HIGH

Medline ReNewal Catheters Recalled Due to Infection Risk

Medline Industries, LP recalled 650 ViewFlex Xtra ICE Catheters on December 22, 2025. The recall affects devices that may contain small particles of residual material. Using these catheters poses a risk of serious health complications such as systemic infection or embolism.

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

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

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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

  1. Check the model and lot numbers on the catheter packaging.
  2. Compare with the recall list provided by Medline.
  3. 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.

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

  • 650 units recalled
  • Risk of systemic infection
  • Potential for serious health complications
  • Stop using the device immediately
View Original Recall on FDA - Medical Devices

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Safety Guide

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Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeCatheter
Sold At
Multiple Retailers

Product Details

Model Numbers
UDI-DI (case) 20197344019554¿ (ea) 10197344019557 Lots EP250324 EP250416 EP250512 EP250521 EP250609 EP250630 EP250710 EP250724
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

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