Medline Industries is recalling 14,379 kits nationwide that include Olympus biopsy valves. The recall follows reports of rubber fragments detaching from the valves during use. Healthcare providers and patients should stop using the affected kits and follow Medline’s recall instructions.
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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These are bronchoscopy and laryngoscopy/bronchoscopy kits that include Olympus biopsy valves. They are used in airway procedures to obtain tissue samples.
Rubber fragments detach from the biopsy valves. Fragments could become a foreign body in the tracheobronchial tree, potentially requiring removal and causing inflammation or hypoxia.
This recall is not a broader industry pattern.
Hospitals and patients may experience procedure delays or additional interventions to remove foreign material. The recall affects a sizable number of kits nationwide.
FDA recall page and Medline recall notices. Look for recall number Z-1709-2026.
Medline will issue further instructions. No specific replacement timeline is provided in the recall notice.
Keep a copy of the recall notice, record model numbers checked, and any correspondence with Medline or risk management.
Model numbers included in the recall: DYNJ900898I and DYNJ901922G; DYKM1417I and DYKM1417J; DYNJ58146A; DYNDA2138A. Distribution: US nationwide in CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX. Quantity: 14,379 kits total. Classification: Class II.
Olympus is investigating an increase in complaints related to rubber fragment detachment in the slit of single-use biopsy valves. No injuries or fatalities are detailed in the recall notice.
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