Medline Industries recalled 41 lots of reprocessed electrophysiology catheters on December 22, 2025. These devices may contain residual material that poses serious health risks. The recall affects several specific model numbers and follows the expansion of a previous recall.
These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025
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. Notification method: Letter
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The recall includes Livewire Steerable Electrophysiology Catheters, models 401582RH, 401940RH, 401904RH, 401914RH, 401932RH, and 401652RH. The devices were distributed nationwide. The quantity of affected catheters is 41.
The recalled catheters may contain small particles of residual material. If used, they can lead to inflammatory responses, systemic infections, granulomatous reactions, or thrombus reactions, which may cause cerebral or pulmonary embolism or deep vein thrombosis.
No specific incidents were reported in connection with this recall. The risk level is categorized as high due to the potential for severe health complications.
Patients and healthcare providers should immediately stop using the affected devices. Contact Medline Industries for further instructions and follow any recall notices.
For more information, call Medline Industries at 1-800-396-2006 or visit their website at www.medline.com.
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