BD Pyxis iMX105Recalls & reported problems

Summary

The FDA's MAUDE database contains 701 adverse event reports that list this exact device (DI 10885403510427), received between Mar 20, 2024 and Sep 30, 2026 — classified as 701 malfunctions.

The most frequently reported specific device problem is “Application Program Problem” (146 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 701 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Application Program Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953968 ↗
• MalfunctionSep 30, 2026Mechanical Problem

  It was reported that when using the BD Pyxis¿ ES Refrigerator bin was failed. Customer tried to reboot and recover the storage space, but the issue persisted.The customer stated that this malfunction occurred while dispensing the medication and the user managed to get the medication from pharmacy, 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 50942461 ↗
• MalfunctionSep 29, 2026Application Program Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931417 ↗
• MalfunctionSep 29, 2026Activation Failure

  It was reported that when using the BD Pyxis¿ ES Refrigerator Helmer experienced a drawer failure.However, there were no delays, adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50930880 ↗
• MalfunctionSep 28, 2026Activation Failure

  It was reported that when using the BD Pyxis¿ ES Refrigerator door became stuck in the unlocked position, while deep bins 1.1 through 1.3 failed to open.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 50912034 ↗
• MalfunctionSep 26, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50908026 ↗
• MalfunctionSep 25, 2026Mechanical Problem

  It was reported that when using the BD Pyxis¿ ES Refrigerator bin was failed and drawer was not detected.The customer stated that this malfunction occurred while dispensing 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 50900121 ↗
• MalfunctionSep 25, 2026Loose or Intermittent Connection

  It was reported that when using the BD Pyxis¿ ES Refrigerator front panel was black and would not open, preventing the removal of medications.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 50900111 ↗
• MalfunctionSep 25, 2026Mechanical Problem

  It was reported that when using the BD Pyxis¿ ES Refrigerator station froze and the application could not be launched. When the user attempted to launch the application, it remained stuck on Initializing Device. The customer attempted to reboot the station several times, but the issue persisted.The customer stated that this malfunction occurred while dispensing 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 50895905 ↗
• MalfunctionSep 25, 2026Application Program Problem

  It was reported that when using the BD Pyxis¿ ES Refrigerator, the station was stuck on initializing device manager. Customer tried to reboot, but issue was not resolved. 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 50893702 ↗
• MalfunctionSep 24, 2026Mechanical Problem

  It was reported that when using the BD Pyxis¿ ES Refrigerator, the system displayed a "Clear Obstruction" error message. The refrigerator door opened; however, the locked bins did not open due to the error, preventing access to medications.The customer stated that this malfunction occurred while dispensing the medication and 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 50883622 ↗
• MalfunctionSep 24, 2026Circuit Failure; Electrical /Electronic Property Problem

  It was reported that when using the BD Pyxis¿ ES Refrigerator, the device became unresponsive after the refrigerator subsystem began continuously cycling through multiple screens. The user rebooted the entire MedStation, during which system updates were applied; however, the station subsequently became stuck on the "Initializing Hardware" screen and was rendered unusable.There were no delay or adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881885 ↗
• MalfunctionSep 24, 2026Electrical /Electronic Property Problem

  It was reported that when using the BD Pyxis¿ ES Refrigerator helmer refrigerator bins 1.1, 1.2, and 1.3 failed and displayed a Device Not on Bus error. The customer rebooted the station and performed a Recover Storage Space procedure; however, the issue persisted and the bins remained non-functional.The customer stated that this malfunction occurred while dispensing 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 50879979 ↗
• MalfunctionSep 23, 2026Application Program Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50875096 ↗
• MalfunctionSep 23, 2026Mechanical Problem; Application Program Problem

  It was reported that when using the BD Pyxis¿ ES Refrigerator was not detected on bus and unable to access the medications.The customer stated that they managed to get the medication from pharmacy that caused 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 50868094 ↗
• MalfunctionSep 23, 2026Application Program Problem

  It was reported that when using the BD Pyxis¿ ES Refrigerator failed to recover the drawer. The customer was able to recover the fridge door, but all internal drawers were not working. However, there were no delays, adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50864470 ↗
• MalfunctionSep 22, 2026Application Program Problem

  It was reported that when using the BD Pyxis¿ ES Refrigerator, refrigerator failed to recover. Customer tried to reboot and recover but issue wasn't resolve. The customer stated that this malfunction caused a delay in dispensing the medications to the patient. However, there were no adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50851756 ↗
• MalfunctionSep 21, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838284 ↗
• MalfunctionSep 21, 2026Loose or Intermittent Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50838276 ↗
• MalfunctionSep 21, 2026Break

  It was reported that when using the BD Pyxis¿ ES Refrigerator, the bin drawer on the PEDS station would not close properly. The user reported that the drawer appeared to be physically damaged. The drawer was unable to close completely and required hardware repair or replacement. Customer tried to reboot/ recover the drawer, but issue doesn't resolve. The customer reported that a malfunction took place when the user tried to dispense medication to the patient. 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 50836471 ↗
• MalfunctionSep 18, 2026Loose or Intermittent Connection

  It was reported that when using the BD Pyxis¿ ES Refrigerator failed and displayed a "Device Not Detected on Bus" error message. The customer also reported that the network cable had been disconnected from the machine. The customer tried to reboot and recover, but the issue persistedThe customer stated that this malfunction occurred while dispensing the medication, and the user managed to get the medication from another station.There were no adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50816612 ↗
• MalfunctionSep 18, 2026No Apparent Adverse Event

  It was reported that when using the BD Pyxis¿ ES Refrigerator, a refrigerator failure occurred. The customer reported that the fridge continues to fail repeatedly. Troubleshooting was performed, and the refrigerator was successfully recovered; however, the failure reoccurred shortly afterward.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 50815287 ↗
• MalfunctionSep 17, 2026Application Program Problem

  It was reported that when using the BD Pyxis¿ ES Refrigerator, the system was not detected on bus. 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 50800729 ↗
• MalfunctionSep 17, 2026Electrical /Electronic Property Problem; Application Program Problem

  It was reported that when using the BD Pyxis¿ ES Refrigerator was not sensing when the door was closed. The customer was attempting to retrieve medications; however, the system failed to recognize that the door had been opened to initiate the next step, requiring the machine to be restarted.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 50798920 ↗
• MalfunctionSep 16, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50792521 ↗