Z-2517-2025Class III

FloPatch FP120, REF: FP120-FOT01-005

Name: Z-2517-2025 FloPatch FP120, REF: FP120-FOT01-005
Creator: Flosonics Medical (R/A 1929803 ONTARIO CORP.)
Published: 2025-08-07
License: https://open.fda.gov/license/

Flosonics Medical (R/A 1929803 ONTARIO Corp.) / initiated 2025-08-07 / Open, Classified / root cause: labeling and UDI

FDA source

Flosonics Medical (R/A 1929803 ONTARIO CORP.) began a recall of FloPatch FP120, REF: FP120-FOT01-005 on 2025-08-07. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2517-2025
Classification: Class III
Status: Open, Classified
Initiated: 2025-08-07
Posted: 2025-09-04
Recalling firm: Flosonics Medical (R/A 1929803 ONTARIO Corp.)
Product: FloPatch FP120, REF: FP120-FOT01-005
Product code: DPW Flowmeter, Blood, Cardiovascular
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 8/7/2025, recall notices were emailed to customers who were asked to do the following: 1. Customers to confirm receipt of recall notice. 2. Customers should dispose of the outer shipping packaging. 3. If desired, customers may request replacement product. For questions, please contact: [email protected]
Quantity in commerce: 9
Distribution: US Nationwide distribution in the state of California.
Product codes and lots: UDI-DI: 10627987360148. Lot: 03250602

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2517-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2517-2025	Class III	Ongoing	Voluntary: Firm initiated	2025-09-10	2025-09-04

Product code DPW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)