Quick Facts at a Glance
- Recall Date
- December 22, 2025
- Hazard Level
- HIGH
- Brand
- Medline Industries, LP
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Medline Industries, LP
- Product type
- Diagnostic Ultrasound Catheter
- Model numbers
- 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
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 22, 2025
Reported by FDA DEVICE
February 18, 2026
RecallRadar source check
February 25, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
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
About This Product
Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters are used in medical settings for diagnostic procedures. They are designed to be reprocessed for multiple uses, making them cost-effective for healthcare providers.
Why This Is Dangerous
The presence of small residual particles in the reprocessed catheters can trigger severe inflammatory responses or infections in patients. These risks can escalate to serious conditions like thrombus reactions or embolisms if the devices are used.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face potential health risks from using the affected devices. Immediate cessation of use is necessary to prevent serious complications.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the catheter packaging or device
- Compare the model number against the recalled list
- Check for any notifications received from Medline Industries
Where to find product info
Model numbers can typically be found on the packaging or directly printed on the catheter device itself.
What timeline to expect
Expect a refund processing timeline of approximately 4-6 weeks after the return of the device.
If the manufacturer is unresponsive
- Document all communications with Medline Industries
- Follow up with customer service
- Consider filing a complaint with the FDA if issues persist.
How to prevent similar issues
- Choose single-use catheters when possible to avoid reprocessing risks
- Verify product safety certifications before purchase
- Ask healthcare providers about device safety and recall history.
Documentation advice
Keep records of all communications regarding the recall, including emails, letters, and any correspondence with healthcare providers.
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Product Details
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.
Key Facts
- Recall date: December 22, 2025
- Quantity recalled: 94 lots
- Affected systems: GE and Siemens
- Risk of serious health issues including embolism
- Class I recall indicating high risk
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Safety Guide
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