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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0720-2026.jsonld",
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  "name": "Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:    1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00.     2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00.    Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.",
  "description": "FDA recall Z-0720-2026 — Mindray DS USA, Inc. dba Mindray North America is recalling Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:    1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00.     2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00.    Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery. (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.",
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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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  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:    1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00.     2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00.    Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Mindray DS USA, Inc. dba Mindray North America"
    }
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0720-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0720-2026: Mindray DS USA, Inc. dba Mindray North America is recalling Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:    1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00.     2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00.    Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery.",
      "text": "The FDA logged enforcement record Z-0720-2026: Mindray DS USA, Inc. dba Mindray North America is voluntarily recalling Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following:    1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00.     2. Exchange Sev E_Vap. (Safety Filling adapter), Part Number: E115-066756-00.    Product Description: The Anesthesia System is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The A9 Anesthesia System utilizes V90 electronic vaporizers for anesthetic agent delivery. — reason: Potential for anesthesia leakage.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-10-20. Affected lots/codes: 1. Part Number: 115-066756-00; DI: 06936415975777; Serial Numbers: AH6A45000871, AH6A45000880, AH6A45000881, AH6A46000929, AH6A46000931, AH6A46000944, AH6A47001200, AH6A44000657, AH6A44000658, AH6A44000661, AH6A44000664, AH6A44000677, AH6A44000678, AH6A44000680, AH6A44000768, AH6A44000778, AH6A46000925, AH6A46000927, AH6A46000928, AH6A46000935, AH6A46000937, AH6A46001114, AH6A47001159, AH6A47001164, AH6A47001174, AH6A47001201, AH6A45000872, AH6A46000932, AH6A46000939, AH6A46000940, AH6A47001196, AH6A47001202, AH6A47001207, AH6A47001215, AH6A46001102, AH6A46001111, AH6A46001116, AH6A47001160, AH6A47001161, AH6A47001163, AH6A47001165, AH6A47001166, AH6A47001167, AH6A47001178, AH6A46001097, AH6A46001117, AH6A44000645, AH6A44000647, AH6A44000648, AH6A44000651, AH6A44000655, AH6A44000656, AH6A44000659, AH6A44000660, AH6A44000662, AH6A44000684, AH6A44000686, AH6A44000687, AH6A44000688, AH6A44000690, AH6A44000691, AH6A44000695, AH6A44000696, AH6A44000698, AH6A44000700, AH6A44000702, AH6A44000703, AH6A44000770, AH6A44000776, AH6A46001090, AH6A46001109, AH6A46001118, AH6A47001171, AH6A47001176, AH6A44000771, AH6A44000772, AH6A45000815, AH6A45000819, AH6A45000821, AH6A45000822, AH6A45000824, AH6A45000825, AH6A45000829, AH6A45000832, AH6A45000834, AH6A45000835, AH6A45000868, AH6A45000869, AH6A45000870, AH6A45000873, AH6A45000874, AH6A45000875, AH6A45000876, AH6A45000877, AH6A45000878, AH6A45000882, AH6A45000883, AH6A45000884, AH6A46000926, AH6A46000930, AH6A46000936, AH6A46000943, AH6A44000779, AH6A44000674, AH6A44000692, AH6A44000777, AH6A45000879, AH6A47001170, AH6A44000765, AH6A44000769, AH6A47001175, AH6A28000535, AH6A46000918, AH6A46000923, AH6A46000924, AH6A46000934, AH6A46000938, AH6A46001091, AH6A46001093, AH6A46001099, AH6A46001100, AH6A46001101, AH6A46001103, AH6A46001104, AH6A46001107, AH6A46001108, AH6A46001110, AH6A46001113, AH6A47001177, AH6A44000679, AH6A44000683, AH6A44000689, AH6A44000697, AH6A44000649, AH6A44000650, AH6A44000652, AH6A44000676, AH6A44000681, AH6A44000682, AH6A44000699, AH6A44000704, AH6A44000766, AH6A44000773, AH6A44000775, AH6A44000780, AH6A47001216, AH6A44000693.  2. Part Number: E115-066756-00; DI: 06936415975777; Serial Number: AH6A45000885.. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
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        "occurred": 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-0720-2026&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-0720-2026&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-0720-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0720-2026 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-0720-2026&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-0720-2026&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-0720-2026/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."
    }
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      "name": "FDA recall details — Z-0720-2026",
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            "Field": "Recall number",
            "Value": "Z-0720-2026",
            "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 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": "Mindray DS USA, Inc. dba Mindray North America",
            "Status": "recorded"
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        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Potential for anesthesia leakage.",
            "Status": "recorded"
          }
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        {
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-10-20",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1. Part Number: 115-066756-00; DI: 06936415975777; Serial Numbers: AH6A45000871, AH6A45000880, AH6A45000881, AH6A46000929, AH6A46000931, AH6A46000944, AH6A47001200, AH6A44000657, AH6A44000658, AH6A44000661, AH6A44000664, AH6A44000677, AH6A44000678, AH6A44000680, AH6A44000768, AH6A44000778, AH6A46000925, AH6A46000927, AH6A46000928, AH6A46000935, AH6A46000937, AH6A46001114, AH6A47001159, AH6A47001164, AH6A47001174, AH6A47001201, AH6A45000872, AH6A46000932, AH6A46000939, AH6A46000940, AH6A47001196, AH6A47001202, AH6A47001207, AH6A47001215, AH6A46001102, AH6A46001111, AH6A46001116, AH6A47001160, AH6A47001161, AH6A47001163, AH6A47001165, AH6A47001166, AH6A47001167, AH6A47001178, AH6A46001097, AH6A46001117, AH6A44000645, AH6A44000647, AH6A44000648, AH6A44000651, AH6A44000655, AH6A44000656, AH6A44000659, AH6A44000660, AH6A44000662, AH6A44000684, AH6A44000686, AH6A44000687, AH6A44000688, AH6A44000690, AH6A44000691, AH6A44000695, AH6A44000696, AH6A44000698, AH6A44000700, AH6A44000702, AH6A44000703, AH6A44000770, AH6A44000776, AH6A46001090, AH6A46001109, AH6A46001118, AH6A47001171, AH6A47001176, AH6A44000771, AH6A44000772, AH6A45000815, AH6A45000819, AH6A45000821, AH6A45000822, AH6A45000824, AH6A45000825, AH6A45000829, AH6A45000832, AH6A45000834, AH6A45000835, AH6A45000868, AH6A45000869, AH6A45000870, AH6A45000873, AH6A45000874, AH6A45000875, AH6A45000876, AH6A45000877, AH6A45000878, AH6A45000882, AH6A45000883, AH6A45000884, AH6A46000926, AH6A46000930, AH6A46000936, AH6A46000943, AH6A44000779, AH6A44000674, AH6A44000692, AH6A44000777, AH6A45000879, AH6A47001170, AH6A44000765, AH6A44000769, AH6A47001175, AH6A28000535, AH6A46000918, AH6A46000923, AH6A46000924, AH6A46000934, AH6A46000938, AH6A46001091, AH6A46001093, AH6A46001099, AH6A46001100, AH6A46001101, AH6A46001103, AH6A46001104, AH6A46001107, AH6A46001108, AH6A46001110, AH6A46001113, AH6A47001177, AH6A44000679, AH6A44000683, AH6A44000689, AH6A44000697, AH6A44000649, AH6A44000650, AH6A44000652, AH6A44000676, AH6A44000681, AH6A44000682, AH6A44000699, AH6A44000704, AH6A44000766, AH6A44000773, AH6A44000775, AH6A44000780, AH6A47001216, AH6A44000693.  2. Part Number: E115-066756-00; DI: 06936415975777; Serial Number: AH6A45000885.",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - US Nationwide distribution in the states of California, Florida, Georgia, Kentucky, Maryland, Mississippi, Missouri, New Jersey, Puerto Rico, Texas, Washington, West Virginia and the country of Canada.",
            "Status": "recorded"
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        }
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}