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Recall

Class III — Flosonics Medical (R/A 1929803 ONTARIO CORP.)

Recalling firmFlosonics Medical (R/A 1929803 Ontario Corp.)
Registered facilityFLOSONICS MEDICAL (R/A 1929803 ONTARIO CORP.) (the firm's only registered facility)
ClassificationClass III
StatusOngoing
ReasonFlowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.
ProductFloPatch FP120, REF: FP120-FOT01-005
Quantity9
DistributionUS Nationwide distribution in the state of California.
Initiated2025-08-07
Classified2025-09-04
Recall numberZ-2517-2025
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 III recall — Flosonics Medical (R/A 1929803 ONTARIO CORP.) (Z-2517-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97427/

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