Skip to content

Pyxis 327 (UDI 10885403477836)Recalls & reported problems

Carefusion 303, Inc. · Pyxis Anesthesia System ES · Class 1

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

Quick summary

This BD Pyxis Anesthesia System ES is a cabinet that dispenses medications during anesthesia care. Its 3,137 reports mostly describe software faults, freezes and dispensing failures that delayed access to medication. The reports include no deaths and 9 injuries. There are 10 open recalls, mostly about software issues that can delay medication access, and one about a fingerprint scanner that may overheat and cause a burn.

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
3,137
Deaths reported
0
Injuries reported
9
Recalls naming it
10

Summary

The FDA's MAUDE database contains 3,137 adverse event reports that list this exact device (DI 10885403477836), received between Jan 3, 2022 and Nov 13, 2025 — classified as 9 injuries, 3,128 malfunctions.

The most frequently reported specific device problem is “Computer Software Problem” (878 reports).

10 FDA recall records name this device's identifier, 10 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: 7 reportsDec 2023: 30 reportsJan 2024: 30 reportsFeb 2024: 41 reportsMar 2024: 38 reportsApr 2024: 20 reportsMay 2024: 43 reportsJun 2024: 27 reportsJul 2024: 16 reportsAug 2024: 23 reportsSep 2024: 23 reportsOct 2024: 48 reportsNov 2024: 20 reportsDec 2024: 47 reportsJan 2025: 160 reportsFeb 2025: 143 reportsMar 2025: 263 reportsApr 2025: 291 reportsMay 2025: 494 reportsJun 2025: 266 reportsJul 2025: 291 reportsAug 2025: 215 reportsSep 2025: 199 reportsOct 2025: 91 reportsNov 2025: 104 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports202420252026494
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-2299-2026 · 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. Feb 6, 2025Open, Classified

    Sync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount of data that takes excessive time, which may cause the dispensing devices to become disconnected from the ES server; dispensing devices will not receive updated information, which may lead to incorrect therapy, and delay in accessing medication.

    Z-1375-2025 · Root cause: Software design · FDA record ↗

  5. 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 ↗

  6. Jan 8, 2025Open, Classified

    Software issues could potentially result in: 1) delays in accessing dispensing software application, 2) wrong therapy (dose, item, timing, etc.), or 3) unauthorized access and/or compliance related issues

    Z-1119-2025 · Root cause: Software design · FDA record ↗

  7. May 2, 2024Open, Classified

    If automated dispensing cabinets have specific software versions, and Component Manager was configured to "installed mode", and software patch KB 5033688 was installed in the production environment, then this will will lead to an error that prevents the user from accessing the dispensing software application, which may delay accessing medication.

    Z-2374-2024 · Root cause: Software change control · FDA record ↗

  8. Feb 1, 2024Open, Classified

    Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss.

    Z-1223-2024 · Root cause: Software design · FDA record ↗

  9. Apr 5, 2023Open, Classified

    Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial loss of patient transaction data, seen as a server upload processing error. Outdated/incorrect information display may contribute to the removal of medication to which the patient is allergic, incorrect dose amount, or discontinued medication.

    Z-1579-2023 · Root cause: Software Design Change · FDA record ↗

  10. Feb 14, 2023Open, Classified

    Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device installations or device replacement upgrades, which may lead to an increased frequency of drawer failures, which could increase the likelihood of patients experiencing delays in receiving medications.

    Z-1207-2023 · Root cause: Software change control · FDA record ↗

Most reported problems

Device problems

  • Computer Software Problem878
  • Mechanical Problem567
  • Communication or Transmission Problem226
  • Electrical /Electronic Property Problem195
  • Failure to Eject188
  • Application Program Freezes or Fails to Launch146
  • Application Program Problem137
  • Application Network Problem116

Patient problems

  • No Clinical Signs, Symptoms or Conditions3,116
  • Insufficient Information102
  • Hemorrhage/Blood Loss/Bleeding3
  • Discomfort2
  • Low Blood Pressure/ Hypotension2
  • Anxiety1
  • Arrhythmia1
  • Fetal Distress1

Recent adverse event reports

The 25 most recent of 3,137 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 13, 2025Application Network Problem; Application Network Problem

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES HAD PATIENT AND ORDERS NOT CROSSED OVER. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND THEY HAD TO ACCESS THE MEDICATIONS 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 23541376 ↗
  • MalfunctionNov 13, 2025Application Program Problem; Application Program Problem

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES WAS TURNING OFF FREQUENTLY DURING SURGERY. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE TRYING TO DISPENSE 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 23540264 ↗
  • MalfunctionNov 13, 2025Computer Software Problem; Computer Software Problem

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION ES SYSTEM BLINKED AND REBOOTED ITSELF DURING THE MIDDLE OF THE PROCEDURE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23540176 ↗
  • MalfunctionNov 12, 2025Loose or Intermittent Connection; Mechanical Problem; Loose or Intermittent Connection; Mechanical Problem

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES DRAWER 2.1 WAS NOT DETECTED ON BUS. PATIENT MEDICATION WAS NOT ABLE TO PULL FROM PYXIS. REQUIRED MAINTENANCE. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN THE DISPENSING OF MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23533664 ↗
  • MalfunctionNov 12, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES WAS NOT TURNING ON DUE TO POWER OUTAGE. 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 23533290 ↗
  • MalfunctionNov 12, 2025Computer Software Problem; Computer Software Problem

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION ES SYSTEM DID NOT REBOOT. THE CUSTOMER STATED THAT IT IMPACTED PATIENT CARE, THERE WAS SLIGHT DELAY.THERE WERE ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23530718 ↗
  • MalfunctionNov 12, 2025Communication or Transmission Problem; Communication or Transmission Problem

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS ANESTHESIA ES SYSTEM WAS NOT COMMUNICATING. CUSTOMER REPORTED THERE WAS A WATER LEAK FROM THE CEILING LAST WEEK AND WE UNPLUGGED THE PYXIS DEVICE TO PREVENT DAMAGE THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23530488 ↗
  • MalfunctionNov 12, 2025Computer System Security Problem; Computer System Security Problem

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS ANESTHESIA ES SYSTEM WAS EXPERIENCING ISSUES AS NURSES WERE UNABLE TO PULL MEDS AT ALL ASCENSION FACILITIES DUE TO CYBER SECURITY ISSUES, EXPIRED PASSWORDS, AND NETWORK LOCKDOWN. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23529913 ↗
  • MalfunctionNov 11, 2025Circuit Failure; Circuit Failure

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES HAD 2 MINI DRAWERS FAILED. 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 23524668 ↗
  • MalfunctionNov 11, 2025Circuit Failure; Circuit Failure

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES, DRAWER WAS FAILED AND NOT DETECTED ON BUS. 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 23523442 ↗
  • MalfunctionNov 11, 2025Loose or Intermittent Connection; Loose or Intermittent Connection

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES HAD DRAWER FAILED MULTIPLE TIMES. 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 23522180 ↗
  • MalfunctionNov 11, 2025Date/Time-Related Software Problem; Date/Time-Related Software Problem

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION ES SYSTEM TIMES WERE OFF ON SEVERAL PYXIS MACHINES WHICH WAS DELAYING ABILITY FOR NURSES TO PULL MEDICATIONS WHEN NEEDED AND AFFECTING CONTROLLED SUBSTANCE REPORTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23522177 ↗
  • MalfunctionNov 11, 2025Break; Break

    IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES UNEXPECTEDLY NOT RESPONDING AND HAD A DOOR FAILURE. THERE WERE NO DELAYS OR ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23522164 ↗
  • MalfunctionNov 11, 2025Computer Software Problem; Computer Software Problem

    IT WAS REPORTED BY THE CUSTOMER THAT AT BD PYXIS¿ ANESTHESIA STATION ES USER WAS GETTING THE NOTICE WHEN TRYING TO REMOVE PROHANCE 15ML (43101310). EVEN THOUGH MEDICATION DID NOT REQUIRE A WITNESS AND THE USER HAD INDEPENDENT OVERRIDE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23521965 ↗
  • MalfunctionNov 11, 2025Break; Break

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES DRAWER WAS UNABLE TO OPEN. THE CUSTOMER STATED THAT THIS MALFUNCTION OCCURRED WHILE DISPENSING THE MEDICATION AND THEY WERE UNABLE TO ACCESS THE MEDICATION THAT 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 23521397 ↗
  • MalfunctionNov 11, 2025Leak/Splash; Leak/Splash

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION ES SYSTEM WAS DOUSED WITH WATER FROM A SPRINKLER SYSTEM. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23521135 ↗
  • MalfunctionNov 11, 2025Computer Software Problem; Computer Software Problem

    IT WAS REPORTED BY THE CUSTOMER THAT AT BD PYXIS¿ ANESTHESIA STATION SCREEN WAS FREEZING, USER COULD NOT ACCESS MEDICATIONS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23520709 ↗
  • MalfunctionNov 11, 2025Computer Operating System Problem; Computer Operating System Problem

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS ANESTHESIA ES SYSTEM HAD INCORRECT TIMES. TIMES WERE OFF ON SEVERAL PYXIS MACHINES, WHICH DELAYED NURSES¿ ABILITY TO PULL MEDICATIONS WHEN NEEDED AND AFFECTED CONTROLLED SUBSTANCE REPORTS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23520707 ↗
  • MalfunctionNov 11, 2025Computer Operating System Problem; Computer Operating System Problem

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS ANESTHESIA ES SYSTEM HAD TIMES OFF BY SEVERAL MINUTES, WHICH WAS DELAYING ABILITY FOR NURSES TO PULL MEDICATIONS WHEN NEEDED. THERE WAS DELAY IN ACCESS AND DISPENSING MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23520706 ↗
  • MalfunctionNov 11, 2025No Apparent Adverse Event; No Apparent Adverse Event

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES HAD DRAWER STRUCK AND DRAWER 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 23520675 ↗
  • MalfunctionNov 11, 2025Computer Software Problem; Computer Software Problem

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS ANESTHESIA ES SYSTEM WAS SHOWING STOCKOUTS ON THE VIEWER STATION. NURSE CANNOT PULL MEDICATION EXISTING IN DEVICE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23520257 ↗
  • MalfunctionNov 11, 2025No Apparent Adverse Event; No Apparent Adverse Event

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES DRAWER HAD SENSOR ISSUE. 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 23520234 ↗
  • MalfunctionNov 11, 2025Failure to Eject; Failure to Eject

    IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS ANESTHESIA ES SYSTEM EXPERIENCED A SHORT CIRCUIT ON CUBIE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23520154 ↗
  • MalfunctionNov 11, 2025Computer Software Problem; Computer Software Problem

    IT WAS REPORTED BY THE CUSTOMER THAT AT BD PYXIS¿ ANESTHESIA STATION ES WAS DOWN. THERE WAS 30 MINUTES DELAY. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23520139 ↗
  • MalfunctionNov 11, 2025Break; Application Network Problem; Break; Application Network Problem

    IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION ES STATION WENT OFFLINE. 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 23520119 ↗

Other CABINET, TABLE AND TRAY, ANESTHESIA devices

All CABINET, TABLE AND TRAY, ANESTHESIA devices →

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