Flexicare Medical Ltd.: Medical Device Recall in 2020 - (Recall #: Z-0801-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

BriteBlade Pro Single-Use Fiber Optic Mac 3, CE01120, Do Not Re-use, Rx Only, REF 040-713U, Sterile EO, Qty 10, (01)15055788723001 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.

Product Classification:

Class II

Date Initiated: November 27, 2019

Date Posted: January 22, 2020

Recall Number: Z-0801-2020

Event ID: 84367

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.

Status: Terminated

Product Quantity: 1,024,890 devices

Code Information:

Part Number/Lot Number 040-713U 180700030 I CCW 040-713U 180900099 I CCW 040-713U 180901353 I CCW 040-713U 181000110 I CCW 040-713U 181000113 I CCW 040-713U 181100001 I CCW 040-713U 181100002 I CCW 040-713U 181200005 I CCW

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated