Class II

Medical Device Recall: 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

ReCor Medical Inc. · January 29, 2026

Reason for Recall

Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.

Distribution

U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.

States Affected

NATIONWIDE

Quantity Affected

24

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1655-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.