to use. Affected units should be checked for the specific identifiers.
The recall does not provide a remedy, so contact Ethicon directly for guidance on handling affected products.
Check the product code Z127H-50, GMDN 16584, or UDI-DI 10705031060227 on the packaging. The lot number 104BQC is also associated with this recall.
We’ve drafted a message you can send Ethicon to request your refund or repair — edit it as you like.
Subject: Recall Z-1514-2025 — Ethicon Ethicon Hello, I own a Ethicon that is covered by recall Z-1514-2025 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.
