BD Pyxis 324 (UDI 10885403512681)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5,301 adverse event reports that list this exact device (DI 10885403512681), received between Mar 23, 2022 and Sep 30, 2026 — classified as 1 death, 1 injury, 5,299 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (1,805 reports).

5 FDA recall records name this device's identifier, 5 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. 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 ↗

2. Nov 14, 2024Open, Classified

   Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.

   Z-0671-2025 · Root cause: Software design · FDA record ↗

3. Apr 15, 2024Open, Classified

   Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.

   Z-1929-2024 · Root cause: Component design/selection · FDA record ↗

4. 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-1123-2025 · Root cause: Device Design · FDA record ↗

5. 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-0972-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 5,301 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Circuit Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50953938 ↗
• MalfunctionSep 29, 2026Application Program Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary tower door failed and it required maintenance.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 50930658 ↗
• MalfunctionSep 29, 2026Application Network Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929845 ↗
• MalfunctionSep 25, 2026Mechanical Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary, tower door was failed to open and close. 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 50898510 ↗
• MalfunctionSep 25, 2026Circuit Failure; Mechanical Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary doors could not be recovered and required maintenance. 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 50895899 ↗
• MalfunctionSep 25, 2026Break

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary system bottom panel paint had stripped and rusted. 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 50895130 ↗
• MalfunctionSep 24, 2026Installation-Related Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary, tower required maintenance when recover storage space. 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 50879964 ↗
• MalfunctionSep 17, 2026Mechanical Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary, the system door 1 continuously failed. The customer reported that the tower door failed multiple times every day and displayed a hardware failure message.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 50798915 ↗
• MalfunctionSep 14, 2026Break; Failure to Align

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary, North Drawer 3.1 failed to open and was reported as jammed. The drawer displayed a failed drawer error on the Pyxis console.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 50749820 ↗
• MalfunctionSep 9, 2026No Apparent Adverse Event

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50697749 ↗
• MalfunctionSep 7, 2026Component Missing

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50646225 ↗
• MalfunctionSep 4, 2026Application Program Freezes or Fails to Launch

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50610673 ↗
• MalfunctionAug 31, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50515751 ↗
• MalfunctionAug 21, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50379889 ↗
• MalfunctionAug 21, 2026Loose or Intermittent Connection

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary, tower door was failed. The customer stated that the malfunction occurred when a user tried to issue medication to the patient and caused a delay in patient care. However, there was no adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50368772 ↗
• MalfunctionAug 20, 2026Mechanical Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary, door failed in tower and required maintenance. The customer stated that this malfunction occurred when the user tried to issue medication to patient and 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 50352498 ↗
• MalfunctionAug 20, 2026Electrical /Electronic Property Problem

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary, the tower door repeatedly failed and produced a clicking noise during operation.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 50343273 ↗
• MalfunctionAug 19, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50330647 ↗
• MalfunctionAug 19, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50321437 ↗
• MalfunctionAug 18, 2026Contamination

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary tower door had failed.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 50293175 ↗
• MalfunctionAug 14, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50248230 ↗
• MalfunctionAug 7, 2026Installation-Related Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50170707 ↗
• MalfunctionAug 6, 2026Contamination; Loose or Intermittent Connection

  It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary system tower door failed every time and the user want to remove a medication. Sometimes, the nurses were able to recover the transaction and attempt the medication removal again; however, it could take several attempts before the removal was successfully processed. The tower door did open but then fail immediately afterward. The customer stated that this malfunction occurred when the user tried to issue medication to patient. However, there were no adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50156001 ↗
• MalfunctionJul 28, 2026

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50056623 ↗
• MalfunctionJul 28, 2026Electrical /Electronic Property Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50053135 ↗