Medline Industries is recalling 14,379 bronchoscopy kits containing Olympus biopsy valves distributed nationwide in the United States. Olympus reports rubber fragments detaching from the valve slit, which could leave a foreign body in a patient’s tracheobronchial tree and may require removal. Hospitals should stop using the affected kits immediately 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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Bronchoscopy kits are used to perform airway examinations and biopsies with disposable biopsy valves from Olympus.
Detachment of rubber fragments from valve slits can create a foreign body in the patient’s airway, potentially delaying procedures and causing inflammation or hypoxia.
This recall is not part of a broader industry pattern.
Clinicians may need to halt procedures with affected kits. Hospitals may incur replacement costs and process delays.
Identify UDI-DI, CS, and LOT codes on the kit label and packaging.
4-8 weeks for processing refunds or replacements typical in recalls of medical devices.
Keep photos of the kit label, packaging, and lot numbers. Save recall notices and correspondence with Medline.
Kits contain Olympus biopsy valves across 13 kit types. 1) BRONCH PROCEDURE KIT, DYKE2091. 2) BRONCHSCOPY, DYNJ900898G and DYNJ901922I. 3) BRONCHSCOPY PACK, DYNJ38313B. 4) BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G and DYNJ32750I. 5) KIT, WR THORACIC, DYNJ911252. 6) LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B. 7) LEX THORACIC, DYNJ902016K and DYNJ902016L. 8) ORGAN PROCUREMENT, DYNJ908686. 9) PULMONARY PACK, DYKE1859. 10) THORACIC, DYNJ901666L. 11) THORACIC ROBOTICS, DYNJ908777A. 12) THORACOTOMY/THORACOSCOPY, DYNJ900482N and DYNJ900482O. 13) XPS, DYNJ907605. Distribution: US nationwide in CA, FL,,
No injuries or incidents have been reported.
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Medline Industries, LP recalled 14,379 Olympus biopsy valve kits sold nationwide to hospitals and clinics. Olympus biopsy valves in the kits may detach rubber fragments from the valve slit. Hospitals and clinics should stop using the devices immediately and follow the recall instructions.
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