{
  "@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-1322-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters:    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm  401211RH  401222RH  401223RH  401226RH  401227RH  401260RH  401261RH  401306RH  401309RH  401312RH  401430RH  401433RH  401435RH  401441RH  401442RH  401443RH  401448RH  401449RH  401450RH  401451RH  401474RH  401860RH  401877RH  401878RH  401890RH  401891RH  401994RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm  402012RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm  402004RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm  402010RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm  402008RH  402009RH",
  "description": "FDA recall Z-1322-2026 — Medline Industries, LP is recalling Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters:    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm  401211RH  401222RH  401223RH  401226RH  401227RH  401260RH  401261RH  401306RH  401309RH  401312RH  401430RH  401433RH  401435RH  401441RH  401442RH  401443RH  401448RH  401449RH  401450RH  401451RH  401474RH  401860RH  401877RH  401878RH  401890RH  401891RH  401994RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm  402012RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm  402004RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm  402010RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm  402008RH  402009RH (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-1322-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters:    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm  401211RH  401222RH  401223RH  401226RH  401227RH  401260RH  401261RH  401306RH  401309RH  401312RH  401430RH  401433RH  401435RH  401441RH  401442RH  401443RH  401448RH  401449RH  401450RH  401451RH  401474RH  401860RH  401877RH  401878RH  401890RH  401891RH  401994RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm  402012RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm  402004RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm  402010RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm  402008RH  402009RH",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Medline Industries, LP"
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1322-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1322-2026: Medline Industries, LP is recalling Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters:    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm  401211RH  401222RH  401223RH  401226RH  401227RH  401260RH  401261RH  401306RH  401309RH  401312RH  401430RH  401433RH  401435RH  401441RH  401442RH  401443RH  401448RH  401449RH  401450RH  401451RH  401474RH  401860RH  401877RH  401878RH  401890RH  401891RH  401994RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm  402012RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm  402004RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm  402010RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm  402008RH  402009RH",
      "text": "The FDA logged enforcement record Z-1322-2026: Medline Industries, LP is voluntarily recalling Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters:    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm  401211RH  401222RH  401223RH  401226RH  401227RH  401260RH  401261RH  401306RH  401309RH  401312RH  401430RH  401433RH  401435RH  401441RH  401442RH  401443RH  401448RH  401449RH  401450RH  401451RH  401474RH  401860RH  401877RH  401878RH  401890RH  401891RH  401994RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm  402012RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm  402004RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm  402010RH;    St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm  402008RH  402009RH — reason: These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-22. Affected lots/codes: 401211RH UDI-DI 10197344043736 Lot EP250317;  401222RH UDI-DI 10197344043712 Lot EP250317;  401223RH UDI-DI 10197344043705 Lot EP250317;  401226RH UDI-DI 10197344043699 Lot EP250307 EP250317;  401227RH UDI-DI 10197344043682 Lots EP250307 EP250317;  401260RH UDI-DI 10197344043668 Lot EP250317;  401261RH UDI-DI 10197344043651 Lot EP250317;  401306RH UDI-DI 10197344043620¿ Lot EP250317;  401309RH UDI-DI 10197344043613 Lot EP250317;  401312RH UDI-DI 10197344043583¿ Lot EP250307;  401430RH UDI-DI 10197344043491 Lots EP250307 EP250317;  401433RH UDI-DI 10197344043484 Lots EP250307 EP250317;  401435RH UDI-DI 10197344043460 Lots EP250307 EP250317;  401441RH UDI-DI 10197344043439 Lots EP250307 EP250317;  401442RH UDI-DI 10197344044245 Lot EP250307;  401443RH UDI-DI 10197344044252 Lots EP250307 EP250317;  401448RH UDI-DI 10197344044283 Lot EP250307;  401449RH UDI-DI 10197344044290 Lot EP250307;  401450RH UDI-DI 10197344044306 Lots EP250307 EP250317;  401451RH UDI-DI 10197344044313 EP250307 EP250317;  401474RH UDI-DI 10197344044351 Lot EP250307;  401860RH UDI-DI 10197344044382 Lots EP250307 EP250317;  401877RH UDI-DI 10197344044436 Lots EP250307 EP250317;  401878RH UDI-DI 10197344044443 Lot EP250307;  401890RH UDI-DI 10197344044450 Lots EP250307 EP250317;  401891RH UDI-DI 10197344044467 Lot EP250307;  401994RH UDI-DI 10197344044542 Lot EP250317;  402012RH UDI-DI 10197344043835 Lots EP250307 EP250317;  402004RH UDI-DI 10197344044566 Lots EP250307 EP250317;  402010RH UDI-DI 10197344044597 Lots EP250307 EP250317;  402008RH UDI-DI 10197344044573 Lot EP250317;  402009RH UDI-DI 10197344044580 Lots EP250307 EP250317  ***Updated 5/18/26***  LOT EP250203 added to the scope of action for the following SKUs 401222RH 401223RH 401226RH 401227RH 401261RH 401430RH 401433RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401860RH 401891RH 402004RH 402010RH 402012RH. 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-1322-2026&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-1322-2026&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-1322-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1322-2026 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-1322-2026&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-1322-2026&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-1322-2026/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-1322-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1322-2026",
            "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 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": "Medline Industries, LP",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-12-22",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "401211RH UDI-DI 10197344043736 Lot EP250317;  401222RH UDI-DI 10197344043712 Lot EP250317;  401223RH UDI-DI 10197344043705 Lot EP250317;  401226RH UDI-DI 10197344043699 Lot EP250307 EP250317;  401227RH UDI-DI 10197344043682 Lots EP250307 EP250317;  401260RH UDI-DI 10197344043668 Lot EP250317;  401261RH UDI-DI 10197344043651 Lot EP250317;  401306RH UDI-DI 10197344043620¿ Lot EP250317;  401309RH UDI-DI 10197344043613 Lot EP250317;  401312RH UDI-DI 10197344043583¿ Lot EP250307;  401430RH UDI-DI 10197344043491 Lots EP250307 EP250317;  401433RH UDI-DI 10197344043484 Lots EP250307 EP250317;  401435RH UDI-DI 10197344043460 Lots EP250307 EP250317;  401441RH UDI-DI 10197344043439 Lots EP250307 EP250317;  401442RH UDI-DI 10197344044245 Lot EP250307;  401443RH UDI-DI 10197344044252 Lots EP250307 EP250317;  401448RH UDI-DI 10197344044283 Lot EP250307;  401449RH UDI-DI 10197344044290 Lot EP250307;  401450RH UDI-DI 10197344044306 Lots EP250307 EP250317;  401451RH UDI-DI 10197344044313 EP250307 EP250317;  401474RH UDI-DI 10197344044351 Lot EP250307;  401860RH UDI-DI 10197344044382 Lots EP250307 EP250317;  401877RH UDI-DI 10197344044436 Lots EP250307 EP250317;  401878RH UDI-DI 10197344044443 Lot EP250307;  401890RH UDI-DI 10197344044450 Lots EP250307 EP250317;  401891RH UDI-DI 10197344044467 Lot EP250307;  401994RH UDI-DI 10197344044542 Lot EP250317;  402012RH UDI-DI 10197344043835 Lots EP250307 EP250317;  402004RH UDI-DI 10197344044566 Lots EP250307 EP250317;  402010RH UDI-DI 10197344044597 Lots EP250307 EP250317;  402008RH UDI-DI 10197344044573 Lot EP250317;  402009RH UDI-DI 10197344044580 Lots EP250307 EP250317  ***Updated 5/18/26***  LOT EP250203 added to the scope of action for the following SKUs 401222RH 401223RH 401226RH 401227RH 401261RH 401430RH 401433RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401860RH 401891RH 402004RH 402010RH 402012RH",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Distribution US nationwide.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}