FDA Medical devices recall ·
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref:… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2182-2025
- Date
- (initiated July 11, 2025)
- Company / brand
- Flexicare Medical (Dongguan) Ltd.
Hengli Town, Dongguan, N/A, China - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3),
Why was it recalled?
Laryngoscope handles may not illuminate as intended.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Distribution
US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
States: Georgia Michigan North Carolina Ohio Oklahoma Pennsylvania South Dakota Texas Virginia Washington Wyoming
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2182-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.