Reported Dec 17, 2025 · Ongoing
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
Nipro Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nipro Medical Corporation · 3150 NW 107th Ave · Doral, FL · 33172-2135
Is this the product you have?
- Hemodialysis System
- Surdial DX REFMC+SDX01 Rx Only
- Lot codes and dates
- UDI00383790008815/Serial
- Numbers2
3,618 of 3,618 codes
20EW000120EW000220EW000520EW000620EW000720EW000820EW000920EW001020EW001120EW001220EW001320EW001420EW001520EW001620EW001720EW001820EW001920EW002020EW002120EW002220EW002320EW002420EW002520EW002620EW002720EW002820EW002920EW003020EW003120EW003220EW003320EW003420EW003520EW003620EW003720EW003820EW003920EW004020EW004120EW004220EW004320EW004420EW004520EW004620EW004820EW004920EW005021EW006121EW006221EW006321EW006421EW006521EW006621EW006721EW006821EW006921EW007021EW007121EW007221EW0073
- Amount recalled
- N/A
Where it was sold
Why it was recalled
Screw may loosen or fallout of Hemodialysis system
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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