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
- 10135910RH UDI-DI 10197344026500 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905, 10135936RH UDI-DI 10197344026517 Lots EP250324 EP250429 EP250521 EP250609 EP250630 EP250710 EP250905
- 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
The ACUSON AcuNav Diagnostic Ultrasound Catheters are used in medical imaging to provide real-time visualization of internal structures. Healthcare providers rely on these devices for accurate diagnoses during procedures.
Why This Is Dangerous
The risk arises from small particles of residual material within the catheters, which can lead to serious health complications if introduced into the body during use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers and healthcare providers must act immediately to prevent potential health risks associated with the use of these catheters.
Practical Guidance
How to identify if yours is affected
- Check the model number on the catheter packaging.
- Verify if the catheter is among the recalled models: 10135910RH or 10135936RH.
- Look for any notifications from healthcare providers regarding the recall.
Where to find product info
Model numbers are typically found on the product packaging or the catheter itself.
What timeline to expect
Expect a refund or replacement processing timeline of approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document all communications with the company.
- Consider reaching out to the FDA for further guidance.
- File a complaint if you do not receive a response.
How to prevent similar issues
- Always check for recalls before purchasing medical devices.
- Look for single-use products to minimize infection risks.
- Ensure devices are from reputable manufacturers.
Documentation advice
Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.
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Product Details
The recall involves the ACUSON AcuNav Ultrasound Catheter models 10135910RH and 10135936RH. These catheters were distributed nationwide in the United States.
Key Facts
- High hazard level
- Risk of serious infections
- Use on GE and Siemens systems
- Follow manufacturer's recall instructions
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Safety Guide
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