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
  • Numbers

    3,618 of 3,618 codes

    • 20EW0001
    • 20EW0002
    • 20EW0005
    • 20EW0006
    • 20EW0007
    • 20EW0008
    • 20EW0009
    • 20EW0010
    • 20EW0011
    • 20EW0012
    • 20EW0013
    • 20EW0014
    • 20EW0015
    • 20EW0016
    • 20EW0017
    • 20EW0018
    • 20EW0019
    • 20EW0020
    • 20EW0021
    • 20EW0022
    • 20EW0023
    • 20EW0024
    • 20EW0025
    • 20EW0026
    • 20EW0027
    • 20EW0028
    • 20EW0029
    • 20EW0030
    • 20EW0031
    • 20EW0032
    • 20EW0033
    • 20EW0034
    • 20EW0035
    • 20EW0036
    • 20EW0037
    • 20EW0038
    • 20EW0039
    • 20EW0040
    • 20EW0041
    • 20EW0042
    • 20EW0043
    • 20EW0044
    • 20EW0045
    • 20EW0046
    • 20EW0048
    • 20EW0049
    • 20EW0050
    • 21EW0061
    • 21EW0062
    • 21EW0063
    • 21EW0064
    • 21EW0065
    • 21EW0066
    • 21EW0067
    • 21EW0068
    • 21EW0069
    • 21EW0070
    • 21EW0071
    • 21EW0072
    • 21EW0073
    2
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.