Brand Name: Paradise¿ Ultrasound Renal Denervation recall
Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description…
Why was Brand Name: Paradise¿ Ultrasound Renal Denervation recalled?
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862
- Product
- Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description…
- Recalling firm
- ReCor Medical Inc.
- Quantity
- 24
- Distribution
- U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
- Recall date
- April 8, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)