FDA Medical devices recall ·
Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿… recall
- Recall number
- Z-1654-2026
- Date
- (initiated January 29, 2026)
- Company / brand
- ReCor Medical Inc.
1049 Elwell Ct, Palo Alto, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4907
Distribution
U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
States: California Colorado Florida Kansas Missouri North Carolina Ohio Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1654-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.