FDA Device recall Z-0496-2022
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
- FDA Device
- Class II
- terminated
- Published 2022-01-19
On 2022-01-19 the FDA classified a Class II recall of Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 by Gentherm Medical, citing this recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0496-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-22 |
| Published | 2022-01-19 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Gentherm Medical |
| Distribution | US |
Product
Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
Reason
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
Identifiers
| code_info | UDI- 10613031861938; Affected Serial Numbers are: (164-76703084 Through 213-76703694) |
|---|
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-0496-2022%22
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