Agency classClass IIOur severity:High FDA (Devices)·Z-0802-2020·Announced 2020-01-22

Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components

Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal spring, washer, and bearing components may become loose and separate from the device.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where loose components could enter a patient's oral cavity, but the source text does not report any injuries or illnesses, fitting the High severity criteria.

Plain-English summary

Flexicare Medical Ltd. is recalling approximately 1,024,890 BriteBlade Pro Single-use Fiber Optic Miller 2 laryngoscope blades. The recall is due to reports that the spring, washer, and bearing components in the block of the laryngoscope blade can become loose and separate from the device. The affected devices are intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis.

The recall covers specific part and lot numbers: 040-722U 181000115, 040-722U 181001520, 040-722U 181200006, 040-722U 181202055, and 040-722U 190100006. These devices were distributed nationwide in the United States and in several international locations, including Australia, Canada, China, the Czech Republic, Denmark, Finland, Ireland, Italy, Kuwait, Lebanon, the Netherlands, Panama, Romania, Russia, South Korea, the UAE, and the UK.

If a blade is disengaged over a patient's mouth, loose parts could enter the oral cavity. This could cause a delay in the procedure while the loose parts are retrieved. Healthcare facilities should stop using the affected devices and contact Flexicare Medical Ltd. for instructions on returning or disposing of them.

The recalled product

Product: BriteBlade Pro Single-se Fiber Optic Miller 2, CE 0120, Do not Re-use, Rx Only, REF, 040-722U, Sterile EO, Qty 10, (01) 15055788722783 The device is intended for direct vision laryngoscopy to obtain an illuminated view of the vocal cords and the glottis by insertion into the…
Manufacturer: Flexicare Medical Ltd.
Category: Medical Device — Laryngoscope Blades
Hazard: loose-parts
foreign-object
Affected units: 1,024,890

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Flexicare Medical Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · Flexicare Medical Ltd.

See all →

Severe
Flexicare ProVu Video Stylet Recalled for Potential Airway Occlusion
FDA (Devices) · 2020-12-02
High
Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
FDA (Devices) · 2020-01-22
High
Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
FDA (Devices) · 2020-01-22
High
Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
FDA (Devices) · 2020-01-22

Same hazard · loose parts