Hemodialysis System, Surdial DX
Medical device recall Z-0912-2026. Published in FDA’s Enforcement Report on Dec 17, 2025.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 17, 2025. Copied from openFDA on Oct 20, 2026.
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Screw may loosen or fallout of Hemodialysis system
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 00383790008815/Serial Numbers: 20EW0001 20EW0002 20EW0005 20EW0006 20EW0007 20EW0008 20EW0009 20EW0010 20EW0011 20EW0012 20EW0013 20EW0014 20EW0015 20EW0016 20EW0017 20EW0018 20EW0019 20EW0020 20EW0021 20EW0022 20EW0023 20EW0024…
Every code shown here, 1,998 characters
UDI: 00383790008815/Serial Numbers: 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 21EW0075 21EW0076 21EW0077 21EW0078 21EW0079 21EW0080 21EW0081 21EW0082 21EW0083 21EW0084 21EW0085 21EW0086 21EW0087 21EW0088 21EW0089 21EW0090 21EW0091 21EW0092 21EW0093 21EW0094 21EW0095 21EW0096 21EW0097 21EW0098 21EW0099 21EW0100 21EW0101 21EW0102 21EW0103 21EW0104 21EW0105 21EW0106 21EW0107 21EW0108 21EW0109 21EW0110 21EW0111 21EW0112 21EW0113 21EW0114 21EW0115 21EW0116 21EW0117 21EW0118 21EW0119 21EW0120 21EW0122 21EW0123 21EW0124 21EW0125 21EW0126 21EW0127 21EW0128 21EW0129 21EW0130 21EW0131 21EW0133 21EW0134 21EW0135 21EW0136 21EW0137 21EW0138 21EW0139 21EW0140 21EW0141 21EW0142 21EW0143 21EW0144 21EW0145 21EW0146 21EW0147 21EW0148 21EW0149 21EW0150 21EW0151 21EW0152 21EW0153 21EW0154 21EW0155 21EW0156 21EW0157 21EW0158 21EW0159 21EW0160 21EW0162 21EW0163 21EW0164 21EW0165 21EW0166 21EW0167 21EW0168 21EW0169 21EW0170 21EW0171 21EW0172 21EW0173 21EW0174 21EW0175 21EW0176 21EW0177 21EW0178 21EW0179 21EW0180 21EW0181 21EW0182 21EW0183 21EW0184 21EW0185 21EW0186 21EW0187 21EW0188 21EW0189 21EW0190 21EW0191 21EW0192 21EW0193 21EW0194 21EW0195 21EW0196 21EW0197 21EW0198 21EW0199 21EW0200 21EW0201 21EW0202 21EW0203 21EW0204 21EW0205 21EW0206 21EW0207 21EW0208 21EW0209 21EW0210 21EW0211 21EW0212 21EW0213 21EW0214 21EW0215 21EW0216 21EW0217 21EW0218 21EW0219 21EW0220 21EW0221 21EW0222 21EW0223 21EW0224 21EW0225 21EW0226 21EW0227 21EW0228 21EW0229 21EW0230 21EW0231 21EW0232 21EW0233 21EW0234 21EW0235…
FDA’s list runs to 46,890 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
21 states and territories.
Every one of them
- Alabama
- Arkansas
- California
- Florida
- Georgia
- Iowa
- Illinois
- Michigan
- Minnesota
- Mississippi
- North Carolina
- North Dakota
- New Jersey
- New York
- Ohio
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Texas
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 27, 2025.
- FDA classified it on Dec 11, 2025.
- FDA’s Enforcement Report published it on Dec 17, 2025.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Nipro Medical Corporation, of Doral, FL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 46,890 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.