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  "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1170-2024.jsonld",
  "@type": "schema:Dataset",
  "name": "3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L",
  "description": "FDA recall Z-1170-2024 — 3M Company - Health Care Business is recalling 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L (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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    "@type": "schema:MedicalDevice",
    "name": "3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L",
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      "name": "FDA recall Z-1170-2024: 3M Company - Health Care Business is recalling 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L",
      "text": "The FDA logged enforcement record Z-1170-2024: 3M Company - Health Care Business is voluntarily recalling 3M Specialty Blade Assembly, REF 9660,70-2011-8491-1, 7100213026, used with used with 3M Surgical Clipper Catalog Number 9661L — reason: 3M has added the following cautionary statement regarding the use of the product:    \"Caution - To reduce the risk of burns, which if not avoided may result in minor injury:  \"  Do not use on injured skin.  \"  Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41¿C (105.8¿F).  \"  Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required.  Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60¿C (140¿F) and the Model 9660 blade maximum temperature may reach 77¿C (170.6¿F).\". Status: Ongoing — the recall is still being carried out.. Initiated 2024-01-12. Affected lots/codes: UDI/DI 50707387789294 (shipper), 30707387789290 (tray), all lot codes. A RECORDED FDA enforcement action (occurred=true).",
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      "reviewStatus": "current",
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      "epistemicStatus": {
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        "supported": true,
        "adjudged": 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-1170-2024&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-1170-2024&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."
    },
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1170-2024/fda-classification",
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      "name": "FDA classified recall Z-1170-2024 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.",
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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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1170-2024/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.",
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      "reviewStatus": "current",
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      "epistemicStatus": {
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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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      "name": "FDA recall details — Z-1170-2024",
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            "Value": "Ongoing — the recall is still being carried out.",
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            "Field": "Recalling firm",
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            "Status": "recorded"
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            "Field": "Reason",
            "Value": "3M has added the following cautionary statement regarding the use of the product:    \"Caution - To reduce the risk of burns, which if not avoided may result in minor injury:  \"  Do not use on injured skin.  \"  Do not leave clipper running unused in air without applying to skin for more than 1 minute as blade temperature may exceed 41¿C (105.8¿F).  \"  Do not leave the clipper blade applied to the same location on the patient s skin for longer than 1 second as potential injury may occur; continuous motion of the clipper during use is required.  Note: If clipper is left running unused in air for 10 minutes without applying to skin, the Model 9690 blade maximum temperature may reach 60¿C (140¿F) and the Model 9660 blade maximum temperature may reach 77¿C (170.6¿F).\"",
            "Status": "recorded"
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            "Field": "Initiated",
            "Value": "2024-01-12",
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            "Field": "Lot/code info",
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            "Status": "recorded"
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          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution.",
            "Status": "recorded"
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