CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report
Various models of BD Pyxis Medbank: Reference numbers recalled
CareFusion 303 is recalling Various models of BD Pyxis Medbank: Reference numbers: 1137-00, distributed nationwide in the US. The recall was initiated on 30 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0367-2026
- FDA event ID
- 97566
- Recalling firm
- CareFusion 303, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Sep 2025
- FDA classified
- 27 Oct 2025
- Reported
- 5 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Sep 2025 | Recall initiated by company | |
| 27 Oct 2025 | Classified by FDA | +27 days |
| 5 Nov 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Product as listed by the FDA
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
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
Questions about this recall
Why was it recalled?
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Which lots are affected?
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
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 97566This product is part of a recall event; the main page for the event is BD Pyxis Pro MedStation Main recalled by CareFusion 303.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | BD Pyxis Pro MedStation Main recalled by CareFusion 303 | CareFusion 303 | Other | Nationwide | |
| CLASS II | Various models of BD Pyxis MedFlex, Reference numbers recalled | CareFusion 303 | Other | Nationwide | |
| CLASS II | Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers recalled | CareFusion 303 | Other | Nationwide | |
| CLASS II | All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF recalled | CareFusion 303 | Other | Nationwide |
More recalls from CareFusion 303
All 143| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | BD Pyxis MedStation ES Tower recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis MedBank Mini recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis MedStation recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis Anesthesia Station ES recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
| Device | CLASS II | BD Pyxis MedStation ES recalled by CareFusion 303 | CareFusion 303 | Temperature Abuse | Nationwide |
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