Recall Z-2187-2025— 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 Laryngoscope Handle Refs:040-310AU and 040-310U. 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 Laryngoscope Handle Refs:040-310AU and 040-310U
Reason for recall
Laryngoscope handles may not illuminate as intended.
Data sourced from openFDA. This site is unofficial and independent of the FDA.