Food, drugs, devices › CareFusion 303, Inc.
Device recall: Various models of BD Pyxis Medbank: Reference numbers: 1137-00 1145-00 1146-00 1147-00 1148-00 138902-01 138903-01 13890
CareFusion 303, Inc. (San Diego, CA) initiated this device recall on 30 Sep 2025; FDA lists 5 product records under event 97566, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. CareFusion 303, Inc. has 99 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
CareFusion 303, Inc., San Diego, CA.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0367-2026 | 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… | 8,262 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0368-2026 | Various models of BD Pyxis MedFlex, Reference numbers: 1119-00 1139-00 139038-01 139039-01 139040-01 139041-01 139043-01 139044-01 139045-01 139046-01 139049-01 139051-01 139052-01 139053-01 139054-01 139055-01 139056-01 139058-01 139059-01 139060-01 139061-01 139064-01 139065-01 139066-01 139067-01 139068-01… | 2,755 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0369-2026 | Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00 | 32 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0370-2026 | BD Pyxis Pro MedStation Main, REF: 1155-00 | 27 units | Class II | Ongoing | 5 Nov 2025 |
| Z-0371-2026 | All Serial Numbers/BD Pyxis CII Safe ES Tower Main, REF: 1116-00 | 443 units | Class II | Ongoing | 5 Nov 2025 |
Context
Other enforcement events for CareFusion 303, Inc.
All 99 events for CareFusion 303, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution - US Nationwide and the countries of Canada, United Arab Emirates, Australia."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.