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  "name": "BD COR GX Instrument  Version or Model: 443990  Catalog Number: 443990",
  "description": "FDA recall Z-0589-2025 — Becton Dickinson & Co. is recalling BD COR GX Instrument  Version or Model: 443990  Catalog Number: 443990 (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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      "name": "FDA recall Z-0589-2025: Becton Dickinson & Co. is recalling BD COR GX Instrument  Version or Model: 443990  Catalog Number: 443990",
      "text": "The FDA logged enforcement record Z-0589-2025: Becton Dickinson & Co. is voluntarily recalling BD COR GX Instrument  Version or Model: 443990  Catalog Number: 443990 — reason: BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.. Status: Ongoing — the recall is still being carried out.. Initiated 2024-10-31. Affected lots/codes: Catalog No: 443990; UDI-DI: 00382904439903; Serial Numbers: CRG0023, CRG0041, CRG0115, CRG0040, CRG0106, CRG0110, CRG0112, CRG0109, CRG0047, CRG0120, CRG0039, CRG0113, CRG0035, CRG0037, CRG0036, VGT0009, CRG0020, CRG0002, VGX0004, CRG0007, CRG0008, CRG0104, CRG0018, CRG0019, CRG0045, CRG0029, CRG0028, CRG0030, CRG0201, CRG0203, CRG0021, CRG0004, CRG0005, CRG0006, CRG0009, CRG0010, CRG0012, CRG0011, CRG0013, CRG0014, CRG0025, CRG0015, CRG0016, CRG0017, CRG0026, CRG0027, CRG0107, CRG0101, CRG0105, CRG0108, CRG0114, CRG0116, CRG0117, CRG0119, CRG0118, CRG0034, CRG0044, CRG0001, CRG0003, CRG0032, CRG0038, CRG0043, CRG0042, CRG0102, CRG0111, CRG0048, CRG0103, CRG0121, CRG0204, CRG0207,. A RECORDED FDA enforcement action (occurred=true).",
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        "value": "Devices recall, status Ongoing",
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      "name": "FDA classified recall Z-0589-2025 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."
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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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        "adjudicator": null
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      "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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            "Status": "recorded"
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          "position": 9,
          "item": {
            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Benin, Bhutan, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Burkina Faso, Burundi, Cambodia, Cameroon, Canada, Chile, China, Colombia, Costa Rica, Cote d'Ivoire, Croatia, Cyprus, Czech Republic, Democratic Republic of the Congo, Denmark, DOM, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Faroe Islands, Fiji, Finland, France, French Guiana, Gambia, Georgia, Germany, Ghana, Greece, Guadeloupe, Guam, Guatemala, Guinea, Guyana, Haiti, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Laos, Latvia, Lebanon Liberia, Libyan Arab Jamahiriya, Liechtenstein, Lithuania, Luxembourg, Macau, Madagascar Malawi, Malaysia, Maldives, Mali, Malta, Martinique, Mauritania, Mauritius, Mayotte Mexico, MKD, Moldova, Mongolia, Morocco, Mozambique, Namibia, Nepal, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Nigeria, Northern Mariana Islands, Norway, Oman, Pakistan, Panama, Papua new Guinea, Paraguay, Peru, Philippines PNG, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russia, Rwanda, Saint Helena San Marino, Saudi Arabia, Senegal, Serbia, Seychelles, Sierra Leone, Singapore, Slovakia Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sudan, Swaziland, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tajikistan, Tanzania, United Republic of Thailand, Timor-Leste, Tonga, Trinidad And Tobago, Tunisia, Turkey, Turkmenistan Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay Uzbekistan, Vietnam, Yemen, Zambia, Zimbabwe.",
            "Status": "recorded"
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