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  "name": "DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27",
  "description": "FDA recall Z-2080-2026 — Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27 (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": "DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27",
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      "name": "FDA recall Z-2080-2026: Katalyst Surgical, LLC is recalling DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27",
      "text": "The FDA logged enforcement record Z-2080-2026: Katalyst Surgical, LLC is voluntarily recalling DEX Ophthalmic Tissue Forceps, 27ga DEX Stiff Super Grip Forceps, Model/Catalog Number: DVF4034-27 — reason: Ophthalmic Tissue Forceps (DEX\") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled  Ophthalmic soft-tissue surgical forceps, probe-like, single use .  Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-25. 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Expiration Date: 06/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M48043 Lot Number: M48043 Expiration Date: 05/27/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M47611 Lot Number: M47611 Expiration Date: 05/27/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48472 Lot Number: M48472 Expiration Date: 06/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250709(17)280709(10)M48658 Lot Number: M48658 Expiration Date: 07/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250709(17)280709(10)M48657 Lot Number: M48657 Expiration Date: 07/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250807(17)280807(10)M49169 Lot Number: M49169 Expiration Date: 08/07/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250806(17)280806(10)M49170 Lot Number: M49170 Expiration Date: 08/06/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250819(17)280819(10)M49287 Lot Number: M49287 Expiration Date: 08/19/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250825(17)280825(10)M49777 Lot Number: M49777 Expiration Date: 08/25/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250825(17)280825(10)M49776 Lot Number: M49776 Expiration Date: 08/25/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49830 Lot Number: M49830 Expiration Date: 08/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49831 Lot Number: M49831 Expiration Date: 08/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49907 Lot Number: M49907 Expiration Date: 08/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250904(17)280904(10)M49906 Lot Number: M49906 Expiration Date: 09/04/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250909(17)280909(10)M49925 Lot Number: M49925 Expiration Date: 09/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250909(17)280909(10)M49926 Lot Number: M49926 Expiration Date: 09/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50538 Lot Number: M50538 Expiration Date: 10/03/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50628 Lot Number: M50628 Expiration Date: 10/03/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50629 Lot Number: M50629 Expiration Date: 10/03/2028  Model No:DVF4034-27 UDI-DI: (01)10817489025557(11)251008(17)281008(10)M50897 Lot Number: M50897 Expiration Date: 10/08/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251008(17)281008(10)M50898 Lot Number: M50898 Expiration Date: 10/08/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251007(17)281007(10)M50678 Lot Number: M50678 Expiration Date: 10/07/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251015(17)281015(10)M50917 Lot Number: M50917 Expiration Date: 10/15/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251017(17)281017(10)M50932 Lot Number: M50932 Expiration Date: 10/17/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251107(17)281107(10)M50993 Lot Number: M50993 Expiration Date: 11/07/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251113(17)281113(10)M51034 Lot Number: M51034 Expiration Date: 11/13/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51076 Lot Number: M51076 Expiration Date: 12/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51077 Lot Number: M51077 Expiration Date: 12/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51131 Lot Number: M51131 Expiration Date: 12/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251212(17)281212(10)M51235 Lot Number: M51235 Expiration Date: 12/12/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251212(17)281212(10)M51236 Lot Number: M51236 Expiration Date: 12/12/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251218(17)281218(10)M51292 Lot Number: M51292 Expiration Date: 12/18/2028  Model No: DVF4034-27 UDI-DI: (01)1081748902557(11)251218(17)281218(10)M51293 Lot Number: M51293 Expiration Date: 12/18/2028  Model No: DVF4034-27 UDI-DI: (01)10718489025557(11)260107(17)290107(10)M51329 Lot Number: 51329 Expiration Date: 01/07/2029  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260115(17)290115(10)M51630 Lot Number: M51630 Expiration Date: 01/15/2029  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260115(17)290115(10)M51629 Lot Number: M51629 Expiration Date: 01/15/2029  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260120(17)290120(10)M51699 Lot Number: M51699 Expiration Date: 01/20/2029  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260120(17)290120(10)M51700 Lot Number: M51700 Expiration Date: 01/20/2029. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2080-2026 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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        "value": "Class II",
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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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        "value": "a recorded enforcement action, not proof of harm or causation; not medical advice",
        "adjudicator": null
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      "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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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
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            "Field": "Recalling firm",
            "Value": "Katalyst Surgical, LLC",
            "Status": "recorded"
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          "item": {
            "Field": "Reason",
            "Value": "Ophthalmic Tissue Forceps (DEX\") are sterile, hand-held ophthalmic surgical instruments designed for grasping, manipulating, compressing, pulling, or joining eye and/or surrounding tissues during surgical procedures. These devices fall under the GMDN code 62478 entitled  Ophthalmic soft-tissue surgical forceps, probe-like, single use .  Double pouched in tyvek pouches, sold in boxes of 5 with an inner and outer box.",
            "Status": "recorded"
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            "Field": "Lot/code info",
            "Value": "Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250429(17)280429(10)M47331 Lot Number: M47331 Expiration Date: 04/29/2028  Model No: DVF4034-27 UDI-DI: (01)1081748902557(11)250527(17)280527(10)M48044 Lot Number: M48044 Expiration Date: 05/27/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250610(17)280610(10)M48163 Lot Number: M48163 Expiration Date: 06/10/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M47612 Lot Number: M47612 Expiration Date: 05/27/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250617(17)280617(10)M48071 Lot Number: M48071 Expiration Date: 06/17/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250610(17)280610(10)M48164 Lot Number: M48164 Expiration Date: 06/10/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48470 Lot Number: M48470 Expiration Date: 06/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48471 Lot Number: M48471 Expiration Date: 06/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M48043 Lot Number: M48043 Expiration Date: 05/27/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250527(17)280527(10)M47611 Lot Number: M47611 Expiration Date: 05/27/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250626(17)280626(10)M48472 Lot Number: M48472 Expiration Date: 06/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250709(17)280709(10)M48658 Lot Number: M48658 Expiration Date: 07/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250709(17)280709(10)M48657 Lot Number: M48657 Expiration Date: 07/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250807(17)280807(10)M49169 Lot Number: M49169 Expiration Date: 08/07/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250806(17)280806(10)M49170 Lot Number: M49170 Expiration Date: 08/06/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250819(17)280819(10)M49287 Lot Number: M49287 Expiration Date: 08/19/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250825(17)280825(10)M49777 Lot Number: M49777 Expiration Date: 08/25/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250825(17)280825(10)M49776 Lot Number: M49776 Expiration Date: 08/25/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49830 Lot Number: M49830 Expiration Date: 08/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49831 Lot Number: M49831 Expiration Date: 08/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250826(17)280826(10)M49907 Lot Number: M49907 Expiration Date: 08/26/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250904(17)280904(10)M49906 Lot Number: M49906 Expiration Date: 09/04/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250909(17)280909(10)M49925 Lot Number: M49925 Expiration Date: 09/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)250909(17)280909(10)M49926 Lot Number: M49926 Expiration Date: 09/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50538 Lot Number: M50538 Expiration Date: 10/03/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50628 Lot Number: M50628 Expiration Date: 10/03/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251003(17)281003(10)M50629 Lot Number: M50629 Expiration Date: 10/03/2028  Model No:DVF4034-27 UDI-DI: (01)10817489025557(11)251008(17)281008(10)M50897 Lot Number: M50897 Expiration Date: 10/08/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251008(17)281008(10)M50898 Lot Number: M50898 Expiration Date: 10/08/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251007(17)281007(10)M50678 Lot Number: M50678 Expiration Date: 10/07/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251015(17)281015(10)M50917 Lot Number: M50917 Expiration Date: 10/15/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251017(17)281017(10)M50932 Lot Number: M50932 Expiration Date: 10/17/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251107(17)281107(10)M50993 Lot Number: M50993 Expiration Date: 11/07/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251113(17)281113(10)M51034 Lot Number: M51034 Expiration Date: 11/13/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51076 Lot Number: M51076 Expiration Date: 12/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51077 Lot Number: M51077 Expiration Date: 12/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251209(17)281209(10)M51131 Lot Number: M51131 Expiration Date: 12/09/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251212(17)281212(10)M51235 Lot Number: M51235 Expiration Date: 12/12/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251212(17)281212(10)M51236 Lot Number: M51236 Expiration Date: 12/12/2028  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)251218(17)281218(10)M51292 Lot Number: M51292 Expiration Date: 12/18/2028  Model No: DVF4034-27 UDI-DI: (01)1081748902557(11)251218(17)281218(10)M51293 Lot Number: M51293 Expiration Date: 12/18/2028  Model No: DVF4034-27 UDI-DI: (01)10718489025557(11)260107(17)290107(10)M51329 Lot Number: 51329 Expiration Date: 01/07/2029  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260115(17)290115(10)M51630 Lot Number: M51630 Expiration Date: 01/15/2029  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260115(17)290115(10)M51629 Lot Number: M51629 Expiration Date: 01/15/2029  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260120(17)290120(10)M51699 Lot Number: M51699 Expiration Date: 01/20/2029  Model No: DVF4034-27 UDI-DI: (01)10817489025557(11)260120(17)290120(10)M51700 Lot Number: M51700 Expiration Date: 01/20/2029",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Peru, Argentina, South Korea, Japan, France.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}