Flexicare recalls BriteBlade Pro laryngoscope blades due to risk of loose parts entering oral cavity during use, potentially delaying procedures. Affected units have specific part numbers and were sold with CE 0120 marking.
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.
Flexicare is recalling BriteBlade Pro single-use laryngoscope blades because loose internal parts could enter the patient's mouth during use, causing procedure delays. This is a serious risk for medical professionals using the device in hospitals or clinics.
The spring, washer, and bearing components inside the laryngoscope blade can become loose and separate from the device. If the blade disengages over the patient's mount, loose parts might enter the patient's mouth, requiring time to retrieve and potentially delaying the procedure.
Healthcare providers using the BriteBlade Pro laryngoscope blades in medical settings are most at risk. Patients undergoing procedures with these blades could experience delays if loose parts enter the oral cavity.
Check for the part number 040-333U on the blade or packaging. The device has a CE 0120 marking and was sold as a single-use, sterile item for laryngoscopy procedures.
Do not use the BriteBlade Pro blade if it has the part number 040-333U or CE 0120 marking.
The firm received reports that spring/washer/bearing components can become loose and separate from the device, potentially entering the patient's mouth and causing procedure delays.
Look for the part number 040-333U on the blade or packaging, and check for the CE 0120 marking.
The recall record does not specify a remedy or fix; the device must be stopped from use immediately.
We’ve drafted a message you can send Flexicare to request your refund or repair — edit it as you like.
Subject: Recall Z-0803-2020 — Flexicare Flexicare Hello, I own a Flexicare that is covered by recall Z-0803-2020 from Flexicare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
