Pyxis 338Recalls & reported problems
Carefusion 303, Inc. · Pyxis Anesthesia System 4000 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Pyxis anesthesia station stores and dispenses medications. The 24 reports mostly describe software problems, medication delays, drawers that fail to open or eject, and liquid spills or leaks; they include no deaths and no injuries. There are 3 open recalls involving a fingerprint scanner that may overheat, labeling about medication-access delays, and fluid entering the station and causing smoke, downtime or fire. Reports fell from 14 to 2 in the last 12 months compared with the previous 12 months.
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
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10885403477829), received between Mar 16, 2022 and Jul 28, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Computer Software Problem” (10 reports).
3 FDA recall records name this device's identifier, 3 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
Recalls naming this device
- Apr 30, 2026Open, Classified
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Z-2300-2026 · Root cause: Component design/selection · FDA record ↗
- 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 ↗
- Apr 15, 2024Open, Classified
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Z-1932-2024 · Root cause: Component design/selection · FDA record ↗
Most reported problems
Device problems
- Computer Software Problem10
- Failure to Eject3
- Application Program Problem2
- Electrical /Electronic Property Problem2
- Leak/Splash2
- Loose or Intermittent Connection2
- Application Program Freezes or Fails to Launch1
- Circuit Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information3
- Convulsion/Seizure1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2026Circuit Failure
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052041 ↗MalfunctionNov 13, 2025Flare or Flash; Flare or Flash
IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS ANESTHESIA 4000 SYSTEM HAD A VIAL OF PROPOFOL THAT BUSTED AND LEAKED INTO PYXIS OR12. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23541572 ↗MalfunctionOct 29, 2025Electrical /Electronic Property Problem; Loose or Intermittent Connection; Application Program Problem; Electrical /Electronic Property Problem; Loose or Intermittent Connection; Application Program Problem
IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION 4000 THE BIO ID HAD FAILED. 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 23413542 ↗MalfunctionOct 15, 2025Loose or Intermittent Connection; Application Program Problem; Loose or Intermittent Connection; Application Program Problem
IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION 4000, MEDICATION MENU HAD FAILED TO APPEAR WHEN THE DRAWER HAD BEEN OPENED, AND USERS HAD TO MANUALLY ENTER THE MEDICATION NAME TO PULL THE MEDICATION FROM THE DRAWER. THE CUSTOMER REPORTED THERE WAS A DELAY IN DISPENSING MEDICATIONS TO THE PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23286208 ↗MalfunctionAug 22, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED BY THE CUSTOMER THAT BD PYXIS¿ ANESTHESIA STATION 4000 POCKET HAD FAILED. UPON INVESTIGATION, THE FIELD SERVICE ENGINEER FOUND THAT THE MINI DRAWER HAD A SPILLED LIQUID. THE SPILLED LIQUID, WHICH CAUSED THE MINI DRAWER'S PATH TO OXIDIZE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22874221 ↗MalfunctionJul 25, 2025Leak/Splash; Failure to Eject; Leak/Splash; Failure to Eject
IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION 4000 HAD AN ISSUE WITH DRAWER POCKETS, STICKY RESIDUE PREVENTED THE POCKET TO EJECT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22613826 ↗MalfunctionJul 7, 2025Failure to Eject; Failure to Eject
IT WAS REPORTED THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION 4000, THE MINI DRAWER WOULD NOT OPEN. THE CUSTOMER REPORTED THAT THERE WAS A DELAY IN 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 22413598 ↗MalfunctionJun 25, 2025Computer Software Problem; Computer Software Problem
IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION 4000, THE STATION HAD A SHORT CIRCUIT AND STORAGE SPACE FAILURE. 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 22328222 ↗MalfunctionJun 6, 2025Difficult to Open or Close; Difficult to Open or Close
IT WAS REPORTED BY THE CUSTOMER THAT WHEN USING THE BD PYXIS¿ ANESTHESIA STATION 4000 SYSTEM, THE DRAWERS WOULD NOT CLOSE. 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 22161912 ↗MalfunctionMay 23, 2025Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION 4000 THE MINI SINGLE DRAWERS DID NOT OPEN ONE AT A TIME; INSTEAD, ALL OPENED AT ONCE. 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 DUE TO THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22080180 ↗MalfunctionMay 21, 2025Failure to Eject; Failure to Eject
IT WAS REPORTED BY THE CUSTOMER THAT BD PYXIS¿ ANESTHESIA STATION 4000 REQUIRED DRAWER TO BE CLEANED AS A PROPOFOL VIAL BROKEN AND LEAKED INTO THE SHAFT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22066717 ↗MalfunctionMay 7, 2025Computer Software Problem; Computer Software Problem
IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION 4000 MINI MATRIX DRAWERS OPENING MORE THAN 1 AT A TIME. THE CUSTOMER STATED THERE WAS A DELAY TO THE PATIENT'S WORKFLOW. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21977749 ↗MalfunctionMay 7, 2025Computer Software Problem; Computer Software Problem
IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION 4000 MINI MATRIX DRAWERS OPENING MORE THAN 1 AT A TIME. THE CUSTOMER STATED THERE WAS A DELAY TO THE PATIENT'S WORKFLOW. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21977746 ↗MalfunctionApr 28, 2025Computer Software Problem; Computer Software Problem
IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION 4000 HAD A STATION WAS NOT COMMUNICATING. THE CUSTOMER STATED THAT THERE WAS A DELAY IN DISPENSING MEDICATION TO A PATIENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21921815 ↗MalfunctionApr 25, 2025Computer Software Problem; Computer Software Problem
IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION 4000 PATIENT WAS NOT SHOWING ON THIS UNIT DURING THE PROCEDURE. NURSE WAS ABLE TO PULL MEDICINE FROM A DIFFERENT DEVICE. THE CUSTOMER STATED THAT THE PATIENT OR USER WAS INVOLVED, AND ISSUE CAUSED A ONE-MINUTE DELAY IN DISPENSING THE MEDICATIONS. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21909138 ↗MalfunctionApr 25, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED BY THE CUSTOMER THAT A BD PYXIS¿ ANESTHESIA STATION 4000 WAS NOT COMMUNICATING, AND DEVICE WAS IN OFFLINE. THE CUSTOMER TRIED TO REBOOT AND RECOVER, BUT THE ISSUE PERSISTED. THE CUSTOMER ADDED THIS MALFUNCTION CAUSED A DELAY IN DISPENSING THE MEDICATION TO THE PATIENT SINCE THEY HAD TO GET THE MEDICATIONS FROM ANOTHER STATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS INCIDENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21908796 ↗MalfunctionMar 27, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS ANESTHESIA ES SYSTEM DRAWER HANDLE COMPLETELY CAME OFF WHEN A USER TRIED TO OPEN IT, PREVENTING USERS FROM REMOVING MEDICATION AND AFFECTING PATIENT CARE. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18984735 ↗MalfunctionJan 5, 2024Computer Software Problem; Computer Software Problem
IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS ANESTHESIA ES SYSTEM UNEXPECTEDLY REBOOTED/SHUT OFF IN THE MIDDLE OF CASES. NO OTHER INFORMATION WAS RELEASED REGARDING THE EVENT. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18450493 ↗MalfunctionDec 28, 2023Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch
IT WAS REPORTED BY THE CUSTOMER THAT A PYXIS ANESTHESIA 4000 SYSTEM FROZE DURING A PROCEDURE, CAUSING A 5-MINUTE DELAY FOR A USER TRYING TO REMOVE MEDICATION. THE AFFECTED PROCEDURE WAS IRRIGATION DEBRIDEMENT TIBIA SURGERY AND FENTANYL THE REQUIRED MEDICATION. CUSTOMER STATED THAT THERE WAS NEITHER HARM NOR DISCOMFORT TO PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED AS THEY REBOOTED THE STATION TO REMOVE MEDICATION. THERE WERE NO ADVERSE EVENTS OR INJURIES REPORTED BASED ON THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18407512 ↗MalfunctionSep 27, 2022Human-Device Interface Problem; Human-Device Interface Problem
CUSTOMER REPORTED THAT A PYXIS ANESTHESIA 4000 SYSTEM BIOMETRIC SCANNER UNEXPECTEDLY STOPPED RESPONDING DURING A PROCEDURE, DELAYING USER ACCESS TO MEDICATION. THE NATURE OF THE PROCEDURE AND THE LENGTH OF THE DELAY WERE NOT DISCLOSED. PATIENT OR USER HARM WAS NOT REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15494221 ↗MalfunctionSep 8, 2022Computer Software Problem; Unintended Application Program Shut Down; Computer Software Problem; Unintended Application Program Shut Down
CUSTOMER REPORTED THAT A PYXIS ANESTHESIA 4000 SYSTEM EXPERIENCES CONTINUOUS SHUTDOWNS AND REBOOTS DURING USE. THE CUSTOMER STATED USER WAS UNABLE TO LOG IN TO DEVICE. THE LENGTH OF THE DELAY TO PATIENT CARE WAS NOT DISCLOSED. THE NATURE OF THE PROCEDURE WAS NOT DISCLOSED. THERE WAS NO REPORTED PATIENT OR USER HARM.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15384834 ↗MalfunctionAug 15, 2022Computer Software Problem; Computer Software Problem
CUSTOMER REPORTED THAT A PYXIS ANESTHESIA 4000 SYSTEM FINGERPRINT READER, UNEXPECTED STOPPED RESPONDING DURING A SCHEDULED HEMICOLECTOMY PREVENTING USER ACCESS TO THE STATION. CUSTOMER WAS ABLE TO RETRIEVE THE UNDISCLOSED REQUIRED MEDICATION FROM A NEARBY STATION. THE REPORTED DELAY TO PATIENT CARE WAS 5 MINUTES. PATIENT OR USER HARM WAS NOT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15223857 ↗MalfunctionMar 17, 2022Computer Software Problem; Computer Software Problem
CUSTOMER REPORTED THAT A PYXIS ANESTHESIA SYSTEM RECEIVED A DATABASE ERROR POPUP WHILE A PATIENT WAS ON THE TABLE. THIS ERROR CAUSED A DELAY TO PATIENT CARE. THE LENGTH OF THE DELAY TO PATIENT CARE WAS NOT DISCLOSED. THE NATURE OF THE PROCEDURE WAS NOT DISCLOSED. PATIENT OR USER HARM WAS NOT REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 13791607 ↗MalfunctionMar 16, 2022Computer Software Problem; Computer Software Problem
CUSTOMER REPORTED THAT A PYXIS ANESTHESIA SYSTEM 4000 REMAINED ON WINDOWS UPDATE SCREEN AFTER DEVICE WAS REBOOTED DURING A PROCEDURE. CUSTOMER REPORTED THAT THE APPLICATION DID NOT LAUNCH UPON REBOOT. USERS WERE PREVENTED FROM ACCESSING THE STATION. THE NATURE OF THE PROCEDURE WAS NOT DISCLOSED. CUSTOMER REPORTED NO ACTUAL HARM TO PATIENT, ONLY THAT PATIENT EXPERIENCED INDUCED SEIZURES LASTING 200 SECONDS.
Patient problems: Convulsion/Seizure; No Clinical Signs, Symptoms or Conditions
MAUDE report 13777545 ↗
Other CABINET, TABLE AND TRAY, ANESTHESIA devices
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- BD Pyxis 324Carefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA5 recalls1 death5,301 reports
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- Pyxis 327Carefusion 303, Inc. · Cabinet, table and tray, anesthesia1 death4,304 reports
- BD Pyxis MEDBANK-TOWERCarefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA30 recalls2,581 reports
- Pyxis 327Carefusion 303, Inc. · CABINET, TABLE AND TRAY, ANESTHESIA10 recalls3,137 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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