BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
Summary
The FDA issued a Class I for BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U by Flexicare Medical (Dongguan) Ltd.. Reason: Laryngoscope handles may not illuminate as intended..
Details
Source
Device Recall
External ID
Z-2184-2025
Action Date
2025-08-13
Status
Ongoing
Category
device
Product Description
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
Lot/Code Info: Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Quantity Affected: N/A
Reason for Recall
Laryngoscope handles may not illuminate as intended.
Distribution
US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-11
Company
Dongguan, N/A
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 172 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Flexicare Medical (Dongguan) Ltd. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Flexicare Medical (Dongguan) Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Flexicare Medical (Dongguan) Ltd. have FDA actions?
Flexicare Medical (Dongguan) Ltd. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2184-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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