Nipro Medical Corporation is recalling the Surdial DX Hemodialysis System (Model MC+SDX01) because a screw within the system may loosen or fall out. This mechanical defect could cause the system to malfunction or fail during hemodialysis treatment. The recall affects thousands of units distributed across the United States. Healthcare providers and clinical facilities should immediately stop using devices with the affected serial numbers and contact the manufacturer or their distributor for a replacement or repair.
A loose or missing screw can lead to mechanical instability or the complete failure of the hemodialysis system during use. If the machine stops functioning during a treatment session, it could lead to serious patient harm or death due to the interruption of blood purification.
Units manufactured between 2020 and 2025 are affected based on serial number prefixes 20EW through 25EW.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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