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  "name": "THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S.  Model: TB-0535FCS  Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed",
  "description": "FDA recall Z-0108-2024 — Olympus Corporation of the Americas is recalling THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S.  Model: TB-0535FCS  Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed (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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  "dateModified": "2026-06-24T07:02:03.626072+00:00",
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    "name": "openFDA drug & device enforcement (recall) reports",
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  "sameAs": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0108-2024&lang=eng",
  "about": {
    "@type": "schema:MedicalDevice",
    "name": "THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S.  Model: TB-0535FCS  Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed",
    "manufacturer": {
      "@type": "schema:Organization",
      "name": "Olympus Corporation of the Americas"
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  "claims": [
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0108-2024/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-0108-2024: Olympus Corporation of the Americas is recalling THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S.  Model: TB-0535FCS  Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed",
      "text": "The FDA logged enforcement record Z-0108-2024: Olympus Corporation of the Americas is voluntarily recalling THUNDERBEAT, 5MM, 35CM, Front-actuated Grip Type S.  Model: TB-0535FCS  Indicated for open, laparoscopic (including single-site surgery) general surgery and gynecological surgery (including urologic, thoracic, plastic and reconstructive, bowel resections, cholecystectomies, Nissen fundoplication, adhesiolysis, oophorectomy, hysterectomies (both vaginal assisted and abdominal) etc) and endoscopic surgery or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping, and dissection is performed — reason: Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery. Status: Ongoing — the recall is still being carried out.. Initiated 2023-09-12. Affected lots/codes: UDI-DI: 4953170409677 Lot Numbers: KR271978  KR314612  KR314613  KR314615  KR314617  KR314618  KR314619  KR314621  KR314622  KR314623  KR314624  KR314626  KR314627  KR314628  KR314629  KR314630  KR314631  KR314632  KR314633  KR314634  KR314638  KR314640  KR314641  KR314644  KR314647  KR314648  KR314650  KR314651  KR314652  KR314654  KR314655  KR314657  KR314659  KR314660  KR314662  KR314663  KR314668  KR314670  KR314671  KR314672  KR314673  KR314674  KR314675  KR314676  KR314679  KR316617  KR316627  KR316629  KR316637  KR316683  KR319616  KR319643  KR319655  KR332609  KR332615  KR332616  KR332623  KR332626  KR335733  KR335754  KR335760 KR335769 KR335770 KR335776 KR335781 KR335784 KR335785 KR335794 KR335796 KR335836 PW308606 PW308607 PW308609 PW308611 PW308613 PW308615 PW308616 PW308663 PW308772 PW308773 PW308774 PW308775 PW308776 PW308786 PW308788  Lots Added January 11, 2024: KR271978 KR314619 KR314627 KR314633 KR314648 KR335770 KR310806 KR314612 KR314621 KR314628 KR314634 KR332616 KR335836 KR310809 KR314613 KR314622 KR314629 KR314638 KR332623 KR333661 KR314615 KR314623 KR314630 KR314640 KR332626 KR342666 KR314617 KR314624 KR314631 KR314641 KR335754 KR314618 KR314626 KR314632 KR314644 KR335769. A RECORDED FDA enforcement action (occurred=true).",
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        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
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        "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-0108-2024&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-0108-2024&lang=eng"
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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-0108-2024/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0108-2024 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
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      "grounding": {
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        "source": "U.S. FDA recall classification (openFDA enforcement)",
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        "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-0108-2024&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-0108-2024/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,
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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-0108-2024",
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            "Value": "Z-0108-2024",
            "Status": "recorded"
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          "item": {
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            "Value": "Devices",
            "Status": "recorded"
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          "item": {
            "Field": "Classification",
            "Value": "Class II",
            "Status": "determination"
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            "Field": "Status",
            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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          "position": 5,
          "item": {
            "Field": "Recalling firm",
            "Value": "Olympus Corporation of the Americas",
            "Status": "recorded"
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          "position": 6,
          "item": {
            "Field": "Reason",
            "Value": "Thunderbeats blue seal button may remain in the engaged position after the button is released and not immediately return to a neutral position may result in prolonged surgery",
            "Status": "recorded"
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        {
          "@type": "schema:ListItem",
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          "item": {
            "Field": "Initiated",
            "Value": "2023-09-12",
            "Status": "recorded"
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          "position": 8,
          "item": {
            "Field": "Lot/code info",
            "Value": "UDI-DI: 4953170409677 Lot Numbers: KR271978  KR314612  KR314613  KR314615  KR314617  KR314618  KR314619  KR314621  KR314622  KR314623  KR314624  KR314626  KR314627  KR314628  KR314629  KR314630  KR314631  KR314632  KR314633  KR314634  KR314638  KR314640  KR314641  KR314644  KR314647  KR314648  KR314650  KR314651  KR314652  KR314654  KR314655  KR314657  KR314659  KR314660  KR314662  KR314663  KR314668  KR314670  KR314671  KR314672  KR314673  KR314674  KR314675  KR314676  KR314679  KR316617  KR316627  KR316629  KR316637  KR316683  KR319616  KR319643  KR319655  KR332609  KR332615  KR332616  KR332623  KR332626  KR335733  KR335754  KR335760 KR335769 KR335770 KR335776 KR335781 KR335784 KR335785 KR335794 KR335796 KR335836 PW308606 PW308607 PW308609 PW308611 PW308613 PW308615 PW308616 PW308663 PW308772 PW308773 PW308774 PW308775 PW308776 PW308786 PW308788  Lots Added January 11, 2024: KR271978 KR314619 KR314627 KR314633 KR314648 KR335770 KR310806 KR314612 KR314621 KR314628 KR314634 KR332616 KR335836 KR310809 KR314613 KR314622 KR314629 KR314638 KR332623 KR333661 KR314615 KR314623 KR314630 KR314640 KR332626 KR342666 KR314617 KR314624 KR314631 KR314641 KR335754 KR314618 KR314626 KR314632 KR314644 KR335769",
            "Status": "recorded"
          }
        },
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "US Nationwide distribution.",
            "Status": "recorded"
          }
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}