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

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

Recall Summary

Recall Number Z-2187-2025
Classification Class I — Serious risk
Date Initiated July 11, 2025
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Flexicare Medical (Dongguan) Ltd.
Location Dongguan, N/A
Product Type Devices
Quantity N/A

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.

Distribution Pattern

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

Lot / Code Information

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

Other Recalls from Flexicare Medical (Dongguan) Ltd.

Recall # Classification Product Date
Z-2182-2025 Class I BritePro Solo Single-Use Fiber Optic Mini Handl... Jul 11, 2025
Z-2184-2025 Class I BritePro Solo Mini with Pro Miller Blade Size 1... Jul 11, 2025
Z-2185-2025 Class I Britepro Solo Stubby Single-Use Fiber Optic Lar... Jul 11, 2025
Z-2183-2025 Class I BritePro Solo Single-Use Fiber Optic Handle and... Jul 11, 2025
Z-2186-2025 Class I BritePro Solo Mini Single-Use Fiber Optic Laryn... Jul 11, 2025

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.