FDA recall Z-2183-2025

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)

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-2183-2025