Flexicare Medical (Dongguan) Ltd.

FDA Regulatory Profile

Flexicare Medical (Dongguan) Ltd. appears in FDA public data with 6 recalls — including 6 Class I (most serious) —, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2185-2025, Class I) was initiated on Jul 11, 2025.

Summary

Total Recalls
6 (6 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2185-2025Class IBritepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000UJul 11, 2025
Z-2187-2025Class IBritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310UJul 11, 2025
Z-2182-2025Class IBritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-012Jul 11, 2025
Z-2183-2025Class IBritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), Jul 11, 2025
Z-2186-2025Class IBritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309UJul 11, 2025
Z-2184-2025Class IBritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415UJul 11, 2025