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RecallWatchMedical Device Safety
Class IIOngoingZ-0912-2026

Nipro Medical Corporation recalls Hemodialysis System

Nipro Medical CorporationDoral, FL, United StatesReported Dec 17, 2025 · 7 months ago
Legal News Analyst ·

Reason for recall

Screw may loosen or fallout of Hemodialysis system

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • Hemodialysis System, Surdial DX REF: MC+SDX01 Rx OnlyUDI
    UDI 00383790008815/Serial
    400 affected lots
    20EW000120EW000220EW000520EW000620EW000720EW000820EW000920EW0010
    +392 more20EW001120EW001220EW001320EW001420EW001520EW001620EW001720EW001820EW001920EW002020EW002120EW002220EW002320EW002420EW002520EW002620EW002720EW002820EW002920EW003020EW003120EW003220EW003320EW003420EW003520EW003620EW003720EW003820EW003920EW004020EW004120EW004220EW004320EW004420EW004520EW004620EW004820EW004920EW005021EW006121EW006221EW006321EW006421EW006521EW006621EW006721EW006821EW006921EW007021EW007121EW007221EW007321EW007521EW007621EW007721EW007821EW007921EW008021EW008121EW008221EW008321EW008421EW008521EW008621EW008721EW008821EW008921EW009021EW009121EW009221EW009321EW009421EW009521EW009621EW009721EW009821EW009921EW010021EW010121EW010221EW010321EW010421EW010521EW010621EW010721EW010821EW010921EW011021EW011121EW011221EW011321EW011421EW011521EW011621EW011721EW011821EW011921EW012021EW012221EW012321EW012421EW012521EW012621EW012721EW012821EW012921EW013021EW013121EW013321EW013421EW013521EW013621EW013721EW013821EW013921EW014021EW014121EW014221EW014321EW014421EW014521EW014621EW014721EW014821EW014921EW015021EW015121EW015221EW015321EW015421EW015521EW015621EW015721EW015821EW015921EW016021EW016221EW016321EW016421EW016521EW016621EW016721EW016821EW016921EW017021EW017121EW017221EW017321EW017421EW017521EW017621EW017721EW017821EW017921EW018021EW018121EW018221EW018321EW018421EW018521EW018621EW018721EW018821EW018921EW019021EW019121EW019221EW019321EW019421EW019521EW019621EW019721EW019821EW019921EW020021EW020121EW020221EW020321EW020421EW020521EW020621EW020721EW020821EW020921EW021021EW021121EW021221EW021321EW021421EW021521EW021621EW021721EW021821EW021921EW022021EW022121EW022221EW022321EW022421EW022521EW022621EW022721EW022821EW022921EW023021EW023121EW023221EW023321EW023421EW023521EW023621EW023721EW023821EW023921EW024021EW024121EW024221EW024321EW024421EW024521EW024621EW024721EW024821EW024921EW025021EW025121EW025221EW025321EW025421EW025521EW025621EW025721EW025821EW025921EW026021EW026121EW026221EW026421EW026521EW026621EW026721EW026821EW026921EW027021EW027121EW027221EW027321EW027421EW027521EW027621EW027721EW027821EW027921EW028021EW028121EW028221EW028321EW028421EW028521EW028622EW028722EW028822EW028922EW029022EW029122EW029222EW029322EW029422EW029522EW029622EW029722EW029822EW029922EW030022EW030122EW030222EW030322EW030422EW030522EW030622EW030722EW030822EW030922EW031022EW031122EW031222EW031322EW031422EW031522EW031622EW031722EW031822EW031922EW032022EW032122EW032222EW032322EW032422EW032522EW032622EW032722EW032822EW032922EW033022EW033122EW033222EW033322EW033422EW033522EW033622EW033722EW033822EW033922EW034022EW034122EW034222EW034322EW034422EW034522EW034622EW034722EW034822EW035122EW035222EW035322EW035422EW035522EW035622EW035722EW035822EW035922EW036023EW036123EW036223EW036323EW036423EW036523EW036623EW036723EW036823EW036923EW037023EW037123EW037223EW037323EW037423EW037523EW037623EW037723EW037823EW037923EW038023EW038123EW038223EW038323EW038423EW038523EW038623EW038723EW038823EW038923EW039023EW039123EW039223EW039323EW039423EW039523EW039623EW039723EW039823EW039923EW040023EW040123EW040223EW040323EW040423EW040523EW040623EW040723EW040823EW040923EW041023EW041123EW041223EW041323EW041423EW041523EW041623EW041723EW041823EW041923EW0420

What the firm is doing

On October 27, 2025, Nipro issued a voluntary recall notification to affected consignees via E-Mail. In addition to provide information on the recall, Nipro asked consignees to take the following actions: 1. Please complete the enclosed SURDIAL DX Hemodialysis System Response Form to ensure the correct contact information for each machine to enable timely service appointments. 2. Pass this notice on to any facility that the Surdial DX Hemodialyis system has been transferred to. 3. Ensure all operators are aware of this recall notification. 4. Maintain a copy of the notification with affected machines. 5. Before each use, verify that the blood pump rotor assembly is securely fastened and operates smoothly without unusual vibration or looseness. 6. Monitor all impacted SURDIAL DX machines during operation for abnormal / unusual sounds, vibration or system error messages associated with the blood pump rotor assembly. 7. If any abnormality occurs, discontinue use immediately, safely remove the patient from the system following your facility protocols as appropriate.

DistributionShow details

US Nationwide distribution in the states of AL, AR, CA, FL, GA, IL, IA, MI, MN, MS, NJ, NY, NC, ND, OH, OR, PA, SC, SD, TX, WV, WC.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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