FDA Device Recall Z-2187-2025

Flexicare Medical (Dongguan) Ltd. · Dongguan, N/A

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death. Distribution is nationwide and the recall remains in progress.

Device

BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310U

Lot / serial / GTIN: Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

Quantity: N/A

Reason for recall

Laryngoscope handles may not illuminate as intended.

Recall record

Recall number: Z-2187-2025
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
Recall initiated: 2025-07-11
Classified by FDA Center: 2025-08-01
FDA published: 2025-08-13
Recalling firm: Flexicare Medical (Dongguan) Ltd.
Firm location: Dongguan, N/A, China

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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