Dongguan, N/A, China
Flexicare Medical (Dongguan) Ltd. recalls
1 recall recorded since 2018, most recently on 11 July 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 11 July 2025
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2182-2025, Z-2184-2025, Z-2187-2025, Z-2185-2025, Z-2183-2025, Z-2186-2025
- 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)
- BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U
- BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
- Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
- 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 (Mill
- BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.