Flexicare Medical Ltd.: Medical Device Recall in 2020 - (Recall #: Z-0803-2020)

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 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.

Product Classification:

Class II

Date Initiated: November 27, 2019

Date Posted: January 22, 2020

Recall Number: Z-0803-2020

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 040-333U 170900328 I OGH 040-333U 180800461 I OGH 040-333U 180900072 I OGH 040-333U 180900104 I OGH 040-333U 181000107 I OGH 040-333U 181100013 I OGH 040-333U 181100097 I OGH 040-333U 181200024 I OGH

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