Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA

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 notified consignees by Urgent Medical Device Recall letter delivered via Federal Express and/or certified mail beginning June 23, 2021. Letter states reason for recall, health risk and action to take: 1. Please immediately quarantine and discontinue use of the affected item code with associated lot and serial numbers listed on Attachment A. 2. Please return affected product as indicated below. All products from the affected item code and associated lot and serial numbers must be returned. 3. If you have distributed the Covidien Sonicision" Reusable Generators listed on Attachment A, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. We request that you contact Medtronic if you experienced a quality problem or adverse event. Email Medtronic Post Market Vigilance at: [email protected] Questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.