Recall Z-1654-2026— ReCor Medical Inc.
Class II · Ongoing
Class II FDA medical device recall by ReCor Medical Inc., initiated 2026-01-29. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- ReCor Medical Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-01-29
- Firm location
- Palo Alto, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.