{ "@context": { "schema": "https://schema.org/", "au": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native#", "@vocab": "https://schema.org/", "claims": { "@id": "au:claims", "@container": "@list" }, "epistemicStatus": "au:epistemicStatus", "occurred": "au:occurred", "supported": "au:supported", "adjudged": "au:adjudged", "operative": "au:operative", "grounding": "au:grounding", "groundingType": "au:groundingType", "adjudicator": "au:adjudicator", "source": "au:source", "sourceUrl": "au:sourceUrl", "value": "au:value", "claimType": "au:claimType", "reviewStatus": "au:reviewStatus", "commercialInfluence": "au:commercialInfluence", "falsifier": "au:falsifier" }, "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1254-2025.jsonld", "@type": "schema:Dataset", "name": "Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009", "description": "FDA recall Z-1254-2025 — Baxter Healthcare Corporation is recalling Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 (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.", "license": "https://creativecommons.org/publicdomain/zero/1.0/", "isAccessibleForFree": true, "isPartOf": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/", "rdfs:isDefinedBy": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/vocab/agent-native", "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" } }, "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1254-2025&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009", "manufacturer": { "@type": "schema:Organization", "name": "Baxter Healthcare Corporation" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1254-2025/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1254-2025: Baxter Healthcare Corporation is recalling Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009", "text": "The FDA logged enforcement record Z-1254-2025: Baxter Healthcare Corporation is voluntarily recalling Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009 — reason: There is the potential for missing motor mounting screws, which may have occurred during the servicing process.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-02-05. Affected lots/codes: UDI/DI 00085412610900, Serial Numbers: 3020290, 3020992, 3020996, 3021929, 3023080, 3023183, 3023537, 3023758, 3500529, 3502799, 3502864, 3510806, 3511639, 3512647, 3514801, 3516888, 3517399, 3517517, 3518558, 3519053, 3564064, 3564818, 3565462, 3565620, 3566022, 3566254, 3567145, 3567218, 3567998, 3568527, 3568922, 3570910, 3571100, 3571598, 3571972, 3573147, 3573504, 3574293, 3575033, 3575107, 3576026, 3576443, 3656732, 3657316, 3657541, 3657814, 3657821, 3657995, 3659259, 3660176, 3660244, 3662986, 3664495, 3665624, 3721608, 3721910, 3721946, 3722620, 3723725, 3724211, 3730270, 3730408, 3732309, 3732476, 3734858, 3735010, 3735261, 3735734, 3738122, 3744219, 3744455, 3746159, 3746749, 3749111, 3749929, 3764591, 3767418, 3519969, 3520138, 3520706, 3520746, 3520829, 3521120, 3521338, 3606099, 3607097, 3607681, 3608730, 3609223, 3610668, 3610820, 3611120, 3611140, 3611650, 3612298, 3612886, 3613052, 3614035, 3615599, 3615816, 3616449, 3666443, 3666451, 3667116, 3668076, 3668654, 3668851, 3669058, 3669126, 3669307, 3670942, 3671444, 3672061, 3672846, 3676099, 3677241, 3679511, 3680542, 3681596, 3681981, 3686743, 3689421, 3691453, 3691496, 3693341, 3696268, 3618354, 3619039, 3619876, 3620296, 3620427, 3620631, 3620643, 3620757, 3621068, 3621252, 3621777, 3623915, 3623963, 3624131, 3624546, 3627519, 3628177, 3630964, 3632085, 3632710, 3632830, 3633267, 3634729, 3634792, 3699321, 3699388, 3699822, 3699917, 3700350, 3700551, 3701785, 3703127, 3703425, 3703513, 3703840, 3704056, 3704228, 3705346, 3706311, 3706762, 3706856, 3707896, 3002100, 3003072, 3004069, 3006254, 3006831, 3009116, 3009918, 3011726, 3012929, 3013032, 3013567, 3014990, 3015179, 3015242, 3016501, 3018280, 3018908, 3020206, 3576448, 3576730, 3576867, 3577158, 3578268, 3578536, 3578772, 3578906, 3584933, 3587077, 3588099, 3590690, 3591061, 3591360, 3591997, 3593297, 3634941, 3635142, 3637457, 3638689, 3640189, 3642200, 3642537, 3642720, 3645079, 3645908, 3646680, 3647126, 3647441, 3647540, 3647866, 3648851, 3648878, 3650355, 3650984, 3651372, 3654108, 3655491, 3655618, 3655785, 3655938, 3656531, 3521873, 3521999, 3522038, 3522253, 3522529, 3523783, 3523984, 3524348, 3524522, 3528869, 3528966, 3529402, 3529628, 3529632, 3529636, 3529928, 3529935, 3530350, 3530787, 3531077, 3531419, 3534705, 3539485, 3539740, 3540240, 3540832, 3595222, 3598809, 3599437, 3601012, 3601382, 3602225, 3603240, 3603637, 3603686, 3603842, 3603852, 3603947, 3604716, 3605640, 3605644, 3605994, 3697496, 3697667, 3697864, 3698034, 3698139, 3698336, 3699050, 3699248, 3541085, 3542213, 3542383, 3542809, 3542839, 3543062, 3543083, 3543172, 3544259, 3546132, 3548337, 3548404, 3549047, 3552392, 3554222, 3554971, 3555901, 3555949, 3556168, 3556278, 3556819, 3556876, 3557131, 3557902, 3560245, 3562324, 3562649, 3562705, 3562975, 3616568, 3616648, 3617327, 3617431, 3617744, 3708183, 3708637, 3708695, 3709027, 3709669, 3710188, 3711475, 3714210, 3715824, 3717594, 3718985.. 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-1254-2025&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-1254-2025&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-1254-2025/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1254-2025 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 }, "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-1254-2025&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-1254-2025&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-1254-2025/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 }, "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": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-1254-2025", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1254-2025", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 2, "item": { "Field": "Product type", "Value": "Devices", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 3, "item": { "Field": "Classification", "Value": "Class I", "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": "Baxter Healthcare Corporation", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "There is the potential for missing motor mounting screws, which may have occurred during the servicing process.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-02-05", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "UDI/DI 00085412610900, Serial Numbers: 3020290, 3020992, 3020996, 3021929, 3023080, 3023183, 3023537, 3023758, 3500529, 3502799, 3502864, 3510806, 3511639, 3512647, 3514801, 3516888, 3517399, 3517517, 3518558, 3519053, 3564064, 3564818, 3565462, 3565620, 3566022, 3566254, 3567145, 3567218, 3567998, 3568527, 3568922, 3570910, 3571100, 3571598, 3571972, 3573147, 3573504, 3574293, 3575033, 3575107, 3576026, 3576443, 3656732, 3657316, 3657541, 3657814, 3657821, 3657995, 3659259, 3660176, 3660244, 3662986, 3664495, 3665624, 3721608, 3721910, 3721946, 3722620, 3723725, 3724211, 3730270, 3730408, 3732309, 3732476, 3734858, 3735010, 3735261, 3735734, 3738122, 3744219, 3744455, 3746159, 3746749, 3749111, 3749929, 3764591, 3767418, 3519969, 3520138, 3520706, 3520746, 3520829, 3521120, 3521338, 3606099, 3607097, 3607681, 3608730, 3609223, 3610668, 3610820, 3611120, 3611140, 3611650, 3612298, 3612886, 3613052, 3614035, 3615599, 3615816, 3616449, 3666443, 3666451, 3667116, 3668076, 3668654, 3668851, 3669058, 3669126, 3669307, 3670942, 3671444, 3672061, 3672846, 3676099, 3677241, 3679511, 3680542, 3681596, 3681981, 3686743, 3689421, 3691453, 3691496, 3693341, 3696268, 3618354, 3619039, 3619876, 3620296, 3620427, 3620631, 3620643, 3620757, 3621068, 3621252, 3621777, 3623915, 3623963, 3624131, 3624546, 3627519, 3628177, 3630964, 3632085, 3632710, 3632830, 3633267, 3634729, 3634792, 3699321, 3699388, 3699822, 3699917, 3700350, 3700551, 3701785, 3703127, 3703425, 3703513, 3703840, 3704056, 3704228, 3705346, 3706311, 3706762, 3706856, 3707896, 3002100, 3003072, 3004069, 3006254, 3006831, 3009116, 3009918, 3011726, 3012929, 3013032, 3013567, 3014990, 3015179, 3015242, 3016501, 3018280, 3018908, 3020206, 3576448, 3576730, 3576867, 3577158, 3578268, 3578536, 3578772, 3578906, 3584933, 3587077, 3588099, 3590690, 3591061, 3591360, 3591997, 3593297, 3634941, 3635142, 3637457, 3638689, 3640189, 3642200, 3642537, 3642720, 3645079, 3645908, 3646680, 3647126, 3647441, 3647540, 3647866, 3648851, 3648878, 3650355, 3650984, 3651372, 3654108, 3655491, 3655618, 3655785, 3655938, 3656531, 3521873, 3521999, 3522038, 3522253, 3522529, 3523783, 3523984, 3524348, 3524522, 3528869, 3528966, 3529402, 3529628, 3529632, 3529636, 3529928, 3529935, 3530350, 3530787, 3531077, 3531419, 3534705, 3539485, 3539740, 3540240, 3540832, 3595222, 3598809, 3599437, 3601012, 3601382, 3602225, 3603240, 3603637, 3603686, 3603842, 3603852, 3603947, 3604716, 3605640, 3605644, 3605994, 3697496, 3697667, 3697864, 3698034, 3698139, 3698336, 3699050, 3699248, 3541085, 3542213, 3542383, 3542809, 3542839, 3543062, 3543083, 3543172, 3544259, 3546132, 3548337, 3548404, 3549047, 3552392, 3554222, 3554971, 3555901, 3555949, 3556168, 3556278, 3556819, 3556876, 3557131, 3557902, 3560245, 3562324, 3562649, 3562705, 3562975, 3616568, 3616648, 3617327, 3617431, 3617744, 3708183, 3708637, 3708695, 3709027, 3709669, 3710188, 3711475, 3714210, 3715824, 3717594, 3718985.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "US: Nationwide", "Status": "recorded" } } ] } ] }