Facility

Withings HK Limited

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

Key facts

2recalls · worst Class II

—inspections in our data

—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)	3013689228
Establishment type	Export Device to the United States But Perform No Other Operation on Device
Location	Unit A, 25F, Billion Plaza II Hong-Kong, HK 00000
Registration status	Active · expires 2026
Parent company	Withings (France) (owner-operator 10035674)
Brand names	Withings Thermo

Activity by year

Recalls (2)

Devices registered here (1)

Continuous Measurement Thermometer
Product code FLL (opens in a new tab) · Class II · General Hospital · 21 CFR 880.2910

Recalls & enforcement

Class IIOngoing2022-12-19
A software bug eliminated the initial ECG activation and review of the ECG under a physician. However, the device is only cleared for use under the care of a physician.
Class IICompleted2018-06-11
Device could not meet the requirements for systolic pressure

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. “Withings HK Limited (FEI 3013689228) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3013689228-withings-hk-limited/

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