FDAHealthJuly 11, 2025
Flexicare Medical (Dongguan) Ltd. — 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
⚠️ Laryngoscope handles may not illuminate as intended.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 11, 2025
US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
What's affected?
- 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), 040-362U (Phillips 2)
- Lot code
- 2007xxxxx
Additional details
Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: N/A.
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