# FDA recall Z-0803-2020

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

## Product

BriteBlade Pro Single-Use Fiber Optic Handle and Blade Mac 3, CE 0120, Do not Re-use, Rx Only, REF, 040-333U, Sterile EO, Qty 10, (01)15055788724138(17)230801(10)180900072    The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the oral cavity to manipulate the tongue and/or the epiglottis.

## 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-0803-2020
- **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-0803-2020

## Citation

> AI Analytics. FDA recall Z-0803-2020. Retrieved 2026-05-30 from https://api.ai-analytics.org/recall/Z-0803-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*