FDA Device recall Z-2240-2021
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade
- FDA Device
- Class II
- terminated
- Published 2021-08-18
On 2021-08-18 the FDA classified a Class II recall of Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade by Covidien, citing 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, hem….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2240-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-06-23 |
| Published | 2021-08-18 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | US |
Product
Covidien Sonicision Reusable Generator-converts electrical power from the battery pack to ultrasonic energy to drive the active blade. Product Number: SCGAA
Reason
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
Identifiers
| code_info | Serial Numbers: 540042X001 540042X002 540042X003 540042X004 540042X005 540042X006 540042X007 540042X008 5400…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 540042X08 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2240-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.