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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0179-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medical convenience kits     Item Number/Description  RCGY52D\tGYN LAPAROSCOPY SPH 0246965  UIGN82M\tGYN (PS 907645)  UIHY16AE\tASC HYSTEROSCOPY PACK (PS 020634)",
  "description": "FDA recall Z-0179-2026 — American Contract Systems Inc. is recalling Medical convenience kits     Item Number/Description  RCGY52D\tGYN LAPAROSCOPY SPH 0246965  UIGN82M\tGYN (PS 907645)  UIHY16AE\tASC HYSTEROSCOPY PACK (PS 020634) (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/",
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  "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-0179-2026&lang=eng",
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    "name": "Medical convenience kits     Item Number/Description  RCGY52D\tGYN LAPAROSCOPY SPH 0246965  UIGN82M\tGYN (PS 907645)  UIHY16AE\tASC HYSTEROSCOPY PACK (PS 020634)",
    "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-0179-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0179-2026: American Contract Systems Inc. is recalling Medical convenience kits     Item Number/Description  RCGY52D\tGYN LAPAROSCOPY SPH 0246965  UIGN82M\tGYN (PS 907645)  UIHY16AE\tASC HYSTEROSCOPY PACK (PS 020634)",
      "text": "The FDA logged enforcement record Z-0179-2026: American Contract Systems Inc. is voluntarily recalling Medical convenience kits     Item Number/Description  RCGY52D\tGYN LAPAROSCOPY SPH 0246965  UIGN82M\tGYN (PS 907645)  UIHY16AE\tASC HYSTEROSCOPY PACK (PS 020634) — 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: FHGY09S UDI-DI 191072234360 lot 8532011 bag serial number 68874879;  LMGY39U UDI-DI 191072209337 Lot 8490211 bag serial numbers 47860009 47861175;  OWGY11Q UDI-DI 191072236555 lot 8389711 bag serial number 17622382;  RCGY52D UDI-DI 191072232670 lot 8142411 bag serial number 17487909;  UIGN82M UDI-DI 191072106674 lot 8084811 bag serial numbers 17391081 17391091 17391111 17391171 lot 8445711 bag serial numbers 17683242 lot 8530511 bag serial numbers 17712404;  UIHY16AE UDI-DI 00191072234117 Lot 8171811 N/A    * If bag serial number is listed as \"n/a\", then entire 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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      "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-0179-2026&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-0179-2026&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."
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      "name": "FDA classified recall Z-0179-2026 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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        "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-0179-2026&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-0179-2026/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-0179-2026",
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            "Value": "Z-0179-2026",
            "Status": "recorded"
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            "Value": "Devices",
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          "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,
          "item": {
            "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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          "item": {
            "Field": "Lot/code info",
            "Value": "FHGY09S UDI-DI 191072234360 lot 8532011 bag serial number 68874879;  LMGY39U UDI-DI 191072209337 Lot 8490211 bag serial numbers 47860009 47861175;  OWGY11Q UDI-DI 191072236555 lot 8389711 bag serial number 17622382;  RCGY52D UDI-DI 191072232670 lot 8142411 bag serial number 17487909;  UIGN82M UDI-DI 191072106674 lot 8084811 bag serial numbers 17391081 17391091 17391111 17391171 lot 8445711 bag serial numbers 17683242 lot 8530511 bag serial numbers 17712404;  UIHY16AE UDI-DI 00191072234117 Lot 8171811 N/A    * If bag serial number is listed as \"n/a\", then entire lot is affected",
            "Status": "recorded"
          }
        },
        {
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution in the states of SD, IA, MN, WA, IL.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}