RegWardenFDA facility compliance records
Company

Fukuda Denshi Co., Ltd.

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

Recalls by year

FDA actions on record by year2015: 1 recalls; 2017: 1 recalls12015201612017201820192020202120222023202420252026
  • Recalls (2)

Registered facilities (4)

Recalls & enforcement

  • Class IICompleted2017-10-16
    For the Fukuda Denshi patient monitor model DS-8100, in less than 0.003% (17) of the 6227 devices sold worldwide, a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term battery backup).
  • Class IITerminated2015-12-21
    A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term Backup battery).

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. “Fukuda Denshi Co., Ltd. — 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-9028352-fukuda-denshi-co-ltd/

Not open yet

Alerts for Fukuda Denshi Co., Ltd.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.