BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U
This recall is currently active, issued August 1, 2025. It was issued by Flexicare Medical (Dongguan) Ltd. Hengli Town No. B-15 Xicheng; Henglizhen Dongguan China.
- Recall Initiated
- July 11, 2025
- Posted
- August 1, 2025
- Recall Number
- Z-2187-2025
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Lot / Code Info
Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Root Cause
Nonconforming Material/Component
Action Taken
On July 11, 2025, Flexicare Medical Limited issued a Urgent: Medical Device Recall notification to affected consignees via E-Mail. Flexicare ask consignees to take the following actions: 1. Review Inventory for affected product and immediately quarantine. 2. All affected devices must be manually checked using the following procedure within customer notification. 3. All devices which demonstrate a failure to illuminate shall be withdrawn from use, quarantined, and returned. 4. If tested devices illuminate, they can continue to be used. Please ensure you subsequently continue to follow the Pre-Use Checks information as per the IFU. 5. Share this notice with any users of the product within your distribution network. 6. If your firm has further distributed the product, please provide them with the notification and inform them to notify their customers. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program . 8. In the event of light failure, the caregiver should revert to the local standard of care, including oxygenation, sourcing a functional laryngoscope, or relying on another method to provide patient ventilation.