ReCor Medical Inc. recalls Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-…

Recall date

January 29, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1654-2026

FDA classification

Class II

Brand / firm

ReCor Medical Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was 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