ReCor Medical Inc. is recalling 25 Paradise Ultrasound Renal Denervation System Catheters because they were distributed after being marked for scrap and are not intended for human use. These nonconforming medical devices do not meet the company's manufacturing standards and should not be used in any clinical procedure. Consumers and healthcare providers should check for affected lot numbers M4907 and M4862 distributed in nine states including California, Florida, and Texas.
The catheters are nonconforming products that were supposed to be destroyed; using them on patients poses an unpredictable risk of injury or device failure because they were never cleared for clinical use.
Recall numbers Z-1654-2026 and Z-1655-2026.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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