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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 96
Distribution
Related recalls
Same manufacturer · Covidien Llc
See all →- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- ModerateCovidien Shiley Disposable Decannulation Plug product labeling error
FDA (Devices) · 2026-07-08
- ModerateCovidien 9 Fr Mon-a-Therm temperature probes lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateCovidien esophageal stethoscope temperature sensors lack FDA clearance
FDA (Devices) · 2026-06-10
- ModerateShiley tracheostomy tubes recalled over incorrect display box labeling
FDA (Devices) · 2026-06-10
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- HighFDA Recalls Opportunity Pro Nitrile Gloves Due to Manufacturing Defects
FDA (Devices) · 2026-10-07
- HighWright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
- HighNOxBOXi Nitric Oxide Delivery System Recalled for Oxygen Sensor Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighCovidien Sonicision Battery Charger Recalled Due to Electric Shock Risk
FDA (Devices) · 2021-12-15
- HighSurgical staplers recalled over a malformed cover tube press
FDA (Devices) · 2025-11-19
- ModerateFDA Recalls HALO Flex Energy Generators Due to Standby Mode Failure
FDA (Devices) · 2012-09-26
- HighTri-Staple 2.0 Surgical Stapler Reloads Recalled for Malfunction Risk
FDA (Devices) · 2023-03-15
- HighCovidien Auto Suture Trocar Recall: Potential Seal Disengagement With Incorrect Mesh Use
FDA (Devices) · 2024-04-10
- HighFDA Recalls 850 Units of Covidien Force TriVerse Electrosurgical Devices
FDA (Devices) · 2019-03-27