Covidien Sonicision Surgical Generator Recalled for Manufacturing Defect Risk
Covidien recalls 96 units of its Sonicision Reusable Generator surgical device due to a manufacturing assembly error that may cause device malfunction, thermal burns, or tissue damage. The defect may also disable the audio indicator that signals device activation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for a risk-of-harm medical device with potential for serious injury including thermal burns, hemorrhage, and tissue damage. However, no illnesses or injuries have been reported in the source, and the hazard remains potential rather than confirmed actual harm.
Plain-English summary
Covidien LLC is recalling 96 units of the Sonicision Reusable Generator, a surgical device that converts electrical power from a battery pack to ultrasonic energy to drive the active blade. The affected units carry serial numbers 540042X001 through 540042X097 and were distributed nationwide across 13 states: Alabama, Arizona, Connecticut, Georgia, Indiana, Massachusetts, Maryland, Minnesota, New York, Ohio, Texas, Virginia, and Washington.
A potential manufacturing assembly error in the production process may cause either a non-functional audio indicator that signals device activation or complete device malfunction. If the affected devices are used, they may result in unintended thermal burns, hemorrhage, or tissue damage. Device malfunction could also delay surgical treatment while an alternate device is located.
The recalled product
- Product
- Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
- Manufacturer
- Covidien Llc
- Hazard
- manufacturing-defect
- thermal-burn
- hemorrhage
- tissue-damage
- device-malfunction
Distribution
Distributed nationwide across the United States.
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