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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1370-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products:  18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15",
  "description": "FDA recall Z-1370-2024 — Alcon Research, LLC is recalling SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products:  18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15 (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:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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    "creator": {
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1370-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products:  18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Alcon Research, LLC"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1370-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1370-2024: Alcon Research, LLC is recalling SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products:  18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15",
      "text": "The FDA logged enforcement record Z-1370-2024: Alcon Research, LLC is voluntarily recalling SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products:  18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76, 5918-39, 9208-66, 15190-16, 9065-25, 5918-39, 16066-15, 16066-15 — reason: Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-02-21. Affected lots/codes: Product/Lot/Expiration/UDI-DI:  18018-06/15T707/02/28/2025/380655148440, 3865-44/15T2RC/02/28/2025/380655148150, 5675-76/15T70E/02/28/2025/380655148174, 13554-11/15V4RC/02/28/2025/380655143711, 18018-06/15V3E0/02/28/2025/380655148440, 15190-16/JZ5179517/06/30/2024/380655148303, 15190-16/JZ5179519/06/30/2024/380655148303, 15190-16/JZ5179521/06/30/2024/380655148303, 15190-16/JZ5179523/06/30/2024/380655148303, 15190-16/JZ5179529/06/30/2024/380655148303, 13554-11/15TAUD/01/31/2026/380655143711, 5918-39/15TE5F/02/28/2025/380655149140, 15190-16/15THVA/04/30/2025/380655148303, 15190-16/15TNXJ/04/30/2025/380655148303, 9208-66/15V8CU/04/30/2025/380651693326, 9208-66/15XVDD/05/31/2025/380651693326, 5675-76/JZ5180811/06/30/2024/380655148174, 5918-39/JZ5180812/06/30/2024/380655149140, 9208-66/JZ5180332/03/31/2025/380651693326, 15190-16/JZ5180856/05/31/2025/380655148303, 9065-25/JZ5187593/11/30/2025/380651682849, 5918-39/JZ5187260/06/30/2024/380655149140, 16066-15/JZ5190913/07/31/2025/380655149683, 16066-15/JZ5191891/07/31/2025/380655149683  Bulb Syringe lots: 96922110001 or 96923100001. 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-1370-2024&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-1370-2024&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."
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1370-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1370-2024 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",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": true,
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-1370-2024&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-1370-2024/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,
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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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            "Value": "Z-1370-2024",
            "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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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Alcon Research, LLC",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Medline Bulb irrigation syringes recalled due to potential for packaging sterile barrier to be breached, and these syringes were packed inside surgical procedure packs that were subsequently terminally sterilized, so after the packs are opened, syringes should be discarded at surgical case end, and not reshelved, because the use of non-sterile bulb irrigation syringes may increase infection risk.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2024-02-21",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Product/Lot/Expiration/UDI-DI:  18018-06/15T707/02/28/2025/380655148440, 3865-44/15T2RC/02/28/2025/380655148150, 5675-76/15T70E/02/28/2025/380655148174, 13554-11/15V4RC/02/28/2025/380655143711, 18018-06/15V3E0/02/28/2025/380655148440, 15190-16/JZ5179517/06/30/2024/380655148303, 15190-16/JZ5179519/06/30/2024/380655148303, 15190-16/JZ5179521/06/30/2024/380655148303, 15190-16/JZ5179523/06/30/2024/380655148303, 15190-16/JZ5179529/06/30/2024/380655148303, 13554-11/15TAUD/01/31/2026/380655143711, 5918-39/15TE5F/02/28/2025/380655149140, 15190-16/15THVA/04/30/2025/380655148303, 15190-16/15TNXJ/04/30/2025/380655148303, 9208-66/15V8CU/04/30/2025/380651693326, 9208-66/15XVDD/05/31/2025/380651693326, 5675-76/JZ5180811/06/30/2024/380655148174, 5918-39/JZ5180812/06/30/2024/380655149140, 9208-66/JZ5180332/03/31/2025/380651693326, 15190-16/JZ5180856/05/31/2025/380655148303, 9065-25/JZ5187593/11/30/2025/380651682849, 5918-39/JZ5187260/06/30/2024/380655149140, 16066-15/JZ5190913/07/31/2025/380655149683, 16066-15/JZ5191891/07/31/2025/380655149683  Bulb Syringe lots: 96922110001 or 96923100001",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of OH, WV.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}