Food, drugs, devices › Gentherm Medical, LLC
Device recall: Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
FDA enforcement event 89193 is a device recall by Gentherm Medical, LLC of Blue Ash, OH, initiated 22 Nov 2021 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 89% of the 900 device enforcement events initiated in 2021 carry the same class.
Status: Terminated, terminated 8 May 2023. Initiation: voluntary: firm initiated. Gentherm Medical, LLC has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Gentherm Medical, LLC, Blue Ash, OH.
Reason for recall
"This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads."
Distribution
"Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0496-2022 | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 | 484 devices | Class II | Terminated | 19 Jan 2022 |
Context
Other enforcement events for Gentherm Medical, LLC
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Jul 2026 | Blanketrol II Model 222S; Thermal regulating system. | Device | Class II | 3 |
| 17 Jun 2021 | Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during ca | Device | Class II | 1 |
All 3 events for Gentherm Medical, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Canada, Chile, Hong Kong, Korea, UAE."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 May 2023. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.