Summary
The FDA issued a Class III for FloPatch FP120, REF: FP120-FOT01-005 by Flosonics Medical (R/A 1929803 ONTARIO CORP.). Reason: 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..
Details
Source
Device Recall
External ID
Z-2517-2025
Action Date
2025-09-10
Status
Ongoing
Category
device
Product Description
FloPatch FP120, REF: FP120-FOT01-005
Lot/Code Info: UDI-DI: 10627987360148. Lot: 03250602
Quantity Affected: 9
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.
Distribution
US Nationwide distribution in the state of California.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-08-07
Company
Toronto, N/A
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 258 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Flosonics Medical (R/A 1929803 ONTARIO CORP.)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Flosonics Medical (R/A 1929803 ONTARIO CORP.) have FDA actions?
This is the only FDA action we have on record for Flosonics Medical (R/A 1929803 ONTARIO CORP.) in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2517-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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