FloPatch FP120, REF: FP120-FOT01-005 recallZ-2517-2025 · Flosonics Medical (R/A 1929803 ONTARIO CORP.) · initiated Aug 7, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Flosonics Medical (R/A 1929803 ONTARIO CORP.) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Labeling Change Control
What the company is doing
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]
Recall details
- Recall number
- Z-2517-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 7, 2025
- Posted by the FDA
- Sep 4, 2025
- Recalling firm
- Flosonics Medical (R/A 1929803 ONTARIO CORP.)
- Quantity
- 9
- Product code
- DPW
- FDA submissions
- K200337, K223843
- Distribution
- US Nationwide distribution in the state of California.
Product description
FloPatch FP120, REF: FP120-FOT01-005
Code information (models, lots, serial numbers)
UDI-DI: 10627987360148. Lot: 03250602
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Dual Adhesive Strap FP120-FOT01-0051929803 Ontario Corp · Flowmeter, Blood, Cardiovascular1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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