{ "@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-1126-2026.jsonld", "@type": "schema:Dataset", "name": "Merit Medical , Custom Inflation Kit REF: K05-00761F\tK05-01717B\tK05-02080D\tK05-02090C\tK05-02221\tK05-02338\tK05-02470\tK05-02954\tK05-03094A\tK05T-00380C\tK05T-01674B\tK05T-01863\tK05T-01915\tK05T-01920F\tK05T-01955\tK05T-02138\tK05T-02138A\tK05T-02272G\tK05T-02272H\tK05T-02533\tK05T-03153\tK05T-03201", "description": "FDA recall Z-1126-2026 — Merit Medical Systems, Inc. is recalling Merit Medical , Custom Inflation Kit REF: K05-00761F\tK05-01717B\tK05-02080D\tK05-02090C\tK05-02221\tK05-02338\tK05-02470\tK05-02954\tK05-03094A\tK05T-00380C\tK05T-01674B\tK05T-01863\tK05T-01915\tK05T-01920F\tK05T-01955\tK05T-02138\tK05T-02138A\tK05T-02272G\tK05T-02272H\tK05T-02533\tK05T-03153\tK05T-03201 (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-1126-2026&lang=eng", "about": { "@type": "schema:MedicalDevice", "name": "Merit Medical , Custom Inflation Kit REF: K05-00761F\tK05-01717B\tK05-02080D\tK05-02090C\tK05-02221\tK05-02338\tK05-02470\tK05-02954\tK05-03094A\tK05T-00380C\tK05T-01674B\tK05T-01863\tK05T-01915\tK05T-01920F\tK05T-01955\tK05T-02138\tK05T-02138A\tK05T-02272G\tK05T-02272H\tK05T-02533\tK05T-03153\tK05T-03201", "manufacturer": { "@type": "schema:Organization", "name": "Merit Medical Systems, Inc." } }, "claims": [ { "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1126-2026/enforcement-record", "@type": "schema:Claim", "name": "FDA recall Z-1126-2026: Merit Medical Systems, Inc. is recalling Merit Medical , Custom Inflation Kit REF: K05-00761F\tK05-01717B\tK05-02080D\tK05-02090C\tK05-02221\tK05-02338\tK05-02470\tK05-02954\tK05-03094A\tK05T-00380C\tK05T-01674B\tK05T-01863\tK05T-01915\tK05T-01920F\tK05T-01955\tK05T-02138\tK05T-02138A\tK05T-02272G\tK05T-02272H\tK05T-02533\tK05T-03153\tK05T-03201", "text": "The FDA logged enforcement record Z-1126-2026: Merit Medical Systems, Inc. is voluntarily recalling Merit Medical , Custom Inflation Kit REF: K05-00761F\tK05-01717B\tK05-02080D\tK05-02090C\tK05-02221\tK05-02338\tK05-02470\tK05-02954\tK05-03094A\tK05T-00380C\tK05T-01674B\tK05T-01863\tK05T-01915\tK05T-01920F\tK05T-01955\tK05T-02138\tK05T-02138A\tK05T-02272G\tK05T-02272H\tK05T-02533\tK05T-03153\tK05T-03201 — reason: Inflation device handle may detach from the syringe during procedure.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-04. Affected lots/codes: Reference Number/UDI/Lot Number: K05-00761F: 00884450294918 H2801768 00884450294918 H2872045 K05-01717B: 00884450139325 H2613573 00884450139325 H2650871 00884450139325 H2697189 00884450139325 H2736533 00884450139325 H2767978 00884450139325 H2787955 00884450139325 H2823896 00884450139325 H2844892 00884450139325 H2849102 00884450139325 H2854783 00884450139325 H2864807 00884450139325 H2869821 00884450139325 H2911094 00884450139325 H2920493 00884450139325 H2937574 00884450139325 H2980776 00884450139325 H3006229 00884450139325 H3030118 00884450139325 H3041746 00884450139325 H3068295 00884450139325 H3077898 00884450139325 H3096168 00884450139325 H3115553 00884450139325 H3125118 00884450139325 H3136596 00884450139325 H3147935 00884450139325 H3179116 00884450139325 H3191157 00884450139325 H3215391 00884450139325 H3227692 00884450139325 H3266089 00884450139325 H3324827 K05-02080D: 00884450141663 H3248072 K05-02090C: 00884450141687 H3079962 K05-02221: 00884450141878 H2867356 00884450141878 H3183526 K05-02338: 00884450139950 H2994406 K05-02470: 00884450140406 H3183534 K05-02954: 00884450298350 H2725969 K05-03094A: 00884450756102 I2725535 00884450756102 I3254468 K05T-00380C: 00884450286999 T2636525 00884450286999 T2697344 00884450286999 T2730359 00884450286999 T2745227 00884450286999 T2779731 00884450286999 T2792255 00884450286999 T2805457 00884450286999 T2842259 00884450286999 T2865498 00884450286999 T2916415 00884450286999 T2981465 00884450286999 T2985902 00884450286999 T3039943 00884450286999 T3054879 00884450286999 T3071602 00884450286999 T3105835 00884450286999 T3128753 00884450286999 T3185484 00884450286999 T3223241 00884450286999 T3229633 00884450286999 T3276968 00884450286999 T3328128 00884450286999 T3356293 K05T-01674B: 00884450140796 T2774647 00884450140796 T2800974 00884450140796 T2823388 00884450140796 T2853488 00884450140796 T2899143 00884450140796 T2981467 00884450140796 T2987762 00884450140796 T3022097 00884450140796 T3022100 00884450140796 T3058385 00884450140796 T3083003 00884450140796 T3121582 00884450140796 T3174127 00884450140796 T3214493 00884450140796 T3229456 00884450140796 T3297510 00884450140796 T3324542 K05T-01863: 00884450315347 T2625813 00884450315347 T2718633 00884450315347 T2762715 00884450315347 T2805459 00884450315347 T2823390 00884450315347 T2863782 00884450315347 T2910718 00884450315347 T2981470 00884450315347 T2997667 00884450315347 T3036044 00884450315347 T3070773 00884450315347 T3108821 00884450315347 T3149886S 00884450315347 T3185539 00884450315347 T3214494 00884450315347 T3216705 00884450315347 T3276914 00884450315347 T3296092 00884450315347 T3328139 K05T-01915: 00884450142882 T2643556 00884450142882 T2675575 00884450142882 T2752946 00884450142882 T2842262 00884450142882 T2893876 00884450142882 T2906056 00884450142882 T2981474 00884450142882 T2987764 00884450142882 T3070812 00884450142882 T3146178 00884450142882 T3216084 00884450142882 T3269009 00884450142882 T3322767 00884450142882 T3356295 K05T-01920F: 00884450260166 T3093916 00884450260166 T3148674 00884450260166 T3204048 00884450260166 T3322760 K05T-01955: 00884450140826 T2643557 00884450140826 T2719601 00884450140826 T2765333 00884450140826 T2823391 00884450140826 T2861459 00884450140826 T2909930 00884450140826 T2945617 00884450140826 T2985905 00884450140826 T3070951 00884450140826 T3111451 00884450140826 T3190818 00884450140826 T3214495 00884450140826 T3278749 00884450140826 T3322843 K05T-02138: 00884450140833 T2716870 00884450140833 T2726918 00884450140833 T2745251 00884450140833 T2983353 00884450140833 T3216028 K05T-02138A: 00884450095607 T3232335 00884450095607 T3271452 00884450095607 T3306685 K05T-02272G: 00884450684023 T2675577 00884450684023 T2726919 00884450684023 T2759596 00884450684023 T2774653 00884450684023 T2800975 00884450684023 T2810448 00884450684023 T2843256 K05T-02272H: 00884450814710 T2871522 00884450814710 T2898650 00884450814710 T2932783 00884450814710 T2985976 00884450814710 T2987768 00884450814710 T3043834 00884450814710 T3071604 00884450814710 T3105836 00884450814710 T3126557 00884450814710 T3185542 00884450814710 T3214496 00884450814710 T3229459 00884450814710 T3276962 00884450814710 T3309860 00884450814710 T3339469 K05T-02533: 00884450255803 T2718634 00884450255803 T2809725 00884450255803 T2849216 00884450255803 T2876922 00884450255803 T2899055 00884450255803 T2909932 00884450255803 T2981490 00884450255803 T3042476 00884450255803 T3071605 00884450255803 T3123415 00884450255803 T3181209 00884450255803 T3185434 00884450255803 T3293210 00884450255803 T3315474 00884450255803 T3336070 K05T-03153: 00884450463796 T2816275 00884450463796 T2850760 00884450463796 T2939991 00884450463796 T2985985 00884450463796 T3033317 00884450463796 T3202468 K05T-03201: 00884450547915 T2656028 00884450547915 T2690357 00884450547915 T2718635 00884450547915 T2823394 00884450547915 T2983258 00884450547915 T3044905 00884450547915 T3054900 00884450547915 T3113160 00884450547915 T3190819 00884450547915 T3216029 00884450547915 T3245297 00884450547915 T3328140. 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-1126-2026&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-1126-2026&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-1126-2026/fda-classification", "@type": "schema:Claim", "name": "FDA classified recall Z-1126-2026 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-1126-2026&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-1126-2026&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-1126-2026/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-1126-2026", "numberOfItems": 9, "itemListElement": [ { "@type": "schema:ListItem", "position": 1, "item": { "Field": "Recall number", "Value": "Z-1126-2026", "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": "Reason", "Value": "Inflation device handle may detach from the syringe during procedure.", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 7, "item": { "Field": "Initiated", "Value": "2025-12-04", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 8, "item": { "Field": "Lot/code info", "Value": "Reference Number/UDI/Lot Number: K05-00761F: 00884450294918 H2801768 00884450294918 H2872045 K05-01717B: 00884450139325 H2613573 00884450139325 H2650871 00884450139325 H2697189 00884450139325 H2736533 00884450139325 H2767978 00884450139325 H2787955 00884450139325 H2823896 00884450139325 H2844892 00884450139325 H2849102 00884450139325 H2854783 00884450139325 H2864807 00884450139325 H2869821 00884450139325 H2911094 00884450139325 H2920493 00884450139325 H2937574 00884450139325 H2980776 00884450139325 H3006229 00884450139325 H3030118 00884450139325 H3041746 00884450139325 H3068295 00884450139325 H3077898 00884450139325 H3096168 00884450139325 H3115553 00884450139325 H3125118 00884450139325 H3136596 00884450139325 H3147935 00884450139325 H3179116 00884450139325 H3191157 00884450139325 H3215391 00884450139325 H3227692 00884450139325 H3266089 00884450139325 H3324827 K05-02080D: 00884450141663 H3248072 K05-02090C: 00884450141687 H3079962 K05-02221: 00884450141878 H2867356 00884450141878 H3183526 K05-02338: 00884450139950 H2994406 K05-02470: 00884450140406 H3183534 K05-02954: 00884450298350 H2725969 K05-03094A: 00884450756102 I2725535 00884450756102 I3254468 K05T-00380C: 00884450286999 T2636525 00884450286999 T2697344 00884450286999 T2730359 00884450286999 T2745227 00884450286999 T2779731 00884450286999 T2792255 00884450286999 T2805457 00884450286999 T2842259 00884450286999 T2865498 00884450286999 T2916415 00884450286999 T2981465 00884450286999 T2985902 00884450286999 T3039943 00884450286999 T3054879 00884450286999 T3071602 00884450286999 T3105835 00884450286999 T3128753 00884450286999 T3185484 00884450286999 T3223241 00884450286999 T3229633 00884450286999 T3276968 00884450286999 T3328128 00884450286999 T3356293 K05T-01674B: 00884450140796 T2774647 00884450140796 T2800974 00884450140796 T2823388 00884450140796 T2853488 00884450140796 T2899143 00884450140796 T2981467 00884450140796 T2987762 00884450140796 T3022097 00884450140796 T3022100 00884450140796 T3058385 00884450140796 T3083003 00884450140796 T3121582 00884450140796 T3174127 00884450140796 T3214493 00884450140796 T3229456 00884450140796 T3297510 00884450140796 T3324542 K05T-01863: 00884450315347 T2625813 00884450315347 T2718633 00884450315347 T2762715 00884450315347 T2805459 00884450315347 T2823390 00884450315347 T2863782 00884450315347 T2910718 00884450315347 T2981470 00884450315347 T2997667 00884450315347 T3036044 00884450315347 T3070773 00884450315347 T3108821 00884450315347 T3149886S 00884450315347 T3185539 00884450315347 T3214494 00884450315347 T3216705 00884450315347 T3276914 00884450315347 T3296092 00884450315347 T3328139 K05T-01915: 00884450142882 T2643556 00884450142882 T2675575 00884450142882 T2752946 00884450142882 T2842262 00884450142882 T2893876 00884450142882 T2906056 00884450142882 T2981474 00884450142882 T2987764 00884450142882 T3070812 00884450142882 T3146178 00884450142882 T3216084 00884450142882 T3269009 00884450142882 T3322767 00884450142882 T3356295 K05T-01920F: 00884450260166 T3093916 00884450260166 T3148674 00884450260166 T3204048 00884450260166 T3322760 K05T-01955: 00884450140826 T2643557 00884450140826 T2719601 00884450140826 T2765333 00884450140826 T2823391 00884450140826 T2861459 00884450140826 T2909930 00884450140826 T2945617 00884450140826 T2985905 00884450140826 T3070951 00884450140826 T3111451 00884450140826 T3190818 00884450140826 T3214495 00884450140826 T3278749 00884450140826 T3322843 K05T-02138: 00884450140833 T2716870 00884450140833 T2726918 00884450140833 T2745251 00884450140833 T2983353 00884450140833 T3216028 K05T-02138A: 00884450095607 T3232335 00884450095607 T3271452 00884450095607 T3306685 K05T-02272G: 00884450684023 T2675577 00884450684023 T2726919 00884450684023 T2759596 00884450684023 T2774653 00884450684023 T2800975 00884450684023 T2810448 00884450684023 T2843256 K05T-02272H: 00884450814710 T2871522 00884450814710 T2898650 00884450814710 T2932783 00884450814710 T2985976 00884450814710 T2987768 00884450814710 T3043834 00884450814710 T3071604 00884450814710 T3105836 00884450814710 T3126557 00884450814710 T3185542 00884450814710 T3214496 00884450814710 T3229459 00884450814710 T3276962 00884450814710 T3309860 00884450814710 T3339469 K05T-02533: 00884450255803 T2718634 00884450255803 T2809725 00884450255803 T2849216 00884450255803 T2876922 00884450255803 T2899055 00884450255803 T2909932 00884450255803 T2981490 00884450255803 T3042476 00884450255803 T3071605 00884450255803 T3123415 00884450255803 T3181209 00884450255803 T3185434 00884450255803 T3293210 00884450255803 T3315474 00884450255803 T3336070 K05T-03153: 00884450463796 T2816275 00884450463796 T2850760 00884450463796 T2939991 00884450463796 T2985985 00884450463796 T3033317 00884450463796 T3202468 K05T-03201: 00884450547915 T2656028 00884450547915 T2690357 00884450547915 T2718635 00884450547915 T2823394 00884450547915 T2983258 00884450547915 T3044905 00884450547915 T3054900 00884450547915 T3113160 00884450547915 T3190819 00884450547915 T3216029 00884450547915 T3245297 00884450547915 T3328140", "Status": "recorded" } }, { "@type": "schema:ListItem", "position": 9, "item": { "Field": "Distribution pattern", "Value": "Worldwide - Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY, St. Thomas , Puerto Rico and the countries of Albania, Algeria, Angola, Argentina, Australia, Austria, Bahrain, Barbados, Belgium, Brazil, Bulgaria, Cambodia, Canada, Cayman Islands, Chile, China, Colombia, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Iceland, India, Indonesia, Ireland, 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" } } ] } ] }