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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2617-2025.jsonld",
  "@type": "schema:Dataset",
  "name": "Brand Name: Atlan  Product Name: Atlan A350XL  Model/Catalog Number: 8621600  Software Version: Not Applicable  Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions  Component: Not applicable",
  "description": "FDA recall Z-2617-2025 — Draeger, Inc. is recalling Brand Name: Atlan  Product Name: Atlan A350XL  Model/Catalog Number: 8621600  Software Version: Not Applicable  Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions  Component: Not applicable (Devices, Class I). 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.",
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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2617-2025&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "Brand Name: Atlan  Product Name: Atlan A350XL  Model/Catalog Number: 8621600  Software Version: Not Applicable  Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions  Component: Not applicable",
    "manufacturer": {
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      "name": "Draeger, Inc."
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2617-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2617-2025: Draeger, Inc. is recalling Brand Name: Atlan  Product Name: Atlan A350XL  Model/Catalog Number: 8621600  Software Version: Not Applicable  Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions  Component: Not applicable",
      "text": "The FDA logged enforcement record Z-2617-2025: Draeger, Inc. is voluntarily recalling Brand Name: Atlan  Product Name: Atlan A350XL  Model/Catalog Number: 8621600  Software Version: Not Applicable  Product Description: The Atlan is an anesthesia workstation intended for use in anesthetizing adults, pediatrics, and neonates. The device can be used for mechanical ventilation, manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing. The device is specified for inhalational anesthesia and/or patient ventilation in accordance with the intended use during surgical or diagnostic interventions  Component: Not applicable — reason: The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-09. Affected lots/codes: Lot Code: UDI-DI Number: 04048675556183 Serial Numbers Distributed in the US: ASTA-0307,ASTA-0309,ASTA-0311,ASTA-0349,ASTA-0350,ASTA-0409 ASTB-0048 ASTC-0244,ASTC-0245 ASTD-0008,ASTD-0009,ASTD-0010,ASTD-0011,ASTD-0013,ASTD-0014,ASTD-0212,ASTD-0239 ASTH-0307,ASTH-0308,ASTH-0309,ASTH-0310,ASTH-0311,ASTH-0332,ASTH-0333,ASTH-0334, ASTH-0335,ASTH-0336,ASTH-0383,ASTH-0384 ASTJ-0014 ASUA-0469,ASUA-0483,ASUA-0484,ASUA-0486,ASUA-0488 ASUB-0093,ASUB-0169,ASUB-0170,ASUB-0171,ASUB-0172,ASUB-0173,ASUB-0174,ASUB-0175, ASUB-0176,ASUB-0183,ASUB-0184,ASUB-0185,ASUB-0186,ASUB-0187,ASUB-0215,ASUB-0216, ASUB-0217,ASUB-0218,ASUB-0219,ASUB-0221,ASUB-0222,ASUB-0250,ASUB-0251,ASUB-0266, ASUB-0267, ASUB-0268,ASUB-0269,ASUB-0270 ASUC-0067,ASUC-0068,ASUC-0069,ASUC-0072,ASUC-0114,ASUC-0115,ASUC-0146,ASUC-0148, ASUC-0149,ASUC-0150,ASUC-0151,ASUC-0153,ASUC-0155,ASUC-0156,ASUC-0157,ASUC-0158, ASUC-0174,ASUC-0175,ASUC-0176,ASUC-0178,ASUC-0179,ASUC-0180,ASUC-0181,ASUC-0182, ASUC-0183,ASUC-0184,ASUC-0185,ASUC-0186,ASUC-0187,ASUC-0188,,ASUC-0189,ASUC-0190, ASUC-0191,ASUC-0192,ASUC-0193,ASUC-0194,ASUC-0196,ASUC-0197,ASUC-0198,ASUC-0199, ASUC-0200,ASUC-0201,ASUC-0202,ASUC-0211,ASUC-0212,ASUC-0213,ASUC-0214,ASUC-0215, ASUC-0216,ASUC-0217,ASUC-0238,ASUC-0239,ASUC-0285,ASUC-0368,ASUC-0369,ASUC-0370, ASUC-0371,ASUC-0372,ASUC-0373 ASUD-0142,ASUD-0142,ASUD-0143,ASUD-0143,ASUD-0144,ASUD-0145,ASUD-0146,ASUD-0147, ASUD-0164,ASUD-0165,ASUD-0165,ASUD-0165,ASUD-0165,ASUD-0187,ASUD-0188,ASUD-0189, ASUD-0190,ASUD-0191,ASUD-0192,ASUD-0193,ASUD-0207,ASUD-0208,ASUD-0209,ASUD-0210, ASUD-0211,ASUD-0212,ASUD-0212,ASUD-0275,ASUD-0276,ASUD-0277,ASUD-0294  Serial Numbers Distributed OUS (Direct shipped from Draegerwerk AG & Co., KGaA): ASUB-0094,ASUB-0279,ASUB-0280,ASUB-0281,ASUB-0282,ASUB-0284,ASUB-0285,ASUB-0286, ASUC-0005,ASUC-0006,ASUC-0007,ASUC-0008,ASUC-0010,ASUC-0011,ASUC-0012,ASUC-0013, ASUC-0014,ASU-0042,ASUC-0043,ASUC-0044,ASUC-0045,ASUC-0046,ASUC-0047,ASUC-0048, ASUC-0049,ASUC-0050,ASUC-0051,ASUC-0052,ASUC-0053,ASUC-0054,ASUC-0057,ASUC-0060, ASUC-0073,ASUC-0074,ASUC-0075,ASUC-0076,ASUC-0077,ASUC-0078,ASUC-0079,ASUC-0080, SUC-0081,ASUC-0082,ASUC-0331,ASUC-0377,ASUC-0378,ASUC-0379,ASUD-0067,ASUD-0068, ASUD-0088,ASUD-0089,ASUD-0091,ASUD-0092,ASUD-0093,ASUD-0094,ASUD-0095,ASUD-0096, ASUD-0097,ASUD-0112,ASUD-0113,ASUD-0114,ASUD-0115,ASUD-0116,ASUD-0117,ASUD-0118, ASUD-0119,ASUD-0120,ASUD-0121,ASUD-0122,ASUD-0160,ASUD-0166. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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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-2617-2025&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-2617-2025&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2617-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2617-2025 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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,
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      "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-2617-2025&lang=eng",
        "value": "Class I",
        "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-2617-2025&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-2617-2025/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
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      "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."
    }
  ],
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      "name": "FDA recall details — Z-2617-2025",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-2617-2025",
            "Status": "recorded"
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          "position": 2,
          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "item": {
            "Field": "Classification",
            "Value": "Class I",
            "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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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Draeger, Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "The device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.",
            "Status": "recorded"
          }
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        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-09-09",
            "Status": "recorded"
          }
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          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Lot Code: UDI-DI Number: 04048675556183 Serial Numbers Distributed in the US: ASTA-0307,ASTA-0309,ASTA-0311,ASTA-0349,ASTA-0350,ASTA-0409 ASTB-0048 ASTC-0244,ASTC-0245 ASTD-0008,ASTD-0009,ASTD-0010,ASTD-0011,ASTD-0013,ASTD-0014,ASTD-0212,ASTD-0239 ASTH-0307,ASTH-0308,ASTH-0309,ASTH-0310,ASTH-0311,ASTH-0332,ASTH-0333,ASTH-0334, ASTH-0335,ASTH-0336,ASTH-0383,ASTH-0384 ASTJ-0014 ASUA-0469,ASUA-0483,ASUA-0484,ASUA-0486,ASUA-0488 ASUB-0093,ASUB-0169,ASUB-0170,ASUB-0171,ASUB-0172,ASUB-0173,ASUB-0174,ASUB-0175, ASUB-0176,ASUB-0183,ASUB-0184,ASUB-0185,ASUB-0186,ASUB-0187,ASUB-0215,ASUB-0216, ASUB-0217,ASUB-0218,ASUB-0219,ASUB-0221,ASUB-0222,ASUB-0250,ASUB-0251,ASUB-0266, ASUB-0267, ASUB-0268,ASUB-0269,ASUB-0270 ASUC-0067,ASUC-0068,ASUC-0069,ASUC-0072,ASUC-0114,ASUC-0115,ASUC-0146,ASUC-0148, ASUC-0149,ASUC-0150,ASUC-0151,ASUC-0153,ASUC-0155,ASUC-0156,ASUC-0157,ASUC-0158, ASUC-0174,ASUC-0175,ASUC-0176,ASUC-0178,ASUC-0179,ASUC-0180,ASUC-0181,ASUC-0182, ASUC-0183,ASUC-0184,ASUC-0185,ASUC-0186,ASUC-0187,ASUC-0188,,ASUC-0189,ASUC-0190, ASUC-0191,ASUC-0192,ASUC-0193,ASUC-0194,ASUC-0196,ASUC-0197,ASUC-0198,ASUC-0199, ASUC-0200,ASUC-0201,ASUC-0202,ASUC-0211,ASUC-0212,ASUC-0213,ASUC-0214,ASUC-0215, ASUC-0216,ASUC-0217,ASUC-0238,ASUC-0239,ASUC-0285,ASUC-0368,ASUC-0369,ASUC-0370, ASUC-0371,ASUC-0372,ASUC-0373 ASUD-0142,ASUD-0142,ASUD-0143,ASUD-0143,ASUD-0144,ASUD-0145,ASUD-0146,ASUD-0147, ASUD-0164,ASUD-0165,ASUD-0165,ASUD-0165,ASUD-0165,ASUD-0187,ASUD-0188,ASUD-0189, ASUD-0190,ASUD-0191,ASUD-0192,ASUD-0193,ASUD-0207,ASUD-0208,ASUD-0209,ASUD-0210, ASUD-0211,ASUD-0212,ASUD-0212,ASUD-0275,ASUD-0276,ASUD-0277,ASUD-0294  Serial Numbers Distributed OUS (Direct shipped from Draegerwerk AG & Co., KGaA): ASUB-0094,ASUB-0279,ASUB-0280,ASUB-0281,ASUB-0282,ASUB-0284,ASUB-0285,ASUB-0286, ASUC-0005,ASUC-0006,ASUC-0007,ASUC-0008,ASUC-0010,ASUC-0011,ASUC-0012,ASUC-0013, ASUC-0014,ASU-0042,ASUC-0043,ASUC-0044,ASUC-0045,ASUC-0046,ASUC-0047,ASUC-0048, ASUC-0049,ASUC-0050,ASUC-0051,ASUC-0052,ASUC-0053,ASUC-0054,ASUC-0057,ASUC-0060, ASUC-0073,ASUC-0074,ASUC-0075,ASUC-0076,ASUC-0077,ASUC-0078,ASUC-0079,ASUC-0080, SUC-0081,ASUC-0082,ASUC-0331,ASUC-0377,ASUC-0378,ASUC-0379,ASUD-0067,ASUD-0068, ASUD-0088,ASUD-0089,ASUD-0091,ASUD-0092,ASUD-0093,ASUD-0094,ASUD-0095,ASUD-0096, ASUD-0097,ASUD-0112,ASUD-0113,ASUD-0114,ASUD-0115,ASUD-0116,ASUD-0117,ASUD-0118, ASUD-0119,ASUD-0120,ASUD-0121,ASUD-0122,ASUD-0160,ASUD-0166",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Devices were imported from Draegerwerk Ag and Co. KGaA and distributed in the following states: AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, MA, MN, MO, NC, NE, NM, NV, NY, OH, PA, TX, UT, VA, WI. Devices were direct shipped from Draegerwerk Ag and Co. KGaA to the following countries: Argentina, Australia, Belgium, Brazil, Chili, China, Croatia, Denmark, Ecuador, France, Georgia, Germany, Greece, Hungary, India, Indonesia, Italy, Japan, Jordan, Kuwait, Lithuania, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Vietnam.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}