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  "description": "FDA recall Z-0367-2026 — CareFusion 303, Inc. is recalling Various models of   BD Pyxis Medbank: Reference numbers: 1137-00  1145-00  1146-00  1147-00  1148-00  138902-01  138903-01  138905-01  138906-01  138907-01  138908-01  138909-01  138910-01  138911-01  138912-01  138913-01  138914-01  138915-01  138916-01  138917-01  138918-01  138919-01  138920-01  138921-01  138922-01  138923-01  138924-01  138926-01  138927-01  138928-01  138929-01  138930-01  138931-01  138932-01  138933-01  138934-01  138936-01  138937-01  138938-01  138939-01  138940-01  138941-01  138942-01  138943-01  138944-01  138945-01  138946-01  138947-01  138948-01  138949-01  138950-01  138951-01  138952-01  138953-01  138954-01  138955-01  138956-01  138957-01  138958-01  138959-01  138960-01  138961-01  138962-01  138963-01  138964-01  138965-01  138966-01  138967-01  138968-01  138969-01  138970-01  138971-01  138972-01  138973-01  138974-01  138975-01  138976-01  138977-01  138978-01  138989-01  138990-01  139000-01  139001-01  139002-01  139011-01  139013-01  139016-01  139018-01  139019-01  139020-01  139021-01  139022-01  139023-01  139028-01  139062-01  139063-01  139073-01  139082-01  139084-01  139085-01  139086-01  139091-01  139122-01  139125-01  139126-01  139127-01  139128-01  139131-01  139141-01  139142-01  139156-01  139163-01  139170-01  139171-01  139172-01  139174-01  139175-01  155081-01  155082-01  155083-01  155084-01  155085-01  155086-01  155087-01  155088-01  155089-01  155090-01  155091-01  155092-01  155093-01  155094-01  155095-01  155096-01  155097-01  155098-01  155099-01  155100-01  155101-01  155102-01  155103-01  155104-01  155105-01  155106-01  155107-01  155108-01  155109-01  155110-01  155111-01  155112-01  155113-01  155114-01  155115-01  155116-01  155117-01  155118-01  155119-01  155120-01  155121-01  155122-01  155123-01  155124-01  155125-01  155126-01  155127-01  155128-01  155129-01  155130-01  155131-01  155132-01  155133-01  155134-01  155135-01  155136-01  155137-01  155138-01  155139-01  155140-01  155141-01  155142-01  155143-01  155144-01  155145-01  155146-01  155147-01  155148-01  155149-01  155150-01  155151-01  155152-01  155153-01  155154-01  155155-01  155156-01  155157-01  155159-01  155160-01  155161-01  155163-01  155165-01  155166-01  155167-01  155168-01  155169-01  155171-01  155288-01  155293-01  155294-01  155299-01  155302-01  155303-01  155304-01  155305-01  155310-01  155311-01  169-03  169-04  169-05  169-06  169-07  169-08  169-09  169-10  169-100  169-101  169-102  169-103  169-104  169-105  169-106  169-107  169-108  169-109  169-11  169-110  169-111  169-112  169-113  169-114  169-115  169-12  169-120  169-124  169-125  169-127  169-128  169-129  169-13  169-131  169-132  169-137  169-138  169-139  169-14  169-140  169-141  169-142  169-143  169-144  169-145  169-15  169-150  169-151  169-152  169-155  169-156  169-159  169-16  169-160  169-161  169-162  169-163  169-164  169-18  169-19  169-20  169-21  169-22  169-23  169-24  169-25  169-26  169-27  169-28  169-29  169-30  169-31  169-32  169-33  169-34  169-35  169-36  169-37  169-38  169-39  169-40  169-41  169-42  169-43  169-44  169-45  169-46  169-47  169-48  169-49  169-50  169-51  169-52  169-53  169-54  169-55  169-56  169-57  169-58  169-59  169-60  169-61  169-62  169-63  169-64  169-65  169-66  169-67  169-68  169-69  169-70  169-71  169-72  169-73  169-74  169-75  169-76  169-77  169-78  169-79  169-80  169-81  169-82  169-83  169-84  169-85  169-86  169-87  169-88  169-89  169-90  169-91  169-92  169-93  169-94  169-95  169-96  169-97  169-98  169-99 (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:Claim",
      "name": "FDA recall Z-0367-2026: CareFusion 303, Inc. is recalling Various models of   BD Pyxis Medbank: Reference numbers: 1137-00  1145-00  1146-00  1147-00  1148-00  138902-01  138903-01  138905-01  138906-01  138907-01  138908-01  138909-01  138910-01  138911-01  138912-01  138913-01  138914-01  138915-01  138916-01  138917-01  138918-01  138919-01  138920-01  138921-01  138922-01  138923-01  138924-01  138926-01  138927-01  138928-01  138929-01  138930-01  138931-01  138932-01  138933-01  138934-01  138936-01  138937-01  138938-01  138939-01  138940-01  138941-01  138942-01  138943-01  138944-01  138945-01  138946-01  138947-01  138948-01  138949-01  138950-01  138951-01  138952-01  138953-01  138954-01  138955-01  138956-01  138957-01  138958-01  138959-01  138960-01  138961-01  138962-01  138963-01  138964-01  138965-01  138966-01  138967-01  138968-01  138969-01  138970-01  138971-01  138972-01  138973-01  138974-01  138975-01  138976-01  138977-01  138978-01  138989-01  138990-01  139000-01  139001-01  139002-01  139011-01  139013-01  139016-01  139018-01  139019-01  139020-01  139021-01  139022-01  139023-01  139028-01  139062-01  139063-01  139073-01  139082-01  139084-01  139085-01  139086-01  139091-01  139122-01  139125-01  139126-01  139127-01  139128-01  139131-01  139141-01  139142-01  139156-01  139163-01  139170-01  139171-01  139172-01  139174-01  139175-01  155081-01  155082-01  155083-01  155084-01  155085-01  155086-01  155087-01  155088-01  155089-01  155090-01  155091-01  155092-01  155093-01  155094-01  155095-01  155096-01  155097-01  155098-01  155099-01  155100-01  155101-01  155102-01  155103-01  155104-01  155105-01  155106-01  155107-01  155108-01  155109-01  155110-01  155111-01  155112-01  155113-01  155114-01  155115-01  155116-01  155117-01  155118-01  155119-01  155120-01  155121-01  155122-01  155123-01  155124-01  155125-01  155126-01  155127-01  155128-01  155129-01  155130-01  155131-01  155132-01  155133-01  155134-01  155135-01  155136-01  155137-01  155138-01  155139-01  155140-01  155141-01  155142-01  155143-01  155144-01  155145-01  155146-01  155147-01  155148-01  155149-01  155150-01  155151-01  155152-01  155153-01  155154-01  155155-01  155156-01  155157-01  155159-01  155160-01  155161-01  155163-01  155165-01  155166-01  155167-01  155168-01  155169-01  155171-01  155288-01  155293-01  155294-01  155299-01  155302-01  155303-01  155304-01  155305-01  155310-01  155311-01  169-03  169-04  169-05  169-06  169-07  169-08  169-09  169-10  169-100  169-101  169-102  169-103  169-104  169-105  169-106  169-107  169-108  169-109  169-11  169-110  169-111  169-112  169-113  169-114  169-115  169-12  169-120  169-124  169-125  169-127  169-128  169-129  169-13  169-131  169-132  169-137  169-138  169-139  169-14  169-140  169-141  169-142  169-143  169-144  169-145  169-15  169-150  169-151  169-152  169-155  169-156  169-159  169-16  169-160  169-161  169-162  169-163  169-164  169-18  169-19  169-20  169-21  169-22  169-23  169-24  169-25  169-26  169-27  169-28  169-29  169-30  169-31  169-32  169-33  169-34  169-35  169-36  169-37  169-38  169-39  169-40  169-41  169-42  169-43  169-44  169-45  169-46  169-47  169-48  169-49  169-50  169-51  169-52  169-53  169-54  169-55  169-56  169-57  169-58  169-59  169-60  169-61  169-62  169-63  169-64  169-65  169-66  169-67  169-68  169-69  169-70  169-71  169-72  169-73  169-74  169-75  169-76  169-77  169-78  169-79  169-80  169-81  169-82  169-83  169-84  169-85  169-86  169-87  169-88  169-89  169-90  169-91  169-92  169-93  169-94  169-95  169-96  169-97  169-98  169-99",
      "text": "The FDA logged enforcement record Z-0367-2026: CareFusion 303, Inc. is voluntarily recalling Various models of   BD Pyxis Medbank: Reference numbers: 1137-00  1145-00  1146-00  1147-00  1148-00  138902-01  138903-01  138905-01  138906-01  138907-01  138908-01  138909-01  138910-01  138911-01  138912-01  138913-01  138914-01  138915-01  138916-01  138917-01  138918-01  138919-01  138920-01  138921-01  138922-01  138923-01  138924-01  138926-01  138927-01  138928-01  138929-01  138930-01  138931-01  138932-01  138933-01  138934-01  138936-01  138937-01  138938-01  138939-01  138940-01  138941-01  138942-01  138943-01  138944-01  138945-01  138946-01  138947-01  138948-01  138949-01  138950-01  138951-01  138952-01  138953-01  138954-01  138955-01  138956-01  138957-01  138958-01  138959-01  138960-01  138961-01  138962-01  138963-01  138964-01  138965-01  138966-01  138967-01  138968-01  138969-01  138970-01  138971-01  138972-01  138973-01  138974-01  138975-01  138976-01  138977-01  138978-01  138989-01  138990-01  139000-01  139001-01  139002-01  139011-01  139013-01  139016-01  139018-01  139019-01  139020-01  139021-01  139022-01  139023-01  139028-01  139062-01  139063-01  139073-01  139082-01  139084-01  139085-01  139086-01  139091-01  139122-01  139125-01  139126-01  139127-01  139128-01  139131-01  139141-01  139142-01  139156-01  139163-01  139170-01  139171-01  139172-01  139174-01  139175-01  155081-01  155082-01  155083-01  155084-01  155085-01  155086-01  155087-01  155088-01  155089-01  155090-01  155091-01  155092-01  155093-01  155094-01  155095-01  155096-01  155097-01  155098-01  155099-01  155100-01  155101-01  155102-01  155103-01  155104-01  155105-01  155106-01  155107-01  155108-01  155109-01  155110-01  155111-01  155112-01  155113-01  155114-01  155115-01  155116-01  155117-01  155118-01  155119-01  155120-01  155121-01  155122-01  155123-01  155124-01  155125-01  155126-01  155127-01  155128-01  155129-01  155130-01  155131-01  155132-01  155133-01  155134-01  155135-01  155136-01  155137-01  155138-01  155139-01  155140-01  155141-01  155142-01  155143-01  155144-01  155145-01  155146-01  155147-01  155148-01  155149-01  155150-01  155151-01  155152-01  155153-01  155154-01  155155-01  155156-01  155157-01  155159-01  155160-01  155161-01  155163-01  155165-01  155166-01  155167-01  155168-01  155169-01  155171-01  155288-01  155293-01  155294-01  155299-01  155302-01  155303-01  155304-01  155305-01  155310-01  155311-01  169-03  169-04  169-05  169-06  169-07  169-08  169-09  169-10  169-100  169-101  169-102  169-103  169-104  169-105  169-106  169-107  169-108  169-109  169-11  169-110  169-111  169-112  169-113  169-114  169-115  169-12  169-120  169-124  169-125  169-127  169-128  169-129  169-13  169-131  169-132  169-137  169-138  169-139  169-14  169-140  169-141  169-142  169-143  169-144  169-145  169-15  169-150  169-151  169-152  169-155  169-156  169-159  169-16  169-160  169-161  169-162  169-163  169-164  169-18  169-19  169-20  169-21  169-22  169-23  169-24  169-25  169-26  169-27  169-28  169-29  169-30  169-31  169-32  169-33  169-34  169-35  169-36  169-37  169-38  169-39  169-40  169-41  169-42  169-43  169-44  169-45  169-46  169-47  169-48  169-49  169-50  169-51  169-52  169-53  169-54  169-55  169-56  169-57  169-58  169-59  169-60  169-61  169-62  169-63  169-64  169-65  169-66  169-67  169-68  169-69  169-70  169-71  169-72  169-73  169-74  169-75  169-76  169-77  169-78  169-79  169-80  169-81  169-82  169-83  169-84  169-85  169-86  169-87  169-88  169-89  169-90  169-91  169-92  169-93  169-94  169-95  169-96  169-97  169-98  169-99 — reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.. Status: Ongoing — the recall is still being carried out.. Initiated 2025-09-30. Affected lots/codes: All Serial Numbers/Ref #/UDI: 1137-00 N/A, 1145-00 10885403517167, 1146-00 10885403517174, 1147-00 10885403517181, 1148-00 10885403517198, 138902-01 N/A, 138903-01 N/A, 138905-01 N/A, 138906-01 N/A, 138907-01 N/A, 138908-01 N/A, 138909-01 N/A, 138910-01 N/A, 138911-01 N/A, 138912-01 N/A, 138913-01 N/A, 138914-01 N/A, 138915-01 N/A, 138916-01 N/A, 138917-01 N/A, 138918-01 N/A, 138919-01 N/A, 138920-01 N/A, 138921-01 N/A, 138922-01 N/A, 138923-01 N/A, 138924-01 N/A, 138926-01 N/A, 138927-01 N/A, 138928-01 N/A, 138929-01 N/A, 138930-01 N/A, 138931-01 N/A, 138932-01 N/A, 138933-01 N/A, 138934-01 N/A, 138936-01 N/A, 138937-01 N/A, 138938-01 N/A, 138939-01 N/A, 138940-01 N/A, 138941-01 N/A, 138942-01 N/A, 138943-01 N/A, 138944-01 N/A, 138945-01 N/A, 138946-01 N/A, 138947-01 N/A, 138948-01 N/A, 138949-01 N/A, 138950-01 N/A, 138951-01 N/A, 138952-01 N/A, 138953-01 N/A, 138954-01 N/A, 138955-01 N/A, 138956-01 N/A, 138957-01 N/A, 138958-01 N/A, 138959-01 N/A, 138960-01 N/A, 138961-01 N/A, 138962-01 N/A, 138963-01 N/A, 138964-01 N/A, 138965-01 N/A, 138966-01 N/A, 138967-01 N/A, 138968-01 N/A, 138969-01 N/A, 138970-01 N/A, 138971-01 N/A, 138972-01 N/A, 138973-01 N/A, 138974-01 N/A, 138975-01 N/A, 138976-01 N/A, 138977-01 N/A, 138978-01 N/A, 138989-01 N/A, 138990-01 N/A, 139000-01 N/A, 139001-01 N/A, 139002-01 N/A, 139011-01 N/A, 139013-01 N/A, 139016-01 N/A, 139018-01 N/A, 139019-01 N/A, 139020-01 N/A, 139021-01 N/A, 139022-01 N/A, 139023-01 N/A, 139028-01 N/A, 139062-01 N/A, 139063-01 N/A, 139073-01 N/A, 139082-01 N/A, 139084-01 N/A, 139085-01 N/A, 139086-01 N/A, 139091-01 N/A, 139122-01 N/A, 139125-01 N/A, 139126-01 N/A, 139127-01 N/A, 139128-01 N/A, 139131-01 N/A, 139141-01 N/A, 139142-01 N/A, 139156-01 N/A, 139163-01 N/A, 139170-01 N/A, 139171-01 N/A, 139172-01 N/A, 139174-01 N/A, 139175-01 N/A, 155081-01 10885403503870, 155082-01 10885403503887, 155083-01 10885403503894, 155084-01 10885403503900, 155085-01 10885403503917, 155086-01 10885403503726, 155087-01 10885403503733, 155088-01 10885403503740, 155089-01 10885403503757, 155090-01 10885403503764, 155091-01 10885403503771, 155092-01 10885403503788, 155093-01 10885403503795, 155094-01 10885403503801, 155095-01 10885403503818, 155096-01 10885403503696, 155097-01 10885403504198, 155098-01 10885403503702, 155099-01 10885403504204, 155100-01 10885403504211, 155101-01 10885403504228, 155102-01 10885403504235, 155103-01 10885403504242, 155104-01 10885403504259, 155105-01 10885403503719, 155106-01 10885403504266, 155107-01 10885403504273, 155108-01 10885403504280, 155109-01 10885403504327, 155110-01 10885403504297, 155111-01 10885403504303, 155112-01 10885403504099, 155113-01 10885403504105, 155114-01 10885403504112, 155115-01 10885403504129, 155116-01 10885403504136, 155117-01 10885403504143, 155118-01 10885403504150, 155119-01 10885403504334, 155120-01 10885403504167, 155121-01 10885403504174, 155122-01 10885403504181, 155123-01 10885403504082, 155124-01 10885403504075, 155125-01 10885403503658, 155126-01 10885403503665, 155127-01 10885403503672, 155128-01 10885403503689, 155129-01 10885403504341, 155130-01 10885403504358, 155131-01 10885403504365, 155132-01 10885403504372, 155133-01 10885403503542, 155134-01 10885403503559, 155135-01 10885403503566, 155136-01 10885403503573, 155137-01 10885403503597, 155138-01 10885403503603, 155139-01 10885403503610, 155140-01 10885403504440, 155141-01 10885403503580, 155142-01 10885403504457, 155143-01 10885403504464, 155144-01 10885403504471, 155145-01 10885403504488, 155146-01 10885403504754, 155147-01 10885403504761, 155148-01 10885403504778, 155149-01 10885403504785, 155150-01 10885403504792, 155151-01 10885403504709, 155152-01 10885403504716, 155153-01 10885403504723, 155154-01 10885403504730, 155155-01 10885403504747 155156-01 10885403504624, 155157-01 10885403504631, 155159-01 10885403504655, 155160-01 10885403504662, 155161-01 10885403504679, 155163-01 10885403504686, 155165-01 10885403504693, 155166-01 10885403504570, 155167-01 10885403504587, 155168-01 10885403504594, 155169-01 10885403504600, 155171-01 10885403504617, 155288-01 10885403508721, 155293-01 10885403509926, 155294-01 10885403509933, 155299-01 10885403510526, 155302-01 10885403510762, 155303-01 10885403510779, 155304-01 10885403510786, 155305-01 10885403510793, 155310-01 10885403510830, 155311-01 10885403510847, 169-03 10885403512575, 169-04 10885403512575, 169-05 10885403512575, 169-06 10885403512575, 169-07 10885403512575, 169-08 10885403512575, 169-09 10885403512575, 169-10 10885403512575, 169-100 10885403512568, 169-101 10885403512544, 169-102 10885403512544, 169-103 10885403512544, 169-104 10885403512544, 169-105 10885403512544, 169-106 10885403512544, 169-107 10885403512544, 169-108 10885403512544, 169-109 10885403512544, 169-11 10885403512575, 169-110 10885403512544, 169-111 10885403512544, 169-112 10885403512544, 169-113 10885403512544, 169-114 10885403512544, 169-115 10885403512544, 169-12 10885403512575, 169-120 10885403512551, 169-124 10885403512551, 169-125 10885403512551, 169-127 10885403512575, 169-128 10885403512575, 169-129 10885403512575, 169-13 10885403512575, 169-131 10885403512568, 169-132 10885403512568, 169-137 10885403512544, 169-138 10885403512568, 169-139 10885403512568, 169-14 10885403512575, 169-140 10885403512568, 169-141 10885403512575, 169-142 10885403512568, 169-143 10885403512568, 169-144 10885403512568, 169-145 10885403512568, 169-15 10885403512575, 169-150 10885403512544, 169-151 10885403512544, 169-152 10885403512544, 169-155 10885403512568, 169-156 10885403512568, 169-159 10885403512544, 169-16 10885403512575, 169-160 10885403512544, 169-161 10885403512544, 169-162 10885403512544, 169-163 10885403512544, 169-164 10885403512544, 169-18 10885403512575, 169-19 10885403512575, 169-20 10885403512575, 169-21 10885403512575, 169-22 10885403512575, 169-23 10885403512568, 169-24 10885403512568, 169-25 10885403512568, 169-26 10885403512568, 169-27 10885403512568, 169-28 10885403512568, 169-29 10885403512568, 169-30 10885403512568, 169-31 10885403512568, 169-32 10885403512568, 169-33 10885403512568, 169-34 10885403512568, 169-35 10885403512568, 169-36 10885403512568, 169-37 10885403512568, 169-38 10885403512568, 169-39 10885403512568, 169-40 10885403512568, 169-41 10885403512568, 169-42 10885403512568, 169-43 10885403512568, 169-44 10885403512568, 169-45 10885403512568, 169-46 10885403512568, 169-47 10885403512568, 169-48 10885403512568, 169-49 10885403512568, 169-50 10885403512568, 169-51 10885403512568, 169-52 10885403512568, 169-53 10885403512568, 169-54 10885403512568, 169-55 10885403512568, 169-56 10885403512568 169-57 10885403512568, 169-58 10885403512568, 169-59 10885403512568, 169-60 10885403512568, 169-61 10885403512568, 169-62 10885403512568, 169-63 10885403512568, 169-64 10885403512568, 169-65 10885403512568 169-66 10885403512568, 169-67 10885403512568, 169-68 10885403512568, 169-69 10885403512568, 169-70 10885403512568, 169-71 10885403512568, 169-72 10885403512568, 169-73 10885403512568, 169-74 10885403512568, 169-75 10885403512568, 169-76 10885403512568, 169-77 10885403512568, 169-78 10885403512568, 169-79 10885403512568, 169-80 10885403512568, 169-81 10885403512568, 169-82 10885403512568, 169-83 10885403512568, 169-84 10885403512568, 169-85 10885403512568, 169-86 10885403512568, 169-87 10885403512568, 169-88 10885403512568, 169-89 10885403512568, 169-90 10885403512568, 169-91 10885403512568, 169-92 10885403512568, 169-93 10885403512568, 169-94 10885403512568, 169-95 10885403512568, 169-96 10885403512568, 169-97 10885403512568, 169-98 10885403512568, 169-99 10885403512568. A RECORDED FDA enforcement action (occurred=true).",
      "claimType": "official_fact",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": true,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "SourceCitation",
        "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-0367-2026&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-0367-2026&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."
    },
    {
      "@id": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/Z-0367-2026/fda-classification",
      "@type": "schema:Claim",
      "name": "FDA classified recall Z-0367-2026 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.",
      "claimType": "regulatory_determination",
      "reviewStatus": "current",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": true,
        "operative": true
      },
      "grounding": {
        "groundingType": "AdjudicativeAct",
        "source": "U.S. FDA recall classification (openFDA enforcement)",
        "sourceUrl": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0367-2026&lang=eng",
        "value": "Class II",
        "adjudicator": {
          "name": "U.S. FDA recall classification (openFDA enforcement)",
          "url": "https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-0367-2026&lang=eng"
        }
      },
      "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-0367-2026/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",
      "commercialInfluence": false,
      "epistemicStatus": {
        "occurred": false,
        "supported": true,
        "adjudged": false,
        "operative": true
      },
      "grounding": {
        "groundingType": "Interpretation",
        "source": "Atlas Commons L5 boundary (enforcement-action ≠ harm causation)",
        "sourceUrl": "https://drug-device-safety-atlas.ryanjhunter.workers.dev/",
        "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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