Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-
Summary
The FDA issued a Class II for Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146- by CareFusion 303, Inc.. Reason: Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire..
Details
Source
Device Recall
External ID
Z-0367-2026
Action Date
2025-11-05
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 8,262 units
Reason for Recall
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-30
Company
San Diego, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 284 device recalls issued in the same week, part of 413 device-related FDA actions this month.
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (CareFusion 303, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does CareFusion 303, Inc. have FDA actions?
CareFusion 303, Inc. has 105 FDA actions in our database, including 103 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0367-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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