CLASS I ONGOING Device recall · Reported 13 Aug 2025 · FDA Enforcement Report
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle recalled
Flexicare Medical (Dongguan) is recalling Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle, distributed nationwide in the US. The recall was initiated on 11 Jul 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2185-2025
- FDA event ID
- 97139
- Recalling firm
- Flexicare Medical (Dongguan), Dongguan, N/A
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 11 Jul 2025
- FDA classified
- 1 Aug 2025
- Reported
- 13 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 11 Jul 2025 | Recall initiated by company | |
| 1 Aug 2025 | Classified by FDA | +21 days |
| 13 Aug 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Laryngoscope handles may not illuminate as intended.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
Where it was distributed
US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
Nationwide GeorgiaMichiganNorth CarolinaOhioOklahomaPennsylvaniaSouth DakotaTexasVirginiaWashingtonWyoming
Questions about this recall
Why was it recalled?
Laryngoscope handles may not illuminate as intended.
Which lots are affected?
Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
Where was it sold?
US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 97139This product is part of a recall event; the main page for the event is BritePro Solo Single-Use Fiber Optic Mini Handle and Blade recalled.
More recalls from Flexicare Medical (Dongguan)
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle recalled | Flexicare Medical (Dongguan) | Device Malfunction | Nationwide |
| Device | CLASS I | BritePro Solo Single-Use Fiber Optic Handle and Blade Refs recalled | Flexicare Medical (Dongguan) | Device Malfunction | Nationwide |
| Device | CLASS I | BritePro Solo Single-Use Fiber Optic Laryngoscope Handle recalled | Flexicare Medical (Dongguan) | Device Malfunction | Nationwide |
| Device | CLASS I | BritePro Solo Mini with Pro Miller Blade Size recalled | Flexicare Medical (Dongguan) | Device Malfunction | Nationwide |
| Device | CLASS I | BritePro Solo Single-Use Fiber Optic Mini Handle and Blade recalled | Flexicare Medical (Dongguan) | Device Malfunction | Nationwide |
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