The Recall Desk
SevereFDA (Devices)·Z-2182-2025·Announced 2025-08-13

Laryngoscope Handles May Not Illuminate During Medical Use

Flexicare Medical is recalling BritePro Solo Single-Use Fiber Optic Mini Handle and Blade laryngoscope handles due to potential illumination failure. Affected units were manufactured between July and December 2020.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This device is classified FDA Class I, which establishes a minimum severity of Severe. Illumination failure in a laryngoscope—a critical airway management device—poses risk of compromised procedural visibility and potential patient harm during intubation.

Plain-English summary

Flexicare Medical (Dongguan) Ltd. is recalling the BritePro Solo Single-Use Fiber Optic Mini Handle and Blade laryngoscope handles. The affected product includes multiple configurations (Mac 1-4, Miller 00-3) with reference numbers 040-02-0110U through 040-02-0430U.

The recall was initiated because the laryngoscope handles may not illuminate as intended. Proper illumination is critical for clinicians to visualize the airway during intubation procedures.

The recalled units were distributed nationwide in the states of Washington, South Dakota, Texas, Virginia, Pennsylvania, Oklahoma, Georgia, Michigan, Wyoming, North Carolina, and Ohio. Affected lot numbers range from 2007xxxxx to 2012xxxxx, representing products manufactured between July 2020 and December 2020.

Healthcare facilities and anesthesia providers who have received these laryngoscope handles should immediately cease use and contact Flexicare Medical for replacement units.

The recalled product

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
Manufacturer
Flexicare Medical (Dongguan) Ltd.
Category
Medical Device — Anesthesia Equipment
Hazard
  • illumination-failure
  • airway-visualization-risk
  • equipment-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category