FDA recall, , Moderate risk
ReCor Medical Paradise Ultrasound Renal Denervation Catheters
The Paradise catheter is nonconforming and not for human use.
Summary by Recall Canary from the FDA notice
What happened
ReCor Medical Inc. of Palo Alto, California, began a recall of the Paradise Ultrasound Renal Denervation System Paradise Catheter on January 29, 2026, because the firm distributed a nonconforming product that was supposed to be scrapped and not for human use.
The FDA added the recall to its Enforcement Report and classified it on March 27, 2026, and in the FDA's weekly enforcement report on April 8, 2026. Distribution was U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI, lot code and model/catalog number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Paradise¿ Ultrasound Renal Denervation System Paradise ¿ Catheter
- UDI-DI
- 00810008950043
- Model/Catalog number
- PRDS-068-02
- Lot code
- M4907
- M4862
Recall details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the states of California, Colorado, Florida, Kansas, Missouri, North Carolina, Ohio, Texas, and Virginia.
- Company
- ReCor Medical Inc.Palo Alto, California
- Hazard
- Unapproved product
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98365
- Recall numbers
- Z-1654-2026 to Z-1655-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
