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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0185-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medical convenience kits     Item Number/Description  BFCT04X\tCATARACT PACK - 205986  CMEY17AI\tEYE PACK - 213187  CMEY17AI\tEYE PACK - 213187  CMEY17AI\tEYE PACK - 213187  PERP25AQ\tPEI RETINAL PACK-206025  RFEY50AC\tEYE PACK-206026  UIVT47AS\tVITRECTOMY SUPPLY",
  "description": "FDA recall Z-0185-2026 — American Contract Systems Inc. is recalling Medical convenience kits     Item Number/Description  BFCT04X\tCATARACT PACK - 205986  CMEY17AI\tEYE PACK - 213187  CMEY17AI\tEYE PACK - 213187  CMEY17AI\tEYE PACK - 213187  PERP25AQ\tPEI RETINAL PACK-206025  RFEY50AC\tEYE PACK-206026  UIVT47AS\tVITRECTOMY SUPPLY (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/",
  "isAccessibleForFree": true,
  "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
  "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native",
  "seeAlso": "https://agenticu.ryanjhunter.workers.dev/commons/the-research-object",
  "dateModified": "2026-06-24T07:02:03.626072+00:00",
  "isBasedOn": {
    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
    "url": "https://open.fda.gov/apis/drug/enforcement/",
    "creator": {
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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-0185-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medical convenience kits     Item Number/Description  BFCT04X\tCATARACT PACK - 205986  CMEY17AI\tEYE PACK - 213187  CMEY17AI\tEYE PACK - 213187  CMEY17AI\tEYE PACK - 213187  PERP25AQ\tPEI RETINAL PACK-206025  RFEY50AC\tEYE PACK-206026  UIVT47AS\tVITRECTOMY SUPPLY",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "American Contract Systems Inc."
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0185-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0185-2026: American Contract Systems Inc. is recalling Medical convenience kits     Item Number/Description  BFCT04X\tCATARACT PACK - 205986  CMEY17AI\tEYE PACK - 213187  CMEY17AI\tEYE PACK - 213187  CMEY17AI\tEYE PACK - 213187  PERP25AQ\tPEI RETINAL PACK-206025  RFEY50AC\tEYE PACK-206026  UIVT47AS\tVITRECTOMY SUPPLY",
      "text": "The FDA logged enforcement record Z-0185-2026: American Contract Systems Inc. is voluntarily recalling Medical convenience kits     Item Number/Description  BFCT04X\tCATARACT PACK - 205986  CMEY17AI\tEYE PACK - 213187  CMEY17AI\tEYE PACK - 213187  CMEY17AI\tEYE PACK - 213187  PERP25AQ\tPEI RETINAL PACK-206025  RFEY50AC\tEYE PACK-206026  UIVT47AS\tVITRECTOMY SUPPLY — reason: Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-04. Affected lots/codes: BFCT04X UDI-DI 191072225955 Lot 7992111 bag serial number  N/A;  CMEY17AI UDI-DI 191072211514 lot 8082511 bag serial numbers 17390960 17390970 17391031;  PERP25AQ UDI-DI 191072199720 lot 8078511 bag serial number 17507000;  RFEY50AC UDI-DI 191072202918 lot 8048811 bag serial number 17483686;  UIVT47AS UDI-DI 191072224569 lot 7969711 bag serial number N/A  * If bag serial number is listed as \"N/A\", then whole lot is affected. 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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        "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-0185-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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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-0185-2026/fda-classification",
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      "name": "FDA classified recall Z-0185-2026 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.",
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      "reviewStatus": "current",
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        "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)",
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0185-2026/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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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "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-0185-2026",
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            "Field": "Recall number",
            "Value": "Z-0185-2026",
            "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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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
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            "Field": "Recalling firm",
            "Value": "American Contract Systems Inc.",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-09-04",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "BFCT04X UDI-DI 191072225955 Lot 7992111 bag serial number  N/A;  CMEY17AI UDI-DI 191072211514 lot 8082511 bag serial numbers 17390960 17390970 17391031;  PERP25AQ UDI-DI 191072199720 lot 8078511 bag serial number 17507000;  RFEY50AC UDI-DI 191072202918 lot 8048811 bag serial number 17483686;  UIVT47AS UDI-DI 191072224569 lot 7969711 bag serial number N/A  * If bag serial number is listed as \"N/A\", then whole lot is affected",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of SD, IA, MN, WA, IL.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}