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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2158-2023.jsonld",
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  "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tNERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220;   b)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773;   c)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B;   d)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A;   e)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B;   f)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571;   g)\tCVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A;   h)\tCVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338;   i)\tBLOCK KIT-LF, Model Number DYNJRA1287A;   j)\tBLOCK KIT-LF, Model Number PAIN1622A;   k)\tBLOCK KIT-LF, Model Number DYNJRA1543;   l)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A;   m)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D;   n)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604;   o)\tBLOCK TRAY, Model Number PAIN1182;",
  "description": "FDA recall Z-2158-2023 — MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tNERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220;   b)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773;   c)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B;   d)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A;   e)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B;   f)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571;   g)\tCVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A;   h)\tCVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338;   i)\tBLOCK KIT-LF, Model Number DYNJRA1287A;   j)\tBLOCK KIT-LF, Model Number PAIN1622A;   k)\tBLOCK KIT-LF, Model Number DYNJRA1543;   l)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A;   m)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D;   n)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604;   o)\tBLOCK TRAY, Model Number PAIN1182; (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/",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tNERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220;   b)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773;   c)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B;   d)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A;   e)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B;   f)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571;   g)\tCVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A;   h)\tCVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338;   i)\tBLOCK KIT-LF, Model Number DYNJRA1287A;   j)\tBLOCK KIT-LF, Model Number PAIN1622A;   k)\tBLOCK KIT-LF, Model Number DYNJRA1543;   l)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A;   m)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D;   n)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604;   o)\tBLOCK TRAY, Model Number PAIN1182;",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "MEDLINE INDUSTRIES, LP - Northfield"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2158-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2158-2023: MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tNERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220;   b)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773;   c)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B;   d)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A;   e)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B;   f)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571;   g)\tCVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A;   h)\tCVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338;   i)\tBLOCK KIT-LF, Model Number DYNJRA1287A;   j)\tBLOCK KIT-LF, Model Number PAIN1622A;   k)\tBLOCK KIT-LF, Model Number DYNJRA1543;   l)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A;   m)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D;   n)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604;   o)\tBLOCK TRAY, Model Number PAIN1182;",
      "text": "The FDA logged enforcement record Z-2158-2023: MEDLINE INDUSTRIES, LP - Northfield is voluntarily recalling Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tNERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220;   b)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773;   c)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B;   d)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A;   e)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B;   f)\tPERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571;   g)\tCVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A;   h)\tCVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338;   i)\tBLOCK KIT-LF, Model Number DYNJRA1287A;   j)\tBLOCK KIT-LF, Model Number PAIN1622A;   k)\tBLOCK KIT-LF, Model Number DYNJRA1543;   l)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A;   m)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D;   n)\tPK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604;   o)\tBLOCK TRAY, Model Number PAIN1182; — reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.. Status: Ongoing — the recall is still being carried out.. Initiated 2023-05-18. Affected lots/codes: all lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model Number DYNJRA1220, UDI/DI (EA)10888277795037, UDI/DI (CS)40888277795038;  b) Model Number DYNJRA1773, UDI/DI (EA)10193489862973, UDI/DI (CS)40193489862974;  c) Model Number DYNJ51107B, UDI/DI (EA)10193489810479, UDI/DI (CS)40193489810470;  d) Model Number DYNJ0703127A, UDI/DI (EA)10889942084630, UDI/DI (CS)40889942084631;  e) Model Number DYNJ42367B, UDI/DI (EA)10193489211511, UDI/DI (CS)40193489211512;  f) Model Number DYNJRA1571, UDI/DI (EA)10193489264739, UDI/DI (CS)40193489264730;  g) Model Number DYNJRA0656A, UDI/DI (EA)10889942225118, UDI/DI (CS)40889942225119;  h) Model Number DYNJ47338, UDI/DI (EA)10888277900172, UDI/DI (CS)40888277900173;  i) Model Number DYNJRA1287A, UDI/DI (EA)10193489773095, UDI/DI (CS)40193489773096;  j) Model Number PAIN1622A, UDI/DI (EA)10193489891690, UDI/DI (CS)40193489891691;  k) Model Number DYNJRA1543, UDI/DI (EA)10193489217667, UDI/DI (CS)40193489217668;  l) Model Number DYNJRA1635A, UDI/DI (EA)10193489367645, UDI/DI (CS)40193489367646;  m) Model Number DYNJ0134147D, UDI/DI (EA)10889942937349, UDI/DI (CS)40889942937340;  n) Model Number DYNJRA1604, UDI/DI (EA)10193489299816, UDI/DI (CS)40193489299817;  o) Model Number PAIN1182, UDI/DI (EA)10889942720927, UDI/DI (CS)40889942720928;. 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-2158-2023&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-2158-2023&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2158-2023/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2158-2023 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,
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      "grounding": {
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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-2158-2023&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-2158-2023&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-2158-2023/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,
        "operative": true
      },
      "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."
    }
  ],
  "hasPart": [
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      "name": "FDA recall details — Z-2158-2023",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-2158-2023",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "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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        {
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "MEDLINE INDUSTRIES, LP - Northfield",
            "Status": "recorded"
          }
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        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2023-05-18",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "all lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model Number DYNJRA1220, UDI/DI (EA)10888277795037, UDI/DI (CS)40888277795038;  b) Model Number DYNJRA1773, UDI/DI (EA)10193489862973, UDI/DI (CS)40193489862974;  c) Model Number DYNJ51107B, UDI/DI (EA)10193489810479, UDI/DI (CS)40193489810470;  d) Model Number DYNJ0703127A, UDI/DI (EA)10889942084630, UDI/DI (CS)40889942084631;  e) Model Number DYNJ42367B, UDI/DI (EA)10193489211511, UDI/DI (CS)40193489211512;  f) Model Number DYNJRA1571, UDI/DI (EA)10193489264739, UDI/DI (CS)40193489264730;  g) Model Number DYNJRA0656A, UDI/DI (EA)10889942225118, UDI/DI (CS)40889942225119;  h) Model Number DYNJ47338, UDI/DI (EA)10888277900172, UDI/DI (CS)40888277900173;  i) Model Number DYNJRA1287A, UDI/DI (EA)10193489773095, UDI/DI (CS)40193489773096;  j) Model Number PAIN1622A, UDI/DI (EA)10193489891690, UDI/DI (CS)40193489891691;  k) Model Number DYNJRA1543, UDI/DI (EA)10193489217667, UDI/DI (CS)40193489217668;  l) Model Number DYNJRA1635A, UDI/DI (EA)10193489367645, UDI/DI (CS)40193489367646;  m) Model Number DYNJ0134147D, UDI/DI (EA)10889942937349, UDI/DI (CS)40889942937340;  n) Model Number DYNJRA1604, UDI/DI (EA)10193489299816, UDI/DI (CS)40193489299817;  o) Model Number PAIN1182, UDI/DI (EA)10889942720927, UDI/DI (CS)40889942720928;",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}