Quick Facts at a Glance
- Recall Date
- January 29, 2026
- Hazard Level
- HIGH
- Brands
- Paradise, 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
- Paradise, ReCor Medical
- Product type
- Ablation catheter for renal denervation
- Model numbers
- PRDS-068-02, M4907
- 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
Paradise Ultrasound Renal Denervation System is designed to reduce hypertension by ablating renal nerves using ultrasound energy. The PRDS-068-02 catheter is a component of this system used in certain clinical settings.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall could disrupt treatment plans for patients relying on renal denervation procedures and require changes in clinical workflows.
Practical Guidance
How to identify if yours is affected
- Check device model PRDS-068-02
- Inspect for Lot M4907 and UDI 00810008950043
- Confirm it was distributed in one of the states listed
Where to find product info
Recall letters and manufacturer communications will include serial numbers, lot numbers, and UDI details.
What timeline to expect
4-8 weeks for replacement or instruction processing.
If the manufacturer is unresponsive
- Contact the manufacturer through the recall channel
- File a complaint with the appropriate regulatory authority if the company is unresponsive
How to prevent similar issues
- Verify recall status before performing procedures using renal denervation equipment
- Register devices to receive recall updates
- Buy from authorized distributors
Documentation advice
Keep copies of all recall notices, medical records related to the device, and communications with the manufacturer.
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Product Details
Model: PRDS-068-02. UDI-DI: 00810008950043. Lot: M4907. Distribution: CA, CO, FL, KS, MO, NC, OH, TX, VA. Units recalled: 1. Sold in the U.S. nationwide via unspecified channels.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- States: CA, CO, FL, KS, MO, NC, OH, TX, VA
- Remedy: Stop use and await manufacturer instructions
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