Flexicare Medical (Dongguan) Ltd. recalls BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130…

Recall date

July 11, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2182-2025

FDA classification

Class I

Brand / firm

Flexicare Medical (Dongguan) Ltd.

Sold / distributed

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

Why it was recalled

Laryngoscope handles may not illuminate as intended.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3),