# FDA recall Z-0804-2020

> **Flexicare Medical Ltd.** · Class II · device recall initiated 2019-11-27.

## Product

BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

## Reason for recall

The firm has received reports that the spring/washer/bearing components in the block of the laryngoscope blade become loose and separated from the device.  If the blade is disengage over the patient's mount it is a possibility that any loose parts could enter the oral cavity which could cause a delay in the procedure while retrieving loose parts.

## Distribution

US: Nationwide  OUS: Australia, Canada, China,  Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, Netherlands, Panama, Romania, Russia, South Korea, UAE, UK

## Key facts

- **Recall number:** Z-0804-2020
- **Recalling firm:** Flexicare Medical Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-27
- **Report date:** 2020-01-22
- **Termination date:** 2021-04-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rhondda Cynon Taff, United Kingdom

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0804-2020

## Citation

> AI Analytics. FDA recall Z-0804-2020. Retrieved 2026-05-29 from https://api.ai-analytics.org/recall/Z-0804-2020. Source: US FDA. Licensed CC0.

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