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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0183-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Medical convenience kits     Item Number/Description  HSLM53AB\tSPINE PACK  MILM82A\tDTC LAMINECTOMY PACK (PS 209475)  RCNA47B\tNEURO ANGIO 0246971  SFLM54AB\tLAMINECTOMY PACK - 219659  UDLM94AA\tLAMINECTOMY PACK - 206064  UILM77AU\tLAMINECTOMY (PS 039500)  UINR44P\tNEURO IR PERIPHERAL (PS 64405)  UISH15AV\tSHUNT PACK (PS 039360)",
  "description": "FDA recall Z-0183-2026 — American Contract Systems Inc. is recalling Medical convenience kits     Item Number/Description  HSLM53AB\tSPINE PACK  MILM82A\tDTC LAMINECTOMY PACK (PS 209475)  RCNA47B\tNEURO ANGIO 0246971  SFLM54AB\tLAMINECTOMY PACK - 219659  UDLM94AA\tLAMINECTOMY PACK - 206064  UILM77AU\tLAMINECTOMY (PS 039500)  UINR44P\tNEURO IR PERIPHERAL (PS 64405)  UISH15AV\tSHUNT PACK (PS 039360) (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,
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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-0183-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Medical convenience kits     Item Number/Description  HSLM53AB\tSPINE PACK  MILM82A\tDTC LAMINECTOMY PACK (PS 209475)  RCNA47B\tNEURO ANGIO 0246971  SFLM54AB\tLAMINECTOMY PACK - 219659  UDLM94AA\tLAMINECTOMY PACK - 206064  UILM77AU\tLAMINECTOMY (PS 039500)  UINR44P\tNEURO IR PERIPHERAL (PS 64405)  UISH15AV\tSHUNT PACK (PS 039360)",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "American Contract Systems Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0183-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0183-2026: American Contract Systems Inc. is recalling Medical convenience kits     Item Number/Description  HSLM53AB\tSPINE PACK  MILM82A\tDTC LAMINECTOMY PACK (PS 209475)  RCNA47B\tNEURO ANGIO 0246971  SFLM54AB\tLAMINECTOMY PACK - 219659  UDLM94AA\tLAMINECTOMY PACK - 206064  UILM77AU\tLAMINECTOMY (PS 039500)  UINR44P\tNEURO IR PERIPHERAL (PS 64405)  UISH15AV\tSHUNT PACK (PS 039360)",
      "text": "The FDA logged enforcement record Z-0183-2026: American Contract Systems Inc. is voluntarily recalling Medical convenience kits     Item Number/Description  HSLM53AB\tSPINE PACK  MILM82A\tDTC LAMINECTOMY PACK (PS 209475)  RCNA47B\tNEURO ANGIO 0246971  SFLM54AB\tLAMINECTOMY PACK - 219659  UDLM94AA\tLAMINECTOMY PACK - 206064  UILM77AU\tLAMINECTOMY (PS 039500)  UINR44P\tNEURO IR PERIPHERAL (PS 64405)  UISH15AV\tSHUNT PACK (PS 039360) — 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: ANLM40AG UDI-DI 191072232076 Lot 8192111 Bag serial number 68195596;  ANPP15AR UDI-DI 191072214423 Lot 8024911 Bag serial number 68055493;  HSLM53AB UDI-DI 191072224095 Lot 8061111 Bag serial number 68138767;  MILM82A UDI-DI 191072231512 Lot 8361111 Bag serial number 68576542;  RCNA47B UDI-DI 191072228536 Lot 8441711 Bag serial number 68680026;  SFLM54AB UDI-DI 191072217400 lot 8105511 Bag serial number N/A;  UDLM94AA UDI-DI 191072214089 Lot 8382011 Bag serial number 17621919;  UILM77AU UDI-DI 191072210333 Lot 8056311 Bag serial number N/A;  UINR44P UDI-DI 191072210340 Lot 8067511 Bag serial numbers 68138618 68140374;  UISH15AV UDI-DI 191072227843 Lot 8028211 Bag serial number 68154067  * If bag serial number is listed as \"N/A\", then whole lot is affected. A RECORDED FDA enforcement action (occurred=true).",
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        "adjudged": 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-0183-2026&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-0183-2026&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-0183-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0183-2026 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",
      "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-0183-2026&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-0183-2026/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-0183-2026",
      "numberOfItems": 9,
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          "item": {
            "Field": "Recall number",
            "Value": "Z-0183-2026",
            "Status": "recorded"
          }
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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        },
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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": "ANLM40AG UDI-DI 191072232076 Lot 8192111 Bag serial number 68195596;  ANPP15AR UDI-DI 191072214423 Lot 8024911 Bag serial number 68055493;  HSLM53AB UDI-DI 191072224095 Lot 8061111 Bag serial number 68138767;  MILM82A UDI-DI 191072231512 Lot 8361111 Bag serial number 68576542;  RCNA47B UDI-DI 191072228536 Lot 8441711 Bag serial number 68680026;  SFLM54AB UDI-DI 191072217400 lot 8105511 Bag serial number N/A;  UDLM94AA UDI-DI 191072214089 Lot 8382011 Bag serial number 17621919;  UILM77AU UDI-DI 191072210333 Lot 8056311 Bag serial number N/A;  UINR44P UDI-DI 191072210340 Lot 8067511 Bag serial numbers 68138618 68140374;  UISH15AV UDI-DI 191072227843 Lot 8028211 Bag serial number 68154067  * 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"
          }
        }
      ]
    }
  ]
}