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U.S. Department of Health and Human Services

Class 2 Device Recall BD Pyxis Medbank

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 Class 2 Device Recall BD Pyxis Medbanksee related information
Date Initiated by FirmSeptember 30, 2025
Date PostedOctober 27, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0367-2026
Recall Event ID 97566
Product Classification Cabinet, table and tray, anesthesia - Product Code BRY
ProductVarious 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
Code Information 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
Recalling Firm/
Manufacturer		 CareFusion 303, Inc.
10020 Pacific Mesa Blvd
San Diego CA 92121-4386
For Additional Information ContactBD Technical Support
1800-727-6102
Manufacturer Reason
for Recall		Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn September 30, 2025, BD issue a Urgent Medical Device Recall Expansion notification to affected consignees via FedEx. BD is asking consignees to take the following actions: 1. Affected products can continue to be used per existing Manuals and Guides. 2. In the event of an accidental fluid spill on the device or in a drawer, users should following instructions outlined within the customer notification. 3. Review the customer letter attachment which provides warnings, cautions and recommendations regarding fluid ingress. 4. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material.
Quantity in Commerce8,262 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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