{
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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0171-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Basic Biopsy Tray;  Item Number/Description:  AKRB26D  ROBOTIC,  AMGL09AA  GENERAL LAPAROSCOPY,  ANLC35AD  LAP CHOLE PACK - 205956,  ANLP25AJ  LAPROSCOPY PACK - 205958,  FYLA38E  LAPCHOLAPPY PACK,  IHDA88AH  DIVINCI GYN URO,  IHLC11AE  LAP GENERAL PACK,  MHLP45AJ  LAPAROSCOPY PACK - 206005,  MHRB88AO  ROBOTIC PACK - 242561,  RCLC51C  LAP CHOLE RCH 0246969,  SMLC53C  LAP CHOLE PACK,  UDLC17AE  DSC LAP CHOLE PACK - 206062,  UIRU84AE  ROBOTIC UROLOGY PACK (PS 060571)",
  "description": "FDA recall Z-0171-2026 — American Contract Systems Inc. is recalling Basic Biopsy Tray;  Item Number/Description:  AKRB26D  ROBOTIC,  AMGL09AA  GENERAL LAPAROSCOPY,  ANLC35AD  LAP CHOLE PACK - 205956,  ANLP25AJ  LAPROSCOPY PACK - 205958,  FYLA38E  LAPCHOLAPPY PACK,  IHDA88AH  DIVINCI GYN URO,  IHLC11AE  LAP GENERAL PACK,  MHLP45AJ  LAPAROSCOPY PACK - 206005,  MHRB88AO  ROBOTIC PACK - 242561,  RCLC51C  LAP CHOLE RCH 0246969,  SMLC53C  LAP CHOLE PACK,  UDLC17AE  DSC LAP CHOLE PACK - 206062,  UIRU84AE  ROBOTIC UROLOGY PACK (PS 060571) (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-0171-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Basic Biopsy Tray;  Item Number/Description:  AKRB26D  ROBOTIC,  AMGL09AA  GENERAL LAPAROSCOPY,  ANLC35AD  LAP CHOLE PACK - 205956,  ANLP25AJ  LAPROSCOPY PACK - 205958,  FYLA38E  LAPCHOLAPPY PACK,  IHDA88AH  DIVINCI GYN URO,  IHLC11AE  LAP GENERAL PACK,  MHLP45AJ  LAPAROSCOPY PACK - 206005,  MHRB88AO  ROBOTIC PACK - 242561,  RCLC51C  LAP CHOLE RCH 0246969,  SMLC53C  LAP CHOLE PACK,  UDLC17AE  DSC LAP CHOLE PACK - 206062,  UIRU84AE  ROBOTIC UROLOGY PACK (PS 060571)",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "American Contract Systems Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0171-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0171-2026: American Contract Systems Inc. is recalling Basic Biopsy Tray;  Item Number/Description:  AKRB26D  ROBOTIC,  AMGL09AA  GENERAL LAPAROSCOPY,  ANLC35AD  LAP CHOLE PACK - 205956,  ANLP25AJ  LAPROSCOPY PACK - 205958,  FYLA38E  LAPCHOLAPPY PACK,  IHDA88AH  DIVINCI GYN URO,  IHLC11AE  LAP GENERAL PACK,  MHLP45AJ  LAPAROSCOPY PACK - 206005,  MHRB88AO  ROBOTIC PACK - 242561,  RCLC51C  LAP CHOLE RCH 0246969,  SMLC53C  LAP CHOLE PACK,  UDLC17AE  DSC LAP CHOLE PACK - 206062,  UIRU84AE  ROBOTIC UROLOGY PACK (PS 060571)",
      "text": "The FDA logged enforcement record Z-0171-2026: American Contract Systems Inc. is voluntarily recalling Basic Biopsy Tray;  Item Number/Description:  AKRB26D  ROBOTIC,  AMGL09AA  GENERAL LAPAROSCOPY,  ANLC35AD  LAP CHOLE PACK - 205956,  ANLP25AJ  LAPROSCOPY PACK - 205958,  FYLA38E  LAPCHOLAPPY PACK,  IHDA88AH  DIVINCI GYN URO,  IHLC11AE  LAP GENERAL PACK,  MHLP45AJ  LAPAROSCOPY PACK - 206005,  MHRB88AO  ROBOTIC PACK - 242561,  RCLC51C  LAP CHOLE RCH 0246969,  SMLC53C  LAP CHOLE PACK,  UDLC17AE  DSC LAP CHOLE PACK - 206062,  UIRU84AE  ROBOTIC UROLOGY PACK (PS 060571) — 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: AKRB26D UDI-DI 191072229366 Lot 7350411 Bag Serial Number 68236939;  AMGL09AA UDI-DI 191072207357 Lot 8459111 Bag Serial Numbers 68678361 68678364;  ANLC35AD UDI-DI 191072211477 LOT 8021911 Bag Serial Number n/a Lot 8173811 Bag Serial Numbers  17556328 17556374 17556376 17556393;  ANLP25AJ UDI-DI 191072236333 Lot 8306311 Bag Serial Numbers  47862596 47862598;  FYLA38E UDI-DI 191072203519 Lot 8134111 Bag Serial Number 17488260;  IHDA88AH UDI-DI 191072226303 Lot 8096211 Bag serial number N/A Lot 8150511 Bag Serial number 68277361;  IHLC11AE UDI-DI 191072226372 Lot 8107911 Bag Serial Number N/A Lot 8192711 Bag Serial Numbers 68195543 68196275;  MHLP45AJ UDI-DI 191072236500 Lot 8527411 Bag serial number 68873222;  MHRB88AO UDI-DI 191072236531 Lot 8322811 Bag serial number 68596086;  RCLC51C UDI-DI 191072235930 Lot 8230311 Bag serial number N/A;  SMLC53C UDI-DI 191072223029 Lot 8195611 Bag serial numbers 68198164 68198213 68198222 68198228 68198229;  UDLC17AE UDI-DI 191072214072 Lot 8501711 Bag serial number 17744347;  UIRU84AE UDI-DI 191072235565 Lot 8319311 Bag serial number 68244060  * If \"N/A\" for bag serial number, 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
      },
      "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-0171-2026&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-0171-2026&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-0171-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0171-2026 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-0171-2026&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-0171-2026&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-0171-2026/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": [
    {
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      "name": "FDA recall details — Z-0171-2026",
      "numberOfItems": 9,
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          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-0171-2026",
            "Status": "recorded"
          }
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          "@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"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
          }
        },
        {
          "@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": "AKRB26D UDI-DI 191072229366 Lot 7350411 Bag Serial Number 68236939;  AMGL09AA UDI-DI 191072207357 Lot 8459111 Bag Serial Numbers 68678361 68678364;  ANLC35AD UDI-DI 191072211477 LOT 8021911 Bag Serial Number n/a Lot 8173811 Bag Serial Numbers  17556328 17556374 17556376 17556393;  ANLP25AJ UDI-DI 191072236333 Lot 8306311 Bag Serial Numbers  47862596 47862598;  FYLA38E UDI-DI 191072203519 Lot 8134111 Bag Serial Number 17488260;  IHDA88AH UDI-DI 191072226303 Lot 8096211 Bag serial number N/A Lot 8150511 Bag Serial number 68277361;  IHLC11AE UDI-DI 191072226372 Lot 8107911 Bag Serial Number N/A Lot 8192711 Bag Serial Numbers 68195543 68196275;  MHLP45AJ UDI-DI 191072236500 Lot 8527411 Bag serial number 68873222;  MHRB88AO UDI-DI 191072236531 Lot 8322811 Bag serial number 68596086;  RCLC51C UDI-DI 191072235930 Lot 8230311 Bag serial number N/A;  SMLC53C UDI-DI 191072223029 Lot 8195611 Bag serial numbers 68198164 68198213 68198222 68198228 68198229;  UDLC17AE UDI-DI 191072214072 Lot 8501711 Bag serial number 17744347;  UIRU84AE UDI-DI 191072235565 Lot 8319311 Bag serial number 68244060  * If \"N/A\" for bag serial number, 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"
          }
        }
      ]
    }
  ]
}