Olympus biopsy valves in Medline Industries, LP thoracic robotic biopsy valve kits are recalled nationwide. The recall covers 14,379 kits distributed across 13 states. Rubber fragments may detach from single-use biopsy valves, creating a risk of a foreign body in the patient’s tracheobronchial tree and possible inflammation or hypoxia. Healthcare providers and patients should stop using the device
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 biopsy valve kits used in thoracic robotic procedures. Consumers rely on sterile, single-use valves to maintain airway safety during procedures.
Rubber fragments detaching from the valves can become a foreign body in the airway, potentially requiring removal and causing inflammation or hypoxia.
This recall is not described as part of a broader industry pattern.
Hospitals may need to halt use of affected kits, potentially delaying procedures and prompting supplier inquiries.
UDI, lot numbers, and kit identifiers are printed on the product packaging and accompanying documentation.
Refunds/replacements or follow-up actions are being coordinated by the manufacturer; typical timelines vary by facility.
Keep copies of recall notices, correspondences, and inventory batch lists.
Kits: Thoracic Robotic biopsy valve kit DYNJ908777B. UDI-DI 10198459269196 (EA) and 40198459269197 (CS). LOTS: 25EBD732, 25GBG733, 25IBQ613, 25JBD457, 25KBT352, 26ABA235, 26ABP735. Distributor/seller: Medline Industries, LP. Nationwide distribution in the US. States: CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX. Price: Unknown.
No injuries or incidents have been reported.
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