Flexicare recalls BriteBlade Pro Single-Use Fiber Optic Mac 3 blades due to loose spring/washer/bearing components that may enter the oral cavity during use, causing procedure delays.
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 Fiber Optic Mac 3 laryngoscope blades because loose internal parts could fall into the patient's mouth during use, potentially delaying procedures. This is a serious risk for medical professionals performing laryngoscopy.
The spring/washer/bearing components in the blade can become loose and separate from the device. If the blade disengages over the patient's mount, loose parts may enter the oral cavity, causing delays in the procedure while retrieving them.
Medical professionals using the BriteBlade Pro blades for laryngoscopy procedures are most at risk. Patients undergoing the procedure may also be affected if loose parts enter the oral cavity.
Check for the model 'BriteBlade Pro Single-Use Fiber Optic Mac 3' with part number REF 040-713U. The product was sold with specific lot numbers including 180700030, 180900099, and others.
Inspect the blade for loose spring/washer/bearing components that may have separated from the device.
Reach out to Flexicare Medical Ltd. for guidance on safe handling or disposal of the recalled blades.
The firm has received reports that spring/washer/bearing components in the blade can become loose and separate, potentially entering the patient's mouth during use.
No, the blade is not safe to use as loose parts could enter the oral cavity, causing procedure delays.
Look for the model 'BriteBlade Pro Single-Use Fiber Optic Mac 3' with part number REF 040-713U and specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Flexicare to request your refund or repair — edit it as you like.
Subject: Recall Z-0801-2020 — Flexicare Flexicare Hello, I own a Flexicare that is covered by recall Z-0801-2020 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.
