FDA Medical Device Recalls (openFDA)
Flexicare Medical (Dongguan) Ltd.: BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)
- Recall number
- Z-2183-2025
- Recalling firm
- Flexicare Medical (Dongguan) Ltd.
- Product
- BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (Miller 2), 040-343U (Miller 3), 040-344U (Miller 4), 040-361U (Phillips 1), 040-362U (Phillips 2)
- Status
- Open, Classified
- Initiated
- 2025-07-11
- Posted
- 2025-08-01
- Terminated
- not on file
- Reason
- Laryngoscope handles may not illuminate as intended.
- Root cause
- Nonconforming Material/Component
- Action
- 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 All devices which demonstrate a failure to illuminate shall be withdrawn from use, quarantined, and returned. 4.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.
- Quantity
- not on file
- Distribution
- US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
- Lot, serial or model codes
- Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CCW
- Firm FEI
- 3006061749
- Firm city
- Dongguan
- Firm state
- not on file
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28