FDA Device recall Z-1654-2026
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Descr…
- FDA Device
- Class II
- ongoing
- Published 2026-04-08
On 2026-04-08 the FDA classified a Class II recall of Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Descr… by Recor Medical, citing due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1654-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-29 |
| Published | 2026-04-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Recor Medical |
| Distribution | US |
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.
Identifiers
| code_info | Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1654-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.