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  "name": "Microtek Patient Drape ECOLAB    AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN  UDI code: (01)10748426139986    AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN  UDI code: (01)10748426139429    These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size.",
  "description": "FDA recall Z-1963-2025 — Microtek Medical, Inc. is recalling Microtek Patient Drape ECOLAB    AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN  UDI code: (01)10748426139986    AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN  UDI code: (01)10748426139429    These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size. (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": "Microtek Patient Drape ECOLAB    AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN  UDI code: (01)10748426139986    AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN  UDI code: (01)10748426139429    These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size.",
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      "name": "Microtek Medical, Inc."
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      "name": "FDA recall Z-1963-2025: Microtek Medical, Inc. is recalling Microtek Patient Drape ECOLAB    AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN  UDI code: (01)10748426139986    AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN  UDI code: (01)10748426139429    These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size.",
      "text": "The FDA logged enforcement record Z-1963-2025: Microtek Medical, Inc. is voluntarily recalling Microtek Patient Drape ECOLAB    AP6MMN Patient Drape, 6mm Adapter Plug Kit REF AP6MMN  UDI code: (01)10748426139986    AP8MMN Patient Drape, 8mm Adapter Plug Kit REF AP8MMN  UDI code: (01)10748426139429    These adapters function as accessories for a device or drape, serving to connect a drape's drain hose to a fluid management device. Their purpose is to reduce the opening of the drain hose to a smaller size. — reason: Due to non-sterile products being labeled as sterile. Status: Ongoing — the recall is still being carried out.. Initiated 2025-04-13. Affected lots/codes: Catalog Number: AP6MMN UDI code: (01)10748426139986 Lot/Batch Numbers: 5272JX0300 7372JX3000 4422JX1900 1502JX0200 5502JX0900 1023JX0200 6023JX0400 1334JX1400  Catalog Number: AP8MMN UDI code: (01)10748426139429 Lot/Batch Numbers: 3454LR3700 2484LR8000 1494LR0600 4025LR2800 2035LR5000 5342JX0600 3292JX0500 4372JX1700 5422JX0600 1402JX1500 4422JX1800 5502JX1000 1023JX3400 5133JX0100 3143JX1100 1173JX1800 6143JX0300 5213JX4000 4233JX1400 5243JX3700 6253JX1400 4293JX2400 1343JX1000 4353JX7800 2373JX0600 5443JX2500 3453JX2900 4463JX1200 3493JX1400 6503JX0300 2034JX1100 1044JX3400 5074JX1500 1104JX1100 5164JX0500 5164JX0700 5164JX0600 5184JX0800 5224JX1400 5234JX3400 1254JX0300 4304JX1100 2334JX1800. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1963-2025&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."
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      "name": "FDA classified recall Z-1963-2025 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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      "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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    {
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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.",
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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
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      "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-1963-2025",
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            "Value": "Z-1963-2025",
            "Status": "recorded"
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Value": "Microtek Medical, Inc.",
            "Status": "recorded"
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            "Value": "Due to non-sterile products being labeled as sterile",
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          "item": {
            "Field": "Initiated",
            "Value": "2025-04-13",
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            "Field": "Lot/code info",
            "Value": "Catalog Number: AP6MMN UDI code: (01)10748426139986 Lot/Batch Numbers: 5272JX0300 7372JX3000 4422JX1900 1502JX0200 5502JX0900 1023JX0200 6023JX0400 1334JX1400  Catalog Number: AP8MMN UDI code: (01)10748426139429 Lot/Batch Numbers: 3454LR3700 2484LR8000 1494LR0600 4025LR2800 2035LR5000 5342JX0600 3292JX0500 4372JX1700 5422JX0600 1402JX1500 4422JX1800 5502JX1000 1023JX3400 5133JX0100 3143JX1100 1173JX1800 6143JX0300 5213JX4000 4233JX1400 5243JX3700 6253JX1400 4293JX2400 1343JX1000 4353JX7800 2373JX0600 5443JX2500 3453JX2900 4463JX1200 3493JX1400 6503JX0300 2034JX1100 1044JX3400 5074JX1500 1104JX1100 5164JX0500 5164JX0700 5164JX0600 5184JX0800 5224JX1400 5234JX3400 1254JX0300 4304JX1100 2334JX1800",
            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "U.S.: AL. AR, CA, CO, CT, FL, GA, IA, IL, IN, KY, MA, MI, NC, NY, OH, OR, TN, TX, and VA  O.U.S.: N/A",
            "Status": "recorded"
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