The Recall Desk
SevereFDA (Devices)·Z-2183-2025·Announced 2025-08-13

BritePro Solo Laryngoscope Handles May Fail to Illuminate During Use

Flexicare Medical is recalling BritePro Solo single-use fiber optic laryngoscope handles manufactured July–December 2020. The handles may not illuminate, preventing proper visualization during airway procedures.

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 is an FDA Class I recall of a critical medical device (laryngoscope) used for airway visualization during intubation. The hazard—failure to illuminate—prevents proper visualization of the airway, creating significant risk of harm during a life-critical procedure. Although no injuries or deaths have been reported in the source, the functional failure of this device in clinical practice represents substantial patient safety risk.

Plain-English summary

Flexicare Medical (Dongguan) Ltd. is recalling BritePro Solo single-use fiber optic laryngoscope handles. Affected products include multiple blade types (Mac 1–4, Miller 1–4, and Phillips 1–2) with lot numbers ranging from 2007xxxxx to 2012xxxxx, manufactured between July 2020 and December 2020. These handles are single-use surgical instruments used to illuminate and visualize the airway during intubation procedures.

The recalled handles may fail to illuminate as intended. Laryngoscopes are designed to provide direct visualization of the vocal cords and airway structures during intubation. When the fiber optic illumination does not function properly, clinicians cannot safely perform the procedure.

This is an FDA Class I recall, indicating a serious safety hazard. The devices were distributed nationwide across Washington, South Dakota, Texas, Virginia, Pennsylvania, Oklahoma, Georgia, Michigan, Wyoming, North Carolina, and Ohio. Healthcare facilities using these products should verify whether they have affected inventory and take appropriate action.

The recalled product

Product
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), 040-36
Manufacturer
Flexicare Medical (Dongguan) Ltd.
Category
Medical Device — Laryngoscope
Hazard
  • illumination-failure

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