PyxisRecalls & reported problems across all models
Carefusion 303, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
16 open recalls name at least one Pyxis model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7,862
- Deaths reported
- 1
- Injuries reported
- 13
- Recalls
- 16
We found 5 models of Pyxis by Carefusion 303, Inc. in the FDA's device registry (GUDID). Together they are named in 7,862 adverse event reports in the FDA's MAUDE database, received between Nov 5, 2018 and Sep 30, 2026 — classified as 1 death, 13 injuries, 7,843 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (1,031 reports).
16 FDA recall records name at least one of these models by its device identifier, 16 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Pyxis recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Apr 30, 2026Open, Classified
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Z-2300-2026 · Root cause: Component design/selection · Recall details · FDA record ↗
- Apr 30, 2026Open, Classified
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Z-2299-2026 · Root cause: Component design/selection · Recall details · FDA record ↗
- Apr 30, 2026Open, Classified
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Z-2297-2026 · Root cause: Component design/selection · Recall details · FDA record ↗
- May 8, 2025Open, Classified
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the dispensing software application, which may lead to delay in access to medications/supplies, and delivery/replenishment of patient specific orders; which may lead to delay in patient care.
Z-2017-2025 · Root cause: Software Design Change · names 2 of these models · Recall details · FDA record ↗
- May 8, 2025Open, Classified
Antivirus software was not consistently installed on impacted devices during the implementation process.
Z-2477-2025 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- Feb 6, 2025Open, Classified
Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.
Z-1375-2025 · Root cause: Software design · Recall details · FDA record ↗
- Jan 8, 2025Open, Classified
Labeling is insufficient regarding delays in access to medication. The firm is strengthening the label as an additional risk mitigation.
Z-1120-2025 · Root cause: Labeling design · names 3 of these models · Recall details · FDA record ↗
- Jan 8, 2025Open, Classified
Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues
Z-1119-2025 · Root cause: Software design · Recall details · FDA record ↗
- May 2, 2024Open, Classified
If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.
Z-2374-2024 · Root cause: Software change control · Recall details · FDA record ↗
- Apr 15, 2024Open, Classified
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Z-1932-2024 · Root cause: Component design/selection · Recall details · FDA record ↗
- Apr 15, 2024Open, Classified
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Z-1928-2024 · Root cause: Component design/selection · Recall details · FDA record ↗
- Feb 23, 2024Open, Classified
Retroactive-Due to increase in complaints, their is a potential for drawer and/or door failures of the medication cabinet which could result in delay in accessing medications.
Z-1125-2025 · Root cause: Device Design · Recall details · FDA record ↗
- Feb 1, 2024Open, Classified
Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss.
Z-1223-2024 · Root cause: Software design · Recall details · FDA record ↗
- Apr 5, 2023Open, Classified
Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload processing error. Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect dose amount, or discontinued medication.
Z-1579-2023 · Root cause: Software Design Change · Recall details · FDA record ↗
- Feb 14, 2023Open, Classified
Drawer and/or door failures that may lead to a delay in access to medications. The following three situations in which drawer and/or door failures may occur have been identified: Situation 1: Door Latch Failure, Situation 2: Cable Ribbon Damage, Situation 3: Magnet Falling Out,
Z-0973-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Feb 14, 2023Open, Classified
Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likelihood of patients experiencing delays in receiving medications.
Z-1207-2023 · Root cause: Software change control · Recall details · FDA record ↗
Most reported Pyxis problems
Device problems
- Computer Software Problem1,031
- Application Program Problem997
- Electrical /Electronic Property Problem956
- Mechanical Problem774
- Circuit Failure545
- Installation-Related Problem534
- Loose or Intermittent Connection495
- Application Network Problem425
Patient problems
- No Clinical Signs, Symptoms or Conditions7,831
- Insufficient Information108
- Hemorrhage/Blood Loss/Bleeding4
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Discomfort2
- Low Blood Pressure/ Hypotension2
- Anxiety1
Pyxis models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pyxis 327Cabinet, table and tray, anesthesia1 death4,304 reports
- Pyxis 327CABINET, TABLE AND TRAY, ANESTHESIA10 recalls3,137 reports
- Pyxis 303CABINET, TABLE AND TRAY, ANESTHESIA7 recalls392 reports
- Pyxis 338CABINET, TABLE AND TRAY, ANESTHESIA3 recalls24 reports
- Pyxis TRANSFUSIONSOFTWARE, BLOOD BANK, STAND ALONE PRODUCTS5 reports
Recent Pyxis adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946185 ↗MalfunctionSep 30, 2026Electrical /Electronic Property Problem
It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the Bio ID device displayed a "Maintenance Required" message.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946175 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection
It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the drawer 2.1 was failed to open. Customer tried to recover but issue did not resolve. The customer stated that the malfunction occurred when a user tried to issue medication to the patient and caused a delay to patient care. However, there were no adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945877 ↗MalfunctionSep 30, 2026Insufficient Device Problem Information
It was reported that when using the BD Pyxis¿ Anesthesia Station ES, draw 2.1 locked did not open and unable to recover. The customer stated that the malfunction occurred when a user tried to issue medication to the patient and caused a delay to patient care. However, there were no adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945876 ↗MalfunctionSep 30, 2026Circuit Failure; Installation-Related Problem
It was reported that when using the BD Pyxis¿ Anesthesia Station ES received the error message "The network interface with name PYIET was not found". User had reinstalled the associated file twice as part of troubleshooting; however, the device continued to fail communication and remained offline.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945869 ↗MalfunctionSep 30, 2026Loose or Intermittent Connection; Application Program Problem
It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the station screen went black, and the cabinet was reported as RSS offline.There were no delay or adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944979 ↗MalfunctionSep 30, 2026Circuit Failure; Electrical /Electronic Property Problem
It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the device displayed a black screen. The customer rebooted the device, but the issue was not resolved.There were no adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944976 ↗MalfunctionSep 30, 2026Break
It was reported that when using the BD Pyxis¿ Anesthesia Station ES device was not communicating with the system. The user verified the non-communication issue on the Pyxis device and indicated that it was not related to the data port.The customer stated that this malfunction occurred while dispensing the medication and they were unable to access the medication, which caused a delay to the patient care. There were no adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944973 ↗MalfunctionSep 30, 2026Application Program Problem
It was reported that when using the BD Pyxis¿ Anesthesia Station ES users were unable to log in to the AWS. A system reset was required to restore functionality and allow user access. The customer reported that this issue had been occurring frequently, resulting in repeated login failures and requiring multiple resets to regain access.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944937 ↗MalfunctionSep 30, 2026Circuit Failure
It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the cubie tray had failed to open. The customer stated that this malfunction occurred while dispensing medication to patients and caused delay in patient care. However, there were no adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944935 ↗MalfunctionSep 30, 2026No Apparent Adverse Event
It was reported that when using the BD Pyxis¿ Anesthesia Station ES, station was not communicating.The customer stated that there was a delay in patient care.There were no adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944934 ↗MalfunctionSep 30, 2026Labelling, Instructions for Use or Training Problem
It was reported that when using the BD Pyxis¿ Anesthesia Station ES, station stock out was not populated on carousel for MedID (b)(6). The customer stated that this malfunction caused a delay in dispensing medication to patients. However, there were no adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944927 ↗MalfunctionSep 30, 2026Misassembled
It was reported that when using the BD Pyxis¿ Anesthesia Station ES, the drawer was reported to be repeatedly failing. Attempts to recover the drawer using the Recover Storage Space function were unsuccessful, and the system displayed a Requires Maintenance message. The only successful method of recovery was manually unlocking the drawer with keys and accessing it from the rear of the unit. Additionally, the affected accessible drawer remained locked even during a procedure, preventing normal operation.The customer stated that this malfunction occurred while dispensing the medication.There were no adverse events or injuries reported due to this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944374 ↗MalfunctionSep 30, 2026Mechanical Jam
It was reported that when using the BD Pyxis¿ Anesthesia Station ES system drawer maps did not populate consistently, preventing the decrementing function from being performed. However, there were no delay and adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944197 ↗MalfunctionSep 30, 2026Insufficient Device Problem Information
It was reported that when using the BD Pyxis¿ Anesthesia Station ES, count was not reflecting correct amount.There were no adverse events or injuries reported based on this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50943540 ↗
Other Carefusion 303, Inc. products
- BD Alaris Infusion System29 models · 1,242,913 reports · 16 recalls
- Alaris25 models · 1,236,345 reports · 16 recalls
- BD Pyxis26 models · 81,193 reports · 66 recalls
- BD Alaris PCU Model 80153 models · 4,071 reports · 2 recalls
- BD Alaris Syringe Module, Model 81102 models · 3,183 reports · 2 recalls
- BD Alaris PCU Module, Model 80152 models · 3,078 reports · 3 recalls
- Alaris PCA Module, Model 81202 models · 918 reports · 2 recalls
- BD Alaris ETCO2 Module, Model 83002 models · 956 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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