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  "name": "Brand Name: DONJOY  Product Name: ICEMAN, W/COLDPAD, NS, RH  Model/Catalog Number: 11-9099  Software Version: No  Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH  The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology.  Component: No",
  "description": "FDA recall Z-2137-2026 — DJO, LLC is recalling Brand Name: DONJOY  Product Name: ICEMAN, W/COLDPAD, NS, RH  Model/Catalog Number: 11-9099  Software Version: No  Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH  The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology.  Component: No (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": "Brand Name: DONJOY  Product Name: ICEMAN, W/COLDPAD, NS, RH  Model/Catalog Number: 11-9099  Software Version: No  Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH  The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology.  Component: No",
    "manufacturer": {
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      "name": "FDA recall Z-2137-2026: DJO, LLC is recalling Brand Name: DONJOY  Product Name: ICEMAN, W/COLDPAD, NS, RH  Model/Catalog Number: 11-9099  Software Version: No  Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH  The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology.  Component: No",
      "text": "The FDA logged enforcement record Z-2137-2026: DJO, LLC is voluntarily recalling Brand Name: DONJOY  Product Name: ICEMAN, W/COLDPAD, NS, RH  Model/Catalog Number: 11-9099  Software Version: No  Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH  The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a variety of indications and protocols as directed by a medical professional. The IceMan CLASSIC3 utilizes DonJoy's recirculation technology.  Component: No — reason: Due to broken connector which may result in a temporary interruption of prescribed cold therapy.. Status: Ongoing — the recall is still being carried out.. Initiated 2026-03-19. Affected lots/codes: Model/Catalog Number: 11-9099 Lot Code: Lot: 110525 GTIN: 00888912000376. A RECORDED FDA enforcement action (occurred=true).",
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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-2137-2026&lang=eng",
        "value": "Devices recall, status Ongoing",
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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
      },
      "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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            "Value": "Ongoing — the recall is still being carried out.",
            "Status": "recorded"
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            "Status": "recorded"
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            "Field": "Reason",
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            "Value": "Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.",
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