Flexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
Flexicare Medical Ltd. is recalling BriteBlade Pro laryngoscope blades because internal components may become loose and separate, posing a risk of entering the patient's oral cavity.
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 is classified as FDA Class II. The hazard involves a risk of harm (foreign object ingestion) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Flexicare Medical Ltd. is recalling BriteBlade Pro Single-Use Fiber Optic Handle and Blade Miller 2 devices. The recall involves 1,024,890 units distributed nationwide in the United States and in several international markets, including Australia, Canada, China, and the United Kingdom.
The firm received reports that the spring, washer, and bearing components within the laryngoscope blade block can become loose and separate from the device. If the blade is disengaged over a patient's mouth, these loose parts could enter the oral cavity, potentially causing a delay in the procedure while the parts are retrieved.
Healthcare providers should stop using the affected devices immediately. The specific part number is 040-342U, and the affected lot numbers are 180802596, 181002320, 181100085, and 181200025. Users should contact Flexicare Medical Ltd. for instructions on returning or disposing of the recalled products.
The recalled product
- Product
- 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
- Manufacturer
- Flexicare Medical Ltd.
- 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 →Related recalls
Same manufacturer · Flexicare Medical Ltd.
See all →- SevereFlexicare ProVu Video Stylet Recalled for Potential Airway Occlusion
FDA (Devices) · 2020-12-02
- HighFlexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
FDA (Devices) · 2020-01-22
- HighFlexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
FDA (Devices) · 2020-01-22
- HighFlexicare BriteBlade Pro Laryngoscope Blades Recalled for Loose Components
FDA (Devices) · 2020-01-22
Same hazard · foreign object ingestion
See all →- HighGive and Go Two-Bite Cupcakes Recalled for Potential Metal Contamination
FDA (Food) · 2021-12-29
- HighAmerican Beverage Corp. Recalls Big Burst Grape Drink Due to Cap Hazard
FDA (Food) · 2013-11-27
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