FDA-Device2021-08-18Class II
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
Covidien Llc
Hazard
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
Sold states
US Nationwide Distribution: AL, AZ, CT, GA, IN, MA, MD, MN, NY, OH, TX, VA and WA.
Affected count
96 units
Manufactured in
15 Hampshire St, N/A, Mansfield, MA, United States
Products
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2240-2021Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief