CLASS II ONGOING Device recall · Reported 15 Dec 2021 · FDA Enforcement Report
Sonicision Battery Charger-intended to charge recalled by Covidien
Covidien is recalling Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to. The recall was initiated on 12 Nov 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0332-2022
- FDA event ID
- 89024
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Nov 2021
- FDA classified
- 3 Dec 2021
- Reported
- 15 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 12 Nov 2021 | Recall initiated by company | |
| 3 Dec 2021 | Classified by FDA | +21 days |
| 15 Dec 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
Brazil
Questions about this recall
Why was it 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
Which lots are affected?
Serial Numbers: MCSB006939, MCSB006947 GTIN: 10884521592896
Where was it sold?
Brazil
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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