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BD Pyxis 324 (UDI 10885403533235)Recalls & reported problems

Carefusion 303, Inc. · BD Pyxis MedStation ES (Auxiliary) · Class 1

Quick summary

This BD Pyxis MedStation auxiliary unit is a medical cabinet. Reports mostly describe mechanical and circuit failures, loose connections, broken parts, and drawers or locks that stop working. There are 7,888 reports, with no deaths and 1 injury. No recalls name this device. Reports rose to 7,027 in the last 12 months from 861 in the 12 months before.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
8,624
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 8,624 adverse event reports that list this exact device (DI 10885403533235), received between Jan 6, 2025 and Sep 30, 2026 — classified as 1 injury, 8,616 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2,115 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 28 reportsFeb 2025: 48 reportsMar 2025: 61 reportsApr 2025: 59 reportsMay 2025: 48 reportsJun 2025: 42 reportsJul 2025: 45 reportsAug 2025: 68 reportsSep 2025: 136 reportsOct 2025: 326 reportsNov 2025: 513 reportsDec 2025: 864 reportsJan 2026: 542 reportsFeb 2026: 591 reportsMar 2026: 702 reportsApr 2026: 649 reportsMay 2026: 743 reportsJun 2026: 855 reportsJul 2026: 886 reportsAug 2026: 655 reportsSep 2026: 763 reportsOct 2026: 0 reports202420252026886
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Mechanical Problem2,115
  • Loose or Intermittent Connection2,070
  • Circuit Failure2,054
  • Break1,396
  • Component Missing624
  • Contamination610
  • Electrical /Electronic Property Problem482
  • Activation Failure476

Patient problems

  • No Clinical Signs, Symptoms or Conditions8,621
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
  • Insufficient Information1

Recent adverse event reports

The 25 most recent of 8,624 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 30, 2026Loose or Intermittent Connection; Installation-Related Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953948 ↗
  • MalfunctionSep 30, 2026Component Missing

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953946 ↗
  • MalfunctionSep 30, 2026Break; Mechanical Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953941 ↗
  • MalfunctionSep 30, 2026Break; Mechanical Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953924 ↗
  • MalfunctionSep 30, 2026Mechanical Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953916 ↗
  • MalfunctionSep 30, 2026Electrical /Electronic Property Problem; Loose or Intermittent Connection

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50953914 ↗
  • MalfunctionSep 30, 2026Loose or Intermittent Connection

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50952590 ↗
  • MalfunctionSep 30, 2026Thermal Decomposition of Device

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50946186 ↗
  • MalfunctionSep 30, 2026Break

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary MCU-A drawer 5 pockets B1 and D3 experienced failures and could not be recovered. The user attempted troubleshooting, including rebooting the device; however, both pockets remained in a failed state and recovery was unsuccessful.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 50944975 ↗
  • MalfunctionSep 30, 2026Mechanical Problem

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary, system auxiliary drawer 7 was failed. The customer stated that they tried to reboot and recover but the issue was not resolved.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 50944972 ↗
  • MalfunctionSep 30, 2026Electrical /Electronic Property Problem

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary system cubie was failed and was unable to release. 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 50944953 ↗
  • MalfunctionSep 30, 2026Component Missing

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary, a drawer failure occurred involving a full-height drawer that failed to stay closed.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 50944938 ↗
  • MalfunctionSep 30, 2026Loose or Intermittent Connection

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary drawer 7 was failed and unable to recover.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 50944928 ↗
  • MalfunctionSep 30, 2026Circuit Failure; Loose or Intermittent Connection

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary drawer was failed. Customer tried to reboot and recover, but issue doesn't resolve. 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 50944925 ↗
  • MalfunctionSep 30, 2026Component Missing

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary drawer was failed and unable to recover.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 50944921 ↗
  • MalfunctionSep 30, 2026Contamination

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary drawer 5 was not detected on bus.As per part investigation, it was determined that the complaint was attributed to visual anomalies indicative of fluid ingress detected on the board. 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 50944382 ↗
  • MalfunctionSep 30, 2026Circuit Failure; Contamination

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary, the drawer failed.As per part investigation, it was determined that the fluid ingress condition of the part module controller.There were no adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942961 ↗
  • MalfunctionSep 30, 2026Break

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary, the drawer 2 was failed and displayed a device not detected on bus error. Reboot and recovery attempts were performed, but the issue persisted. 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 50942731 ↗
  • MalfunctionSep 30, 2026Labelling, Instructions for Use or Training Problem

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary, a cached credential issue occurred. Following a major technology outage, users at EHSC were unable to log in to the Pyxis cabinets after the Ethernet connection was disconnected. The issue prevented access to the cabinets and ultimately required staff to open the back of the units to manually access cubies. The customer reported that other sites within the region were able to log in without issue, indicating the problem was isolated to the affected location.There were no delay or adverse events or injuries reported based on this event.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50942539 ↗
  • MalfunctionSep 30, 2026Component Missing

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary VGH4SP1 drawer 6.2 would not open automatically and required users to manually pull the drawer open. Additionally, staff reported difficulties closing the drawer, indicating intermittent drawer operation issues.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 50942482 ↗
  • MalfunctionSep 29, 2026Circuit Failure; Mechanical Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50933764 ↗
  • MalfunctionSep 29, 2026Circuit Failure; Mechanical Problem

    It was reported that when using the BD Pyxis¿ MedStation¿ ES Auxiliary drawer was failed and required maintenance. The customer unplugged and reconnected the power cable, attempted a reboot, and performed a recovery; however, the issue persisted.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 50933759 ↗
  • MalfunctionSep 29, 2026Contamination; Mechanical Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50932760 ↗
  • MalfunctionSep 29, 2026Contamination

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50932713 ↗
  • MalfunctionSep 29, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50932667 ↗

Other Cabinet, table and tray, anesthesia devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.