Recall Z-2182-2025— 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 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),. 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 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),
Reason for recall
Laryngoscope handles may not illuminate as intended.
Data sourced from openFDA. This site is unofficial and independent of the FDA.