Covidien recalls specific Sonicision Reusable Generators due to potential manufacturing errors that may cause device failure, leading to injury risks like burns or tissue damage during medical procedures.
Potential for a manufacturing assembly error-may result in a non-functional audio indicator of device activation or a non-functional device, may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located
Covidien is recalling certain Sonicision Reusable Generators that may not function properly, risking unintended thermal burns, hemorrhage, or tissue damage during medical procedures. This could delay critical treatment if the device fails.
The device may have a manufacturing error that causes it to fail during use. This could lead to unintended thermal burns, hemorrhage, or tissue damage, and delay treatment while a replacement device is found.
Healthcare professionals using the recalled generators for medical procedures are most at risk. Patients undergoing treatments with these devices may face delayed care or injury if the generator fails.
Check for product number SCGAA or serial numbers starting with 540042X001 to 540042X095 and 540042X097. The device identifier (GTIN/UPN) is 10884521592865.
Verify if your generator has the product number SCGAA or serial numbers listed in the recall notice.
Reach out to Covidien for guidance on whether your device is affected and next steps.
The product number is SCGAA.
Serial numbers range from 540042X001 to 540042X095 and 540042X097.
The recall record does not specify a remedy, so no fix is mentioned.
We’ve drafted a message you can send Covidien to request your refund or repair — edit it as you like.
Subject: Recall Z-2240-2021 — Covidien Covidien Hello, I own a Covidien that is covered by recall Z-2240-2021 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.
