Z-0332-2022Class II

Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide...

Name: Z-0332-2022 Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide...
Creator: Covidien Llc
Published: 2021-11-12
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2021-11-12 / Open, Classified

FDA source

Covidien Llc began a recall of Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and... on 2021-11-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0332-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-11-12
Posted: 2021-12-03
Recalling firm: Medtronic, Inc.
Product: 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
Product code: LFL Instrument, Ultrasonic Surgical
Reason for recall: 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: Under Investigation by firm
Action: 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]
Quantity in commerce: 2 units OUS
Distribution: Brazil
Product codes and lots: Serial Numbers: MCSB006939, MCSB006947 GTIN: 10884521592896

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0332-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0332-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-12-15	2021-12-03

Product code LFL

K180149UnclassifiedSonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion GuideCovidien, LLC / cleared 2018-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)