FDA Medical devices recall ·

FloPatch FP120 recall

Recall number
Z-2517-2025
Date
(initiated August 7, 2025)
Company / brand
Flosonics Medical (R/A 1929803 ONTARIO CORP.)
Fourth Floor, Oneeleven, Toronto, N/A, Canada
Category
Medical devices › Class III
Classification
Class III
Status
Ongoing
Units affected
9
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

FloPatch FP120, REF: FP120-FOT01-005

Why was it recalled?

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.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

UDI-DI: 10627987360148. Lot: 03250602

Distribution

US Nationwide distribution in the state of California.

States: California

What does Class III mean?

Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).

Source: FDA (medical devices), recall Z-2517-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.