Recall Z-2183-2025— Flexicare Medical (Dongguan) Ltd.
Class I · Ongoing
Class I FDA medical device recall by Flexicare Medical (Dongguan) Ltd., initiated 2025-07-11. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Flexicare Medical (Dongguan) Ltd.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-07-11
- Firm location
- Dongguan, N/A, China
Product 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 for recall
Laryngoscope handles may not illuminate as intended.
Data sourced from openFDA. This site is unofficial and independent of the FDA.