Home / Recalls / ReCor Medical Inc. / Z-1654-2026

Z-1654-2026 Class II Ongoing

Recalled by ReCor Medical Inc. — Palo Alto, CA

Recall Details

Product Type: Devices
Report Date: April 8, 2026
Initiation Date: January 29, 2026
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1

Product Description

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 for Recall

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

Distribution Pattern

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

Code Information

Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907