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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0427-2026.jsonld",
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  "name": "Tandem Mobi Insulin Pump:  Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).  Pump, Tandem Mobi, Control-IQ/1010750,  Pump, Tandem Mobi, Control-IQ, Replacement/1012719,  Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501,  Pump, Tandem Mobi, Control-IQ 7.7/1013655,  Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656,  Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700,  Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081",
  "description": "FDA recall Z-0427-2026 — Tandem Diabetes Care, Inc. is recalling Tandem Mobi Insulin Pump:  Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).  Pump, Tandem Mobi, Control-IQ/1010750,  Pump, Tandem Mobi, Control-IQ, Replacement/1012719,  Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501,  Pump, Tandem Mobi, Control-IQ 7.7/1013655,  Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656,  Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700,  Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081 (Devices, Class I). 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",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0427-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Tandem Mobi Insulin Pump:  Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).  Pump, Tandem Mobi, Control-IQ/1010750,  Pump, Tandem Mobi, Control-IQ, Replacement/1012719,  Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501,  Pump, Tandem Mobi, Control-IQ 7.7/1013655,  Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656,  Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700,  Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Tandem Diabetes Care, Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0427-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0427-2026: Tandem Diabetes Care, Inc. is recalling Tandem Mobi Insulin Pump:  Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).  Pump, Tandem Mobi, Control-IQ/1010750,  Pump, Tandem Mobi, Control-IQ, Replacement/1012719,  Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501,  Pump, Tandem Mobi, Control-IQ 7.7/1013655,  Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656,  Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700,  Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081",
      "text": "The FDA logged enforcement record Z-0427-2026: Tandem Diabetes Care, Inc. is voluntarily recalling Tandem Mobi Insulin Pump:  Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps capable of both basal and bolus delivery of insulin. The pumps utilize a motor-driven mechanism to deliver insulin from within a disposable cartridge, through an infusion set, into a patient s subcutaneous tissue. As with current insulin infusion pumps on the U.S. market, the desired timing and quantity of the insulin delivery is programmed by the user (i.e., the patient).  Pump, Tandem Mobi, Control-IQ/1010750,  Pump, Tandem Mobi, Control-IQ, Replacement/1012719,  Pump, Tandem Mobi, Control-IQ 7.6.0.3, Medicare/1013501,  Pump, Tandem Mobi, Control-IQ 7.7/1013655,  Pump, Tandem Mobi, Control-IQ, 7.7, Replacement/1013656,  Pump, Tandem Mobi, Control-IQ 7.7, Medicare/1013700,  Pharmacy Kit, Starter Pack, Tandem Mobi 7.7/1014081 — reason: Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: \"Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped\", which could result in hyperglycemia.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-06. Affected lots/codes: Software versions: 7.6.0.1, 7.6.0.3, and 7.7.0.1 Catalog/UDI-DI: 1010750/00389152075013, 1012719/00389152271910, 1013501/00389152350110, 1013655/00389152365510, 1013656/00389152365619, 1013700/00389152370019, 1014081/00389152408170. 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": {
        "groundingType": "SourceCitation",
        "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-0427-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
        "adjudicator": {
          "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-0427-2026&lang=eng"
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      },
      "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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0427-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0427-2026 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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",
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        "supported": true,
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        "value": "Class I",
        "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-0427-2026&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0427-2026/boundary",
      "@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": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
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      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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-0427-2026",
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            "Value": "Z-0427-2026",
            "Status": "recorded"
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            "Field": "Classification",
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            "Value": "Ongoing — the recall is still being carried out.",
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          "item": {
            "Field": "Recalling firm",
            "Value": "Tandem Diabetes Care, Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor failure due to a software issue causing Malfunction 12: \"Pump cannot operate, the mobile app can no longer receive data from the pump. Insulin delivery and any active CGM Sessions have been stopped\", which could result in hyperglycemia.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-10-06",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Software versions: 7.6.0.1, 7.6.0.3, and 7.7.0.1 Catalog/UDI-DI: 1010750/00389152075013, 1012719/00389152271910, 1013501/00389152350110, 1013655/00389152365510, 1013656/00389152365619, 1013700/00389152370019, 1014081/00389152408170",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, PT, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY",
            "Status": "recorded"
          }
        }
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}