CLASS II Device recall · Reported 18 Aug 2021 · FDA Enforcement Report
Sonicision Reusable Generator-converts electrical power recalled
Covidien is recalling Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to, distributed nationwide in the US. The recall was initiated on 23 Jun 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-2240-2021
- FDA event ID
- 88271
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jun 2021
- FDA classified
- 10 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Jun 2021 | Recall initiated by company | |
| 10 Aug 2021 | Classified by FDA | +48 days |
| 18 Aug 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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
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 Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
Where it was distributed
US Nationwide Distribution: AL, AZ, CT, GA, IN, MA, MD, MN, NY, OH, TX, VA and WA.
Nationwide AlabamaArizonaConnecticutGeorgiaIndianaMassachusettsMarylandMinnesotaNew YorkOhioTexasVirginiaWashington
Questions about this recall
Is Sonicision Reusable Generator-converts electrical power from the battery pack to recalled?
Yes. Covidien recalled Sonicision Reusable Generator-converts electrical power from the battery pack to on 23 Jun 2021. The recall is Class II and its status is Terminated. Recall number Z-2240-2021.
Why was it 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
Which lots are affected?
Serial Numbers: 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 540042X061 540042X062 540042X063 540042X064 540042X065 540042X066 540042X067 540042X068 540042X069 540042X070 540042X071 540042X072 540042X073 540042X074 540042X075 540042X076 540042X077 540042X078 540042X079 540042X080 540042X081 540042X082 540042X083 540042X084 540042X085 540042X086 540042X087 540042X088 540042X089 540042X090 540042X091 540042X092 540042X093 540042X094 540042X095 540042X097 UDI-Device Identifier (GTIN/UPN):10884521592865
Where was it sold?
US Nationwide Distribution: AL, AZ, CT, GA, IN, MA, MD, MN, NY, OH, TX, VA and WA.
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 21 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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