The Recall Desk
HighFDA (Devices)·Z-0332-2022·Announced 2021-12-15

Covidien Sonicision Battery Charger Recalled Due to Electric Shock Risk

Covidien is recalling Sonicision Battery Chargers (serial numbers MCSB006939 and MCSB006947) due to a risk of electric shock if used with a faulty or bypassed grounding circuit.

What this means for you

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 FDA Class II medical device recall involves a risk of electric shock, a serious potential harm. The source text does not report any illnesses or injuries. The hazard is conditional, requiring specific electrical circumstances (faulty or bypassed grounding circuit). This meets the rubric criterion for risk-of-harm products where injury has not yet been reported (severity 3).

Plain-English summary

Covidien LLC is recalling the Sonicision Battery Charger (Item Code: CBCA), a medical device intended to charge the Sonicision Reusable Battery Pack and provide information on battery charging progress and battery pack status.

The charger poses an intermittent risk of electric shock to users if operated in conjunction with a faulty or bypassed Mains Protective Earth (Ground) circuit. This safety issue could occur under specific electrical conditions within institutions.

Two units bearing serial numbers MCSB006939 and MCSB006947 have been identified in this recall. The affected devices were distributed to Brazil. Users should immediately discontinue use of the recalled charger and contact Covidien LLC or their distributor for further instructions.

The recalled product

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
Manufacturer
Covidien Llc
Category
Medical Device — Surgical Equipment / Battery Charger
Hazard
  • electric-shock

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Serial Numbers: MCSB006939
  • MCSB006947 GTIN: 10884521592896

Distribution

Distribution scope not specified by the agency.

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