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Recall Observatory FDA recall evidence

Device product

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

Z-2187-2025

July 11, 2025

Class I

Product summary

Firm
Flexicare Medical (Dongguan) Ltd.
Event
Event 97139
Status
Ongoing
Classification
Class I
Quantity
N/A
Official record key
device-enforcement:Z-2187-2025

Official wording

Reason: Laryngoscope handles may not illuminate as intended.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Laryngoscope handles may not illuminate as intended.