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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1245-2026.jsonld",
  "@type": "schema:Dataset",
  "name": "Vortex Surgical    1. 23GA Laser Probe Curved  Cat No. VS0120.23    2. 25GA Laser Probe Curved  Cat No. VS0120.25    3. 25GA Laser Probe Flex-Tip  Cat No. VS0130.25    4. 25GA Laser Probe Illuminated Curved  Cat No. VS0125.25B    5. 25GA Laser Probe MaxReach  Cat No. VS0140.25    6. 25GA Laser Probe Straight  Cat No. VS0110.25",
  "description": "FDA recall Z-1245-2026 — Vortex Surgical Inc. is recalling Vortex Surgical    1. 23GA Laser Probe Curved  Cat No. VS0120.23    2. 25GA Laser Probe Curved  Cat No. VS0120.25    3. 25GA Laser Probe Flex-Tip  Cat No. VS0130.25    4. 25GA Laser Probe Illuminated Curved  Cat No. VS0125.25B    5. 25GA Laser Probe MaxReach  Cat No. VS0140.25    6. 25GA Laser Probe Straight  Cat No. VS0110.25 (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/",
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  "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": {
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      "name": "U.S. Food & Drug Administration"
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1245-2026&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "Vortex Surgical    1. 23GA Laser Probe Curved  Cat No. VS0120.23    2. 25GA Laser Probe Curved  Cat No. VS0120.25    3. 25GA Laser Probe Flex-Tip  Cat No. VS0130.25    4. 25GA Laser Probe Illuminated Curved  Cat No. VS0125.25B    5. 25GA Laser Probe MaxReach  Cat No. VS0140.25    6. 25GA Laser Probe Straight  Cat No. VS0110.25",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Vortex Surgical Inc."
    }
  },
  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1245-2026/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1245-2026: Vortex Surgical Inc. is recalling Vortex Surgical    1. 23GA Laser Probe Curved  Cat No. VS0120.23    2. 25GA Laser Probe Curved  Cat No. VS0120.25    3. 25GA Laser Probe Flex-Tip  Cat No. VS0130.25    4. 25GA Laser Probe Illuminated Curved  Cat No. VS0125.25B    5. 25GA Laser Probe MaxReach  Cat No. VS0140.25    6. 25GA Laser Probe Straight  Cat No. VS0110.25",
      "text": "The FDA logged enforcement record Z-1245-2026: Vortex Surgical Inc. is voluntarily recalling Vortex Surgical    1. 23GA Laser Probe Curved  Cat No. VS0120.23    2. 25GA Laser Probe Curved  Cat No. VS0120.25    3. 25GA Laser Probe Flex-Tip  Cat No. VS0130.25    4. 25GA Laser Probe Illuminated Curved  Cat No. VS0125.25B    5. 25GA Laser Probe MaxReach  Cat No. VS0140.25    6. 25GA Laser Probe Straight  Cat No. VS0110.25 — 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 Laser Probe Curved Pouch UDI 810123480036 Box UDI 810123480180 Lot 2411027  2. 25GA Laser Probe Curved Pouch UDI 810123480043 Box UDI 810123480197 Lot 2411026  3. 25GA Laser Probe Flex-Tip Pouch UDI 810123480111 Box UDI 810123480265 Lot 2411024 2411031  4. 25GA Laser Probe Illuminated Curved Pouch UDI 810123480098 Box UDI 810123480241 Lot 2411025  5. 25GA Laser Probe MaxReach Pouch UDI 810123480135 Box UDI 810123480289 Lot 2410029 2411023  6. 25GA Laser Probe Straight Pouch UDI 810123480012 Box UDI 810123480166 Lot 2411030. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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      "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-1245-2026&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-1245-2026&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-1245-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-1245-2026 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-1245-2026&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-1245-2026&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-1245-2026/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
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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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      "name": "FDA recall details — Z-1245-2026",
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          "item": {
            "Field": "Recall number",
            "Value": "Z-1245-2026",
            "Status": "recorded"
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          "position": 2,
          "item": {
            "Field": "Product type",
            "Value": "Devices",
            "Status": "recorded"
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          "position": 3,
          "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": "Vortex Surgical Inc.",
            "Status": "recorded"
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          "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"
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          "item": {
            "Field": "Initiated",
            "Value": "2025-12-16",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "1. 23GA Laser Probe Curved Pouch UDI 810123480036 Box UDI 810123480180 Lot 2411027  2. 25GA Laser Probe Curved Pouch UDI 810123480043 Box UDI 810123480197 Lot 2411026  3. 25GA Laser Probe Flex-Tip Pouch UDI 810123480111 Box UDI 810123480265 Lot 2411024 2411031  4. 25GA Laser Probe Illuminated Curved Pouch UDI 810123480098 Box UDI 810123480241 Lot 2411025  5. 25GA Laser Probe MaxReach Pouch UDI 810123480135 Box UDI 810123480289 Lot 2410029 2411023  6. 25GA Laser Probe Straight Pouch UDI 810123480012 Box UDI 810123480166 Lot 2411030",
            "Status": "recorded"
          }
        },
        {
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          "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"
          }
        }
      ]
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}