Covidien recalls VersaOne Reusable Positioning Cannula 11mm Standard (Model RC11STS) due to potential metal shavings from welding. Affected units have specific serial numbers. Consumers should check their product details.
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
Covidien is recalling VersaOne Reusable Positioning Cannula 11mm Standard (Model RC11STS) because a manufacturing defect may cause metal shavings at the weld point. This could lead to tissue damage during medical procedures if the shavings enter the body.
The defect occurs at the weld where the cannula and body components join. Metal shavings (burrs) could potentially enter the body during medical procedures, causing tissue damage or injury.
Medical professionals using the VersaOne Reusable Positioning Cannula 11mm Standard (Model RC11STS) are most at risk. Patients undergoing procedures with this cannula may be affected if metal shavings cause injury.
Check for the model number RC11STS on the product. Affected units have specific serial numbers listed in the recall notice, including C20RSL0083 through C21RSK0028.
Review the model number and serial numbers listed in the recall notice to confirm if your VersaOne Reusable Positioning Cannula 11mm Standard is affected.
The recall states there is a potential risk of metal shavings from a manufacturing defect, so affected units should be checked and replaced if necessary.
Check the model number (RC11STS) and serial numbers listed in the recall notice, which include specific numbers like C20RSL0083 through C21RSK0028.
The recall does not specify a remedy, so you should check with the manufacturer or healthcare provider for guidance.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1464-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1464-2023 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.
