Brand Name: Paradise¿ Ultrasound Renal Denervation System Product… — Class II medical device recall Z-1655-2026
Ongoing recall by ReCor Medical Inc., reported 2026-04-08, distributed nationwide. Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
| Recall number | Z-1655-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ReCor Medical Inc., Palo Alto, CA, United States |
| Recall initiated | 2026-01-29 |
| Classified | 2026-03-27 |
| Reported by FDA | 2026-04-08 |
| Distributed | Nationwide (US) |
| Quantity | 24 |
| UPC / GTIN / UDI-DI | 00810008950043 |
| Lot numbers | M4862 |
| Model numbers | PRDS-068-02 |
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 for recall
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1655-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.