BD Pyxis 352Recalls & reported problems

Summary

The FDA's MAUDE database contains 898 adverse event reports that list this exact device (DI 10885403512674), received between Sep 15, 2022 and Sep 30, 2026 — classified as 898 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (125 reports).

12 FDA recall records name this device's identifier, 12 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 30, 2026Open, Classified

   Fingerprint scanner may overheat to a temperature to cause 1st degree burn.

   Z-2302-2026 · Root cause: Component design/selection · FDA record ↗

2. Nov 20, 2025Open, Classified

   Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to generate a duplicate address, which causes an error and the drawer to fail, which may lead to inability or delay in accessing stored items, delay in the replenishment of ADCs or patient specific medications stored outside of ADCs.

   Z-0962-2026 · Root cause: Device Design · FDA record ↗

3. 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 · FDA record ↗

4. 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 · FDA record ↗

5. 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 · FDA record ↗

6. 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 · FDA record ↗

7. 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 · FDA record ↗

8. 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 · FDA record ↗

9. 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 · FDA record ↗

10. Apr 5, 2023Open, Classified

    Due to an automated dispensing cabinet software issue, when a medication single order contains more than one component and at least one is unavailable for a multi-item or combination order, the order may display as grayed out; alternate location tooltip will display "Server connection failed," not listing other area devices where unavailable item(s) may be found, which may lead to delayed therapy.

    Z-0906-2025 · Root cause: Software design · FDA record ↗

11. 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 · FDA record ↗

12. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 898 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Circuit Failure; Loose or Intermittent Connection

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower drawer 1.1 was not detected on bus.The customer stated that this malfunction occurred while dispensing the medication.There were no adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50944944 ↗
• MalfunctionSep 29, 2026Installation-Related Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower was approximately 10 minutes behind the correct time, causing orders to not cross over in a timely manner.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 50930689 ↗
• MalfunctionSep 29, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930685 ↗
• MalfunctionSep 28, 2026Application Program Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower device with upload stopped.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 50916251 ↗
• MalfunctionSep 28, 2026Break; Loose or Intermittent Connection; Application Program Problem; Installation-Related Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower device was in disconnect mode and on critical override. 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 50914043 ↗
• MalfunctionSep 28, 2026Installation-Related Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50914017 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower, biometric identification (Bio-ID) was failed. However, there were no delay to patient care and adverse events or injuries reported based on this incident.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50913771 ↗
• MalfunctionSep 28, 2026Application Program Freezes or Fails to Launch

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower, the system had a medical device correction issue. 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 50913267 ↗
• MalfunctionSep 28, 2026Mechanical Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower an entire drawer had failed. 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 50912623 ↗
• MalfunctionSep 25, 2026Electrical /Electronic Property Problem; Loose or Intermittent Connection

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower system biometric identifier required maintenance. The customer reported that the biometric identifier (Bio-ID) was not functioning and that there was no light illuminated on the Bio-ID scanner. Users were unable to use the Bio-ID to log in to the station and were required to use alternative authentication methods. The station displayed the error message "Bio-ID Requires Maintenance." 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 50895094 ↗
• MalfunctionSep 25, 2026Contamination

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower, the biometric identifier failed.As per part investigation, it was determined that the fluid ingress observed during visual inspection.There were no adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50893200 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower, station was not powering on at all. The customer reported that a malfunction took place when the user tried to dispense medication to the patient. However, there were no delays or adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883628 ↗
• MalfunctionSep 24, 2026Mechanical Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower door had failed. The customer stated that this malfunction occurred while dispensing the medication. There were no adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881111 ↗
• MalfunctionSep 23, 2026Unintended Application Program Shut Down

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower, the station repeatedly reverted to a frozen blue CareFusion screen.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 50867870 ↗
• MalfunctionSep 23, 2026Electrical /Electronic Property Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower had biometric identifier failure and not allowing user to login. The customer reported login issue was deemed as reportable event. However, there were no delay to patient care and adverse events or injuries reported based on this incident.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865833 ↗
• MalfunctionSep 23, 2026Communication or Transmission Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower device was failed to communicate. The customer stated that this malfunction caused a delay in dispensing medication to patients, but the user was able to get the medications from another station. However, there were no adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865830 ↗
• MalfunctionSep 23, 2026Application Network Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower, Registered Nurse reported an inability to remove the medication after the scheduled stop date/time. The order was missing from the Due Now and All Orders windows after it was modified to add a stop date. The order remained visible in the server's Orders tab.The customer reported 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 50865825 ↗
• MalfunctionSep 23, 2026Application Program Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower the device was stuck on update screen. However, there were no delay or adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50865812 ↗
• MalfunctionSep 23, 2026Break; Electrical /Electronic Property Problem; Loose or Intermittent Connection; Application Program Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower, the station was offline in Remote Support Service (RSS), and the device was unavailable for use. The customer reported that the main screen was black and displayed only a password box.The customer stated that this malfunction occurred while dispensing the medication and they were unable to access/issue 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 50865801 ↗
• MalfunctionSep 21, 2026Application Program Freezes or Fails to Launch

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower, the user was unable to login and failed to pull medication.The customer stated that this malfunction caused a delay in dispensing medication to patients.There were no adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50839364 ↗
• MalfunctionSep 21, 2026Circuit Failure

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower, Cathlab2 drawer was failed and device not on the bus. 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 50836501 ↗
• MalfunctionSep 21, 2026Application Program Problem; Installation-Related Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower, station was stuck on a fatal error. The customer tried to reboot, but the issue persisted. The customer stated that there was a 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 50835248 ↗
• MalfunctionSep 18, 2026Installation-Related Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower, delayed in orders crossing over and order was not there due to the pyxis time being about 10 minutes behind. The customer stated that the malfunction occurred when a user tried to pull 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 50819840 ↗
• MalfunctionSep 17, 2026Application Program Freezes or Fails to Launch

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower screen was frozen and stuck on blue screen.However, there were no delays, adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50802836 ↗
• MalfunctionSep 17, 2026Application Program Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Tower, the system became frozen on the blue screen, and the Remote Support Service (RSS) went offline. The customer rebooted the station, but issue persisted. The customer stated that this malfunction caused a delay while dispensing medications to the patient and the user managed to get medications from pharmacy. However, there were no adverse events or injuries reported based on this incident.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50801690 ↗