The Recall Desk
SevereFDA (Devices)·Z-2185-2025·Announced 2025-08-13

BritePro Solo stubby laryngoscope handles may not illuminate as intended

Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handles are being recalled because the handles may not illuminate as intended.

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: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.

Plain-English summary

The Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle, REF 040-03-0000U, is being recalled. The source does not state a quantity. Affected lots run from 2007xxxxx to 2012xxxxx, covering July 2020 to December 2020.

The stated reason is that the laryngoscope handles may not illuminate as intended. The FDA classified the action as Class I, its most serious classification.

Distribution was nationwide in the United States, including Washington, South Dakota, Texas, Virginia, Pennsylvania, Oklahoma, Georgia, Michigan and Wyoming. The handles are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected stock using the REF and lot range above and follow the instructions issued by the manufacturer.

The recalled product

Product
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
Manufacturer
Flexicare Medical (Dongguan) Ltd.
Category
Medical Device — Laryngoscope
Hazard
  • illumination-failure
  • airway-management
  • single-use
  • class-i

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