Covidien recalls specific Plain Gut Absorbable Sutures due to potential unsterile product from supplier calibration issues. Use may cause infection or vision loss in eye sutures. Affected lots and GTINs listed.
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.
Covidien is recalling certain Plain Gut Absorbable Sutures because they may not have been properly sterilized during manufacturing. This could lead to infections or vision loss if used in eye procedures.
The sutures were made by a supplier with a calibration issue during sterilization, which could result in unsterile product. Using unsterile sutures may cause infections or, specifically for eye procedures, lead to vision loss.
Surgical patients and healthcare providers who use these sutures. Those with eye surgeries are at higher risk for vision loss.
Check for the product names: Plain Gut 5/0 18 P-13 X12 (SG-5686) or Plain Gut 4-0 18 UD SC-11 DA (SG828-2). Look for GTINs 20884521055756 or 20884521750118 and lots D2G1825FZY, D2H0754FZY, or D2E2595ZY.
Identify the product name, GTIN, and lot number to confirm if your sutures are affected.
Covidien found a supplier calibration issue during sterilization that may result in unsterile product.
Use may cause infection or, in eye procedures, lead to vision loss.
Check for the product names, GTINs 20884521055756 or 20884521750118, and lots D2G1825FZY, D2H0754FZY, or D2E2595ZY.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1390-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1390-2023 from Covidien. 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.
