Medline Industries recalled 511 reprocessed AcuNav ultrasound catheters on December 22, 2025. These devices may contain small particles that can cause serious health risks such as systemic infections and embolisms. Healthcare providers must stop using the affected devices immediately to prevent potentially life-threatening complications.
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 involves the ACUSON AcuNav Ultrasound Catheter models 10135910RH and 10135936RH. These catheters were distributed nationwide in the United States.
The recalled catheters may contain small particles of residual material. If used, they pose a risk of inflammatory response, systemic infection, and serious conditions such as cerebral or pulmonary embolism.
There have been no reported injuries or deaths associated with this recall at this time. However, the potential health risks are significant.
Stop using the affected devices immediately. Contact Medline Industries or your healthcare provider for further instructions on returning the product.
For more information, contact Medline Industries, LP at their customer service number. Additional details are available on the FDA website.
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