🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: January 29, 2026 ReCor Medical Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
ReCor Medical Inc.
Reason for Recall:
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full 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

Product Codes/Lot Numbers:

Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1655-2026