RegWardenFDA facility compliance records
Recall

Class I — Flexicare Medical (Dongguan) Ltd.

Recalling firmFLEXICARE MEDICAL LTD.
Registered facilityView this company's 4 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass I
StatusOngoing
ReasonLaryngoscope handles may not illuminate as intended.
ProductBritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
QuantityN/A
DistributionUS Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
Initiated2025-07-11
Classified2025-08-01
Recall numberZ-2184-2025
InitiationVoluntary: Firm initiated

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

Cite this record

RegWarden. “Class I recall — Flexicare Medical (Dongguan) Ltd. (Z-2184-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97139/

Not open yet

Alerts for FLEXICARE MEDICAL 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.