Reported Aug 18, 2021 · Terminated

Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive…

Covidien LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Covidien Llc · 15 Hampshire St · Mansfield, MA · 02048-1113

Is this the product you have?

  • Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade
  • Product NumberSCGAA
Lot codes and dates
  • Serial Numbers

    96 of 96 codes

    • 540042X001
    • 540042X002
    • 540042X003
    • 540042X004
    • 540042X005
    • 540042X006
    • 540042X007
    • 540042X008
    • 540042X009
    • 540042X010
    • 540042X011
    • 540042X012
    • 540042X013
    • 540042X014
    • 540042X015
    • 540042X016
    • 540042X017
    • 540042X018
    • 540042X019
    • 540042X020
    • 540042X021
    • 540042X022
    • 540042X023
    • 540042X024
    • 540042X025
    • 540042X026
    • 540042X027
    • 540042X028
    • 540042X029
    • 540042X030
    • 540042X031
    • 540042X032
    • 540042X033
    • 540042X034
    • 540042X035
    • 540042X036
    • 540042X037
    • 540042X038
    • 540042X039
    • 540042X040
    • 540042X041
    • 540042X042
    • 540042X043
    • 540042X044
    • 540042X045
    • 540042X046
    • 540042X047
    • 540042X048
    • 540042X049
    • 540042X050
    • 540042X051
    • 540042X052
    • 540042X053
    • 540042X054
    • 540042X055
    • 540042X056
    • 540042X057
    • 540042X058
    • 540042X059
    • 540042X060
  • UDI-Device Identifier (GTIN/UPN)10884521592865
Amount recalled
96 units

Where it was sold

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 28, 2025 · Data as of Sep 19, 7:32 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.