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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3078-2024.jsonld",
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  "name": "Syringes with Low Dead Space labeled as:    a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899;   b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554;   c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1\" (low dead space), Model No. 181023L, UPC Sold in Canada Only;   d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8\" low dead space), Model No. 12558LDS, UPC 810062435319;   e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165;   f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only",
  "description": "FDA recall Z-3078-2024 — Sol-Millennium Medical Inc. is recalling Syringes with Low Dead Space labeled as:    a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899;   b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554;   c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1\" (low dead space), Model No. 181023L, UPC Sold in Canada Only;   d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8\" low dead space), Model No. 12558LDS, UPC 810062435319;   e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165;   f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only (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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    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
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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-3078-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Syringes with Low Dead Space labeled as:    a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899;   b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554;   c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1\" (low dead space), Model No. 181023L, UPC Sold in Canada Only;   d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8\" low dead space), Model No. 12558LDS, UPC 810062435319;   e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165;   f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Sol-Millennium Medical Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-3078-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-3078-2024: Sol-Millennium Medical Inc. is recalling Syringes with Low Dead Space labeled as:    a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899;   b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554;   c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1\" (low dead space), Model No. 181023L, UPC Sold in Canada Only;   d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8\" low dead space), Model No. 12558LDS, UPC 810062435319;   e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165;   f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only",
      "text": "The FDA logged enforcement record Z-3078-2024: Sol-Millennium Medical Inc. is voluntarily recalling Syringes with Low Dead Space labeled as:    a) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. 180011LDS, UPC 840368511899;   b) SOL-M 1ml Slip Tip Syringe w/o needle (low dead space), Model No. P180011LDS, UPC 810018097554;   c) SOL-M 1ml Luer Lock Syringe w/Exch Needle 23G*1\" (low dead space), Model No. 181023L, UPC Sold in Canada Only;   d) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8\" low dead space), Model No. 12558LDS, UPC 810062435319;   e) SOL-M 1ml Luer Lock Syringe w/o Needle (PP) (low dead space), Model No. P180001PP, UPC 818392018165;   f) SOL-M 1ml TB Slip Tip Syringe w/Exch Needle 25G*5/8'' (low dead space), Model No. 181025S, UPC Sold in Canada Only — reason: Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-05-09. Affected lots/codes: a) Model No. 180011LDS, UPC 840368511899, Lot Numbers:  1102070, 1107062, 2002005, 2006004, 2012008, 2909022, 2911053, 19052401;  b) Model No. P180011LDS, UPC 810018097554, Lot Numbers:  4104025, 4104100, 4108014, 4108015, 4108017, 4108095, 4109088, 4202001, 4301003, 4303047, 4312032;  c) Model No. 181023L, UPC Sold in Canada Only, Lot Numbers:  4301029;  d) Model No. 12558LDS, UPC 810062435319, Lot Numbers:  7210016;  e) Model No. P180001PP, UPC 818392018165, Lot Numbers:  4104027, 4104028, 4104029, 4104030, 4104031, 4104032, 4105038, 4106031, 4106032, 4106033, 4106074, 4106075, 4106079, 4106080, 4106081, 4106082, 4106083, 4106086, 8103004, 8104004, 8104006, 8104007, 8104008, 8105038, 8105047, 8105053, 8105054, 8106011, 8106014, 8106024, 8106025, 8106026, 8106027, 8106028, 8106029, 8106030, 8106031, 8106032, 8106033;  f) Model No. 181025S, UPC NONE, Lot Numbers:  4110059, 4110091, 4110092, 4212021, 4303009, 4303010, 4303011, 4303012, 4304016,. 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-3078-2024&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-3078-2024&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-3078-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-3078-2024 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,
        "operative": true
      },
      "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-3078-2024&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-3078-2024&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-3078-2024/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."
    }
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      "name": "FDA recall details — Z-3078-2024",
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            "Field": "Recall number",
            "Value": "Z-3078-2024",
            "Status": "recorded"
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          "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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          "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": "Sol-Millennium Medical Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.",
            "Status": "recorded"
          }
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        {
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          "item": {
            "Field": "Initiated",
            "Value": "2024-05-09",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "a) Model No. 180011LDS, UPC 840368511899, Lot Numbers:  1102070, 1107062, 2002005, 2006004, 2012008, 2909022, 2911053, 19052401;  b) Model No. P180011LDS, UPC 810018097554, Lot Numbers:  4104025, 4104100, 4108014, 4108015, 4108017, 4108095, 4109088, 4202001, 4301003, 4303047, 4312032;  c) Model No. 181023L, UPC Sold in Canada Only, Lot Numbers:  4301029;  d) Model No. 12558LDS, UPC 810062435319, Lot Numbers:  7210016;  e) Model No. P180001PP, UPC 818392018165, Lot Numbers:  4104027, 4104028, 4104029, 4104030, 4104031, 4104032, 4105038, 4106031, 4106032, 4106033, 4106074, 4106075, 4106079, 4106080, 4106081, 4106082, 4106083, 4106086, 8103004, 8104004, 8104006, 8104007, 8104008, 8105038, 8105047, 8105053, 8105054, 8106011, 8106014, 8106024, 8106025, 8106026, 8106027, 8106028, 8106029, 8106030, 8106031, 8106032, 8106033;  f) Model No. 181025S, UPC NONE, Lot Numbers:  4110059, 4110091, 4110092, 4212021, 4303009, 4303010, 4303011, 4303012, 4304016,",
            "Status": "recorded"
          }
        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, Panama",
            "Status": "recorded"
          }
        }
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}