Class II — ReCor Medical Inc.
| Recalling firm | Recor Medical, Inc. |
|---|---|
| Registered facility | RECOR MEDICAL (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use. |
| 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 |
| Quantity | 1 |
| Distribution | U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA. |
| Initiated | 2026-01-29 |
| Classified | 2026-03-27 |
| Recall number | Z-1654-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ReCor Medical Inc. (Z-1654-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98365/
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