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Pyxis 303Recalls & reported problems

Carefusion 303, Inc. · BD Pyxis MedStation 4000 (Main) · Class 1

7 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Quick summary

This BD Pyxis MedStation is an automated medication cabinet. Its 385 reports include 3 injuries and no deaths, and mostly describe software problems and drawers that fail to open. 7 open recalls name this device, covering an overheating fingerprint scanner, software and antivirus gaps, fluid that can cause smoke or fire, and drawer or door failures that delay access to medicines. Reports dropped to 103 over the last year from 277 the year 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
392
Deaths reported
0
Injuries reported
3
Recalls naming it
7

Summary

The FDA's MAUDE database contains 392 adverse event reports that list this exact device (DI 10885403512629), received between May 5, 2022 and Sep 21, 2026 — classified as 3 injuries, 389 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (89 reports).

7 FDA recall records name this device's identifier, 7 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.

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: 1 reportsNov 2024: 0 reportsDec 2024: 2 reportsJan 2025: 9 reportsFeb 2025: 8 reportsMar 2025: 12 reportsApr 2025: 3 reportsMay 2025: 11 reportsJun 2025: 19 reportsJul 2025: 75 reportsAug 2025: 45 reportsSep 2025: 48 reportsOct 2025: 45 reportsNov 2025: 50 reportsDec 2025: 17 reportsJan 2026: 4 reportsFeb 2026: 5 reportsMar 2026: 7 reportsApr 2026: 0 reportsMay 2026: 6 reportsJun 2026: 5 reportsJul 2026: 4 reportsAug 2026: 5 reportsSep 2026: 7 reportsOct 2026: 0 reports20242025202675
Last 36 months. The most recent month may be incomplete.

Recalls naming this device

  1. Apr 30, 2026Open, Classified

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

    Z-2297-2026 · Root cause: Component design/selection · FDA record ↗

  2. 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 ↗

  3. 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 ↗

  4. 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 ↗

  5. Apr 15, 2024Open, Classified

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

    Z-1928-2024 · Root cause: Component design/selection · FDA record ↗

  6. 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-1125-2025 · Root cause: Device Design · FDA record ↗

  7. 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-0973-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Device problems

  • Computer Software Problem89
  • Failure to Eject81
  • Mechanical Problem41
  • Communication or Transmission Problem28
  • Application Program Problem27
  • Application Program Freezes or Fails to Launch20
  • Electrical /Electronic Property Problem14
  • Leak/Splash14

Patient problems

  • No Clinical Signs, Symptoms or Conditions390
  • Insufficient Information3
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

The 25 most recent of 392 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 21, 2026Break

    It was reported that when using the BD Pyxis¿ MedStation¿ 4000 drawer 1 was failed. 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 50837677 ↗
  • MalfunctionSep 18, 2026Circuit Failure; Loose or Intermittent Connection

    It was reported that when using the BD Pyxis¿ MedStation¿ 4000, drawer failed, device had powered down and the screen went black; after powering back on, attempts to remove medication resulted in maintenance and drawer failure alerts, with the affected drawer unable to recover despite no visible obstructions and normal operation of the emergency release latch.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 50817558 ↗
  • MalfunctionSep 15, 2026Contamination; Loose or Intermittent Connection; Mechanical Problem

    It was reported that when using the BD Pyxis¿ MedStation¿ 4000 the 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 50768969 ↗
  • MalfunctionSep 8, 2026Break

    It was reported that when using the BD Pyxis¿ MedStation¿ 4000, drawer was failed. The customer stated that this malfunction occurred while dispensing the medication and they had to access the medications from another station/pharmacy that caused 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 50661687 ↗
  • MalfunctionSep 7, 2026Component Missing; Failure to Align

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50648011 ↗
  • MalfunctionSep 1, 2026Contamination; Electrical /Electronic Property Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50538157 ↗
  • MalfunctionSep 1, 2026Application Program Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50538117 ↗
  • MalfunctionAug 31, 2026Electrical /Electronic Property Problem; Mechanical Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50523163 ↗
  • MalfunctionAug 19, 2026Contamination; Mechanical Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50328771 ↗
  • MalfunctionAug 11, 2026Loose or Intermittent Connection; Mechanical Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50211040 ↗
  • MalfunctionAug 7, 2026Break; Circuit Failure

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50171237 ↗
  • MalfunctionAug 3, 2026Contamination; Component Missing; Failure to Align

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50115938 ↗
  • MalfunctionJul 31, 2026Application Program Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50096856 ↗
  • MalfunctionJul 29, 2026Application Program Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50067933 ↗
  • MalfunctionJul 28, 2026Electrical /Electronic Property Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50049411 ↗
  • MalfunctionJul 17, 2026Application Network Problem

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25851808 ↗
  • MalfunctionJun 30, 2026Application Program Problem

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ 4000 SCREEN WAS FROZEN AND STUCK ON THE INVENTORY SCREEN. NO ERROR MESSAGE WAS DISPLAYED. THERE WERE NO DELAY, ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25665407 ↗
  • MalfunctionJun 16, 2026Loose or Intermittent Connection

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ 4000 DRAWER HAD FAILED AND REQUIRED MAINTENANCE. THE CUSTOMER PERFORMED REBOOT AND RECOVERY ATTEMPTS; HOWEVER, THE ISSUE PERSISTED. POWER CABLE WAS UNPLUGGED AND RECONNECTED, BUT THE ISSUE PERSISTED. BACK PANEL WAS OPENED AND CHECKED; ISSUE STILL PERSISTED. 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 25517419 ↗
  • MalfunctionJun 12, 2026Application Network Problem

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ 4000, THE STATION WAS OFFLINE AND WAS STUCK IN CAREFUSION SCREEN. HOWEVER, THERE WERE NO DELAY AND NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25483433 ↗
  • MalfunctionJun 9, 2026No Apparent Adverse Event; Application Program Freezes or Fails to Launch

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ 4000 WAS IN A BLACK SCREEN STATE. THE CUSTOMER STATED THAT THERE WAS A DELAY IN PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED DUE TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25439275 ↗
  • MalfunctionJun 8, 2026Application Program Problem

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ 4000, SYSTEM WAS STUCK IN LOADING SCREEN. THE CUSTOMER INFORMED THAT THE SCREEN DISPLAYED INITIALIZING PYXIS BUS DEVICE SCREEN. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHEN DISPENSING MEDICATION TO PATIENTS AND CAUSED 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 25423265 ↗
  • MalfunctionMay 18, 2026Application Program Problem

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ 4000, STATION WAS NOT COMMUNICATED, ALL NEW ORDER WAS NOT CROSSING OVER TO PYXIS. 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 25200877 ↗
  • MalfunctionMay 15, 2026Contamination

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ 4000 STATION WAS STUCK ON THE WINDOWS LOGIN SCREEN. THE CUSTOMER STATED THAT THEY TRIED TO REBOOT THE STATION, 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 25181103 ↗
  • MalfunctionMay 12, 2026Thermal Decomposition of Device; Loose or Intermittent Connection

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ 4000, THE HALF HEIGHT CUBIE DRAWER 2-1 FAILED. AS PER PART INVESTIGATION, IT WAS DETERMINED THAT THERE WAS THERMAL DAMAGE OBSERVED DUE TO A SHORT BETWEEN ADJACENT COPPER STRANDS OF THE ASSY RETRACTOR DWR HH CUBIE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25146316 ↗
  • MalfunctionMay 11, 2026Break; Contamination

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ MEDSTATION¿ 4000, A DRAWER FAILURE OCCURRED. THE SAME DRAWER FAILED MULTIPLE TIMES. STAFF RECOVERED THE DRAWER AND RESUMED USE; HOWEVER, THE DRAWER FAILED AGAIN, EITHER DURING THE SAME SHIFT OR ON THE FOLLOWING DAY. 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 25134552 ↗

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