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  "name": "Pediatric care bed;  Product Designation: KayserBett IDA;",
  "description": "FDA recall Z-2212-2026 — KAYSERBETTEN GMBH & CO. KG is recalling Pediatric care bed;  Product Designation: KayserBett IDA; (Devices, Class I). 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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      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-2212-2026/enforcement-record",
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      "name": "FDA recall Z-2212-2026: KAYSERBETTEN GMBH & CO. KG is recalling Pediatric care bed;  Product Designation: KayserBett IDA;",
      "text": "The FDA logged enforcement record Z-2212-2026: KAYSERBETTEN GMBH & CO. KG is voluntarily recalling Pediatric care bed;  Product Designation: KayserBett IDA; — reason: If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that the patient (child) or third parties (children) will operate the hand control and trap themselves or others under the bed frame or between the bed frame and the floor. This can lead to serious injuries or even death of the patient (child) or third parties (children).. Status: Ongoing — the recall is still being carried out.. Initiated 2026-05-04. Affected lots/codes: Product Designation: KayserBett IDA; UDI-DI: 426038961IDAGU; Serial Number: 386, 387, 388, 389, 390, 391, 392, 635, 636, 637, 638, 639, 641, 642, 643, 644, 645, 646, 647, 1072, 1073, 1074, 1075, 1076, 1077, 1078, 1079, 1080, 1081, 1082, 1083, 1085, 1086, 1087, 1088, 1089, 1090, 1110, 1111, 1446, 1447, 1448, 1449, 1648, 1649, 1950, 1975, 1976, 1982, 1983, 1998, 2001, 2003, 2004, 2337, 2338, 2339, 2340, 2341, 2342, 2343, 2344, 2345, 2396, 2763, 2764, 2765, 2766, 2767, 2770, 2771, 2772, 2773, 2774, 3087, 3088, 3089, 3090, 3091, 3092, 3167, 3299, 3300, 3301, 3302, 3303, 3304, 3305, 3306, 3309, 3310, 3311, 3312, 3313, 3314, 3740, 3741, 3760, 4223, 4232, 4233, 4234, 4235, 4236, 4237, 4239, 4240, 4242, 4243, 4244, 4245, 4246, 4247, 4248, 4249, 4250, 4567, 4568, 4569, 4570, 4571, 4572, 4573, 4574, 4575, 4576, 4577, 4578, 4579, 4580, 4581, 4582, 4583, 4584, 4986, 5238, 5254, 5255, 5256, 5257, 5258, 5259, 5637, 5919, 5920, 5921, 5922, 5923, 5924, 5925, 5926, 5937, 5938, 5939, 5940, 5948, 6332, 6338, 6339, 6340, 6341, 6342, 6343, 6344, 6345, 6346, 6347, 6351, 6355, 6795, 6796, 7176, 7177, 7178, 7179, 7180, 7181, 7182, 7183, 7184, 7185, 7186, 7187, 7188, 7189, 7190, 7191, 7192, 7193, 7194, 7195, 7617, 7618, 7619, 7620, 7621, 7622, 7623, 8242, 8243, 8244, 8245, 8588, 8589, 8590, 8591, 8592, 8593, 8594, 8595, 8596, 8597, 8598, 8599, 8600, 8601, 8602, 8603, 8608, 8609, 8691, 8704, 8912, 8921, 8922, 8923, 8924, 8925, 8926, 8927, 8928, 8929, 8930, 9725, 9726, 9727, 10350, 10351, 10352, 10819, 10820, 10821, 10822, 10823, 10824, 10825, 11186, 11367, 11368, 11369, 11370, 11371, 11372, 11797, 11798, 11799, 11800, 11801, 11802, 11803, 11804, 11805, 11806, 11807, 11808, 12247, 12248, 12249, 12250, 12251, 12252, 12253, 12254, 12255, 12256, 12257, 12397, 12398, 12399, 12782, 12783, 12963, 12964, 12965, 12966, 12967, 12968, 12969, 12970, 12971, 12972, 13486, 13487, 13488, 13489, 13490, 13491, 13492, 13493, 13494, 13495, 13496, 13497, 13912, 13913, 13914, 13915, 13916, 13917, 13918, 14942, 14944, 14952, 14953, 15912, 15913, 15914, 16403, 16404, 16405, 16406, 16407, 16408, 16409, 16410, 16411, 16984, 16985, 16986, 16987, 16988, 16989, 16990, 16991, 16992, 16993, 16994, 17577, 17578, 17579, 17580, 17581, 17582, 17583, 17584, 17585, 17586, 17587, 18494, 19112, 19113, 19114, 20151, 20152, 20153, 20154, 20155, 20156, 20157, 20158, 20963, 20964, 20965, 20966, 20967, 20968, 20969, 20970, 20972, 21192, 21193, 21194;. A RECORDED FDA enforcement action (occurred=true).",
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      "name": "FDA classified recall Z-2212-2026 as Class I",
      "text": "The FDA assigned this recall Class I: Class I — the FDA judged there is a reasonable probability that use of the product would cause serious harm or death.. 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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      "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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