Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic recall
Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE…
Why was Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
10439072RH UDI-DI 10197344157297 Lots EP250724 EP250808; 10439236RH UDI-DI 10197344157303 Lots EP250724 EP250808; 10438577RH UDI-DI 10197344157273 Lots EP250724 EP250808; 10439011RH UDI-DI (case) 20197344157287¿ (ea) 10197344157280¿ Lots EP250724 EP250808
- Product
- Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter Use on GE…
- Recalling firm
- Medline Industries, LP
- Quantity
- 94
- Distribution
- Distribution US nationwide.
- Recall date
- February 18, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)