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  "name": "Brand Name: Atlan  Product Name: Atlan A350  Model/Catalog Number: 8211500  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-2616-2025 — Draeger, Inc. is recalling Brand Name: Atlan  Product Name: Atlan A350  Model/Catalog Number: 8211500  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": "Brand Name: Atlan  Product Name: Atlan A350  Model/Catalog Number: 8211500  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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      "name": "FDA recall Z-2616-2025: Draeger, Inc. is recalling Brand Name: Atlan  Product Name: Atlan A350  Model/Catalog Number: 8211500  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-2616-2025: Draeger, Inc. is voluntarily recalling Brand Name: Atlan  Product Name: Atlan A350  Model/Catalog Number: 8211500  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. 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ASUD-0106,ASUD-0107,ASUD-0108,ASUD-0109,ASUD-0126,ASUD-0127,ASUD-0128,ASUD-0129, ASUD-0130,ASUD-0131,ASUD-0133,ASUD-0135,ASUD-0136,ASUD-0140,ASUD-0141,ASUD-0150, ASUD-0168,ASUD-0173,ASUD-0174,ASUD-0175,ASUD-0181,ASUD-0182,ASUD-0183,ASUD-0184, ASUD-0185,ASUD-0186,ASUD-0196,ASUD-0198,ASUD-0199,ASUD-0200,ASUD-0201,ASUD-0202, ASUD-0203,ASUD-0204,ASUD-0205,ASUD-0206,ASUD-0219,ASUD-0220,ASUD-0221,ASUD-0222, ASUD-0223,ASUD-0224,ASUD-0225,ASUD-0226,ASUD-0227,ASUD-0228,ASUD-0238,ASUD-0239, ASUD-0245,ASUD-0246,ASUD-0247,ASUD-0248,ASUD-0249,ASUD-0250,ASUD-0251,ASUD-0252, ASUD-0253,ASUD-0258,ASUD-0259,ASUD-0260,ASUD-0273,ASUD-0274. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
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      "grounding": {
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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-2616-2025&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-2616-2025&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-2616-2025/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2616-2025 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,
        "operative": true
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      "grounding": {
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        "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-2616-2025&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-2616-2025&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-2616-2025/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": {
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        "supported": true,
        "adjudged": false,
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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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  "hasPart": [
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      "name": "FDA recall details — Z-2616-2025",
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          "item": {
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            "Value": "Z-2616-2025",
            "Status": "recorded"
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            "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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          "item": {
            "Field": "Initiated",
            "Value": "2025-09-09",
            "Status": "recorded"
          }
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          "item": {
            "Field": "Lot/code info",
            "Value": "Lot Code: UDI-DI Number: 04048675556176 Serial Numbers Distributed in the US: ASTB-0181 ASTC-0005,ASTC-0006,ASTC-0007 ASTD-0244,ASTD-0259 ASTE-0180,ASTE-0254,ASTE-0255  ASTH-0083,ASTH-0464 ASUA-0479,ASUA-0482 ASUB-0012,ASUB-0013,ASUB-0015,ASUB-0017,ASUB-0018,ASUB-0292 ASUC-0065,ASUC-0084,ASUC-0085,ASUC-0086,ASUC-0087,ASUC-0088,ASUC-0090,ASUC-0091, ASUC-0092,ASUC-0096,ASUC-0097,ASUC-0099,ASUC-0100,ASUC-0101,ASUC-0102,ASUC-0103, ASUC-0104,ASUC-0105,ASUC-0107,ASUC-0108,ASUC-0109,ASUC-0110,ASUC-0111,ASUC-0112, ASUC-0113,ASUC-0116,ASUC-0117,ASUC-0118,ASUC-0119,ASUC-0120,ASUC-0121,ASUC-0122, ASUC-0123,ASUC-0125,ASUC-0126,ASUC-0127,ASUC-0128,ASUC-0129,ASUC-0130,ASUC-0131, ASUC-0132,ASUC-0133,ASUC-0134,ASUC-0135,ASUC-0136,ASUC-0137,ASUC-0138,ASUC-0139, ASUC-0140,ASUC-0141,ASUC-0142,ASUC-0143,ASUC-0143,ASUC-0144,ASUC-0145,ASUC-0162, ASUC-0163,ASUC-0164,ASUC-0165,ASUC-0166,ASUC-0167,ASUC-0168,ASUC-0169,ASUC-0170, ASUC-0171,ASUC-0172,ASUC-0173,ASUC-0203,ASUC-0204,ASUC-0205,ASUC-0206,ASUC-0207, ASUC-0208,ASUC-0209,ASUC-0210,ASUC-0218,ASUC-0219,ASUC-0220,ASUC-0221,ASUC-0222, ASUC-0223,ASUC-0224,ASUC-0225,ASUC-0235,ASUC-0236,ASUC-0237,ASUC-0340,ASUC-0341 ASUD-0244,ASUD-0261,ASUD-0262,ASUD-0263,ASUD-0267,ASUD-0281,ASUD-0282,ASUD-0283  Serial Numbers Distributed OUS ASUA-0353,ASUA-0441,ASUA-0447,ASUA-0472,ASUA-0478,ASUA-0496,,SUA-0497,ASUA-0500, ASUB-0004,ASUB-0024,ASUB-0025,ASUB-0030,ASUB-0033,ASUB-0034,ASUB-0035,ASUB-0038, ASUB-0039,ASUB-0040,ASUB-0041,ASUB-0043,ASUB-0044,ASUB-0046,ASUB-0048,ASUB-0063, ASUB-0064,ASUB-0066,ASUB-0067,ASUB-0069,ASUB-0073,ASUB-0074,ASUB-0075,ASUB-0076, ASUB-0077,ASUB-0095,ASUB-0096,ASUB-0097,ASUB-0098,ASUB-0099,ASUB-0100,ASUB-0101, ASUB-0102,ASUB-0104,ASUB-0105,ASUB-0107,ASUB-0108,ASUB-0109,ASUB-0112,ASUB-0113, ASUB-0114,ASUB-0115,ASUB-0116,ASUB-0118,ASUB-0120,ASUB-0121,ASUB-0122,ASUB-0123, ASUB-0124,ASUB-0128,ASUB-0129,ASUB-0130,ASUB-0136,ASUB-0137,ASUB-0139,ASUB-0140, ASUB-0141,ASUB-0143,ASUB-0144,ASUB-0145,ASUB-0146,ASUB-0147,ASUB-0148,ASUB-0149, ASUB-0150,ASUB-0151,ASUB-0152,ASUB-0153,ASUB-0154,ASUB-0155,ASUB-0156,ASUB-0157, ASUB-0158,ASUB-0159,ASUB-0160,ASUB-0161,ASUB-0162,ASUB-0163,ASUB-0177,ASUB-0178, ASUB-0188,ASUB-0189,ASUB-0190,ASUB-0191,ASUB-0192,ASUB-0193,ASUB-0194,ASUB-0195, ASUB-0196,ASUB-0197,ASUB-0198,ASUB-0199,ASUB-0201,ASUB-0202,ASUB-0203,ASUB-0204, ASUB-0205,ASUB-0206,ASUB-0207,ASUB-0208,ASUB-0209,ASUB-0210,ASUB-0211,ASUB-0223, ASUB-0224,ASUB-0225,ASUB-0226,ASUB-0227,ASUB-0229,ASUB-0230,ASUB-0231,ASUB-0232, ASUB-0233,ASUB-0234,ASUB-0235,ASUB-0236,ASUB-0237,ASUB-0238,ASUB-0240,ASUB-0243, ASUB-0245,ASUB-0252,ASUB-0253,ASUB-0254,ASUB-0255,ASUB-0256,ASUB-0257,ASUB-0258, ASUB-0260,ASUB-0261,ASUB-0262,ASUB-0263,ASUB-0264,ASUB-0265,ASUB-0271,ASUB-0272, ASUB-0273,ASUB-0276,ASUB-0278,ASUC-0001ASUC-0004,ASUC-0016,ASUC-0017,ASUC-0018, ASUC-0019,ASUC-0020,ASUC-0022,ASUC-0024,ASUC-0026,,ASUC-0028,,ASUC-0030,ASUC-0031, ASUC-0032,ASUC-0033,ASUC-0034,ASUC-0035,ASUC-0036,ASUC-0039,ASUC-0061,ASUC-0062, ASUC-0063,ASUC-0226,ASUC-0227,ASUC-0228,ASUC-0229,ASUC-0230,ASUC-0232,ASUC-0233, ASUC-0234,ASUC-0247,ASUC-0248,ASUC-0249,ASUC-0250,ASUC-0251,ASUC-0252,ASUC-0253, ASUC-0254,ASUC-0255,ASUC-0256,ASUC-0257,ASUC-0262,ASUC-0263,ASUC-0264,ASUC-0265, ASUC-0266,ASUC-0267,ASUC-0269,ASUC-0272,ASUC-0273,ASUC-0274,ASUC-0275,ASUC-0276, ASUC-0277,ASUC-0278,ASUC-0279,ASUC-0284,ASUC-0286,ASUC-0287,ASUC-0288,ASUC-0289, ASUC-0290,ASUC-0291,ASUC-0292,ASUC-0293,ASUC-0294,ASUC-0295,ASUC-0296,ASUC-0300, ASUC-0301,ASUC-0302,ASUC-0303,ASUC-0304,ASUC-0305,ASUC-0306ASUC-0307,ASUC-0308, ASUC-0309,ASUC-0310,ASUC-0311,ASUC-0314,ASUC-0315,ASUC-0316,ASUC-0319,ASUC-0320, ASUC-0321,ASUC-0322,ASUC-0323,ASUC-0339,ASUC-0342,ASUC-0343,ASUC-0344,ASUC-0345, ASUC-0346,ASUC-0348,ASUC-0349,ASUC-0350,ASUC-0351,ASUC-0352,ASUC-0353,ASUC-0354, ASUC-0355,ASUC-0356,ASUC-0357,ASUC-0358,ASUC-0359,ASUC-0360,ASUC-0361,ASUC-0362, ASUC-0363,ASUC-0364,ASUC-0365,ASUC-0366,ASUC-0367,ASUC-0380,ASUC-0381,ASUC-0382, ASUC-0383,ASUC-0384,ASUC-0385,ASUC-0386,ASUC-0387,ASUC-0391,ASUC-0392,ASUC-0393, ASUC-0394,ASUC-0395,ASUC-0396,ASUC-0397,ASUC-0398,ASUC-0399,ASUC-0400,ASUC-0401, ASUC-0402,ASUC-0403,ASUC-0404,ASUC-0405,ASUC-0406,ASUC-0407,ASUC-0408,ASUC-0409, ASUC-0410,ASUC-0416,ASUD-0001,ASUD-0002,ASUD-0004,ASUD-0005,ASUD-0006,ASUD-0007, ASUD-0008,ASUD-0009,ASUD-0010,ASUD-0011,ASUD-0012,ASUD-0013,ASUD-0014,ASUD-0015, ASUD-0016,ASUD-0018,ASUD-0019,ASUD-0020,ASUD-0022,ASUD-0023,ASUD-0041,ASUD-0042, ASUD-0043,ASUD-0044,ASUD-0046,ASUD-0047,ASUD-0048,ASUD-0049,ASUD-0050,ASUD-0051, ASUD-0057,ASUD-0059,ASUD-0060,ASUD-0061,ASUD-0062,ASUD-0063,ASUD-0064,ASUD-0065, ASUD-0066,ASUD-0074,ASUD-0075,ASUD-0077,ASUD-0078,ASUD-0079,ASUD-0080,ASUD-0081, ASUD-0098,ASUD-0099,ASUD-0100,ASUD-0101,ASUD-0102,ASUD-0103,ASUD-0104,ASUD-0105, ASUD-0106,ASUD-0107,ASUD-0108,ASUD-0109,ASUD-0126,ASUD-0127,ASUD-0128,ASUD-0129, ASUD-0130,ASUD-0131,ASUD-0133,ASUD-0135,ASUD-0136,ASUD-0140,ASUD-0141,ASUD-0150, ASUD-0168,ASUD-0173,ASUD-0174,ASUD-0175,ASUD-0181,ASUD-0182,ASUD-0183,ASUD-0184, ASUD-0185,ASUD-0186,ASUD-0196,ASUD-0198,ASUD-0199,ASUD-0200,ASUD-0201,ASUD-0202, ASUD-0203,ASUD-0204,ASUD-0205,ASUD-0206,ASUD-0219,ASUD-0220,ASUD-0221,ASUD-0222, ASUD-0223,ASUD-0224,ASUD-0225,ASUD-0226,ASUD-0227,ASUD-0228,ASUD-0238,ASUD-0239, ASUD-0245,ASUD-0246,ASUD-0247,ASUD-0248,ASUD-0249,ASUD-0250,ASUD-0251,ASUD-0252, ASUD-0253,ASUD-0258,ASUD-0259,ASUD-0260,ASUD-0273,ASUD-0274",
            "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"
          }
        }
      ]
    }
  ]
}