BCIRecalls & reported problems across all models

We found 31 models of BCI by Icu Medical, Inc. in the FDA's device registry (GUDID). Together they are named in 421 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2017 and Aug 13, 2026 — classified as 2 injuries, 419 malfunctions.

The most frequently reported specific device problem is “Device Alarm System” (84 reports).

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

BCI 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. Feb 14, 2025Open, Classified

   Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

   Z-1405-2025 · Root cause: Process control · Recall details · FDA record ↗

2. Feb 14, 2025Open, Classified

   Airway adapter does not meet specification and may break off when attaching a valve or tube. Device failure may result in inaccurate readings, a break in airway circuit, and loss of ventilation. A break in the airway circuit could result in inability to ventilate, hypoxia, cardiopulmonary collapse, or death.

   Z-1404-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported BCI problems

BCI models

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

• BCI 8401

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  100 reports
• BCI 9004050

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  52 reports
• BCI WW1100

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  1 recall2 reports
• BCI WW8214

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  1 recall0 reports
• BCI 8400

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  35 reports
• BCI WW1030EN

  Oximeter
  34 reports
• BCI 8400D

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  29 reports
• BCI WW1000EN

  Oximeter
  28 reports
• BCI 9004051

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  24 reports
• BCI WW1000A1EN

  Oximeter
  21 reports
• BCI 3301A1

  Oximeter
  16 reports
• BCI 3043

  CATHETER, INTRAVASCULAR, DIAGNOSTIC
  14 reports
• BCI 9004000

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  10 reports
• BCI 6004001

  SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
  8 reports
• BCI WW3078

  Oximeter
  8 reports
• BCI WW1030P1EN

  Oximeter
  8 reports
• BCI 3311

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  6 reports
• BCI WW1020EN

  Oximeter
  4 reports
• BCI 9004002

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  3 reports
• BCI 1303

  Oximeter
  3 reports
• BCI 3304

  Oximeter
  2 reports
• BCI 9004003

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  2 reports
• BCI 9004001

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  2 reports
• BCI 920654230A

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  2 reports
• BCI 3025

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  2 reports
• BCI 6004006

  SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
  1 report
• BCI 9004005

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  1 report
• BCI 9004007

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  1 report
• BCI 1121

  ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
  1 report
• BCI WW1020A1EN

  Oximeter
  1 report
• BCI WW1020P1EN

  Oximeter
  1 report

Recent BCI adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Fire; Temperature Problem

  It was reported that the AC adapter caught fire and the plastic piece that goes into the bottom in the device melted. When the BCI Spectro2 Pulse Oximeter was connected to the AC adapter, the facility had noticed a burning smell followed by a plastic smell. The facility immediately investigated and observed that the connector was hot to touch, the plastic connector was melted and the metal at the connector was burnt. It burned the night stand too. There were patient involvement and no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241671 ↗
• MalfunctionSep 9, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE WAS SHOWING ERROR OF "SR ERR". THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23007307 ↗
• MalfunctionMay 15, 2025Circuit Failure; Circuit Failure

  IT WAS REPORTED THAT IT IS DISPLAYING MESSAGE NEW TIDAL CO2 MODULE, AND CRACKING IN THE PLASTIC SCREEN MODULE. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22031707 ↗
• MalfunctionMay 1, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE DEVICE WAS SHOWING A SENSOR ERROR MESSAGE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942506 ↗
• MalfunctionMay 1, 2025Failure to Recalibrate; Failure to Recalibrate

  IT WAS REPORTED THAT DEVICE FAILED GAS CALIBRATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942480 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT THE PARTS KEPT BREAKING IN HALF. THERE WERE 2 PATIENTS' INVOLVEMENT, AND NO PATIENT WAS HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777671 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT THE AIRWAY ADAPTER OF THE DEVICE BROKE IN HALF WHICH IS KNOWN AS A RECALL. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THE EVENT. THERE WAS ALSO NO MEDICAL INTERVENTION. HOWEVER, THE CARE TEAM NEEDED TO KEEP ADJUSTING AIRWAY ADAPTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777213 ↗
• MalfunctionMar 31, 2025Low Readings; Low Readings

  CORRECTION: THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21734554 ↗
• MalfunctionJan 15, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT UPON POWER UP "CAN'T GET PAST THE CODE. TRIED TO RESTART THE DEVICE DIDN'T FIX THE ISSUE. GOT ERROR ERR 18 OXIM_INIT". NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158241 ↗
• MalfunctionJan 14, 2025Failure to Calibrate; Failure to Calibrate

  IT WAS REPORTED THAT DURING START-UP THE DEVICE WOULD NOT CALIBRATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147836 ↗
• MalfunctionJan 9, 2025Output below Specifications; Output below Specifications

  IT WAS REPORTED THAT THE MONITORING DEVICE HAD A "LOW O2 UNSTABLE" ERROR. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118046 ↗
• MalfunctionJan 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE MONITORING DEVICE PRODUCED THE INCORRECT VALUE. EVENT OCCURRED WHILE IN USE WITH THE PATIENT, DURING PATIENT ADMINISTRATION. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069285 ↗
• MalfunctionJan 3, 2025Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED THAT THE MONITORING DEVICE HAD AN ERROR WITH THE CO2 SENSOR. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21069284 ↗
• MalfunctionJun 11, 2024Device Alarm System; Device Alarm System

  IT WAS REPORTED THAT THE DEVICE HAS HIGH CO2 SENSOR ERROR ALARM. THE EVENT OCCURRED DURING PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19511089 ↗
• MalfunctionJun 11, 2024Failure to Sense; Calibration Problem; Failure to Sense; Calibration Problem

  IT WAS REPORTED THAT THE CO2 SENSOR FAILED DURING HIGH CALIBRATION. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19510962 ↗

Other Icu Medical, Inc. products

• CADD123 models · 53,012 reports · 21 recalls
• Medfusion16 models · 13,114 reports · 5 recalls
• Bivona469 models · 2,811 reports · 29 recalls
• Level 152 models · 3,733 reports · 1 recall
• Portex409 models · 3,479 reports · 5 recalls
• Cleo6 models · 2,782 reports
• Pneupac23 models · 1,972 reports
• Medex98 models · 774 reports · 23 recalls