RegWardenFDA facility compliance records
Company

Withings (France)

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

Recalls by year

FDA actions on record by year2018: 1 recalls; 2022: 1 recalls201712018201920202021120222023202420252026
  • Recalls (2)

Registered facilities (3)

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. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Withings (France) — 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-10035674-withings-france/

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