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  "name": "RelayPro Thoracic Stent-Graft System (various sizes)  Reference numbers: 28-N4-32-104-32U\t28-N4-32-164-28U\t28-N4-32-164-32U\t28-N4-32-209-28U\t28-N4-32-209-32U\t28-N4-32-259-32U\t28-N4-34-109-34U\t28-N4-34-154-30U\t28-N4-34-154-34U\t28-N4-34-209-30U\t28-N4-34-209-34U\t28-N4-34-259-34U\t28-N4-36-109-36U\t28-N4-36-154-32U\t28-N4-36-154-36U\t28-N4-36-199-32U\t28-N4-36-199-36U\t28-N4-36-259-36U\t28-N4-38-109-38U\t28-N4-38-154-34U\t28-N4-38-154-38U\t28-N4-38-199-34U\t28-N4-38-199-38U\t28-N4-38-259-38U\t28-N4-40-114-40U\t28-N4-40-154-36U\t28-N4-40-154-40U\t28-N4-40-204-36U\t28-N4-40-204-40U\t28-N4-40-259-40U\t28-N4-42-114-42U\t28-N4-42-159-38U\t28-N4-42-159-42U\t28-N4-42-204-38U\t28-N4-42-204-42U\t28-N4-42-259-42U\t28-N4-44-114-44U\t28-N4-44-164-40U\t28-N4-44-164-44U\t28-N4-44-209-40U\t28-N4-44-209-44U\t28-N4-44-259-40U\t28-N4-44-259-44U\t28-N4-46-114-46U\t28-N4-46-164-42U\t28-N4-46-164-46U\t28-N4-46-209-42U\t28-N4-46-209-46U\t28-N4-46-259-42U",
  "description": "FDA recall Z-2160-2026 — Bolton Medical Inc. is recalling RelayPro Thoracic Stent-Graft System (various sizes)  Reference numbers: 28-N4-32-104-32U\t28-N4-32-164-28U\t28-N4-32-164-32U\t28-N4-32-209-28U\t28-N4-32-209-32U\t28-N4-32-259-32U\t28-N4-34-109-34U\t28-N4-34-154-30U\t28-N4-34-154-34U\t28-N4-34-209-30U\t28-N4-34-209-34U\t28-N4-34-259-34U\t28-N4-36-109-36U\t28-N4-36-154-32U\t28-N4-36-154-36U\t28-N4-36-199-32U\t28-N4-36-199-36U\t28-N4-36-259-36U\t28-N4-38-109-38U\t28-N4-38-154-34U\t28-N4-38-154-38U\t28-N4-38-199-34U\t28-N4-38-199-38U\t28-N4-38-259-38U\t28-N4-40-114-40U\t28-N4-40-154-36U\t28-N4-40-154-40U\t28-N4-40-204-36U\t28-N4-40-204-40U\t28-N4-40-259-40U\t28-N4-42-114-42U\t28-N4-42-159-38U\t28-N4-42-159-42U\t28-N4-42-204-38U\t28-N4-42-204-42U\t28-N4-42-259-42U\t28-N4-44-114-44U\t28-N4-44-164-40U\t28-N4-44-164-44U\t28-N4-44-209-40U\t28-N4-44-209-44U\t28-N4-44-259-40U\t28-N4-44-259-44U\t28-N4-46-114-46U\t28-N4-46-164-42U\t28-N4-46-164-46U\t28-N4-46-209-42U\t28-N4-46-209-46U\t28-N4-46-259-42U (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.",
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    "name": "RelayPro Thoracic Stent-Graft System (various sizes)  Reference numbers: 28-N4-32-104-32U\t28-N4-32-164-28U\t28-N4-32-164-32U\t28-N4-32-209-28U\t28-N4-32-209-32U\t28-N4-32-259-32U\t28-N4-34-109-34U\t28-N4-34-154-30U\t28-N4-34-154-34U\t28-N4-34-209-30U\t28-N4-34-209-34U\t28-N4-34-259-34U\t28-N4-36-109-36U\t28-N4-36-154-32U\t28-N4-36-154-36U\t28-N4-36-199-32U\t28-N4-36-199-36U\t28-N4-36-259-36U\t28-N4-38-109-38U\t28-N4-38-154-34U\t28-N4-38-154-38U\t28-N4-38-199-34U\t28-N4-38-199-38U\t28-N4-38-259-38U\t28-N4-40-114-40U\t28-N4-40-154-36U\t28-N4-40-154-40U\t28-N4-40-204-36U\t28-N4-40-204-40U\t28-N4-40-259-40U\t28-N4-42-114-42U\t28-N4-42-159-38U\t28-N4-42-159-42U\t28-N4-42-204-38U\t28-N4-42-204-42U\t28-N4-42-259-42U\t28-N4-44-114-44U\t28-N4-44-164-40U\t28-N4-44-164-44U\t28-N4-44-209-40U\t28-N4-44-209-44U\t28-N4-44-259-40U\t28-N4-44-259-44U\t28-N4-46-114-46U\t28-N4-46-164-42U\t28-N4-46-164-46U\t28-N4-46-209-42U\t28-N4-46-209-46U\t28-N4-46-259-42U",
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      "name": "FDA recall Z-2160-2026: Bolton Medical Inc. is recalling RelayPro Thoracic Stent-Graft System (various sizes)  Reference numbers: 28-N4-32-104-32U\t28-N4-32-164-28U\t28-N4-32-164-32U\t28-N4-32-209-28U\t28-N4-32-209-32U\t28-N4-32-259-32U\t28-N4-34-109-34U\t28-N4-34-154-30U\t28-N4-34-154-34U\t28-N4-34-209-30U\t28-N4-34-209-34U\t28-N4-34-259-34U\t28-N4-36-109-36U\t28-N4-36-154-32U\t28-N4-36-154-36U\t28-N4-36-199-32U\t28-N4-36-199-36U\t28-N4-36-259-36U\t28-N4-38-109-38U\t28-N4-38-154-34U\t28-N4-38-154-38U\t28-N4-38-199-34U\t28-N4-38-199-38U\t28-N4-38-259-38U\t28-N4-40-114-40U\t28-N4-40-154-36U\t28-N4-40-154-40U\t28-N4-40-204-36U\t28-N4-40-204-40U\t28-N4-40-259-40U\t28-N4-42-114-42U\t28-N4-42-159-38U\t28-N4-42-159-42U\t28-N4-42-204-38U\t28-N4-42-204-42U\t28-N4-42-259-42U\t28-N4-44-114-44U\t28-N4-44-164-40U\t28-N4-44-164-44U\t28-N4-44-209-40U\t28-N4-44-209-44U\t28-N4-44-259-40U\t28-N4-44-259-44U\t28-N4-46-114-46U\t28-N4-46-164-42U\t28-N4-46-164-46U\t28-N4-46-209-42U\t28-N4-46-209-46U\t28-N4-46-259-42U",
      "text": "The FDA logged enforcement record Z-2160-2026: Bolton Medical Inc. is voluntarily recalling RelayPro Thoracic Stent-Graft System (various sizes)  Reference numbers: 28-N4-32-104-32U\t28-N4-32-164-28U\t28-N4-32-164-32U\t28-N4-32-209-28U\t28-N4-32-209-32U\t28-N4-32-259-32U\t28-N4-34-109-34U\t28-N4-34-154-30U\t28-N4-34-154-34U\t28-N4-34-209-30U\t28-N4-34-209-34U\t28-N4-34-259-34U\t28-N4-36-109-36U\t28-N4-36-154-32U\t28-N4-36-154-36U\t28-N4-36-199-32U\t28-N4-36-199-36U\t28-N4-36-259-36U\t28-N4-38-109-38U\t28-N4-38-154-34U\t28-N4-38-154-38U\t28-N4-38-199-34U\t28-N4-38-199-38U\t28-N4-38-259-38U\t28-N4-40-114-40U\t28-N4-40-154-36U\t28-N4-40-154-40U\t28-N4-40-204-36U\t28-N4-40-204-40U\t28-N4-40-259-40U\t28-N4-42-114-42U\t28-N4-42-159-38U\t28-N4-42-159-42U\t28-N4-42-204-38U\t28-N4-42-204-42U\t28-N4-42-259-42U\t28-N4-44-114-44U\t28-N4-44-164-40U\t28-N4-44-164-44U\t28-N4-44-209-40U\t28-N4-44-209-44U\t28-N4-44-259-40U\t28-N4-44-259-44U\t28-N4-46-114-46U\t28-N4-46-164-42U\t28-N4-46-164-46U\t28-N4-46-209-42U\t28-N4-46-209-46U\t28-N4-46-259-42U — reason: Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-04-22. Affected lots/codes: All Lots/(Ref Number/Proximal Diameter/DI)28-N4-32-104-32U/ 32/ (01)00843576150461; 28-N4-32-164-28U/ 32/ (01)00843576150959; 28-N4-32-164-32U/ 32/ (01)00843576150591; 28-N4-32-209-28U/ 32/ (01)00843576151055; 28-N4-32-209-32U/ 32/ (01)00843576150720; 28-N4-32-259-32U/ 32/ (01)00843576150850; 28-N4-34-109-34U/ 34/ (01)00843576150478; 28-N4-34-154-30U/ 34/ (01)00843576150966; 28-N4-34-154-34U/ 34/ (01)00843576150607; 28-N4-34-209-30U/ 34/ (01)00843576151062; 28-N4-34-209-34U/ 34/ (01)00843576150737; 28-N4-34-259-34U/ 34/ (01)00843576150867; 28-N4-36-109-36U/ 36/ (01)00843576150485; 28-N4-36-154-32U/ 36/ (01)00843576150973; 28-N4-36-154-36U/ 36/ (01)00843576150614; 28-N4-36-199-32U/ 36/ (01)00843576151079; 28-N4-36-199-36U/ 36/ (01)00843576150744; 28-N4-36-259-36U/ 36/ (01)00843576150874; 28-N4-38-109-38U/ 38/ (01)00843576150492; 28-N4-38-154-34U/ 38/ (01)00843576150980; 28-N4-38-154-38U/ 38/ (01)00843576150621; 28-N4-38-199-34U/ 38/ (01)00843576151086; 28-N4-38-199-38U/ 38/ (01)00843576150751; 28-N4-38-259-38U/ 38/ (01)00843576150881; 28-N4-40-114-40U/ 40/ (01)00843576150508; 28-N4-40-154-36U/ 40/ (01)00843576150997; 28-N4-40-154-40U/ 40/ (01)00843576150638; 28-N4-40-204-36U/ 40/ (01)00843576151093; 28-N4-40-204-40U/ 40/ (01)00843576150768; 28-N4-40-259-40U/ 40/ (01)00843576150898; 28-N4-42-114-42U/ 42/ (01)00843576150515; 28-N4-42-159-38U/ 42/ (01)00843576151000; 28-N4-42-159-42U/ 42/ (01)00843576150645; 28-N4-42-204-38U/ 42/ (01)00843576151109; 28-N4-42-204-42U/ 42/ (01)00843576150775; 28-N4-42-259-42U/ 42/ (01)00843576150904; 28-N4-44-114-44U/ 44/ (01)00843576150522; 28-N4-44-164-40U/ 44/ (01)00843576151017; 28-N4-44-164-44U/ 44/ (01)00843576150652; 28-N4-44-209-40U/ 44/ (01)00843576151116; 28-N4-44-209-44U/ 44/ (01)00843576150782; 28-N4-44-259-40U/ 44/ (01)00843576151215; 28-N4-44-259-44U/ 44/ (01)00843576150911; 28-N4-46-114-46U/ 46/ (01)00843576150539; 28-N4-46-164-42U/ 46/ (01)00843576151024; 28-N4-46-164-46U/ 46/ (01)00843576150669; 28-N4-46-209-42U/ 46/ (01)00843576151123; 28-N4-46-209-46U/ 46/ (01)00843576150799; 28-N4-46-259-42U/ 46/ (01)00843576151222. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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          "name": "openFDA drug & device enforcement (recall) reports — U.S. FDA",
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      "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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2160-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-2160-2026 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.",
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        "value": "Class I",
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        }
      },
      "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."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2160-2026/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",
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      "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."
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            "Status": "recorded"
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            "Status": "recorded"
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            "Status": "determination"
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          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Bolton Medical Inc.",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.",
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            "Field": "Initiated",
            "Value": "2026-04-22",
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          "item": {
            "Field": "Lot/code info",
            "Value": "All Lots/(Ref Number/Proximal Diameter/DI)28-N4-32-104-32U/ 32/ (01)00843576150461; 28-N4-32-164-28U/ 32/ (01)00843576150959; 28-N4-32-164-32U/ 32/ (01)00843576150591; 28-N4-32-209-28U/ 32/ (01)00843576151055; 28-N4-32-209-32U/ 32/ (01)00843576150720; 28-N4-32-259-32U/ 32/ (01)00843576150850; 28-N4-34-109-34U/ 34/ (01)00843576150478; 28-N4-34-154-30U/ 34/ (01)00843576150966; 28-N4-34-154-34U/ 34/ (01)00843576150607; 28-N4-34-209-30U/ 34/ (01)00843576151062; 28-N4-34-209-34U/ 34/ (01)00843576150737; 28-N4-34-259-34U/ 34/ (01)00843576150867; 28-N4-36-109-36U/ 36/ (01)00843576150485; 28-N4-36-154-32U/ 36/ (01)00843576150973; 28-N4-36-154-36U/ 36/ (01)00843576150614; 28-N4-36-199-32U/ 36/ (01)00843576151079; 28-N4-36-199-36U/ 36/ (01)00843576150744; 28-N4-36-259-36U/ 36/ (01)00843576150874; 28-N4-38-109-38U/ 38/ (01)00843576150492; 28-N4-38-154-34U/ 38/ (01)00843576150980; 28-N4-38-154-38U/ 38/ (01)00843576150621; 28-N4-38-199-34U/ 38/ (01)00843576151086; 28-N4-38-199-38U/ 38/ (01)00843576150751; 28-N4-38-259-38U/ 38/ (01)00843576150881; 28-N4-40-114-40U/ 40/ (01)00843576150508; 28-N4-40-154-36U/ 40/ (01)00843576150997; 28-N4-40-154-40U/ 40/ (01)00843576150638; 28-N4-40-204-36U/ 40/ (01)00843576151093; 28-N4-40-204-40U/ 40/ (01)00843576150768; 28-N4-40-259-40U/ 40/ (01)00843576150898; 28-N4-42-114-42U/ 42/ (01)00843576150515; 28-N4-42-159-38U/ 42/ (01)00843576151000; 28-N4-42-159-42U/ 42/ (01)00843576150645; 28-N4-42-204-38U/ 42/ (01)00843576151109; 28-N4-42-204-42U/ 42/ (01)00843576150775; 28-N4-42-259-42U/ 42/ (01)00843576150904; 28-N4-44-114-44U/ 44/ (01)00843576150522; 28-N4-44-164-40U/ 44/ (01)00843576151017; 28-N4-44-164-44U/ 44/ (01)00843576150652; 28-N4-44-209-40U/ 44/ (01)00843576151116; 28-N4-44-209-44U/ 44/ (01)00843576150782; 28-N4-44-259-40U/ 44/ (01)00843576151215; 28-N4-44-259-44U/ 44/ (01)00843576150911; 28-N4-46-114-46U/ 46/ (01)00843576150539; 28-N4-46-164-42U/ 46/ (01)00843576151024; 28-N4-46-164-46U/ 46/ (01)00843576150669; 28-N4-46-209-42U/ 46/ (01)00843576151123; 28-N4-46-209-46U/ 46/ (01)00843576150799; 28-N4-46-259-42U/ 46/ (01)00843576151222",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - distribution in the US Territory of Puerto Rico and the countries of Argentina, Chile, Canada, Colombia, Mexico, United Kingdom.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}