{ "@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-1123-2026.jsonld", "@type": "schema:Dataset", "name": "Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B\tIN4130/CNK\tIN4130/H\tIN4130/JPH\tIN4130/K\tIN4130/KRK\tIN4130/L\tIN4130/T\tIN4230/JPH\tIN4230/K\tIN4330/CNK\tIN4330/K\tIN4352/K\tIN4430/K\tIN4530/CNK\tIN4530/K\tIN4530/T\tIN4802/K\tIN4802/T\tIN4852/K\tIN4901/A\tIN4902/A\tIN4903/A\tIN4904/A\tIN4905/A\tIN4906/A\tIN4907/A\tIN4908\tIN4909\tIN4910\tIN4911/A\tIN4912\tIN4913/A\tIN4914/A\tIN4915\tIN4916/A\tIN4917/A\tIN4918/A\tIN4919/A", "description": "FDA recall Z-1123-2026 — Merit Medical Systems, Inc. is recalling Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B\tIN4130/CNK\tIN4130/H\tIN4130/JPH\tIN4130/K\tIN4130/KRK\tIN4130/L\tIN4130/T\tIN4230/JPH\tIN4230/K\tIN4330/CNK\tIN4330/K\tIN4352/K\tIN4430/K\tIN4530/CNK\tIN4530/K\tIN4530/T\tIN4802/K\tIN4802/T\tIN4852/K\tIN4901/A\tIN4902/A\tIN4903/A\tIN4904/A\tIN4905/A\tIN4906/A\tIN4907/A\tIN4908\tIN4909\tIN4910\tIN4911/A\tIN4912\tIN4913/A\tIN4914/A\tIN4915\tIN4916/A\tIN4917/A\tIN4918/A\tIN4919/A (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-1123-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B\tIN4130/CNK\tIN4130/H\tIN4130/JPH\tIN4130/K\tIN4130/KRK\tIN4130/L\tIN4130/T\tIN4230/JPH\tIN4230/K\tIN4330/CNK\tIN4330/K\tIN4352/K\tIN4430/K\tIN4530/CNK\tIN4530/K\tIN4530/T\tIN4802/K\tIN4802/T\tIN4852/K\tIN4901/A\tIN4902/A\tIN4903/A\tIN4904/A\tIN4905/A\tIN4906/A\tIN4907/A\tIN4908\tIN4909\tIN4910\tIN4911/A\tIN4912\tIN4913/A\tIN4914/A\tIN4915\tIN4916/A\tIN4917/A\tIN4918/A\tIN4919/A", "manufacturer": { "@type": "schema:Organization", "name": "Merit Medical Systems, Inc." } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1123-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1123-2026: Merit Medical Systems, Inc. is recalling Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B\tIN4130/CNK\tIN4130/H\tIN4130/JPH\tIN4130/K\tIN4130/KRK\tIN4130/L\tIN4130/T\tIN4230/JPH\tIN4230/K\tIN4330/CNK\tIN4330/K\tIN4352/K\tIN4430/K\tIN4530/CNK\tIN4530/K\tIN4530/T\tIN4802/K\tIN4802/T\tIN4852/K\tIN4901/A\tIN4902/A\tIN4903/A\tIN4904/A\tIN4905/A\tIN4906/A\tIN4907/A\tIN4908\tIN4909\tIN4910\tIN4911/A\tIN4912\tIN4913/A\tIN4914/A\tIN4915\tIN4916/A\tIN4917/A\tIN4918/A\tIN4919/A", "text": "The FDA logged enforcement record Z-1123-2026: Merit Medical Systems, Inc. is voluntarily recalling Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B\tIN4130/CNK\tIN4130/H\tIN4130/JPH\tIN4130/K\tIN4130/KRK\tIN4130/L\tIN4130/T\tIN4230/JPH\tIN4230/K\tIN4330/CNK\tIN4330/K\tIN4352/K\tIN4430/K\tIN4530/CNK\tIN4530/K\tIN4530/T\tIN4802/K\tIN4802/T\tIN4852/K\tIN4901/A\tIN4902/A\tIN4903/A\tIN4904/A\tIN4905/A\tIN4906/A\tIN4907/A\tIN4908\tIN4909\tIN4910\tIN4911/A\tIN4912\tIN4913/A\tIN4914/A\tIN4915\tIN4916/A\tIN4917/A\tIN4918/A\tIN4919/A — reason: Inflation device handle may detach from the syringe during procedure.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-04. 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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-1123-2026&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-1123-2026&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-1123-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1123-2026 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-1123-2026&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-1123-2026&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-1123-2026/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-1123-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1123-2026", "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": "Merit Medical Systems, Inc.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 6, "item": { "Field": 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Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Republic of Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Luxembourg, Madagascar, Mexico, Monaco, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, San Marino, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Trinidad and Tobago, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Bolivarian, Republic of Viet Nam.", "Status": "recorded" } } ] } ] }