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
- Catheter
- Model numbers
- UDI-DI (case) 20197344019554¿ (ea) 10197344019557 Lots EP250324 EP250416 EP250512 EP250521 EP250609 EP250630 EP250710 EP250724
- 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 ViewFlex Xtra ICE Catheter is a medical device used for various procedures including diagnostic imaging. Healthcare providers rely on these catheters to ensure patient safety and comfort during procedures.
Why This Is Dangerous
The presence of small particles can cause adverse reactions in patients, leading to serious health complications. It is critical to avoid using affected devices to prevent these risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may face health risks if they have used these catheters. It is crucial for healthcare providers to take immediate action to protect patient safety.
Practical Guidance
How to identify if yours is affected
- Check the model and lot numbers on the catheter packaging.
- Compare with the recall list provided by Medline.
- If in doubt, consult your healthcare provider.
Where to find product info
Look for the model number and lot number on the catheter packaging or accompanying documentation.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks.
If the manufacturer is unresponsive
- Follow up with Medline Industries if you do not receive a response within the expected timeline.
- Document all communications for your records.
How to prevent similar issues
- Always verify the safety of medical devices before use.
- Look for recent recalls on FDA's website.
- Choose single-use devices when possible.
Documentation advice
Keep records of your purchase, including receipts and correspondence with the manufacturer.
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Product Details
The recall involves the ViewFlex Xtra ICE Catheter, model D087031RH, UDI-DI 20197344019554. The affected lots include EP250324, EP250416, EP250512, EP250521, EP250609, EP250630, EP250710, and EP250724. These catheters were distributed nationwide in the U.S.
Key Facts
- Risk of systemic infection
- Potential for serious health complications
- Stop using the device immediately
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Safety Guide
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