← FDA ENFORCEMENT
Z-1654-2026Class II

ReCor Medical Inc.

Recalling firm
ReCor Medical Inc.
Product type
Device
Status
Ongoing
Report date
2026-04-08
Distribution
U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
Firm state
CA
Product quantity
1
Initiated by
Voluntary: Firm initiated
Reason for recall

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

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

Code / lot info

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

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.