Recall of Paradise Catheter by ReCor Medical Inc.
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 voluntarily recalling one unit of the Paradise Catheter due to it being a nonconforming product not intended for human use, affecting nationwide distribution in several U.S. states.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 16, 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, fda, Devices.
What Happened
ReCor Medical Inc. is recalling the product because the firm distributed a nonconforming item that was supposed to be scrapped and not used for human purposes.
Which Products Are Affected
The affected product is the Paradise Ultrasound Renal Denervation System, specifically the Paradise Catheter with Model/Catalog Number: PRDS-068-02. Only 1 unit is involved, with Lot Number: M4907 and UDI-DI: 00810008950043. It was distributed in the states of CA, CO, FL, KS, MO, NC, OH, TX, and VA.
What You Should Do
Consumers should contact ReCor Medical Inc. as per the firm's initial notification letter for further instructions regarding this recall.
Why This Matters
This recall underscores the need for proper quality control in medical devices to ensure patient safety, as nonconforming products could potentially lead to ineffective treatment.
Source
FDA Recall Number: Z-1654-2026. For more information, refer to the FDA website.
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 (962 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to April 16, 2026.
Frequently Asked Questions
Common questions about this FDA recall.