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  "name": "4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x    3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x    5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x    5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x    6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x    4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x    5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x    5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x",
  "description": "FDA recall Z-0526-2025 — Karl Storz Endoscopy is recalling 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x    3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x    5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x    5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x    6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x    4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x    5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x    5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x (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.",
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    "name": "openFDA drug & device enforcement (recall) reports",
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    "name": "4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x    3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x    5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x    5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x    6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x    4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x    5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x    5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x",
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      "name": "Karl Storz Endoscopy"
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    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0526-2025/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0526-2025: Karl Storz Endoscopy is recalling 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x    3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x    5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x    5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x    6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x    4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x    5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x    5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x",
      "text": "The FDA logged enforcement record Z-0526-2025: Karl Storz Endoscopy is voluntarily recalling 4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x    3.5 x 70 mm REF 28206CBS Full Radius Resector, sterile, 6x    5.5 x 120 mm REF 28205NDS Aggr. Pro Line Shaver Blade, sterile, 6x    5.5 x 120 mm REF 20205FDS Round Burr, sterile, 6x    6.5 x 120 mm REF 28205HES, Aggressive Barrel Burr, sterile, 6x    4.2 x 120 mm REF 28205GDS Finish Barrel Burr, sterile, 6x    5.5 x 180 mm REF 28208IDS Semi Hooded Barrel Burr, sterile, 6x    5.5 x 120 mm REF 28205HDS Aggressive Barrel Burr, sterile, 6x — reason: Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-11. Affected lots/codes: Material Number: 28208BKS UDI-DI code: 04048551110751 Lot Numbers: 81375N 84424N 84813N 85013N 86065N 86387N 88675N 88377N 89289N 89032N 89365N 89635N 89971N 90202N 93038N 91838N  Material Number: 28206CBS UDI-DI code: Lot Numbers: 80066N 81369N 83233N 83478N 84444N 85877N 90894N  Material Number: 28205NDS UDI-DI code:  Lot Numbers: 83468N 84074N 83220N 84265N 84410N 85015N 84809N 85357N 86362N 87048N 91382N 93323N  Material Number: 28205FDS UDI-DI code: Lot Numbers: 82968N 84246N 83460N 84416N 84440N 85352N 86057N 87456N 86361N 86091N 87049N 88223N 82233N 88755N 88491N 89902N 90702N 90200N 90531N 92248N 93022N 96143N 95045N  Material Number: 28205HES UDI-DI code: Lot Numbers: 81806N 84978N 82127N 86078N 88756N 79745N 89950N 90679N 90911N 92548N-3 92548N-2 92548N-1 93707N 93027N 92955N 91032N 95051N 92995N  Material Number: 28205GDS UDI-DI code: Lot Numbers: 82969N 83245N 84247N 84804N 85880N 85353N 87045N 90214N 86380N 90532N 93023N 91039N 95046N 95679N  Material Number: 28208IDS UDI-DI code: Lot Numbers: 83236N 83268N 82133N 84447N 85362N 86364N 87863N 86807N 88483N 89033N 89024N 89905N 89679N 89959N 90913N 92551N-2 92552N-1 92552N-2 92551N-1 91318N 93033N 91381N 93086N 94862N  Material  Number: 28205HDS UDI-DI code: Lot Numbers: 83219N 83466N 84250N 85184N 84808N 86084N 86085N 86388N 86049N 87864N 88408N 88481N 88767N 89027N 89657N 89949N 89957N 90510N 91490N 93330N 93349N 91031N 90910N 91040N 93026N 93997N 93035N. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
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        "value": "Devices recall, status Ongoing",
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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-0526-2025/fda-classification",
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      "name": "FDA classified recall Z-0526-2025 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.",
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      "reviewStatus": "current",
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        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "value": "Class II",
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          "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-0526-2025&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-0526-2025/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.",
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        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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        "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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      "name": "FDA recall details — Z-0526-2025",
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            "Value": "Z-0526-2025",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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          "position": 4,
          "item": {
            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Karl Storz Endoscopy",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Due to holes detected in the inner barrier system that may compromise the sterility of the affected products.",
            "Status": "recorded"
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          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2024-10-11",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "Material Number: 28208BKS UDI-DI code: 04048551110751 Lot Numbers: 81375N 84424N 84813N 85013N 86065N 86387N 88675N 88377N 89289N 89032N 89365N 89635N 89971N 90202N 93038N 91838N  Material Number: 28206CBS UDI-DI code: Lot Numbers: 80066N 81369N 83233N 83478N 84444N 85877N 90894N  Material Number: 28205NDS UDI-DI code:  Lot Numbers: 83468N 84074N 83220N 84265N 84410N 85015N 84809N 85357N 86362N 87048N 91382N 93323N  Material Number: 28205FDS UDI-DI code: Lot Numbers: 82968N 84246N 83460N 84416N 84440N 85352N 86057N 87456N 86361N 86091N 87049N 88223N 82233N 88755N 88491N 89902N 90702N 90200N 90531N 92248N 93022N 96143N 95045N  Material Number: 28205HES UDI-DI code: Lot Numbers: 81806N 84978N 82127N 86078N 88756N 79745N 89950N 90679N 90911N 92548N-3 92548N-2 92548N-1 93707N 93027N 92955N 91032N 95051N 92995N  Material Number: 28205GDS UDI-DI code: Lot Numbers: 82969N 83245N 84247N 84804N 85880N 85353N 87045N 90214N 86380N 90532N 93023N 91039N 95046N 95679N  Material Number: 28208IDS UDI-DI code: Lot Numbers: 83236N 83268N 82133N 84447N 85362N 86364N 87863N 86807N 88483N 89033N 89024N 89905N 89679N 89959N 90913N 92551N-2 92552N-1 92552N-2 92551N-1 91318N 93033N 91381N 93086N 94862N  Material  Number: 28205HDS UDI-DI code: Lot Numbers: 83219N 83466N 84250N 85184N 84808N 86084N 86085N 86388N 86049N 87864N 88408N 88481N 88767N 89027N 89657N 89949N 89957N 90510N 91490N 93330N 93349N 91031N 90910N 91040N 93026N 93997N 93035N",
            "Status": "recorded"
          }
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide - U.S. Nationwide distribution in the states of AL, FL, IA, IN, KS, MA, MO, MT, NJ, NY, OH, PA, TX, TN, and VA. The countries of Canada and Germany.",
            "Status": "recorded"
          }
        }
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}