Flexicare Medical Ltd.: Medical Device Recall in 2020 - (Recall #: Z-0804-2020)

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 Miller 2, CE 0120, Do not Re-use, Rx Only, REF: 040-342U, Sterile EO, Qty 10, UDI: (01)15055788724053(17)230901(10)181002320

Product Classification:

Class II

Date Initiated: November 27, 2019

Date Posted: January 22, 2020

Recall Number: Z-0804-2020

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: 040-342U 180802596 I OGH 040-342U 181002320 I OGH 040-342U 181100085 I OGH 040-342U 181200025 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