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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0174-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medical convenience kits     Item Number/Description  BUCY78E\tCYSTO PACK  CMCP10X\tCYSTO PACK - 205972  IHCY10Y\tCYSTO PACK  MHCY35AE\tCYSTO PACK- 212487  PLBY52E\tCYSTO PACK  UDCY31Z\tCYSTO PACK - 206047  UICY28L\tMOR CYSTO PACK",
  "description": "FDA recall Z-0174-2026 — American Contract Systems Inc. is recalling Medical convenience kits     Item Number/Description  BUCY78E\tCYSTO PACK  CMCP10X\tCYSTO PACK - 205972  IHCY10Y\tCYSTO PACK  MHCY35AE\tCYSTO PACK- 212487  PLBY52E\tCYSTO PACK  UDCY31Z\tCYSTO PACK - 206047  UICY28L\tMOR CYSTO PACK (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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  "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": {
      "@type": "schema:GovernmentOrganization",
      "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-0174-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medical convenience kits     Item Number/Description  BUCY78E\tCYSTO PACK  CMCP10X\tCYSTO PACK - 205972  IHCY10Y\tCYSTO PACK  MHCY35AE\tCYSTO PACK- 212487  PLBY52E\tCYSTO PACK  UDCY31Z\tCYSTO PACK - 206047  UICY28L\tMOR CYSTO PACK",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "American Contract Systems Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0174-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0174-2026: American Contract Systems Inc. is recalling Medical convenience kits     Item Number/Description  BUCY78E\tCYSTO PACK  CMCP10X\tCYSTO PACK - 205972  IHCY10Y\tCYSTO PACK  MHCY35AE\tCYSTO PACK- 212487  PLBY52E\tCYSTO PACK  UDCY31Z\tCYSTO PACK - 206047  UICY28L\tMOR CYSTO PACK",
      "text": "The FDA logged enforcement record Z-0174-2026: American Contract Systems Inc. is voluntarily recalling Medical convenience kits     Item Number/Description  BUCY78E\tCYSTO PACK  CMCP10X\tCYSTO PACK - 205972  IHCY10Y\tCYSTO PACK  MHCY35AE\tCYSTO PACK- 212487  PLBY52E\tCYSTO PACK  UDCY31Z\tCYSTO PACK - 206047  UICY28L\tMOR CYSTO PACK — 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: BUCY78E UDI-DI 191072235350 Lot 8531411 Bag serial number 17705421;  CMCP10X UDI-DI 191072228215 Lot 8392411 Bag serial number  17622370;  IHCY10Y UDI-DI 191072159922 Lot 8026111 Bag serial number 17499185 Lot 8346211 Bag serial number 17692649 Lot 8444211 Bag serial number 17681124;  MHCY35AE UDI-DI 191072228864 Lot 7990511 Bag serial number N/A;  PLBY52E UDI-DI 191072141415 Lot 8016811 Bag serial number 17435184;  UDCY31Z UDI-DI 00191072213990 Lot 8043211 Bag serial number 17483121 17483122 17483143 17483144 17485283;  UICY28L UDI-DI 191072205537 Lot 8217311 Bag serial number  17598793  * 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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        "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-0174-2026&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-0174-2026&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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0174-2026/fda-classification",
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      "name": "FDA classified recall Z-0174-2026 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",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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        "groundingType": "AdjudicativeAct",
        "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-0174-2026&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-0174-2026/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",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
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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-0174-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0174-2026",
            "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,
          "item": {
            "Field": "Recalling firm",
            "Value": "American Contract Systems Inc.",
            "Status": "recorded"
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          "position": 6,
          "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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        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-09-04",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "BUCY78E UDI-DI 191072235350 Lot 8531411 Bag serial number 17705421;  CMCP10X UDI-DI 191072228215 Lot 8392411 Bag serial number  17622370;  IHCY10Y UDI-DI 191072159922 Lot 8026111 Bag serial number 17499185 Lot 8346211 Bag serial number 17692649 Lot 8444211 Bag serial number 17681124;  MHCY35AE UDI-DI 191072228864 Lot 7990511 Bag serial number N/A;  PLBY52E UDI-DI 191072141415 Lot 8016811 Bag serial number 17435184;  UDCY31Z UDI-DI 00191072213990 Lot 8043211 Bag serial number 17483121 17483122 17483143 17483144 17485283;  UICY28L UDI-DI 191072205537 Lot 8217311 Bag serial number  17598793  * 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"
          }
        }
      ]
    }
  ]
}