BD Pyxis 1139-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,509 adverse event reports that list this exact device (DI 10885403512704), received between Feb 23, 2024 and Sep 30, 2026 — classified as 1,508 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (417 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Sep 30, 2025Open, Classified

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

   Z-0368-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Jul 10, 2025Open, Classified

   Reports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow.

   Z-2321-2025 · Root cause: Use error · Recall details · FDA record ↗

3. Mar 11, 2025Open, Classified

   Users trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a software issue that results in 2 destock transactions and 2 stock transactions, which results in doubling the bin quantity, which may result in a delay in access to desired medications and/or supplies, which may lead to temporary body function impairment.

   Z-1639-2025 · Root cause: Software design · Recall details · FDA record ↗

4. Mar 11, 2025Open, Classified

   Due to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect transaction quantity to be recorded. This bug can also result in the CUBIE opening more times than needed for the transaction to be completed, which may result in a patient receiving more than the intended dose of medication.

   Z-1545-2025 · Root cause: Software design · Recall details · FDA record ↗

5. Jan 23, 2025Open, Classified

   Due to fingerprint scanner failing resulting in the scanner heating up.

   Z-1207-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

6. Jan 10, 2025Open, Classified

   Automated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential delays in retrieving contents/ accessing medications that may result from power loss or potential automated dispensing device malfunctions.

   Z-1206-2025 · Root cause: Labeling design · Recall details · FDA record ↗

7. Jan 8, 2025Open, Classified

   Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

   Z-1227-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

8. Jan 8, 2025Open, Classified

   Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

   Z-1230-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

9. Jan 8, 2025Open, Classified

   Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

   Z-1228-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. Jan 8, 2025Open, Classified

    Labeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms.

    Z-1229-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

11. Oct 5, 2023Open, Classified

    If "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first requiring the RxVerify Validation Code be entered/without validation from a pharmacist, which could lead to unintended and incorrect medication removal.

    Z-1552-2025 · Root cause: Software design · Recall details · FDA record ↗

12. Dec 12, 2022Open, Classified

    Due to customer complaints related to the MedBank software which may indicate that a different medication is loaded in a cubie (drawer) pocket than what is physically loaded and listed on the pocket label. As a result of this issue, a patient could receive the wrong medication or wrong dose of medication that could lead to patient harm.

    Z-0928-2023 · Root cause: Software design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 1,509 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026No Apparent Adverse Event

  It was reported that when using the BD Pyxis¿ Medflex 1000, system user was unable to issue medication. Customer reported receiving a "Wrong Barcode Scanned" error when attempting to issue medication. 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 50942724 ↗
• MalfunctionSep 30, 2026Application Program Problem

  It was reported that when using the BD Pyxis¿ Medflex 1000 user was unable to issue medication, and the RxVerify request was rejected. The customer confirmed that on the patient order list screen, the item validation code status for the override request was displayed as Rejected.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 50942491 ↗
• MalfunctionSep 29, 2026Application Program Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50933001 ↗
• MalfunctionSep 29, 2026Break; Thermal Decomposition of Device

  It was reported that when using the BD Pyxis¿ Medflex 1000 the keyboard malfunctioned.As per part investigation, it was determined that the complaint was attributed to the physical damage of part PN 358591-01, which resulted in thermal damage and produced a functional failure that prevented proper keyboard functionality.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 50932711 ↗
• MalfunctionSep 29, 2026Labelling, Instructions for Use or Training Problem

  It was reported that when using the BD Pyxis¿ Medflex 1000 unable to issue medication. The drawer latched, but no drawer opened.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 50929694 ↗
• MalfunctionSep 29, 2026Installation-Related Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50929282 ↗
• MalfunctionSep 29, 2026Installation-Related Problem

  It was reported that when using the BD Pyxis¿ Medflex 1000 drawer was not opening. The customer stated that there was no delay, but the malfunction occurred when the user tried to issue medication 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 50929265 ↗
• MalfunctionSep 28, 2026Installation-Related Problem

  It was reported that when using the BD Pyxis¿ Medflex 2000 user attempted to retrieve medication, but the drawer 04 and 05 did not open.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 50912030 ↗
• MalfunctionSep 28, 2026Electrical /Electronic Property Problem; Application Program Problem

  It was reported that when using the BD Pyxis¿ Medflex 2000 user was unable to issue an item because it had been destocked by the system. A message appeared on the screen stating that the item was not found and that the position would be destocked. The user was unable to proceed because another message prompted them to close the drawer, although no door or drawer was open. The same message had appeared earlier when the user attempted to issue medication from drawer 6; however, the user was able to issue the item from another bin.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 50911618 ↗
• MalfunctionSep 28, 2026Installation-Related Problem

  It was reported that when using the BD Pyxis¿ Medflex 1000 wrong drawer opened.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 50911151 ↗
• MalfunctionSep 28, 2026Application Program Problem

  It was reported that when using the BD Pyxis¿ Medflex 1000, multiple Discrepancies were identified involving Lorazepam 0.5 mg tablets and Oxycodone 5 mg tablets. The customer reported recurring countback errors where inventory counts unexpectedly increased during medication transactions. A C35 report was reviewed and confirmed multiple discrepancies for both medications. The customer requested investigation to determine whether the issue was related to user processing/counting errors or a potential system-related issueThere were no delay or adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50911145 ↗
• MalfunctionSep 25, 2026Loose or Intermittent Connection

  It was reported that when using the BD Pyxis¿ Medflex 1000, the user was unable to issue SOLU-MEDROL 40MG/ML due to a failed Matrix Drawer 5. No drawer opened during the dispense attempt, preventing access to the medication.The customer reported that a malfunction took place when the user tried to dispense medication to the patient. There were no delay or adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897331 ↗
• MalfunctionSep 24, 2026No Apparent Adverse Event

  It was reported that when using the BD Pyxis¿ Medflex 1000 user tried to issue a medication, multiple drawers opened at once.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 50882614 ↗
• MalfunctionSep 22, 2026Installation-Related Problem

  It was reported that when using the BD Pyxis¿ Medflex 1000 user was unable to issue medication because the right-hand pane was not populating with information needed to complete the transaction.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 50851072 ↗
• MalfunctionSep 21, 2026Application Program Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840607 ↗
• MalfunctionSep 21, 2026Labelling, Instructions for Use or Training Problem

  It was reported that when using the BD Pyxis¿ Medflex 1000, a drawer failure was reported involving the Bio ID fingerprint login system. The customer experienced difficulty logging into the cabinet using their fingerprint, as the Bio ID indicator was flashing between red and blue lights and was not recognizing enrolled fingerprints. As a result, users were unable to authenticate and access the cabinet through biometric login.There were no delay or adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50837695 ↗
• MalfunctionSep 21, 2026Installation-Related Problem

  It was reported that when using the BD Pyxis¿ Medflex 1000, validation code was not working when user tried to issue the medication (Tramadol) for a patient.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 50837661 ↗
• MalfunctionSep 21, 2026Use of Device Problem

  It was reported that when using the BD Pyxis¿ Medflex 1000 the user was unable to issue medication.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 50837138 ↗
• MalfunctionSep 17, 2026Break

  It was reported that when using the BD Pyxis¿ Medflex 2000, drawer was malfunctioned.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 50801693 ↗
• MalfunctionSep 16, 2026Loose or Intermittent Connection

  It was reported that when using the BD Pyxis¿ Medflex 1000 drawer 9 malfunctioned and failed to open.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 50790343 ↗
• MalfunctionSep 15, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50775475 ↗
• MalfunctionSep 15, 2026Electrical /Electronic Property Problem

  It was reported that when using the BD Pyxis¿ Medflex 1000, drawer 4 failed to open. Customer tried to reboot and recover but issue was not 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 50772176 ↗
• MalfunctionSep 15, 2026Use of Device Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772154 ↗
• MalfunctionSep 15, 2026Mechanical Problem

  It was reported that when using the BD Pyxis¿ Medflex 1000, drawer 4 was not opening. 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 50768166 ↗
• MalfunctionSep 15, 2026Use of Device Problem

  It was reported that when using the BD Pyxis¿ Medflex 1000, a user was unable to override a medication for a patient profile. Investigation revealed that the patient did not have an active morphine order in the system. The customer was attempting to add and override the medication; however, the medication was classified as a High Alert medication, and the user only had General Alert access privileges. As a result, the override could not be completed.The customer reported that a malfunction took place when the user tried to dispense medication to the patient. There were no delay or adverse events or injuries reported based on this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50767700 ↗