FDAHealthJanuary 29, 2026
ReCor Medical Inc. — Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation cathete
⚠️ Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- January 29, 2026
U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
What's affected?
- Product
- 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
- Brand
- ReCor Medical Inc.
- Lot code
- Model
Additional details
Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 24.
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