Drug recall
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog…
FDA recall event 98365 · Class II · ReCor Medical Inc.
Key facts
| Event ID | 98365 |
|---|---|
| Recall numbers | Z-1654-2026, Z-1655-2026 |
| Recalling firm | ReCor Medical Inc. |
| Product type | Devices |
| Products | 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 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. |
| Initiation date | Jan 29, 2026 |
| Report date | Apr 8, 2026 |
| City | Palo Alto |
| State | CA |
| Country | United States |
| FEI number | 3010024164 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: