Z-2183-2025 Class I Ongoing
FDA device recall Z-2183-2025 was initiated by Flexicare Medical (Dongguan) Ltd. on July 11, 2025 and is designated Class I. Reason for recall: Laryngoscope handles may not illuminate as intended. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- August 13, 2025
- Initiation Date
- July 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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)
Reason for Recall
Laryngoscope handles may not illuminate as intended.
Distribution Pattern
US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.
Code Information
Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020)