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  "name": "Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes:  a) 12241, b) 12243, c) 12251",
  "description": "FDA recall Z-1406-2023 — Avanos Medical, Inc. is recalling Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes:  a) 12241, b) 12243, c) 12251 (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": "Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes:  a) 12241, b) 12243, c) 12251",
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      "name": "Avanos Medical, Inc."
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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1406-2023/enforcement-record",
      "@type": "schema:Claim",
      "name": "FDA recall Z-1406-2023: Avanos Medical, Inc. is recalling Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes:  a) 12241, b) 12243, c) 12251",
      "text": "The FDA logged enforcement record Z-1406-2023: Avanos Medical, Inc. is voluntarily recalling Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes:  a) 12241, b) 12243, c) 12251 — reason: Incorrect expiration date.. Status: Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.. Initiated 2023-02-03. Affected lots/codes: a) 12241, Lot Numbers:  20067528, 20069614, 20077132, 20079287, 20079286, 20079285, 20079284, 20079283, 20079282, 20082126, 20082118, 20082119, 20082120, 20082121, 20082122, 20086314;  b) 12243, Lot Numbers:  20050262, 20050263, 20050261, 20050264, 20050265, 20058683, 20058689, 20061145, 20061947, 20061946, 20062596, 20062597, 20063681, 20063682, 20064346, 20064347, 20064363, 20064364, 20064656, 20064657, 20065662, 20065663, 20065667, 20065668, 20067519, 20067520, 20067478, 20069597, 20069598, 20069601, 20072177, 20072184, 20072181, 20072182, 20072183, 20072189, 20075102, 20075104, 20077212, 20075105, 20077328, 20077391, 20077403, 20077407, 20079296, 20079297, 20079312, 20079313, 20079260, 20079261, 20079299, 20079300, 20079301, 20079315, 20084389, 20084390, 20082130, 20082175, 20082176, 20082177, 20086318, 20086319, 20082179, 20086271, 20086272, 20088628, 20088600, 20089012, 20089015, 20090190, 20090206, 20090191;  c) 12251, Lot Numbers:  20054925, 20054926, 20056744, 20056745, 20057662, 20057664, 20057663, 20057665, 20058694, 20058695, 20058696, 20058697, 20061147, 20061148, 20061149, 20061951, 20061952, 20061953, 20062605, 20062608, 20062609, 20063691, 20063692, 20063693, 20064348, 20064349, 20064350, 20065664, 20065665, 20065666, 20067479, 20067501, 20067502, 20067500, 20067503, 20067504, 20069599, 20069602, 20069603, 20069600, 20069604, 20069605, 20072178, 20072188, 20072190, 20072179, 20072191, 20072180, 20072187, 20075101, 20075097, 20075098, 20075099, 20075100, 20075085, 20075086, 20075087, 20075088, 20076648, 20075089, 20075090, 20075094, 20077330, 20075095, 20077384, 20077383, 20077385, 20077375, 20077376, 20077397, 20077377, 20077378, 20077398, 20077379, 20077380, 20077381, 20077382, 20079226, 20079227, 20079228, 20079229, 20079243, 20079250, 20079252, 20079253, 20079255, 20079256, 20079235, 20079236, 20079237, 20079239, 20079240, 20079241, 20079242, 20082076, 20082077, 20082078, 20082079, 20082080, 20082082, 20082083, 20082084, 20082086, 20082087, 20082090, 20082091, 20082092, 20082103, 20082093, 20082094, 20082095, 20082073, 20082074, 20082075, 20082098, 20082070, 20082071, 20082072, 20086306, 20086309, 20086310, 20086305, 20086307, 20086308, 20086275, 20086276, 20086277, 20086278, 20086279, 20086300, 20086301, 20086302, 20086303, 20086304, 20088253, 20088256, 20088254, 20088257, 20088258, 20088259, 20088260, 20088261, 20088255, 20088262, 20088263, 20088264, 20088265, 20088266, 20088619, 20088620, 20088621, 20088622, 20088623, 20089019, 20089080, 20089081, 20089082. A RECORDED FDA enforcement action (occurred=true).",
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        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-1406-2023&lang=eng",
        "value": "Devices recall, status Terminated",
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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-1406-2023/fda-classification",
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      "name": "FDA classified recall Z-1406-2023 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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      "reviewStatus": "current",
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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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-1406-2023/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",
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      "epistemicStatus": {
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        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
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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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          "item": {
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            "Value": "Incorrect expiration date.",
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            "Value": "a) 12241, Lot Numbers:  20067528, 20069614, 20077132, 20079287, 20079286, 20079285, 20079284, 20079283, 20079282, 20082126, 20082118, 20082119, 20082120, 20082121, 20082122, 20086314;  b) 12243, Lot Numbers:  20050262, 20050263, 20050261, 20050264, 20050265, 20058683, 20058689, 20061145, 20061947, 20061946, 20062596, 20062597, 20063681, 20063682, 20064346, 20064347, 20064363, 20064364, 20064656, 20064657, 20065662, 20065663, 20065667, 20065668, 20067519, 20067520, 20067478, 20069597, 20069598, 20069601, 20072177, 20072184, 20072181, 20072182, 20072183, 20072189, 20075102, 20075104, 20077212, 20075105, 20077328, 20077391, 20077403, 20077407, 20079296, 20079297, 20079312, 20079313, 20079260, 20079261, 20079299, 20079300, 20079301, 20079315, 20084389, 20084390, 20082130, 20082175, 20082176, 20082177, 20086318, 20086319, 20082179, 20086271, 20086272, 20088628, 20088600, 20089012, 20089015, 20090190, 20090206, 20090191;  c) 12251, Lot Numbers:  20054925, 20054926, 20056744, 20056745, 20057662, 20057664, 20057663, 20057665, 20058694, 20058695, 20058696, 20058697, 20061147, 20061148, 20061149, 20061951, 20061952, 20061953, 20062605, 20062608, 20062609, 20063691, 20063692, 20063693, 20064348, 20064349, 20064350, 20065664, 20065665, 20065666, 20067479, 20067501, 20067502, 20067500, 20067503, 20067504, 20069599, 20069602, 20069603, 20069600, 20069604, 20069605, 20072178, 20072188, 20072190, 20072179, 20072191, 20072180, 20072187, 20075101, 20075097, 20075098, 20075099, 20075100, 20075085, 20075086, 20075087, 20075088, 20076648, 20075089, 20075090, 20075094, 20077330, 20075095, 20077384, 20077383, 20077385, 20077375, 20077376, 20077397, 20077377, 20077378, 20077398, 20077379, 20077380, 20077381, 20077382, 20079226, 20079227, 20079228, 20079229, 20079243, 20079250, 20079252, 20079253, 20079255, 20079256, 20079235, 20079236, 20079237, 20079239, 20079240, 20079241, 20079242, 20082076, 20082077, 20082078, 20082079, 20082080, 20082082, 20082083, 20082084, 20082086, 20082087, 20082090, 20082091, 20082092, 20082103, 20082093, 20082094, 20082095, 20082073, 20082074, 20082075, 20082098, 20082070, 20082071, 20082072, 20086306, 20086309, 20086310, 20086305, 20086307, 20086308, 20086275, 20086276, 20086277, 20086278, 20086279, 20086300, 20086301, 20086302, 20086303, 20086304, 20088253, 20088256, 20088254, 20088257, 20088258, 20088259, 20088260, 20088261, 20088255, 20088262, 20088263, 20088264, 20088265, 20088266, 20088619, 20088620, 20088621, 20088622, 20088623, 20089019, 20089080, 20089081, 20089082",
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            "Field": "Distribution pattern",
            "Value": "Worldwide distribution - US Nationwide and the countries of Canada, Germany, Netherlands, France, Switzerland, Great Britain, Israel, and India.",
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