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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0176-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medical convenience kits     Item Number/Description  ANCV78BC\tHEART PACK - 205947  HGCV05K\tCV SET UP PACK  MHPP97AR\tPACEMAKER PACK- 206010  UDBH37AW\tBASIC HEART PACK - 206044  UHPP82AH\tPERIPHERAL PACK - 209533  UICD62AN\tCARDIOVASCUALR SUPPLY (PS 907285)  UICT16F\t CARDIO THORACIC DRAPE PACK (PS 907284)  UIVA75I\tVASCULAR PACK",
  "description": "FDA recall Z-0176-2026 — American Contract Systems Inc. is recalling Medical convenience kits     Item Number/Description  ANCV78BC\tHEART PACK - 205947  HGCV05K\tCV SET UP PACK  MHPP97AR\tPACEMAKER PACK- 206010  UDBH37AW\tBASIC HEART PACK - 206044  UHPP82AH\tPERIPHERAL PACK - 209533  UICD62AN\tCARDIOVASCUALR SUPPLY (PS 907285)  UICT16F\t CARDIO THORACIC DRAPE PACK (PS 907284)  UIVA75I\tVASCULAR 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/",
  "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": {
      "@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-0176-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medical convenience kits     Item Number/Description  ANCV78BC\tHEART PACK - 205947  HGCV05K\tCV SET UP PACK  MHPP97AR\tPACEMAKER PACK- 206010  UDBH37AW\tBASIC HEART PACK - 206044  UHPP82AH\tPERIPHERAL PACK - 209533  UICD62AN\tCARDIOVASCUALR SUPPLY (PS 907285)  UICT16F\t CARDIO THORACIC DRAPE PACK (PS 907284)  UIVA75I\tVASCULAR PACK",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "American Contract Systems Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0176-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0176-2026: American Contract Systems Inc. is recalling Medical convenience kits     Item Number/Description  ANCV78BC\tHEART PACK - 205947  HGCV05K\tCV SET UP PACK  MHPP97AR\tPACEMAKER PACK- 206010  UDBH37AW\tBASIC HEART PACK - 206044  UHPP82AH\tPERIPHERAL PACK - 209533  UICD62AN\tCARDIOVASCUALR SUPPLY (PS 907285)  UICT16F\t CARDIO THORACIC DRAPE PACK (PS 907284)  UIVA75I\tVASCULAR PACK",
      "text": "The FDA logged enforcement record Z-0176-2026: American Contract Systems Inc. is voluntarily recalling Medical convenience kits     Item Number/Description  ANCV78BC\tHEART PACK - 205947  HGCV05K\tCV SET UP PACK  MHPP97AR\tPACEMAKER PACK- 206010  UDBH37AW\tBASIC HEART PACK - 206044  UHPP82AH\tPERIPHERAL PACK - 209533  UICD62AN\tCARDIOVASCUALR SUPPLY (PS 907285)  UICT16F\t CARDIO THORACIC DRAPE PACK (PS 907284)  UIVA75I\tVASCULAR 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: ANCV78BB UDI-DI 191072214362 Lot 8133811 Bag serial number 68273380;  ANCV78BC UDI-DI 191072235169 Lot 8499811 Bag serial numbers N/A;  HGCV05K UDI-DI 191072212474 Lot 8021411 Bag serial number 68154464;  MHPP97AR UDI-DI 191072237446 Lot 8527511 Bag serial number N/A;  UDBH37AW UDI-DI 191072235299 Lot 8194311 Bag serial numbers 68198334 68198335;  UHPP82AH UDI-DI 191072216434 Lot 8112811 Bag serial number N/A;  UICD62AN UDI-DI 191072200495 Lot 7999011 Bag serial number N/A;  UICT16F UDI-DI 191072150431 Lot 8000411 Bag serial number N/A Lot 8331311 Bag serial number  17627819 Lot 8429011 Bag serial number 17749736;  UIVA75I UDI-DI 191072229052 Lot 8056011 Bag serial number N/A;  UIVA75J UDI-DI 191072235602 Lot 8422011 Bag serial number 68667536  * If Bag serial number is \"n/a\", then all of that 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-0176-2026&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-0176-2026&lang=eng"
        }
      },
      "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-0176-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0176-2026 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
      },
      "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-0176-2026&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-0176-2026&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-0176-2026/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,
        "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."
    }
  ],
  "hasPart": [
    {
      "@type": "schema:ItemList",
      "name": "FDA recall details — Z-0176-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0176-2026",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "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": "American Contract Systems Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-09-04",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "ANCV78BB UDI-DI 191072214362 Lot 8133811 Bag serial number 68273380;  ANCV78BC UDI-DI 191072235169 Lot 8499811 Bag serial numbers N/A;  HGCV05K UDI-DI 191072212474 Lot 8021411 Bag serial number 68154464;  MHPP97AR UDI-DI 191072237446 Lot 8527511 Bag serial number N/A;  UDBH37AW UDI-DI 191072235299 Lot 8194311 Bag serial numbers 68198334 68198335;  UHPP82AH UDI-DI 191072216434 Lot 8112811 Bag serial number N/A;  UICD62AN UDI-DI 191072200495 Lot 7999011 Bag serial number N/A;  UICT16F UDI-DI 191072150431 Lot 8000411 Bag serial number N/A Lot 8331311 Bag serial number  17627819 Lot 8429011 Bag serial number 17749736;  UIVA75I UDI-DI 191072229052 Lot 8056011 Bag serial number N/A;  UIVA75J UDI-DI 191072235602 Lot 8422011 Bag serial number 68667536  * If Bag serial number is \"n/a\", then all of that 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"
          }
        }
      ]
    }
  ]
}