Abbott recalled reprocessed steerable diagnostic catheters on December 22, 2025, after discovering potential contamination. The devices may contain small particles that pose risks of systemic infection or embolism. A total of 311 units are affected nationwide.
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 recalled products include multiple models of Abbott Inquiry Steerable Diagnostic Catheters. Specific models include 81105RH, 81172RH, 81202RH, 81483RH, and others. These devices were distributed across the United States.
The affected catheters may contain small particles of residual material. Using these devices can lead to inflammatory responses, systemic infections, or serious conditions such as pulmonary embolism or deep vein thrombosis.
No specific incidents have been reported, but the potential for serious health risks is high. The recall is classified as Class I, indicating a significant risk to health.
Stop using the affected devices immediately. Contact Medline Industries, LP or your healthcare provider for further instructions and follow the recall process outlined in their notification.
For more information, contact Medline Industries at [contact number] or visit their website at [website URL]. Additional details can be found in the recall notice at the FDA website.
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