FDA recall Z-2184-2025

Flexicare Medical (Dongguan) Ltd. · Class I · device

Product

BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415U

Reason for recall

Laryngoscope handles may not illuminate as intended.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2025-07-11
Report date
2025-08-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dongguan, N/A, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2184-2025