CLASS III ONGOING Device recall · Reported 10 Sep 2025 · FDA Enforcement Report
FloPatch FP120 recalled by Flosonics Medical (R/A
Flosonics Medical (R/A 1929803 ONTARIO CORP.) is recalling FloPatch FP120, distributed nationwide in the US. The recall was initiated on 7 Aug 2025 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2517-2025
- FDA event ID
- 97427
- Recalling firm
- Flosonics Medical (R/A 1929803 ONTARIO CORP.), Toronto, N/A
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 7 Aug 2025
- FDA classified
- 4 Sep 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 7 Aug 2025 | Recall initiated by company | |
| 4 Sep 2025 | Classified by FDA | +28 days |
| 10 Sep 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
FloPatch FP120, REF: FP120-FOT01-005
Where it was distributed
US Nationwide distribution in the state of California.
Questions about this recall
Is FloPatch FP120 recalled?
Yes. Flosonics Medical (R/A 1929803 ONTARIO CORP.) recalled FloPatch FP120 on 7 Aug 2025. The recall is Class III and its status is Ongoing. Recall number Z-2517-2025.
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.
Which lots are affected?
UDI-DI: 10627987360148. Lot: 03250602
Where was it sold?
US Nationwide distribution in the state of California.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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