FDAFDA · Food and drugs·Recall number Z-2182-2025
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),
Published August 13, 2025 · Recall initiated: July 11, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Laryngoscope handles may not illuminate as intended.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Flexicare Medical (Dongguan) Ltd.
- Distributor
- US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
- Lot
- Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- China
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.