FDAHealthJuly 11, 2025
Flexicare Medical (Dongguan) Ltd. — BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong
⚠️ 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 Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-02-0400U (Miller 00), 040-02-0410U (Miller 1), 040-02-0420U (Miller 2), 040-02-0430U (Miller 3),
- 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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