Gentherm Medical, LLC
Gentherm Medical, LLC has 3 FDA enforcement events on this register (5 product records) between 2021 and 2026: 3 device; the busiest year was 2021 with 2.
0% of its events are Class I; the most common class is Class II (3). 1 event is listed as ongoing; the recalling firm's address is in OH.
Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.
Enforcement events
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 13 Jul 2026 | Blanketrol II Model 222S; Thermal regulating system. | Device | Class II | 3 | Ongoing |
| 22 Nov 2021 | Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193 | Device | Class II | 1 | Terminated |
| 17 Jun 2021 | Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. 86022. Used to cool or warm blood during cardiopulmonary bypass procedures | Device | Class II | 1 | Terminated |
By type and class
Class I: 0% of this firm's events; 18% of all events on the register.
Events by year
Questions and answers
How many FDA recalls has Gentherm Medical, LLC had?
3 enforcement events (5 product records) on this register, 2021–2026: 3 device.
Are any Gentherm Medical, LLC recalls ongoing?
1 event is listed as ongoing in the current openFDA export.
What class are Gentherm Medical, LLC recalls?
3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.
Where does this data come from?
openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.
Provenance
Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.