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
- Electrophysiology Catheter
- Model numbers
- 401582RH UDI-DI (case) 20888277407517¿ (ea) 10888277407510 Lots EP250618 EP250630, 401940RH UDI-DI 10888277407480 Lot EP250618, 401904RH UDI-DI (case) 20888277407609¿ (ea) 10888277407602 Lots EP250618 EP250630, 401914RH UDI-DI (case) 20888277407524¿ (ea) 10888277407527 Lot EP250618, 401932RH UDI-DI (case) 20888277407678¿ (ea) 10888277407671 Lots EP250618 EP250630, 401652RH UDI-DI 10888277407572 Lots EP250618 EP250630
- 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
Electrophysiology catheters are medical devices used in heart procedures to diagnose and treat arrhythmias. They are crucial for mapping electrical activity in the heart and delivering therapies.
Why This Is Dangerous
The risk arises from potential residual material within the catheters that can cause severe inflammatory and thrombotic reactions, posing significant health risks to patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers should refrain from using the affected catheters to avoid serious health consequences, which could require medical intervention.
Practical Guidance
How to identify if yours is affected
- Locate the model number on the product packaging or the catheter itself.
- Verify if your catheter matches any of the recalled models: 401582RH, 401940RH, 401904RH, 401914RH, 401932RH, 401652RH.
- Check for any notification letters from Medline regarding the recall.
Where to find product info
Serial numbers and model information can typically be found on the packaging or the device itself, often near the base or handle of the catheter.
What timeline to expect
Expect the refund process to take approximately 4-6 weeks once your request is submitted.
If the manufacturer is unresponsive
- Contact Medline Industries directly for follow-up.
- Document all correspondence regarding your refund request.
- Consider reaching out to the Consumer Product Safety Commission for further assistance.
How to prevent similar issues
- Look for single-use or sterile alternatives when necessary.
- Check for safety certifications on medical devices.
- Stay informed on product recalls and safety warnings from manufacturers.
Documentation advice
Keep records of your purchase, such as receipts and any correspondence with Medline, as well as photographs of the product if applicable.
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Product Details
The recall includes Livewire Steerable Electrophysiology Catheters, models 401582RH, 401940RH, 401904RH, 401914RH, 401932RH, and 401652RH. The devices were distributed nationwide. The quantity of affected catheters is 41.
Key Facts
- Risk of serious health complications
- Stop using affected devices immediately
- Contact Medline for instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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