PlainRecalls
FDA Devices Critical Class I Ongoing

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)

Reported: August 13, 2025 Initiated: July 11, 2025 #Z-2183-2025

Product Description

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)

Reason for Recall

Laryngoscope handles may not illuminate as intended.

Details

Units Affected
N/A
Distribution
US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
Location
Dongguan, N/A

Frequently Asked Questions

What product was recalled?
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). Recalled by Flexicare Medical (Dongguan) Ltd.. Units affected: N/A.
Why was this product recalled?
Laryngoscope handles may not illuminate as intended.
Which agency issued this recall?
This recall was issued by the FDA Devices on August 13, 2025. Severity: Critical. Recall number: Z-2183-2025.