Sonicision recallZ-0332-2022 · Covidien Llc · initiated Nov 12, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Covidien Llc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Intermittent risk of electric shock to users if an affected charger is used in conjunction with a faulty or bypassed institutions Mains Protective Earth (Ground) circuit
FDA root cause category: Under Investigation by firm
What the company is doing
Medtronic customer communication translated by in-country representatives emailed on November 12, 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 the associated serial numbers listed above. 2. Please return affected product as indicated below. All products from the affected item code and associated serial numbers must be returned. 3. If you have distributed the Covidien Sonicision" Battery Chargers listed above, 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. Fax to 800-895-6140 or email to [email protected] Credit for returned affected product will be issued based on the RGA number. Exception: Customers with zero inventory, fax to 651-367-2624 or email to [email protected]
Recall details
- Recall number
- Z-0332-2022
- Status
- Open, Classified
- Initiated by the company
- Nov 12, 2021
- Recalling firm
- Covidien Llc
- Quantity
- 2 units OUS
- Product code
- LFL
- FDA submissions
- K180149
- Distribution
- Brazil
Product description
Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Code information (models, lots, serial numbers)
Serial Numbers: MCSB006939, MCSB006947 GTIN: 10884521592896
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Sonicision CBCACovidien LP · Instrument, ultrasonic surgical1 recall0 reports
Product lines
Other devices under the same FDA submission
7 devices cleared under K180149 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Sonicision SCDA39Covidien LP · Instrument, ultrasonic surgical1 death355 reports
- Sonicision SCGAACovidien LP · Instrument, ultrasonic surgical1 recall4 reports
- Sonicision SCDA26Covidien LP · Instrument, ultrasonic surgical30 reports
- Sonicision SCDA48Covidien LP · Instrument, ultrasonic surgical14 reports
- Sonicision SCDA13Covidien LP · Instrument, ultrasonic surgical12 reports
- Sonicision SCBACovidien LP · Instrument, ultrasonic surgical3 reports
- Sonicision SCBACovidien LP · Instrument, ultrasonic surgical2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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