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  "name": "DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S",
  "description": "FDA recall Z-2075-2026 — Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S (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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2075-2026/enforcement-record",
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      "name": "FDA recall Z-2075-2026: Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S",
      "text": "The FDA logged enforcement record Z-2075-2026: Katalyst Surgical, LLC is voluntarily recalling DEX Ophthalmic Tissue Forceps, 25ga DEX Stiff Maculorhexis Forceps, Model/Catalog Number: DVF4019-25-S — reason: Field Safety Corrective Action for IFU in DEX Forceps and Scissors.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-25. Affected lots/codes: Lot Code: Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251017(17)281017(10)M50541 Lot Number: M50541 Expiration Date: 10/17/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251017(17)281017(10)M50542 Lot Number: M50542 Expiration Date: 10/17/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251023(17)281023(10)M50632 Lot Number: M50632 Expiration Date: 10/23/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251023(17)281023(10)M50633 Lot Number: M50633 Expiration Date: 10/23/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251113(17)281113(10)M50936 Lot Number: M50936 Expiration Date: 11/13/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251113(17)281113(10)M50996 Lot Number: M50996 Expiration Date: 11/13/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51039 Lot Number: M51039 Expiration Date: 11/25/2028   Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51040 Lot Number: M51040 Expiration Date: 11/25/2028   Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51081 Lot Number: M51081 Expiration Date: 11/25/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251126(17)281126(10)M51138 Lot Number: M51138 Expiration Date: 11/26/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250422(17)280422(10)M47122 Lot Number: M47122 Expiration Date: 04/22/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250422(17)280422(10)M47123 Lot Number: M47123 Expiration Date: 04/22/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250429(17)280429(10)M47336 Lot Number: M47336 Expiration Date: 04/29/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250618(17)280618(10)M48308 Lot Number: M48308 Expiration Date: 06/18/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250709(17)280709(10)M48660 Lot Number: M48660 Expiration Date: 07/09/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250807(17)280807(10)M49294 Lot Number: M49294 Expiration Date: 08/07/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250819(17)280819(10)M49784 Lot Number: M49784 Expiration Date: 08/19/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250826(17)280826(10)M49839 Lot Number: M49839 Expiration Date: 08/26/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250826(17)280826(10)M49910 Lot Number: M49910 Expiration Date: 08/26/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250904(17)280904(0)M49929 Lot Number: M49929 Expiration Date: 09/04/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250909)17)280909(10)M49930 Lot Number: M49930 Expiration Date: 09/09/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250917(17)280917(10)M50215 Lot Number: M50215 Expiration Date: 09/17/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50427 Lot Number: M50427 Expiration Date: 09/24/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50429 Lot Number: M50429 Expiration Date:  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50428 Lot Number: M50428 Expiration Date: 09/24/2028. A RECORDED FDA enforcement action (occurred=true).",
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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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      "name": "FDA classified recall Z-2075-2026 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.",
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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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      "@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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        "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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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Field": "Recalling firm",
            "Value": "Katalyst Surgical, LLC",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Field Safety Corrective Action for IFU in DEX Forceps and Scissors.",
            "Status": "recorded"
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          "item": {
            "Field": "Initiated",
            "Value": "2026-03-25",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "Lot Code: Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251017(17)281017(10)M50541 Lot Number: M50541 Expiration Date: 10/17/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251017(17)281017(10)M50542 Lot Number: M50542 Expiration Date: 10/17/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251023(17)281023(10)M50632 Lot Number: M50632 Expiration Date: 10/23/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251023(17)281023(10)M50633 Lot Number: M50633 Expiration Date: 10/23/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251113(17)281113(10)M50936 Lot Number: M50936 Expiration Date: 11/13/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251113(17)281113(10)M50996 Lot Number: M50996 Expiration Date: 11/13/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51039 Lot Number: M51039 Expiration Date: 11/25/2028   Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51040 Lot Number: M51040 Expiration Date: 11/25/2028   Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251125(17)281125(10)M51081 Lot Number: M51081 Expiration Date: 11/25/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)251126(17)281126(10)M51138 Lot Number: M51138 Expiration Date: 11/26/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250422(17)280422(10)M47122 Lot Number: M47122 Expiration Date: 04/22/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250422(17)280422(10)M47123 Lot Number: M47123 Expiration Date: 04/22/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250429(17)280429(10)M47336 Lot Number: M47336 Expiration Date: 04/29/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250618(17)280618(10)M48308 Lot Number: M48308 Expiration Date: 06/18/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250709(17)280709(10)M48660 Lot Number: M48660 Expiration Date: 07/09/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250807(17)280807(10)M49294 Lot Number: M49294 Expiration Date: 08/07/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250819(17)280819(10)M49784 Lot Number: M49784 Expiration Date: 08/19/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250826(17)280826(10)M49839 Lot Number: M49839 Expiration Date: 08/26/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250826(17)280826(10)M49910 Lot Number: M49910 Expiration Date: 08/26/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250904(17)280904(0)M49929 Lot Number: M49929 Expiration Date: 09/04/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250909)17)280909(10)M49930 Lot Number: M49930 Expiration Date: 09/09/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250917(17)280917(10)M50215 Lot Number: M50215 Expiration Date: 09/17/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50427 Lot Number: M50427 Expiration Date: 09/24/2028  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50429 Lot Number: M50429 Expiration Date:  Model No: DVF4019-25-S UDI-DI: (01)10840096205135(11)250924(17)280924(10)M50428 Lot Number: M50428 Expiration Date: 09/24/2028",
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            "Field": "Distribution pattern",
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