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  "name": "MEDLINE convenience kits labeled as:    1) HEAD AND NECK, REF CDS984259O;   2) HEAD AND NECK, REF CDS984259P;   3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F;   4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I;   5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F;   6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O;   7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P;   8) THYROID MOFF PACK-LF, REF DYNJ0429430S;   9) NASALPLASTY #61-RF, REF DYNJ27320V;   10) MIDDLE EAR PACK, REF DYNJ55235C;   11) HEAD AND NECK, REF DYNJ64235B;   12) NECK PACK SRM-LF, REF DYNJ65020C;   13) ACH HEAD & NECK PACK-LF, REF DYNJ67754B;   14) ENT HEAD NECK PACK, REF DYNJ68211B;   15) OSC ENT HEAD PACK, REF DYNJ68957B;   16) EAR UM-LF, REF DYNJ902331D;   17) HEAD&NECK, REF DYNJ906655G;   18) ENT-LF, REF DYNJ907577;   19) MAJOR HEAD AND NECK PPS, REF DYNJ9425991Q;   20) MINOR ENT # 56653-LF, REF DYNJVB91072A.",
  "description": "FDA recall Z-0516-2026 — Medline Industries, LP is recalling MEDLINE convenience kits labeled as:    1) HEAD AND NECK, REF CDS984259O;   2) HEAD AND NECK, REF CDS984259P;   3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F;   4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I;   5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F;   6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O;   7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P;   8) THYROID MOFF PACK-LF, REF DYNJ0429430S;   9) NASALPLASTY #61-RF, REF DYNJ27320V;   10) MIDDLE EAR PACK, REF DYNJ55235C;   11) HEAD AND NECK, REF DYNJ64235B;   12) NECK PACK SRM-LF, REF DYNJ65020C;   13) ACH HEAD & NECK PACK-LF, REF DYNJ67754B;   14) ENT HEAD NECK PACK, REF DYNJ68211B;   15) OSC ENT HEAD PACK, REF DYNJ68957B;   16) EAR UM-LF, REF DYNJ902331D;   17) HEAD&NECK, REF DYNJ906655G;   18) ENT-LF, REF DYNJ907577;   19) MAJOR HEAD AND NECK PPS, REF DYNJ9425991Q;   20) MINOR ENT # 56653-LF, REF DYNJVB91072A. (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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    "@type": "schema:MedicalDevice",
    "name": "MEDLINE convenience kits labeled as:    1) HEAD AND NECK, REF CDS984259O;   2) HEAD AND NECK, REF CDS984259P;   3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F;   4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I;   5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F;   6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O;   7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P;   8) THYROID MOFF PACK-LF, REF DYNJ0429430S;   9) NASALPLASTY #61-RF, REF DYNJ27320V;   10) MIDDLE EAR PACK, REF DYNJ55235C;   11) HEAD AND NECK, REF DYNJ64235B;   12) NECK PACK SRM-LF, REF DYNJ65020C;   13) ACH HEAD & NECK PACK-LF, REF DYNJ67754B;   14) ENT HEAD NECK PACK, REF DYNJ68211B;   15) OSC ENT HEAD PACK, REF DYNJ68957B;   16) EAR UM-LF, REF DYNJ902331D;   17) HEAD&NECK, REF DYNJ906655G;   18) ENT-LF, REF DYNJ907577;   19) MAJOR HEAD AND NECK PPS, REF DYNJ9425991Q;   20) MINOR ENT # 56653-LF, REF DYNJVB91072A.",
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      "name": "Medline Industries, LP"
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0516-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0516-2026: Medline Industries, LP is recalling MEDLINE convenience kits labeled as:    1) HEAD AND NECK, REF CDS984259O;   2) HEAD AND NECK, REF CDS984259P;   3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F;   4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I;   5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F;   6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O;   7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P;   8) THYROID MOFF PACK-LF, REF DYNJ0429430S;   9) NASALPLASTY #61-RF, REF DYNJ27320V;   10) MIDDLE EAR PACK, REF DYNJ55235C;   11) HEAD AND NECK, REF DYNJ64235B;   12) NECK PACK SRM-LF, REF DYNJ65020C;   13) ACH HEAD & NECK PACK-LF, REF DYNJ67754B;   14) ENT HEAD NECK PACK, REF DYNJ68211B;   15) OSC ENT HEAD PACK, REF DYNJ68957B;   16) EAR UM-LF, REF DYNJ902331D;   17) HEAD&NECK, REF DYNJ906655G;   18) ENT-LF, REF DYNJ907577;   19) MAJOR HEAD AND NECK PPS, REF DYNJ9425991Q;   20) MINOR ENT # 56653-LF, REF DYNJVB91072A.",
      "text": "The FDA logged enforcement record Z-0516-2026: Medline Industries, LP is voluntarily recalling MEDLINE convenience kits labeled as:    1) HEAD AND NECK, REF CDS984259O;   2) HEAD AND NECK, REF CDS984259P;   3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F;   4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I;   5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F;   6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O;   7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P;   8) THYROID MOFF PACK-LF, REF DYNJ0429430S;   9) NASALPLASTY #61-RF, REF DYNJ27320V;   10) MIDDLE EAR PACK, REF DYNJ55235C;   11) HEAD AND NECK, REF DYNJ64235B;   12) NECK PACK SRM-LF, REF DYNJ65020C;   13) ACH HEAD & NECK PACK-LF, REF DYNJ67754B;   14) ENT HEAD NECK PACK, REF DYNJ68211B;   15) OSC ENT HEAD PACK, REF DYNJ68957B;   16) EAR UM-LF, REF DYNJ902331D;   17) HEAD&NECK, REF DYNJ906655G;   18) ENT-LF, REF DYNJ907577;   19) MAJOR HEAD AND NECK PPS, REF DYNJ9425991Q;   20) MINOR ENT # 56653-LF, REF DYNJVB91072A. — reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-30. Affected lots/codes: 1) REF CDS984259O:  UDI/DI 10195327297817 (each), 40195327297818 (case), Lot Numbers:  23FBR754, 23GBH766, 24ABP608, 24BBN514;   2) REF CDS984259P:  UDI/DI 10195327647827 (each), 40195327647828 (case), Lot Numbers:  24DBQ755;   3) REF DYNJ0160700F:  UDI/DI 10195327304294 (each), 40195327304295 (case), Lot Numbers:  23FDA156, 23GDA649;   4) REF DYNJ0161710I:  UDI/DI 10195327375003 (each), 40195327375004 (case), Lot Numbers:  23EDB639, 23FDA196, 23GDA674;   5) REF DYNJ0161795F:  UDI/DI 10195327375010 (each), 40195327375011 (case), Lot Numbers:  23FDA246, 23HDA365;   6) REF DYNJ0429404O:  UDI/DI 10195327050092 (each), 40195327050093 (case), Lot Numbers:  23GMI073, 23JMC414, 23LMA073;   7) REF DYNJ0429404P:  UDI/DI 10195327587581 (each), 40195327587582 (case), Lot Numbers:  23LMH745, 24BME178, 24DMF230;    8) REF DYNJ0429430S:  UDI/DI 10195327689841 (each), 40195327689842 (case), Lot Numbers:  24LME516;   9) REF DYNJ27320V:  UDI/DI 10195327104719 (each), 40195327104710 (case), Lot Numbers:  23GBT502, 24ABD023, 24ABX584, 24DBA020, 24DBU467, 24FBD739;   10) REF DYNJ55235C:  UDI/DI 10195327412081 (each), 40195327412082 (case), Lot Numbers:  23GBN444, 23IBU467;   11) REF DYNJ64235B:  UDI/DI 10193489382662 (each), 40193489382663 (case), Lot Numbers:  23FMB928;   12) REF DYNJ65020C:  UDI/DI 10195327528218 (each), 40195327528219 (case), Lot Numbers: 23JMD840, 23LME135, 24FMH184;    13) REF DYNJ67754B:  UDI/DI 10195327227982 (each), 40195327227983 (case), Lot Numbers: 23EBK256, 23HBM886, 23IBP461, 23JBR528;     14) REF DYNJ68211B:  UDI/DI 10195327352493 (each), 40195327352494 (case), Lot Numbers:  23HMC691;   15) REF DYNJ68957B:  UDI/DI 10195327512033 (each), 40195327512034 (case), Lot Numbers:  23JMD230, 24AMB618;   16) REF DYNJ902331D:  UDI/DI 10195327698089 (each), 40195327698080 (case), Lot Numbers:  24EBC946, 24EBV522;   17) REF DYNJ906655G:  UDI/DI 10195327301835 (each), 40195327301836 (case), Lot Numbers:  24ADB523;   18) REF DYNJ907577:  UDI/DI 10193489437713 (each), 40193489437714 (case), Lot Numbers:  23GBB195, 23GBN735;   19) REF DYNJ9425991Q:  UDI/DI 10195327587604 (each), 40195327587605 (case), Lot Numbers:  24ALB133;   20) REF DYNJVB91072A:  UDI/DI 10195327466428 (each), 40195327466429 (case), Lot Numbers:  23HLB079, 23ILA192, 24ALA650.. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0516-2026&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-0516-2026&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-0516-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0516-2026 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",
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      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": 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-0516-2026&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-0516-2026&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-0516-2026/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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        "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-0516-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0516-2026",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "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": "Medline Industries, LP",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-09-30",
            "Status": "recorded"
          }
        },
        {
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1) REF CDS984259O:  UDI/DI 10195327297817 (each), 40195327297818 (case), Lot Numbers:  23FBR754, 23GBH766, 24ABP608, 24BBN514;   2) REF CDS984259P:  UDI/DI 10195327647827 (each), 40195327647828 (case), Lot Numbers:  24DBQ755;   3) REF DYNJ0160700F:  UDI/DI 10195327304294 (each), 40195327304295 (case), Lot Numbers:  23FDA156, 23GDA649;   4) REF DYNJ0161710I:  UDI/DI 10195327375003 (each), 40195327375004 (case), Lot Numbers:  23EDB639, 23FDA196, 23GDA674;   5) REF DYNJ0161795F:  UDI/DI 10195327375010 (each), 40195327375011 (case), Lot Numbers:  23FDA246, 23HDA365;   6) REF DYNJ0429404O:  UDI/DI 10195327050092 (each), 40195327050093 (case), Lot Numbers:  23GMI073, 23JMC414, 23LMA073;   7) REF DYNJ0429404P:  UDI/DI 10195327587581 (each), 40195327587582 (case), Lot Numbers:  23LMH745, 24BME178, 24DMF230;    8) REF DYNJ0429430S:  UDI/DI 10195327689841 (each), 40195327689842 (case), Lot Numbers:  24LME516;   9) REF DYNJ27320V:  UDI/DI 10195327104719 (each), 40195327104710 (case), Lot Numbers:  23GBT502, 24ABD023, 24ABX584, 24DBA020, 24DBU467, 24FBD739;   10) REF DYNJ55235C:  UDI/DI 10195327412081 (each), 40195327412082 (case), Lot Numbers:  23GBN444, 23IBU467;   11) REF DYNJ64235B:  UDI/DI 10193489382662 (each), 40193489382663 (case), Lot Numbers:  23FMB928;   12) REF DYNJ65020C:  UDI/DI 10195327528218 (each), 40195327528219 (case), Lot Numbers: 23JMD840, 23LME135, 24FMH184;    13) REF DYNJ67754B:  UDI/DI 10195327227982 (each), 40195327227983 (case), Lot Numbers: 23EBK256, 23HBM886, 23IBP461, 23JBR528;     14) REF DYNJ68211B:  UDI/DI 10195327352493 (each), 40195327352494 (case), Lot Numbers:  23HMC691;   15) REF DYNJ68957B:  UDI/DI 10195327512033 (each), 40195327512034 (case), Lot Numbers:  23JMD230, 24AMB618;   16) REF DYNJ902331D:  UDI/DI 10195327698089 (each), 40195327698080 (case), Lot Numbers:  24EBC946, 24EBV522;   17) REF DYNJ906655G:  UDI/DI 10195327301835 (each), 40195327301836 (case), Lot Numbers:  24ADB523;   18) REF DYNJ907577:  UDI/DI 10193489437713 (each), 40193489437714 (case), Lot Numbers:  23GBB195, 23GBN735;   19) REF DYNJ9425991Q:  UDI/DI 10195327587604 (each), 40195327587605 (case), Lot Numbers:  24ALB133;   20) REF DYNJVB91072A:  UDI/DI 10195327466428 (each), 40195327466429 (case), Lot Numbers:  23HLB079, 23ILA192, 24ALA650.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}