Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
type: Dataset
description: FDA recall Z-0912-2026 — Nipro Medical Corporation is recalling Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only (Devices, Class II). The enforcement record is RECORDED; the classification is a DETERMINATION (FDA's regulatory verdict); the boundary is INTERPRETATION (a recall ≠ harm to a specific person). Source: openFDA. CC0.
license: https://creativecommons.org/publicdomain/zero/1.0/
is accessible for free: true
is part of: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
is defined by: https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native
see also: https://agenticu.ryanjhunter.workers.dev/commons/the-research-object
date modified: 2026-06-24T07:02:03.626072+00:00
is based on: openFDA drug & device enforcement (recall) reports
  type: Dataset
  creator: U.S. Food & Drug Administration
about: Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
  type: MedicalDevice
  manufacturer: Nipro Medical Corporation
claims: FDA recall Z-0912-2026: Nipro Medical Corporation is recalling Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
claims: FDA classified recall Z-0912-2026 as Class II
claims: What an FDA recall is — and is NOT
has part: FDA recall details — Z-0912-2026
  type: ItemList
  number of items: 9
  item list element: ListItem
    position: 1
    item:
      field: Recall number
      value: Z-0912-2026
      status: recorded
  item list element: ListItem
    position: 2
    item:
      field: Product type
      value: Devices
      status: recorded
  item list element: ListItem
    position: 3
    item:
      field: Classification
      value: Class II
      status: determination
  item list element: ListItem
    position: 4
    item:
      field: Status
      value: Ongoing — the recall is still being carried out.
      status: recorded
  item list element: ListItem
    position: 5
    item:
      field: Recalling firm
      value: Nipro Medical Corporation
      status: recorded
  item list element: ListItem
    position: 6
    item:
      field: Reason
      value: Screw may loosen or fallout of Hemodialysis system
      status: recorded
  item list element: ListItem
    position: 7
    item:
      field: Initiated
      value: 2025-10-27
      status: recorded
  item list element: ListItem
    position: 8
    item:
      field: Lot/code info
      value: 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 21…
      status: recorded
  item list element: ListItem
    position: 9
    item:
      field: Distribution pattern
      value: 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.
      status: recorded

FDA recall Z-0912-2026: Nipro Medical Corporation is recalling Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only
type: Claim
text: The FDA logged enforcement record Z-0912-2026: Nipro Medical Corporation is voluntarily recalling Hemodialysis System, Surdial DX REF: MC+SDX01 Rx Only — reason: Screw may loosen or fallout of Hemodialysis system. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-27. Affected lots/codes: 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 21…
claim type: official_fact
review status: current
commercial influence: false
epistemic status:
  occurred: true
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: SourceCitation
  source: openFDA drug & device enforcement (recall) reports — U.S. FDA
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Devices recall, status Ongoing
  adjudicator: openFDA drug & device enforcement (recall) reports — U.S. FDA
falsifier: A RECORD of measured/reported events (occurred=true) from openFDA drug & device enforcement (recall) reports — U.S. FDA; superseded when openFDA drug & device enforcement (recall) reports — U.S. FDA publishes its next release.

FDA classified recall Z-0912-2026 as Class II
type: Claim
text: The FDA assigned this recall Class II: Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.. This is the FDA's official risk classification — its regulatory DETERMINATION of the hazard category (a verdict constituted by the FDA's recognition, occurred=FALSE), adjudged=TRUE because the FDA issued it. It is NOT a measurement of harm to any specific person.
claim type: regulatory_determination
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: true
  operative: true
grounding:
  grounding type: AdjudicativeAct
  source: U.S. FDA recall classification (openFDA enforcement)
  source url: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm
  value: Class II
  adjudicator: U.S. FDA recall classification (openFDA enforcement)
falsifier: occurred=FALSE: a regulatory DETERMINATION (an authority's classification/judgment) has NO material truthmaker independent of recognition — it is constituted by U.S. FDA recall classification (openFDA enforcement)'s say-so (a Searle institutional fact), not measured. adjudged=TRUE because U.S. FDA recall classification (openFDA enforcement) (an external authority) issued it. Distinct from a recorded measurement (which has an independent truthmaker) and from a modeled figure (a computed quantity, not a verdict). Challengeable; superseded if the authority reclassifies.

What an FDA recall is — and is NOT
type: Claim
text: A recall is a RECORDED FDA enforcement action — the FDA logged that a firm is removing or correcting a product, classed by the FDA's risk judgment. It does NOT establish that any specific unit is affected or caused harm; causation is not established. This record informs and compares — it is NOT medical advice and does not tell anyone to start or stop a drug or device. For a medical decision, route to the FDA recall record and a licensed pharmacist or prescriber.
claim type: interpretation
review status: current
commercial influence: false
epistemic status:
  occurred: false
  supported: true
  adjudged: false
  operative: true
grounding:
  grounding type: Interpretation
  source: Atlas Commons L5 boundary (enforcement-action ≠ harm causation)
  source url: https://drug-device-safety-atlas.ryanjhunter.workers.dev/
  value: a recorded enforcement action, not proof of harm or causation; not medical advice
falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.