Medline Industries, LP recalled 14,379 Airway Exam Kits containing Olympus biopsy valves nationwide. The recall cites rubber fragments detaching from the slit of single-use biopsy valves. Potential harm includes a foreign body in the patient’s tracheobronchial tree, inflammatory response, hypoxia, and longer procedures. Providers and patients should stop using the kit and follow recall directions.
Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions
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The Airway Exam Kit is used in airway assessment during medical procedures. It includes single-use Olympus biopsy valves as part of the kit.
Detachment of rubber fragments from the valve slit can lead to a foreign body in the tracheobronchial tree, potentially requiring removal and causing inflammation or hypoxia.
This recall is not described as part of a broader industry pattern in the provided data.
The incident could disrupt procedures and necessitate medical intervention. No injuries reported yet, but the hazard is serious for patients.
FDA enforcement page linked to recall Z-1705-2026 and Medline recall notice.
Remedies and processing timelines will be provided by the manufacturer; typical refunds or replacements in similar recalls range from 4-8 weeks.
Keep the recall notice, packaging, lot/UDI numbers, and correspondence with Medline as part of the medical records.
Model numbers: Airway Exam Kit DYKE1796. UDI-DI 10193489874716 (ea) 40193489874717 (case). Lot numbers: 24CBT023, 24FBB701, 24LBL343, 25GBP141. Sold nationwide in the United States in states CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX. Sold by Medline Industries, LP. Sold date and price not disclosed.
No injuries or incidents have been reported.
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