BD AlarisRecalls & reported problems across all models

We found 2 models of BD Alaris by Carefusion 303, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between May 28, 2024 and May 28, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer Operating System Problem” (1 report).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

BD Alaris recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Oct 17, 2025Class IOpen, Classified

   If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.

   Z-0430-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. Jul 8, 2025Class IOpen, Classified

   Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

   Z-2179-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported BD Alaris problems

BD Alaris models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• BD Alaris 8100

  Pump, infusion
  2 recalls0 reports
• BD Alaris 8015

  Pump, infusion
  1 report

Recent BD Alaris adverse event reports

The 1 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2024Device Alarm System; Computer Operating System Problem; Device Alarm System; Computer Operating System Problem

  IT WAS REPORTED THAT THE PC UNIT (SOFTWARE VERSION 12.3.1.2) HAD A SYSTEM ERROR (ERROR CODE 9-1513-202) DURING SIMULATION TESTING. THE USER WAS INITIALLY ATTEMPTED TO RECREATE AN ISSUE ¿WITHOUT A MAX IN THE PCA AND THEN ADDING IT IN AFTER THE INFUSION STARTED¿ AND THE USER WAS UNABLE TO RECREATE A SYSTEM ERROR AT THAT TIME¿. A FEW HOURS LATER, THE USER STATED THAT THE DEVICE ¿SUDDENLY GOT A SYSTEM ERROR¿. THE USER WAS UNABLE TO SILENCE THE ALARM. NONE OF THE MODULES WERE INFUSING AT THE TIME. THE PROGRAMMING THAT THE USER WAS DOING WAS ¿KETAMINE GREATER THAN 45KG CONCENTRATION 500MG/50ML PCA DOSE 10 MG LOCKOUT INTERVAL 15 MINUTES AND CONTINUOUS DOSE 15MG/HR. NO MAX AND THEN START AND ONCE STARTED WENT BACK AND ADDED A MAX¿. THE USER REPORTEDLY INITIALLY DID THIS SEVERAL TIMES WITHOUT AN ERROR. AS PREVIOUSLY STATED, A FEW HOURS LATER, WHILE SITTING IN STANDBY WITH DEVICE TURNED ON WITHOUT AN INFUSION RUNNING, IT WENT INTO SYSTEM ERROR. THERE WAS NO PATIENT INVOLVEMENT AS THE EVENT OCCURRED IN A TEST ENVIRONMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19402558 ↗

Other Carefusion 303, Inc. products

• BD Alaris Infusion System29 models · 1,242,913 reports · 16 recalls
• Alaris25 models · 1,236,345 reports · 16 recalls
• BD Pyxis26 models · 81,193 reports · 66 recalls
• Pyxis5 models · 7,862 reports · 16 recalls
• BD Alaris PCU Model 80153 models · 4,071 reports · 2 recalls
• BD Alaris Syringe Module, Model 81102 models · 3,183 reports · 2 recalls
• BD Alaris PCU Module, Model 80152 models · 3,078 reports · 3 recalls
• Alaris PCA Module, Model 81202 models · 918 reports · 2 recalls