{ "@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-1203-2026.jsonld", "@type": "schema:Dataset", "name": "Chest Drainage Units and Accessories: Product Code\tDescription 1. 8888571562\tCardinal Health Sentinel Seal CDU 2. 8888571513\tCardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489\tCardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370\tCardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299\tCardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406\tCardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315\tCardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100\tCardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105\tOUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570\tOUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308\tCardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900\tCardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL", "description": "FDA recall Z-1203-2026 — Cardinal Health 200, LLC is recalling Chest Drainage Units and Accessories: Product Code\tDescription 1. 8888571562\tCardinal Health Sentinel Seal CDU 2. 8888571513\tCardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489\tCardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370\tCardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299\tCardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406\tCardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315\tCardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100\tCardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105\tOUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570\tOUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308\tCardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900\tCardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL (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.", "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-1203-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Chest Drainage Units and Accessories: Product Code\tDescription 1. 8888571562\tCardinal Health Sentinel Seal CDU 2. 8888571513\tCardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489\tCardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370\tCardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299\tCardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406\tCardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315\tCardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100\tCardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105\tOUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570\tOUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308\tCardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900\tCardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL", "manufacturer": { "@type": "schema:Organization", "name": "Cardinal Health 200, LLC" } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1203-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1203-2026: Cardinal Health 200, LLC is recalling Chest Drainage Units and Accessories: Product Code\tDescription 1. 8888571562\tCardinal Health Sentinel Seal CDU 2. 8888571513\tCardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489\tCardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370\tCardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299\tCardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406\tCardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315\tCardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100\tCardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105\tOUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570\tOUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308\tCardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900\tCardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL", "text": "The FDA logged enforcement record Z-1203-2026: Cardinal Health 200, LLC is voluntarily recalling Chest Drainage Units and Accessories: Product Code\tDescription 1. 8888571562\tCardinal Health Sentinel Seal CDU 2. 8888571513\tCardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489\tCardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370\tCardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299\tCardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406\tCardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315\tCardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100\tCardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105\tOUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570\tOUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308\tCardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900\tCardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL — reason: The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-26. Affected lots/codes: All units affected by IFU update. UDI-DI: 1. 8888571562 Cardinal Health Sentinel Seal CDU 50192253003091 (CS) 10192253003093 (EA) 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 50192253003084 (CS) 10192253003086 (EA) 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 50192253003077 (CS) 10192253003079 (EA) 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 50192253003039 (CS) 10192253003031 (EA) 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 50192253003015 (CS) 10192253003017 (EA) 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 50192253003060 (CS) 10192253003062 (EA) 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 50192253003022 (CS) 10192253003024 (EA) 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 50192253002643 (CS) 10192253002645 (EA) 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 50192253002308 (CS) 10192253002300 (CS) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 50192253002292 (CS) 10192253002294 (EA) 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 50192253002650 (CS) 10192253002652 (EA) 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL 50192253002667 (CS) 10192253002669 (EA). 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-1203-2026&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-1203-2026&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-1203-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1203-2026 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-1203-2026&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-1203-2026&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-1203-2026/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." } ], "hasPart": [ { "@type": "schema:ItemList", "name": "FDA recall details — Z-1203-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1203-2026", "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 II", "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": "Cardinal Health 200, LLC", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": "Reason", "Value": "The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-12-26", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "All units affected by IFU update. UDI-DI: 1. 8888571562 Cardinal Health Sentinel Seal CDU 50192253003091 (CS) 10192253003093 (EA) 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 50192253003084 (CS) 10192253003086 (EA) 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 50192253003077 (CS) 10192253003079 (EA) 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 50192253003039 (CS) 10192253003031 (EA) 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 50192253003015 (CS) 10192253003017 (EA) 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 50192253003060 (CS) 10192253003062 (EA) 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 50192253003022 (CS) 10192253003024 (EA) 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 50192253002643 (CS) 10192253002645 (EA) 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 50192253002308 (CS) 10192253002300 (CS) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 50192253002292 (CS) 10192253002294 (EA) 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 50192253002650 (CS) 10192253002652 (EA) 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL 50192253002667 (CS) 10192253002669 (EA)", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.", "Status": "recorded" } } ] } ] }