Z-2185-2025 Class I Ongoing
FDA device recall Z-2185-2025 was initiated by Flexicare Medical (Dongguan) Ltd. on Jul 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
- Aug 13, 2025
- Initiation Date
- Jul 11, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
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)