# FDA recall Z-2183-2025

> **Flexicare Medical (Dongguan) Ltd.** · Class I · device recall initiated 2025-07-11.

## Product

BritePro Solo Single-Use Fiber Optic Handle and Blade  Refs:  040-331U (Mac 1),  040-332U (Mac 2),   040-333U (Mac 3),  040-335U (Mac 3.5)  040-334U (Mac 4),    040-341U (Miller 1),   040-342U (Miller 2),  040-343U (Miller 3),  040-344U (Miller 4),  040-361U (Phillips 1),  040-362U (Phillips 2)

## Reason for recall

Laryngoscope handles may not illuminate as intended.

## Distribution

US Nationwide distribution in the states of WA, SD, TX, VA, PA, OK, GA, MI, WY, NC, OH.

## Key facts

- **Recall number:** Z-2183-2025
- **Recalling firm:** Flexicare Medical (Dongguan) Ltd.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-07-11
- **Report date:** 2025-08-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dongguan, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2183-2025

## Citation

> AI Analytics. FDA recall Z-2183-2025. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2183-2025. Source: US FDA. Licensed CC0.

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