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  "name": "NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I  The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.",
  "description": "FDA recall Z-0127-2026 — Applied Medical Technology Inc is recalling NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I  The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. (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:MedicalDevice",
    "name": "NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I  The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.",
    "manufacturer": {
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      "name": "Applied Medical Technology Inc"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0127-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0127-2026: Applied Medical Technology Inc is recalling NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I  The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients.",
      "text": "The FDA logged enforcement record Z-0127-2026: Applied Medical Technology Inc is voluntarily recalling NutraGlide Nasal Feeding Tube with Stylet and ENFit, 5 F - 6 F x 55, REF E NRT-05055-I  The NutraGlide Nasal Feeding Tube is a feeding tube placed through the nose and ending in the stomach or intestine used for the administration of nutrition, fluids, and medications in neonatal, pediatric, and adult patients. — reason: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.. Status: Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).. Initiated 2025-08-12. Affected lots/codes: Box UDI (01)00842071149628(17)280601(10)250711-237, Pouch UDI:  (01)00842071149505(17)280701(10)250707-412, (01)00842071149505(17)280601(10)250701-300.    Box UDI (01)00842071149628(17)280701(10)250717-425, Pouch UDI:  (01)00842071149505(17)280701(10)250710-247,  (01)00842071149505(17)280701(10)250710-246.    Box UDI (01)00842071149628(17)280601(10)250709-162, Pouch UDI:  (01)00842071149505(17)280701(10)250702-222,  (01)00842071149505(17)280601(10)250627-420, (01)00842071149505(17)280701(10)250702-412.    Box UDI (01)00842071149628(17)280601(10)250710-217, Pouch UDI:  (01)00842071149505(17)280701(10)250702-169, (01)00842071149505(17)280701(10)250702-138, (01)00842071149505(17)280701(10)250702-220, (01)00842071149505(17)280601(10)250630-093, (01)00842071149505(17)280601(10)250630-048, (01)00842071149505(17)280601(10)250630-047, (01)00842071149505(17)280601(10)250630-046, (01)00842071149505(17)280701(10)250702-170.     Box UDI (01)00842071149628(17)280601(10)250710-307, Pouch UDI:  (01)00842071149505(17)280701(10)250707-457, (01)00842071149505(17)280701(10)250702-414, (01)00842071149505(17)280601(10)250701-302, (01)00842071149505(17)280601(10)250701-301, (01)00842071149505(17)280701(10)250702-137.    Box UDI (01)00842071149628(17)280601(10)250620-347, Pouch UDI:  (01)00842071149505(17)280601(10)250617-066, (01)00842071149505(17)280601(10)250617-067, (01)00842071149505(17)280601(10)250617-101.    Box UDI (01)00842071149628(17)280601(10)250626-400, Pouch UDI:  (01)00842071149505(17)280601(10)250609-364.    Box UDI (01)00842071149628(17)280601(10)250618-493, Pouch UDI:  (01)00842071149505(17)280601(10)250609-360, (01)00842071149505(17)280601(10)250604-076, (01)00842071149505(17)280601(10)250611-223, (01)00842071149505(17)280601(10)250612-097, (01)00842071149505(17)280601(10)250609-363, (01)00842071149505(17)280601(10)250609-362.    Box UDI (01)00842071149628(17)280501(10)250612-388, Pouch UDI:  (01)00842071149505(17)280601(10)250605-139, (01)00842071149505(17)280601(10)250603-078, (01)00842071149505(17)280601(10)250604-383.    Box UDI (01)00842071149628(17)280601(10)250616-372, Pouch UDI:  (01)00842071149505(17)280601(10)250604-075, (01)00842071149505(17)280601(10)250604-382, (01)00842071149505(17)280601(10)250605-338.. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Completed",
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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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0127-2026/fda-classification",
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      "name": "FDA classified recall Z-0127-2026 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.",
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        "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-0127-2026&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-0127-2026&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-0127-2026/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",
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      "epistemicStatus": {
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        "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-0127-2026",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-0127-2026",
            "Status": "recorded"
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          "position": 2,
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            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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            "Field": "Classification",
            "Value": "Class II",
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            "Value": "Completed — the FDA has determined all recalling-firm actions are complete (the FDA's review may still be open).",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Applied Medical Technology Inc",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-08-12",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Box UDI (01)00842071149628(17)280601(10)250711-237, Pouch UDI:  (01)00842071149505(17)280701(10)250707-412, (01)00842071149505(17)280601(10)250701-300.    Box UDI (01)00842071149628(17)280701(10)250717-425, Pouch UDI:  (01)00842071149505(17)280701(10)250710-247,  (01)00842071149505(17)280701(10)250710-246.    Box UDI (01)00842071149628(17)280601(10)250709-162, Pouch UDI:  (01)00842071149505(17)280701(10)250702-222,  (01)00842071149505(17)280601(10)250627-420, (01)00842071149505(17)280701(10)250702-412.    Box UDI (01)00842071149628(17)280601(10)250710-217, Pouch UDI:  (01)00842071149505(17)280701(10)250702-169, (01)00842071149505(17)280701(10)250702-138, (01)00842071149505(17)280701(10)250702-220, (01)00842071149505(17)280601(10)250630-093, (01)00842071149505(17)280601(10)250630-048, (01)00842071149505(17)280601(10)250630-047, (01)00842071149505(17)280601(10)250630-046, (01)00842071149505(17)280701(10)250702-170.     Box UDI (01)00842071149628(17)280601(10)250710-307, Pouch UDI:  (01)00842071149505(17)280701(10)250707-457, (01)00842071149505(17)280701(10)250702-414, (01)00842071149505(17)280601(10)250701-302, (01)00842071149505(17)280601(10)250701-301, (01)00842071149505(17)280701(10)250702-137.    Box UDI (01)00842071149628(17)280601(10)250620-347, Pouch UDI:  (01)00842071149505(17)280601(10)250617-066, (01)00842071149505(17)280601(10)250617-067, (01)00842071149505(17)280601(10)250617-101.    Box UDI (01)00842071149628(17)280601(10)250626-400, Pouch UDI:  (01)00842071149505(17)280601(10)250609-364.    Box UDI (01)00842071149628(17)280601(10)250618-493, Pouch UDI:  (01)00842071149505(17)280601(10)250609-360, (01)00842071149505(17)280601(10)250604-076, (01)00842071149505(17)280601(10)250611-223, (01)00842071149505(17)280601(10)250612-097, (01)00842071149505(17)280601(10)250609-363, (01)00842071149505(17)280601(10)250609-362.    Box UDI (01)00842071149628(17)280501(10)250612-388, Pouch UDI:  (01)00842071149505(17)280601(10)250605-139, (01)00842071149505(17)280601(10)250603-078, (01)00842071149505(17)280601(10)250604-383.    Box UDI (01)00842071149628(17)280601(10)250616-372, Pouch UDI:  (01)00842071149505(17)280601(10)250604-075, (01)00842071149505(17)280601(10)250604-382, (01)00842071149505(17)280601(10)250605-338.",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US distribution to MA and RI",
            "Status": "recorded"
          }
        }
      ]
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}