Medical device recalls High risk

Flexicare Medical (Dongguan) Ltd. recalls BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U

Recall date
July 11, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2186-2025
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 Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U

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