Recall Z-2517-2025— Flosonics Medical (R/A 1929803 ONTARIO CORP.)

Name: FDA recall Z-2517-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-07

Class III · Ongoing

Class III FDA medical device recall by Flosonics Medical (R/A 1929803 ONTARIO CORP.), initiated 2025-08-07. It names 2 FDA 510(k) clearances: K223843, K200337. 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..

Recalling firm: Flosonics Medical (R/A 1929803 ONTARIO CORP.)
Classification: Class III
Status: Ongoing
Initiated: 2025-08-07
Firm location: Toronto, N/A, Canada

510(k) clearances named in this recall

2 on FDA's record

K223843 — FloPatch FP120Flosonics Medical·cleared 2023-05-03
K200337 — FloPatch (FP120)Flosonics Medical (R/A 1929803 Ontario Corp.)·cleared 2020-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

FloPatch FP120, REF: FP120-FOT01-005

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.