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 Electrophysiology Catheter
- Model numbers
- 401211RH UDI-DI 10197344043736 Lot EP250317, 401222RH UDI-DI 10197344043712 Lot EP250317, 401223RH UDI-DI 10197344043705 Lot EP250317, 401226RH UDI-DI 10197344043699 Lot EP250307 EP250317, 401227RH UDI-DI 10197344043682 Lots EP250307 EP250317, 401260RH UDI-DI 10197344043668 Lot EP250317, 401261RH UDI-DI 10197344043651 Lot EP250317, 401306RH UDI-DI 10197344043620¿ Lot EP250317 +12 more
- 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
These diagnostic electrophysiology catheters are used in medical procedures to assess and treat heart conditions. They are critical in diagnosing arrhythmias and other cardiovascular issues.
Why This Is Dangerous
The risk stems from potential contamination with residual materials, which can provoke severe inflammatory responses and lead to systemic complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall poses a significant safety concern for patients undergoing electrophysiological procedures, necessitating immediate cessation of use and consultation with healthcare providers.
Practical Guidance
How to identify if yours is affected
- Check the model number on your catheter against the recall list.
- Verify the lot number if available.
- If uncertain, contact your healthcare provider.
Where to find product info
Model and lot numbers are typically found on the packaging or the device itself.
What timeline to expect
Expect up to 6 weeks for refund processing after returning the product.
If the manufacturer is unresponsive
- Document all communication attempts with Medline.
- Reach out to the FDA or local health department for guidance.
How to prevent similar issues
- Select single-use devices to avoid contamination risks.
- Check for FDA clearance and recall history before purchase.
- Consult healthcare providers for advice on safe products.
Documentation advice
Keep records of all communication, receipts, and photographs of the product.
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Product Details
The recall includes various models of St. Jude Medical Supreme Diagnostic Electrophysiology Catheters. Models affected include 401211RH, 401222RH, 401223RH, among others. These were distributed nationwide in the U.S.
Key Facts
- Recall affects 48 units of electrophysiology catheters
- Potential contamination with residual materials
- Risks include systemic infection and embolism complications
- Stop using affected devices immediately
- Contact Medline for further instructions
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Safety Guide
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