Gentherm Medical LLC
3 recall(s) on record — most severe on record: Class II.
Recalls by year
- Recalls (3)
Registered facilities (1)
- Jiangmen Dacheng Medical Equipment Co., Ltd. FEI 3010168054 · CN
Recalls & enforcement
- Class IIOngoing2026-07-13Overheating of the 115V CPU board may cause the device to shut down.
- Class IITerminated2021-11-22This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
- Class IITerminated2021-06-17There is a potential risk of device contamination and patient infection associated with the device because of the potential for organisms (including Nontuberculous mycobacteria NTM) to grow in the water systems of any heater-cooler device, and contaminated water from any heater-c…
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.
Cite this record
RegWarden. “Gentherm Medical LLC — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10042384-gentherm-medical-llc/
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