Alaris 8300 (UDI 10885403830013)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8,444 adverse event reports that list this exact device (DI 10885403830013), received between Feb 9, 2018 and Sep 15, 2026 — classified as 2 deaths, 8 injuries, 8,434 malfunctions.

The most frequently reported specific device problem is “Break” (3,037 reports).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K031741); they may or may not involve this specific model.

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.

Recalls naming this device

1. Aug 15, 2024Open, Classified

   Due to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or monitoring.

   Z-3140-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 8,444 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Failure to Calibrate

  It was reported that a failure was observed during a planned preventive maintenance or recall remediation service event. There was no reported patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50766772 ↗
• MalfunctionApr 17, 2026Failure to Calibrate

  IT WAS REPORTED THAT THE DEVICE HAD NOT SAVING MAINTENANCE DATE AFTER PM. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24909162 ↗
• MalfunctionApr 13, 2026Inadequate or Insufficient Training

  IT WAS REPORTED THAT THE 8300 FAILED CO2 CALIBRATION TEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24854147 ↗
• MalfunctionMar 30, 2026No Device Output

  IT WAS REPORTED THAT THE DEVICE HAD LEAK DOWN TEST IS FAILING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24727164 ↗
• MalfunctionMar 30, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE HAD ERROR CODE: 571. 6241. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726728 ↗
• MalfunctionMar 30, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE HAD RIGHT SIDE OF THE GAS INLET/OUTLET DOOR IS EXPANDED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711878 ↗
• MalfunctionMar 30, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE HAD TOP OF GAS INLET/OUTLET DOOR IS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24711832 ↗
• MalfunctionMar 24, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679963 ↗
• MalfunctionMar 19, 2026Failure to Calibrate

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24636078 ↗
• MalfunctionMar 11, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE HAD FAILED SENSOR CALIBRATION, 'UNKNOWN ERROR'. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567445 ↗
• MalfunctionFeb 3, 2026Calibration Problem

  IT WAS REPORTED THAT THE DEVICE HAD CO2 FUNCTION NOT WORKING - INACCURATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24244189 ↗
• MalfunctionJan 29, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24208080 ↗
• MalfunctionJan 29, 2026Inadequate or Insufficient Training

  IT WAS REPORTED THAT 8300 ERROR CODE 570.6500. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207458 ↗
• MalfunctionJan 29, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24207154 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT THE CUSTOMER REQUESTED ASSISTANCE IN INTERPRETING THE LOGS FOR PCA AND ETCO2 MODULES. SPECIFIC TIME UNDER REVIEW IS FROM (B)(6) 2025 THRU (B)(6) 2025. CUSTOMER STATES THEY ARE TRYING TO UNDERSTAND WHEN THE ETCO2 MODULE WAS ACTIVATED AND MONITORING THE PATIENT VERSUS NOT MONITORING THE PATIENT. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24127315 ↗
• MalfunctionJan 16, 2026Corroded; No Device Output

  IT WAS REPORTED THAT THE DEVICE HAD LEAK TEST FAILURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24093065 ↗
• MalfunctionJan 8, 2026Device Alarm System

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTATIVE MAINTENANCE, RECALL REMEDIATION, OR REPAIR ORDER SERVICE EVENT. [DEPOT REPAIR];[PUMP SHOWING ERROR - 571.6241]. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24000222 ↗
• MalfunctionJan 2, 2026Calibration Problem

  IT WAS REPORTED THAT THE DEVICE HAD FAILS CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23942860 ↗
• MalfunctionJan 1, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE HAD IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23940935 ↗
• MalfunctionDec 31, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE HAD IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933194 ↗
• MalfunctionDec 31, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932825 ↗
• MalfunctionDec 31, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE HAD IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932679 ↗
• MalfunctionDec 31, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE HAD IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932668 ↗
• MalfunctionDec 31, 2025Communication or Transmission Problem; Communication or Transmission Problem

  IT WAS REPORTED THAT THE DEVICE HAD IT WAS REPORTED THAT A FAILURE WAS OBSERVED DURING A PLANNED PREVENTIVE MAINTENANCE OR RECALL REMEDIATION SERVICE EVENT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23932667 ↗
• MalfunctionDec 30, 2025Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE 8300 DID NOT START THE WARMUP AND FAILED PREVENTIVE MAINTENANCE DURING RATE ACCURACY TEST GIVING AN UNKNOWN ERROR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931650 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031741. One submission often covers many models, so check the product and lot details in each record.

• Z-2443-2019 · Jul 1, 2019 · Terminated
  Alaris EtCO2, Model 8300, UDI: 10885403830013, CareFusion for models 11634567 and 8300ADXeN933
• Z-0455-2016 · Nov 12, 2015 · Terminated
  Alaris EtCO2 Module, Model 8300. A capnograph that continuously monitors end tidal carbon dioxide (EtCO2), fractional inspired carbon dioxide (FiCO2), and respiratory rate (RR).