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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Device
Medical Devices/Monitoring Devices

FloPatch FP120 Flowmeter Patches Recalled for Incorrect Expiry Date

Agency Publication Date: September 4, 2025
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Summary

Flosonics Medical is recalling approximately 9 units of the FloPatch FP120 (REF: FP120-FOT01-005) flowmeter patch because the outer shipping packaging displays an incorrect expiration date. The label incorrectly reads 2025-06-20, when the actual correct expiration date for these patches is 2026-06-20. This labeling error affects product lot 03250602 distributed in California. Consumers should contact the manufacturer or their distributor for instructions regarding the labeled date.

Risk

The incorrect expiration date lists the product as expiring one year earlier than it actually does. This could result in medical facilities discarding functional, sterile equipment prematurely, although the error does not impact the actual performance or safety of the medical device itself.

What You Should Do

  1. This recall affects FloPatch FP120 flowmeter patches (model REF: FP120-FOT01-005) with lot number 03250602.
  2. Check the outer shipping packaging for a human-readable expiry date that reads 2025-06-20 and verify the UDI-DI 10627987360148.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. Call the FDA at 1-888-463-6332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: FloPatch FP120
Model / REF:
FP120-FOT01-005
Lot Numbers:
03250602
UDI:
10627987360148

The expiry date on the outer shipping packaging reads 2025-06-20 but should read 2026-06-20.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97427
Status: Active
Manufacturer: Flosonics Medical (R/A 1929803 ONTARIO CORP.)
Sold By: Medical device distributors
Manufactured In: Canada
Units Affected: 9
Distributed To: California

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.