RecallRadar

FDA Device recall Z-2517-2025

FloPatch FP120, REF: FP120-FOT01-005

On 2025-09-10 the FDA classified a Class III recall of FloPatch FP120, REF: FP120-FOT01-005 by Flosonics Medical R A 1929803 Ontario, citing flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2517-2025
ClassificationClass III
Statusongoing
Initiated2025-08-07
Published2025-09-10
Last updated2026-09-13 11:57 UTC
CompanyFlosonics Medical R A 1929803 Ontario
DistributionUS

Product

FloPatch FP120, REF: FP120-FOT01-005

Reason

Flowmeter patch as a human readable expiry date on the outer shipping packaging that reads 2025-06-20 when it should read 2026-06-20.

Identifiers

code_infoUDI-DI: 10627987360148. Lot: 03250602

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2517-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.