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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2446-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "Puritan Bennett 500 Series Ventilators (Description/REF):  PURITAN BENNETT 560 VENTILATOR/4096600,  PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01,  PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02,  PURITAN BENNETT 560 VENTILATOR APAC/4096600-03,  Puritan Bennett 560 Ventilator LATAM/4096600-04,  Puritan Bennett 560 Ventilator EMEA/4096600-05,  Puritan Bennett 560 Ventilator CAN ANZ/4096600-06,  Puritan Bennett 540 Ventilator USA/4097100  Puritan Bennett 520 Ventilator/4098300,  Puritan Bennett 520 Ventilator EU-DIV/4098300-01,  Puritan Bennett 520 Ventilator Japan/4098300-02,  Puritan Bennett 520 Ventilator APAC/4098300-03,  Puritan Bennett 520 Ventilator EMEA/4098300-05,  Puritan Bennett 520 Ventilator CAN/ANZ/4098300-06,  DL4096600 DL PB560 VENTILATOR/DL4096600,  DL4096600-06 RFB PB560 VENT CAN ANZ/DL4096600-06,  REFURBISHED PB540 VENTILATOR/DL4097100,  Puritan Bennett 540 Ventilator Refurbished/DS4097100",
  "description": "FDA recall Z-2446-2024 — Covidien is recalling Puritan Bennett 500 Series Ventilators (Description/REF):  PURITAN BENNETT 560 VENTILATOR/4096600,  PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01,  PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02,  PURITAN BENNETT 560 VENTILATOR APAC/4096600-03,  Puritan Bennett 560 Ventilator LATAM/4096600-04,  Puritan Bennett 560 Ventilator EMEA/4096600-05,  Puritan Bennett 560 Ventilator CAN ANZ/4096600-06,  Puritan Bennett 540 Ventilator USA/4097100  Puritan Bennett 520 Ventilator/4098300,  Puritan Bennett 520 Ventilator EU-DIV/4098300-01,  Puritan Bennett 520 Ventilator Japan/4098300-02,  Puritan Bennett 520 Ventilator APAC/4098300-03,  Puritan Bennett 520 Ventilator EMEA/4098300-05,  Puritan Bennett 520 Ventilator CAN/ANZ/4098300-06,  DL4096600 DL PB560 VENTILATOR/DL4096600,  DL4096600-06 RFB PB560 VENT CAN ANZ/DL4096600-06,  REFURBISHED PB540 VENTILATOR/DL4097100,  Puritan Bennett 540 Ventilator Refurbished/DS4097100 (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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    "@type": "schema:Dataset",
    "name": "openFDA drug & device enforcement (recall) reports",
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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-2446-2024&lang=eng",
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    "@type": "schema:MedicalDevice",
    "name": "Puritan Bennett 500 Series Ventilators (Description/REF):  PURITAN BENNETT 560 VENTILATOR/4096600,  PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01,  PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02,  PURITAN BENNETT 560 VENTILATOR APAC/4096600-03,  Puritan Bennett 560 Ventilator LATAM/4096600-04,  Puritan Bennett 560 Ventilator EMEA/4096600-05,  Puritan Bennett 560 Ventilator CAN ANZ/4096600-06,  Puritan Bennett 540 Ventilator USA/4097100  Puritan Bennett 520 Ventilator/4098300,  Puritan Bennett 520 Ventilator EU-DIV/4098300-01,  Puritan Bennett 520 Ventilator Japan/4098300-02,  Puritan Bennett 520 Ventilator APAC/4098300-03,  Puritan Bennett 520 Ventilator EMEA/4098300-05,  Puritan Bennett 520 Ventilator CAN/ANZ/4098300-06,  DL4096600 DL PB560 VENTILATOR/DL4096600,  DL4096600-06 RFB PB560 VENT CAN ANZ/DL4096600-06,  REFURBISHED PB540 VENTILATOR/DL4097100,  Puritan Bennett 540 Ventilator Refurbished/DS4097100",
    "manufacturer": {
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      "name": "Covidien"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2446-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-2446-2024: Covidien is recalling Puritan Bennett 500 Series Ventilators (Description/REF):  PURITAN BENNETT 560 VENTILATOR/4096600,  PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01,  PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02,  PURITAN BENNETT 560 VENTILATOR APAC/4096600-03,  Puritan Bennett 560 Ventilator LATAM/4096600-04,  Puritan Bennett 560 Ventilator EMEA/4096600-05,  Puritan Bennett 560 Ventilator CAN ANZ/4096600-06,  Puritan Bennett 540 Ventilator USA/4097100  Puritan Bennett 520 Ventilator/4098300,  Puritan Bennett 520 Ventilator EU-DIV/4098300-01,  Puritan Bennett 520 Ventilator Japan/4098300-02,  Puritan Bennett 520 Ventilator APAC/4098300-03,  Puritan Bennett 520 Ventilator EMEA/4098300-05,  Puritan Bennett 520 Ventilator CAN/ANZ/4098300-06,  DL4096600 DL PB560 VENTILATOR/DL4096600,  DL4096600-06 RFB PB560 VENT CAN ANZ/DL4096600-06,  REFURBISHED PB540 VENTILATOR/DL4097100,  Puritan Bennett 540 Ventilator Refurbished/DS4097100",
      "text": "The FDA logged enforcement record Z-2446-2024: Covidien is voluntarily recalling Puritan Bennett 500 Series Ventilators (Description/REF):  PURITAN BENNETT 560 VENTILATOR/4096600,  PURITAN BENNETT PB560 VENTILATOR EU-DIV/4096600-01,  PURITAN BENNETT 560 VENTILATOR JAPAN/4096600-02,  PURITAN BENNETT 560 VENTILATOR APAC/4096600-03,  Puritan Bennett 560 Ventilator LATAM/4096600-04,  Puritan Bennett 560 Ventilator EMEA/4096600-05,  Puritan Bennett 560 Ventilator CAN ANZ/4096600-06,  Puritan Bennett 540 Ventilator USA/4097100  Puritan Bennett 520 Ventilator/4098300,  Puritan Bennett 520 Ventilator EU-DIV/4098300-01,  Puritan Bennett 520 Ventilator Japan/4098300-02,  Puritan Bennett 520 Ventilator APAC/4098300-03,  Puritan Bennett 520 Ventilator EMEA/4098300-05,  Puritan Bennett 520 Ventilator CAN/ANZ/4098300-06,  DL4096600 DL PB560 VENTILATOR/DL4096600,  DL4096600-06 RFB PB560 VENT CAN ANZ/DL4096600-06,  REFURBISHED PB540 VENTILATOR/DL4097100,  Puritan Bennett 540 Ventilator Refurbished/DS4097100 — reason: Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of cumulative duration may pose harm to health due to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro released from some components in the ventilator gas pathway. Status: Ongoing — the recall is still being carried out.. Initiated 2024-06-24. Affected lots/codes: REF/UDI-DI(GTIN): 4096600/10884521087798 4096600-01/10884521195998 4096600-02/10884521196001 4096600-03/10884521196018 4096600-04/10884521196025 4096600-05/10884521196032 4096600-06/10884521196377 4097100/4097100 4098300/10884521183636 4098300-01/10884521195943 4098300-02/4098300-02 4098300-03/10884521195967 4098300-05/10884521195981 4098300-06/10884521196384 DL4096600/10884521786509 DL4096600-06/10884521786516 DL4097100/DL4097100 DS4097100/DS4097100  All device serial numbers used before distribution of PB500 Series Ventilator User Manual and Clinician's Manual addendum, PT00196729 A, 2024-06-11. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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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-2446-2024&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-2446-2024&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."
    },
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2446-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2446-2024 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": {
        "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-2446-2024&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-2446-2024&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-2446-2024/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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        "adjudged": false,
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        "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-2446-2024",
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            "Field": "Recall number",
            "Value": "Z-2446-2024",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "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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        {
          "@type": "schema:ListItem",
          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Covidien",
            "Status": "recorded"
          }
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        {
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Any single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more than one ventilator over time, the use of these devices for more than 14 years of cumulative duration may pose harm to health due to a volatile organic compound (VOC), 2-propanol, 1,3-dichloro released from some components in the ventilator gas pathway",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-06-24",
            "Status": "recorded"
          }
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "REF/UDI-DI(GTIN): 4096600/10884521087798 4096600-01/10884521195998 4096600-02/10884521196001 4096600-03/10884521196018 4096600-04/10884521196025 4096600-05/10884521196032 4096600-06/10884521196377 4097100/4097100 4098300/10884521183636 4098300-01/10884521195943 4098300-02/4098300-02 4098300-03/10884521195967 4098300-05/10884521195981 4098300-06/10884521196384 DL4096600/10884521786509 DL4096600-06/10884521786516 DL4097100/DL4097100 DS4097100/DS4097100  All device serial numbers used before distribution of PB500 Series Ventilator User Manual and Clinician's Manual addendum, PT00196729 A, 2024-06-11",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US: KY, OH, GA, MN, IN,UT, IL, NJ, NY, PR, LA, MD, MO, TN, MA, ME, CA, SC, AR, TX, WI, PA, CO, MI, NM, RI, VA, DC, VT, NC, NH, WV, NV, IA.  OUS: Argentina, Australia, Bangladesh, Belgium, Botswana, Brazil, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Lithuania, Malaysia, Mexico, Montenegro, Namibia, Nepal, New Zealand, Nigeria, Panama, Poland, Reunion, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, Viet Nam, South Africa, Austria, Kenya, Latvia, Lebanon, Mongolia, Nicaragua, Thailand, Tunisia, Algeria, Jordan, Libya, Malawi, Qatar, Pakistan, United Arab Emirates, Oman, Peru, Philippines, Bhutan, Iran - Islamic Republic Of, Bolivia, Kuwait, Egypt, Switzerland, Sudan, Norway, Korea - Republic Of, Bahrain, Ethiopia, Paraguay",
            "Status": "recorded"
          }
        }
      ]
    }
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}