ReCor Medical Inc. recalls Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Cathet
- Recalling company
- ReCor Medical Inc.
- 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
- Reason
- Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jan 29, 2026
- Reported
- Apr 8, 2026
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
- Status
- Ongoing
- Quantity
- 1
- Lot / codes
- Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907
- Company location
- Palo Alto, CA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1654-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1654-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.