Covidien recalls VersaOne Reusable Positioning Cannula 8mm Standard (Model RC8STS) due to potential metal shavings from welding. Affected units have specific serial numbers. Stop using immediately to avoid injury.
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 8mm Standard (Model RC8STS) because a manufacturing flaw may cause metal shavings at the weld point. This could lead to injury if the shavings damage tissue during medical procedures.
The cannula has a manufacturing defect where metal shavings (burrs) can form at the weld joint between the cannula and body components. During medical procedures, these shavings could potentially damage tissue or cause injury if they become lodged in the body.
Medical professionals using this specific cannula model in surgeries or procedures are affected. Patients undergoing procedures with this cannula may be at risk of injury from metal shavings.
Check for the model number RC8STS on the cannula. Affected units have specific serial numbers listed in the recall notice, including many starting with C21RAE or C21RAH.
Discontinue use of the affected cannula to prevent potential tissue injury from metal shavings.
The model number is RC8STS.
Check for the model number RC8STS and look for the specific serial numbers listed in the recall notice, which include many starting with C21RAE or C21RAH.
The recall does not specify a return process, but you should stop using it immediately to avoid injury.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-1463-2023 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-1463-2023 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.
