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
Take action
Contact the company
📍Recalling firmCovidien Llc15 Hampshire St · Mansfield, MA 02048-1113
“Covidien Sonicision Reusable Generator Recall: Risk of device failure causing injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62313-covidien-sonicision-reusable-generator-recall-risk-of-device-failure-causing. Based on FDA recall #Z-2240-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2240-2021%22&limit=1).
The FDA announced on June 23, 2021, that Covidien LLC is recalling the Covidien Sonicision Reusable Generator due to a potential manufacturing assembly error. The hazard includes non-functional audio indicators or devices, which may cause unintended thermal burns, hemorrhage, or tissue damage. Owners should contact the company for further instructions.
How to tell if you have it
Brand: Covidien
Product: Sonicision Reusable Generator
Product Number: SCGAA
Serial Numbers: 540042X001 through 540042X095 and 540042X097
UDI-Device Identifier (GTIN/UPN): 10884521592865
The hazard
The recall addresses a potential manufacturing assembly error that may result in a non-functional audio indicator of device activation or a non-functional device. This defect may cause unintended thermal burn, hemorrhage, or tissue damage and a delay of treatment while an alternate device is located.
Context
GovInfoNow's records show Covidien LLC has 52 other recalls on record since August 7, 2017. Other recent recalls include the Covidien EndoFLIP System recall from May 13, 2026, and the Covidien Mon-a-Therm Temperature Probe Recall from April 23, 2026. Similar recent recalls of similar products include the Covidien V-Loc 90 Wound Closure Device Recall from June 24, 2026, and the Erbe Flexible Cryoprobe Recall from February 12, 2026.
How to tell if you have this one
Check for product number SCGAA or serial numbers starting with 540042X001 to 540042X095 and 540042X097. The device identifier (GTIN/UPN) is 10884521592865.
Brand
Covidien
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Status
Verify if your generator has the product number SCGAA or serial numbers listed in the recall notice.
Contact Manufacturer
Reach out to Covidien for guidance on whether your device is affected and next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution: AL, AZ, CT, GA, IN, MA, MD, MN, NY, OH, TX, VA and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Connecticut, Georgia, Indiana, Maryland, Massachusetts, Minnesota, New York, Ohio, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2240-2021 (June 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2240-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.