Flexicare recalls BriteBlade Pro laryngoscope blades due to loose parts that may enter patient's mouth, causing procedure delays. Affected units have specific part numbers and were sold with CE 0120 certification.
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, potentially delaying procedures. This recall affects medical devices used in surgeries requiring laryngoscopy.
The spring, washer, and bearing components inside the blade can become loose and separate from the handle. If the blade disengages over the patient's mount, loose parts might enter the patient's mouth, requiring time to retrieve and delaying the procedure.
Healthcare professionals using laryngoscopes for procedures like intubation are most at risk. Patients undergoing surgery with these devices may experience delays if parts become disengaged.
Check for the part number 040-342U on the blade or handle. The product was sold with CE 0120 certification and includes specific lot numbers like 180802596, 181002320, 181100085, and 181200025.
Inspect the blade for loose spring, washer, or bearing components that may have separated from the handle.
Reach out to Flexicare Medical for guidance on whether the blade is affected and next steps.
The recall states that loose parts could enter the patient's mouth, so it is not safe to use without checking for disengagement.
Look for part number 040-342U on the blade or handle, with specific lot numbers like 180802596, 181002320, 181100085, or 181200025.
The recall does not require immediate stop-use; however, you should check for loose parts before use.
We’ve drafted a message you can send Flexicare Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0804-2020 — Flexicare Medical Flexicare Medical Hello, I own a Flexicare Medical that is covered by recall Z-0804-2020 from Flexicare Medical. 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.
