Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿... recall (ReCor Medical Inc.)
Medical deviceClass IIOngoing
Summary: ReCor Medical Inc. is recalling Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation. Reason: Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
What is being recalled
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation
Why
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA. (states named: California, Colorado, Florida, Kansas, Missouri, North Carolina, Ohio, Texas, Virginia)
How to tell if yours is affected
Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1654-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 29, 2026 |
| Reported | April 8, 2026 |
| Company | ReCor Medical Inc. |
| Company location | Palo Alto, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1 |
More recalls from ReCor Medical Inc. · all medical device recalls · recalls from January 2026