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

FDA Recall #Z-2187-2025 — Class I — July 11, 2025

Recall #Z-2187-2025 Date: July 11, 2025 Classification: Class I Status: Ongoing

Product Description

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

Reason for Recall

Laryngoscope handles may not illuminate as intended.

Recalling Firm

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

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Devices

Product Quantity

N/A

Distribution

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

Code Information

Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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