FDA Recall of Paradise Ultrasound Renal Denervation System
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
ReCor Medical Inc. is recalling 24 units of the Paradise Catheter due to distribution of a nonconforming product intended for scrapping and not for human use.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 15, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, cpsc, Devices.
What Happened
ReCor Medical Inc. is recalling the product due to distributing a nonconforming item that was supposed to be scrapped and not intended for human use.
Which Products Are Affected
The affected product is the Paradise Ultrasound Renal Denervation System, specifically the Paradise Catheter. The model/catalog number is PRDS-068-02. A total of 24 units are involved, with Lot Code: Model No PRDS-068-02; UDI-DI 00810008950043; Lot Number: M4862. The products were distributed nationwide in the United States, specifically in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
What You Should Do
Consumers who have the affected product should contact ReCor Medical Inc. at their address: 1049 Elwell Ct, Palo Alto, CA 94303-4308, as the recall was initiated via letter. Follow the firm's instructions for returns or refunds related to recall number Z-1655-2026.
Why This Matters
This recall involves a medical device that was not meant for human use, potentially posing health risks to patients. It highlights the importance of ensuring product conformity in medical distributions to maintain safety standards.
Source
Attribution: FDA. For more information, visit the FDA website at https://www.fda.gov.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,229 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 15, 2026.
Frequently Asked Questions
Common questions about this FDA recall.