Flexicare Medical (Dongguan) Ltd.: Device Recall

Recall #Z-2183-2025 · 07/11/2025

Class I: Dangerous

Recall Details

Recall Number: Z-2183-2025
Classification: Class I
Product Type: Device
Recalling Firm: Flexicare Medical (Dongguan) Ltd.
Status: Ongoing
Date Initiated: 07/11/2025
Location: Dongguan, N/A, China
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

Laryngoscope handles may not illuminate as intended.

Product Description

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)

Distribution Pattern

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

Other Recalls by Flexicare Medical (Dongguan) Ltd.

Class I: Dangerous 07/11/2025

Laryngoscope handles may not illuminate as intended.
Class I: Dangerous 07/11/2025

Laryngoscope handles may not illuminate as intended.
Class I: Dangerous 07/11/2025

Laryngoscope handles may not illuminate as intended.
Class I: Dangerous 07/11/2025

Laryngoscope handles may not illuminate as intended.
Class I: Dangerous 07/11/2025

Laryngoscope handles may not illuminate as intended.

View all recalls by Flexicare Medical (Dongguan) Ltd. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.