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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1740-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)",
  "description": "FDA recall Z-1740-2026 — Medtronic MiniMed, Inc. is recalling MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) (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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1740-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)",
    "manufacturer": {
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      "name": "Medtronic MiniMed, Inc."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1740-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1740-2026: Medtronic MiniMed, Inc. is recalling MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755)",
      "text": "The FDA logged enforcement record Z-1740-2026: Medtronic MiniMed, Inc. is voluntarily recalling MiniMed 630G Insulin Pump (MMT-1714, MMT-1715, MMT-1754, MMT-1755) — reason: All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-02-13. Affected lots/codes: Pump: UDI-DI(GTIN): User Guide Name(Part-Version):  MiniMed 630G Insulin Pump: 763000253066, 643169752726, 763000101527, 763000190446, 763000317591, 763000157043, 643169752726, 763000101527, 763000190446, 763000317591, 643169873841, 643169878648, 763000179632, 76300031759101, 76300031759103, 76300031762103, 763000367091, 763000317621, 763000157043, 76300031762101:  MiniMed 630G System(M020092C004 1);  MINIMED 630G and  MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1);  MiniMed 630G Insulin pump MODEL MMT-1714(M993428A262 1);  MiniMed 630G System User Guide(M020092C001 3, M020092C003 1, M020092C005 1);  MINIMED 630G SYSTEM USER GUIDE mg/dL(M979512A011 1);  MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(MP6026120-262 1);  MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(M030278C001 3, M030278C002 1);  MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE mmol/L (MP6026120-024 1);  MiniMed Veo with Enlite Threshold Suspend Performance(M10577668A262 1).. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
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        "source": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1740-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1740-2026&lang=eng"
        }
      },
      "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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1740-2026/fda-classification",
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      "name": "FDA classified recall Z-1740-2026 as Class II",
      "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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1740-2026&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1740-2026&lang=eng"
        }
      },
      "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."
    },
    {
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      "@type": "schema:Claim",
      "name": "What an FDA recall is — and is NOT",
      "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.",
      "claimType": "interpretation",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
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        "supported": true,
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        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
      },
      "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."
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      "name": "FDA recall details — Z-1740-2026",
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            "Value": "Z-1740-2026",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Medtronic MiniMed, Inc.",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of insulin when the pump is elevated or lowered relative to the infusion site, respectively, because of changes in gravitational force impacting hydrostatic and hydrodynamic pressures. Insulin over-delivery, which can occur when the pump is elevated relative to the infusion site, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An under-delivery of insulin, which can occur at lowered pump height conditions relative to the infusion site, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Initiated",
            "Value": "2026-02-13",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Pump: UDI-DI(GTIN): User Guide Name(Part-Version):  MiniMed 630G Insulin Pump: 763000253066, 643169752726, 763000101527, 763000190446, 763000317591, 763000157043, 643169752726, 763000101527, 763000190446, 763000317591, 643169873841, 643169878648, 763000179632, 76300031759101, 76300031759103, 76300031762103, 763000367091, 763000317621, 763000157043, 76300031762101:  MiniMed 630G System(M020092C004 1);  MINIMED 630G and  MINIMED 670G INSULIN PUMP SYSTEM(M042888C002 1);  MiniMed 630G Insulin pump MODEL MMT-1714(M993428A262 1);  MiniMed 630G System User Guide(M020092C001 3, M020092C003 1, M020092C005 1);  MINIMED 630G SYSTEM USER GUIDE mg/dL(M979512A011 1);  MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(MP6026120-262 1);  MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE(M030278C001 3, M030278C002 1);  MINIMED 630G WITH SMARTGUARD TECHNOLOGY SYSTEM USER GUIDE mmol/L (MP6026120-024 1);  MiniMed Veo with Enlite Threshold Suspend Performance(M10577668A262 1).",
            "Status": "recorded"
          }
        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution including in the states of OR, CA, AZ, NY,TX,FL, OH, MO, TN,NJ, NC, SC, IL, VA, WA, DC, GA, PA, MS,IA, MI, NH, OK, SD, MT, WI, WV, MA, LA, MN, RI, AR, ME, AL, IN, UT, KY, CO, ND, MD, CT, NM, KS, ID, NV, DE, NE, VT, AK, HI, WY, PR, VI and the countries of Taiwan, New Zealand, Australia, Bangladesh, Brunei Darussalam, Cambodia, Indonesia, Malaysia, Maldives, Philippines, Thailand, Vietnam, Singapore, Pakistan, Hong Kong, China, Argentina, Aruba, Barbados, Bermuda, Bolivia, Plurinational State Of, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, Puerto Rico, Trinidad And Tobago, Uruguay, Venezuela, Canada, South Korea, India, Albania, Algeria, Andorra, Armenia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Bosnia And Herzegovina, Botswana, Bulgaria, Canary Islands, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, French Guyana, French Polynes., Georgia, Germany, Gibraltar, Greece, Guadeloupe, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Liechtenstein, Lithuania, Luxembourg, Macedonia, Malawi, Malta, Martinique, Mauritius, Mayotte, Moldavia, Montenegro, Morocco, Namibia, Netherlands, New Caledonia, Nigeria, Northern Ireland, Norway, Oman, Poland, Portugal, Qatar, Reunion, Romania, Russia, San Marino, Saudi Arabia, Serbia, Sierra Leone, Slovakia, Slovenia, South Africa, Spain, St.Pier,Miquel., Sudan, Sweden, Switzerland, Syrian Arab Republic, Tanzania, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Yemen, Zambia, Zimbabwe.",
            "Status": "recorded"
          }
        }
      ]
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}