{
  "@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-1247-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Vortex Disposable Forceps and Cannula    1. 23GA ACTU8 Forceps Adaptive  VS0740.23    2. 25GA ACTU8 Forceps Adaptive  VS0740.25    3. 25GA ACTU8 Forceps ILM  VS0744.25    4. 25GA ACTU8 Forceps ILM -Myopic  VS0744.25-35    5. 25GA ACTU8 Forceps Pro-Grip  VS0713.25    6. 25GA ACTU8 Talon Forceps ILM  VS0752.25    7. 25GA ACTU8 Talon Forceps Pro-Grip  VS0751.25    8. 27GA ACTU8 Forceps ILM  VS0744.27    9. 23GA Soft Tip Cannula  VS0200.23    10. 23GA Soft Tip Cannula - 0.5mm  VS0205.23    11. 25GA Soft Tip Cannula  VS0200.25    12. 25GA Soft Tip Cannula - 0.5mm  VS0205.25    13. 25GA Soft Tip Cannula - 0.5mm - Bulk  VS0205.25B    14. 25GA Soft Tip Cannula-Bulk  VS0200.25B    15. 27GA Soft Tip Cannula  VS0200.27",
  "description": "FDA recall Z-1247-2026 — Vortex Surgical Inc. is recalling Vortex Disposable Forceps and Cannula    1. 23GA ACTU8 Forceps Adaptive  VS0740.23    2. 25GA ACTU8 Forceps Adaptive  VS0740.25    3. 25GA ACTU8 Forceps ILM  VS0744.25    4. 25GA ACTU8 Forceps ILM -Myopic  VS0744.25-35    5. 25GA ACTU8 Forceps Pro-Grip  VS0713.25    6. 25GA ACTU8 Talon Forceps ILM  VS0752.25    7. 25GA ACTU8 Talon Forceps Pro-Grip  VS0751.25    8. 27GA ACTU8 Forceps ILM  VS0744.27    9. 23GA Soft Tip Cannula  VS0200.23    10. 23GA Soft Tip Cannula - 0.5mm  VS0205.23    11. 25GA Soft Tip Cannula  VS0200.25    12. 25GA Soft Tip Cannula - 0.5mm  VS0205.25    13. 25GA Soft Tip Cannula - 0.5mm - Bulk  VS0205.25B    14. 25GA Soft Tip Cannula-Bulk  VS0200.25B    15. 27GA Soft Tip Cannula  VS0200.27 (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.",
  "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-1247-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Vortex Disposable Forceps and Cannula    1. 23GA ACTU8 Forceps Adaptive  VS0740.23    2. 25GA ACTU8 Forceps Adaptive  VS0740.25    3. 25GA ACTU8 Forceps ILM  VS0744.25    4. 25GA ACTU8 Forceps ILM -Myopic  VS0744.25-35    5. 25GA ACTU8 Forceps Pro-Grip  VS0713.25    6. 25GA ACTU8 Talon Forceps ILM  VS0752.25    7. 25GA ACTU8 Talon Forceps Pro-Grip  VS0751.25    8. 27GA ACTU8 Forceps ILM  VS0744.27    9. 23GA Soft Tip Cannula  VS0200.23    10. 23GA Soft Tip Cannula - 0.5mm  VS0205.23    11. 25GA Soft Tip Cannula  VS0200.25    12. 25GA Soft Tip Cannula - 0.5mm  VS0205.25    13. 25GA Soft Tip Cannula - 0.5mm - Bulk  VS0205.25B    14. 25GA Soft Tip Cannula-Bulk  VS0200.25B    15. 27GA Soft Tip Cannula  VS0200.27",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Vortex Surgical Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1247-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1247-2026: Vortex Surgical Inc. is recalling Vortex Disposable Forceps and Cannula    1. 23GA ACTU8 Forceps Adaptive  VS0740.23    2. 25GA ACTU8 Forceps Adaptive  VS0740.25    3. 25GA ACTU8 Forceps ILM  VS0744.25    4. 25GA ACTU8 Forceps ILM -Myopic  VS0744.25-35    5. 25GA ACTU8 Forceps Pro-Grip  VS0713.25    6. 25GA ACTU8 Talon Forceps ILM  VS0752.25    7. 25GA ACTU8 Talon Forceps Pro-Grip  VS0751.25    8. 27GA ACTU8 Forceps ILM  VS0744.27    9. 23GA Soft Tip Cannula  VS0200.23    10. 23GA Soft Tip Cannula - 0.5mm  VS0205.23    11. 25GA Soft Tip Cannula  VS0200.25    12. 25GA Soft Tip Cannula - 0.5mm  VS0205.25    13. 25GA Soft Tip Cannula - 0.5mm - Bulk  VS0205.25B    14. 25GA Soft Tip Cannula-Bulk  VS0200.25B    15. 27GA Soft Tip Cannula  VS0200.27",
      "text": "The FDA logged enforcement record Z-1247-2026: Vortex Surgical Inc. is voluntarily recalling Vortex Disposable Forceps and Cannula    1. 23GA ACTU8 Forceps Adaptive  VS0740.23    2. 25GA ACTU8 Forceps Adaptive  VS0740.25    3. 25GA ACTU8 Forceps ILM  VS0744.25    4. 25GA ACTU8 Forceps ILM -Myopic  VS0744.25-35    5. 25GA ACTU8 Forceps Pro-Grip  VS0713.25    6. 25GA ACTU8 Talon Forceps ILM  VS0752.25    7. 25GA ACTU8 Talon Forceps Pro-Grip  VS0751.25    8. 27GA ACTU8 Forceps ILM  VS0744.27    9. 23GA Soft Tip Cannula  VS0200.23    10. 23GA Soft Tip Cannula - 0.5mm  VS0205.23    11. 25GA Soft Tip Cannula  VS0200.25    12. 25GA Soft Tip Cannula - 0.5mm  VS0205.25    13. 25GA Soft Tip Cannula - 0.5mm - Bulk  VS0205.25B    14. 25GA Soft Tip Cannula-Bulk  VS0200.25B    15. 27GA Soft Tip Cannula  VS0200.27 — reason: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-12-16. Affected lots/codes: 1. 23GA ACTU8 Forceps Adaptive Pouch UDI 810123481125 Box UDI 810123481538 Lot 2411009  2. 25GA ACTU8 Forceps Adaptive Pouch UDI 810123481132 Box UDI 810123481545 Lot 2410051  3. 25GA ACTU8 Forceps ILM Pouch UDI 810123481231 Box UDI 810123481644 Lot 2410021 2410053 2411006  4. 25GA ACTU8 Forceps ILM -Myopic Pouch UDI 810123481248 Box UDI 810123481651 Lot 2410059  5. 25GA ACTU8 Forceps Pro-Grip Pouch UDI 810123481101 Box UDI 810123481514 Lot 2410050 2411011  6. 25GA ACTU8 Talon Forceps ILM Pouch UDI 810123481835 Box UDI 810123481859 Lot 2411003  7. 25GA ACTU8 Talon Forceps Pro-Grip Pouch UDI 810123482375 Box UDI 810123482405 Lot 2410060  8. 27GA ACTU8 Forceps ILM Pouch UDI 810123481255 Box UDI 810123481668 Lot 2410054  9. 23GA Soft Tip Cannula UDI Pouch 810123480302 Box UDI 810123480562 Lot 2410037  10. 23GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480388 Box UDI 810123480661 Lot 2411032  11. 25GA Soft Tip Cannula UDI Pouch 810123480319 Box UDI 810123480586 Lot 2410039  12. 25GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480395 Box UDI 810123480678 Lot 2410041  13. 25GA Soft Tip Cannula - 0.5mm - Bulk UDI Pouch 810123480395 Box UDI 810123481927 Lot 2410042 2411018  14. 25GA Soft Tip Cannula-Bulk UDI Pouch 810123480319 Box UDI 810123480593 Lot 2410040  15. 27GA Soft Tip Cannula UDI Pouch 810123480326 Box UDI 810123480609 Lot 2412026. 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-1247-2026&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-1247-2026&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-1247-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1247-2026 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.",
      "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-1247-2026&lang=eng",
        "value": "Class II",
        "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-1247-2026&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-1247-2026/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-1247-2026",
      "numberOfItems": 9,
      "itemListElement": [
        {
          "@type": "schema:ListItem",
          "position": 1,
          "item": {
            "Field": "Recall number",
            "Value": "Z-1247-2026",
            "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 II",
            "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": "Vortex Surgical Inc.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 7,
          "item": {
            "Field": "Initiated",
            "Value": "2025-12-16",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1. 23GA ACTU8 Forceps Adaptive Pouch UDI 810123481125 Box UDI 810123481538 Lot 2411009  2. 25GA ACTU8 Forceps Adaptive Pouch UDI 810123481132 Box UDI 810123481545 Lot 2410051  3. 25GA ACTU8 Forceps ILM Pouch UDI 810123481231 Box UDI 810123481644 Lot 2410021 2410053 2411006  4. 25GA ACTU8 Forceps ILM -Myopic Pouch UDI 810123481248 Box UDI 810123481651 Lot 2410059  5. 25GA ACTU8 Forceps Pro-Grip Pouch UDI 810123481101 Box UDI 810123481514 Lot 2410050 2411011  6. 25GA ACTU8 Talon Forceps ILM Pouch UDI 810123481835 Box UDI 810123481859 Lot 2411003  7. 25GA ACTU8 Talon Forceps Pro-Grip Pouch UDI 810123482375 Box UDI 810123482405 Lot 2410060  8. 27GA ACTU8 Forceps ILM Pouch UDI 810123481255 Box UDI 810123481668 Lot 2410054  9. 23GA Soft Tip Cannula UDI Pouch 810123480302 Box UDI 810123480562 Lot 2410037  10. 23GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480388 Box UDI 810123480661 Lot 2411032  11. 25GA Soft Tip Cannula UDI Pouch 810123480319 Box UDI 810123480586 Lot 2410039  12. 25GA Soft Tip Cannula - 0.5mm UDI Pouch 810123480395 Box UDI 810123480678 Lot 2410041  13. 25GA Soft Tip Cannula - 0.5mm - Bulk UDI Pouch 810123480395 Box UDI 810123481927 Lot 2410042 2411018  14. 25GA Soft Tip Cannula-Bulk UDI Pouch 810123480319 Box UDI 810123480593 Lot 2410040  15. 27GA Soft Tip Cannula UDI Pouch 810123480326 Box UDI 810123480609 Lot 2412026",
            "Status": "recorded"
          }
        },
        {
          "@type": "schema:ListItem",
          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.",
            "Status": "recorded"
          }
        }
      ]
    }
  ]
}