BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U

FDA device recall Z-2187-2025 · posted 2025-08-01 · Open, Classified

Recall details

Recalling firm

Flexicare Medical (Dongguan) Ltd.

Reason for recall

Laryngoscope handles may not illuminate as intended.

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 All devices which demonstrate a failure to illuminate shall be withdrawn from use, quarantined, and returned. 4.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

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

CCW

Distribution

US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.

Date initiated

2025-07-11

Date posted

2025-08-01

Location

Dongguan, China