# FDA recall Z-1655-2026

> **ReCor Medical Inc.** · Class II · device recall initiated 2026-01-29.

## 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.

## Distribution

U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.

## Key facts

- **Recall number:** Z-1655-2026
- **Recalling firm:** ReCor Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-01-29
- **Report date:** 2026-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Palo Alto, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1655-2026

## Citation

> AI Analytics. FDA recall Z-1655-2026. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-1655-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*