Flexicare Medical (Dongguan) Ltd. recalls BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1)

Laryngoscope handles may not illuminate as intended.

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 All devices which demonstrate a failure to illuminate shall be withdrawn from use, quarantined, and returned. 4.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.

• FDA enforcement recordOfficial FDA database entry for Z-2182-2025
• FDA device classification · CCWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5540The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Flexicare Medical (Dongguan) Ltd.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.