FDA recall Z-2182-2025

Product

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),

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-2182-2025