Quick Facts at a Glance
- Recall Date
- January 29, 2026
- Hazard Level
- HIGH
- Brand
- ReCor Medical
- 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
- ReCor Medical
- Product type
- Renal denervation ablation catheter
- Model numbers
- PRDS-068-02
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 29, 2026
Reported by FDA DEVICE
April 8, 2026
RecallRadar source check
April 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ReCor Medical Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Paradise Ultrasound Renal Denervation System includes a catheter used in renal denervation procedures. It is distributed in healthcare settings within the United States.
Why This Is Dangerous
The recall addresses a nonconforming product that should have been scrapped, posing potential safety concerns if used in patients.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Healthcare providers may need to identify and segregate affected catheters, adjust procedures, and contact patients if exposure occurred.
Practical Guidance
How to identify if yours is affected
- 1. Locate device labeling for model PRDS-068-02.
- 2. Verify the UDI-DI 00810008950043.
- 3. Confirm Lot M4862.
- 4. Check distribution list for facilities in CA, CO, FL, KS, MO, NC, OH, TX, VA.
Where to find product info
Device labeling and FDA recall page summarize identifiers.
What timeline to expect
Not specified in recall notice.
If the manufacturer is unresponsive
- Document all attempts to contact ReCor Medical.
- File a report with the FDA if needed.
- Seek legal guidance if manufacturer is unresponsive.
How to prevent similar issues
- Verify device identifiers before use.
- Use only devices from authorized distributors.
- Keep recall notices accessible to appropriate staff.
Documentation advice
Retain recall notice, packaging, labeling, correspondence with manufacturer, and any patient exposure records.
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Product Details
Model/Catalog Number PRDS-068-02. UDI-DI 00810008950043. Lot Number M4862. Quantity 24. Sold nationwide in CA, CO, FL, KS, MO, NC, OH, TX, and VA.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Distributed nationwide in CA, CO, FL, KS, MO, NC, OH, TX, VA
- Recall date 2026-01-29; Status: ACTIVE; Hazard level HIGH
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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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