Medline Industries recalled 94 lots of Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters on December 22, 2025. The catheters may contain small particles that pose a risk of serious health issues. Users should stop using the devices immediately and follow manufacturer instructions for return.
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 the following model numbers: 10439072RH, 10439236RH, 10438577RH, and 10439011RH. These devices were distributed nationwide in the United States. No specific price was mentioned.
The recalled catheters may contain small particles of residual material. Use of these devices could lead to inflammatory response, systemic infection, or serious conditions such as cerebral embolism or deep vein thrombosis.
No specific incidents were reported in the recall data. However, the potential for serious health complications exists.
Stop using the affected catheters immediately. Follow the recall instructions provided by Medline Industries and consult your healthcare provider for next steps.
For further assistance, contact Medline Industries, LP. Detailed information can be found on their recall page at the FDA website.
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