Lower riskMedical device recall · FDA · Published November 22, 2021
Gentherm Electri-Cool II Cold Therapy Unit: Labeling Update Needed
Gentherm recalls Electri-Cool II Portable Cold Therapy Units with model 767 and part number 86193 due to labeling updates for safe operation with Cold Therapy pads.
“Gentherm Electri-Cool II Cold Therapy Unit: Labeling Update Needed.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61507-gentherm-electri-cool-ii-cold-therapy-unit-labeling-update-needed. Based on FDA recall #Z-0496-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0496-2022%22&limit=1).
Gentherm Medical, LLC recalled the Electri-Cool II Portable Cold Therapy Unit (Model 767) due to labeling errors regarding operation instructions. The Food and Drug Administration announced the Class II recall on November 22, 2021.
How to tell if you have it
Brand: Gentherm
Product: Electri-Cool II Portable Cold Therapy Unit
Model Number: 767
Part Number: 86193
UDI: 10613031861938
Serial Numbers: 164-76703084 through 213-76703694
The hazard
The recall addresses a labeling update to provide revised instructions on how to operate the unit with Cold Therapy pads.
Context
GovInfoNow's records show Gentherm Medical, LLC has two other recalls on record since June 17, 2021. On July 13, 2026, the company recalled the Blanketrol III Model 233 Thermal Regulator due to an overheating risk. On June 17, 2021, Gentherm recalled the Hemotherm 400CE Cooler/Heater because of a potential patient infection risk from device contamination. Other recent recalls of similar products include the Philips Allura Xper FD10C Medical System recall dated December 15, 2025, and the Medline Convenience Kits recalls dated May 28, 2026.
How to tell if you have this one
Check for model number 767 and part number 86193 on the unit. Affected units have serial numbers from 164-76703084 through 213-76703694.
Brand
Gentherm
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Review Labeling Instructions
Check the unit for updated labeling instructions to ensure safe operation with Cold Therapy pads.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0496-2022 (November 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0496-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.