Covidien recalls Step Bladeless Trocars with possible unsterile product due to supplier calibration issues. Use may cause infection or vision loss in eye sutures. Affected units include specific product numbers and lots.
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 Step Bladeless Trocars that may not be properly sterilized during manufacturing, which could lead to infections or vision loss if used in eye procedures. This recall affects specific product models and lots sold to medical facilities.
The trocars may not be properly sterilized due to a supplier calibration issue during the contract sterilization process. This unsterile product could cause infections in general use or specific vision loss if used with eye sutures.
Medical facilities using these trocars for procedures like eye surgeries are most at risk. Patients undergoing surgery with the affected products could face infection or vision loss.
Check for product number S101010, GTIN 10884521090767, and lot number P2G0069 on the device packaging. These items were sold to medical facilities starting from the date of manufacture.
Identify the product number S101010, GTIN 10884521090767, and lot number P2G0069 on the device packaging.
Covidien identified a supplier calibration issue during sterilization that may result in unsterile products, posing infection or vision loss risks.
Check the product number, GTIN, and lot number on the packaging to see if it matches the recalled items. Contact Covidien for further instructions.
The recall indicates a potential for infection or vision loss with eye sutures, but no specific injury mechanism is described for general use.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1387-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1387-2023 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.
