Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle… — Class I medical device recall Z-2185-2025
Ongoing recall by Flexicare Medical (Dongguan) Ltd., reported 2025-08-13, distributed nationwide. Laryngoscope handles may not illuminate as intended.
| Recall number | Z-2185-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Flexicare Medical (Dongguan) Ltd., Dongguan, N/A, China |
| Recall initiated | 2025-07-11 |
| Classified | 2025-08-01 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Lot numbers | 2007XXXXX, 2012XXXXX |
| Model numbers | 040-03-0000U |
Product
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000U
Reason for recall
Laryngoscope handles may not illuminate as intended.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2185-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.