FDA Device recall Z-2186-2025
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
- FDA Device
- Class I
- ongoing
- Published 2025-08-13
On 2025-08-13 the FDA classified a Class I recall of BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U by Flexicare Medical Dongguan, citing laryngoscope handles may not illuminate as intended.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2186-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-07-11 |
| Published | 2025-08-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Flexicare Medical Dongguan |
| Distribution | US |
Product
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309U
Reason
Laryngoscope handles may not illuminate as intended.
Identifiers
| code_info | Lots: 2007xxxxx to 2012xxxxx (July-2020 to Dec-2020) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2186-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.