Facility

Jiangmen Dacheng Medical Equipment Co., Ltd.

3 recall(s) on record — most severe on record: Class II.

Key facts

3recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3010168054
Establishment type	Manufacture Medical Device
Location	#8 South of Jiaobei Hengkeng Jiangmen Guangdong, CN 52900
Registration status	Active · expires 2026
Parent company	Gentherm Medical LLC (owner-operator 10042384)
Brand names	Infant Under Body Blanket IOB-028; Jackson Warming Blanket IOB-024; Small Size Warming Suit IOB-301; Large Size Warming Suit IOB-303; Large Half Body Blanket IOB-026; Extra Large Size Warming Suit IOB-304; Lithotomy/Orthopedic Under Body Blanket IOB-029; Infant Full Body/Under Body Blanket IOB-025; Large Full Body Blanket IOB-027; Medium Size Warming Suit IOB-302

Activity by year

Recalls (3)
Inspections (1)

Devices registered here (1)

System, Thermal Regulating
Product code DWJ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.5900

Recalls & enforcement

Class IIOngoing2026-07-13
Overheating of the 115V CPU board may cause the device to shut down.
Class IITerminated2021-11-22
This recall has been initiated to provide a labeling update with revised instruction how to operate the unit with Cold Therapy pads.
Class IITerminated2021-06-17
There 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…

FDA inspections (1)

NAI2016-05-04
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by Gentherm Medical LLC

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Jiangmen Dacheng Medical Equipment Co., Ltd. (FEI 3010168054) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3010168054-jiangmen-dacheng-medical-equipment-co-lt/

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