FDA Enforcement
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)
Recall: Z-2183-2025
·
Reported August 13, 2025
Enforcement
- Recall Number
- Z-2183-2025
- Event ID
- 97139
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Flexicare Medical (Dongguan) Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 13, 2025
- Initiation Date
- July 11, 2025
- Classification Date
- August 1, 2025
- Address
- Hengli Town, No. B-15 Xicheng; Henglizhen, Dongguan, N/A, N/A, China
Description
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)
Reason
Laryngoscope handles may not illuminate as intended.
Code Info
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.
Quantity
N/A