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Flexicare Medical (Dongguan) Ltd. FDA Recalls
6 recalls on file across devices, 6 of them Class I and 6 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02Class IJul 11, 2025Laryngoscope handles may not illuminate as intended. |
| BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309UClass IJul 11, 2025Laryngoscope handles may not illuminate as intended. |
| BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), Class IJul 11, 2025Laryngoscope handles may not illuminate as intended. |
| BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415UClass IJul 11, 2025Laryngoscope handles may not illuminate as intended. |
| Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000UClass IJul 11, 2025Laryngoscope handles may not illuminate as intended. |
| BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310UClass IJul 11, 2025Laryngoscope handles may not illuminate as intended. |