RecallRadar
FDA · Medical devicesClass I

Flexicare Medical (Dongguan) Ltd. medical device recall: BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref:…

Key facts

Agency
U.S. Food and Drug Administration (FDA)
Program
Medical devices
Classification
Class I
Status
Ongoing
Event ID
97139
Recall initiated
Jul 11, 2025
Classified by FDA
Aug 1, 2025
Posted in Enforcement Report
Aug 13, 2025
Recalling firm
Flexicare Medical (Dongguan) Ltd.
Firm location
Dongguan, China
Initiated by
Voluntary: Firm initiated
Firm notified customers by
Letter
Products in this event
6

What to do

Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.

View the official FDA record ↗

Reason for recall

Laryngoscope handles may not illuminate as intended.

What the classification means

  • Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Jul 11, 2025. FDA classified it 21 days later, on Aug 1, 2025. This recall event covers 6 separate products, each with its own FDA recall number. Distribution reported by FDA: US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.

Recalled products (6)

  • Z-2182-2025 Class I Ongoing

    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),

    Codes / lots: Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

  • Z-2183-2025 Class I Ongoing

    BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)

    Codes / lots: Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

  • Z-2184-2025 Class I Ongoing

    BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U

    Codes / lots: Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

  • Z-2185-2025 Class I Ongoing

    Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U

    Codes / lots: Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

  • Z-2186-2025 Class I Ongoing

    BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U

    Codes / lots: Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

  • Z-2187-2025 Class I Ongoing

    BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U

    Codes / lots: Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

Source and freshness

Source
U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
Official notice
FDA Enforcement Report, event 97139
Raw record
openFDA API (JSON)
Dataset last updated by FDA
Nov 3, 2026
Imported by RecallRadar
Nov 4, 2026

Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.