NA GF-210R (UDI 04931921106891)Recalls & reported problems

Summary

The FDA's MAUDE database contains 386 adverse event reports that list this exact device (DI 04931921106891), received between May 11, 2016 and Jun 22, 2026 — classified as 385 malfunctions.

The most frequently reported specific device problem is “Output Problem” (231 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 386 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE GF-210RA MULTI GAS UNIT IS EXPERIENCING INTERMITTENT READINGS. THEY REPLACED THE SAMPLING LINE TO CLEAR ANY POSSIBLE BLOCKAGE. THEY REPLACED THE WATER TRAP. THESE TROUBLESHOOTING STEPS DID NOT RESOLVE THE ISSUE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25580888 ↗
• MalfunctionJun 11, 2026Unable to Obtain Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BIOMED) REPORTED THAT THE MULTIGAS UNIT WAS GIVING "CHECK WATER TRAP" AND "SAMPLE LINE" ERROR MESSAGES RANDOMLY WHILE IN OPERATION. WHEN THIS HAPPENED, THE DEVICE WOULD NOT OPERATE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25477856 ↗
• MalfunctionApr 21, 2026Gas Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIGAS UNIT WAS NOT MEASURING END-TIDAL CO2 (ETCO2). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938847 ↗
• MalfunctionApr 16, 2026Unable to Obtain Readings; Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT AFTER RECEIVING THE MULTIGAS UNIT BACK FROM REPAIR ON TICKET (B)(4), IT WAS STILL GIVING AN "EXTERNAL DEVICE FAILURE" ERROR MESSAGE WHEN TESTING IT IN TWO SEPARATE ROOMS. THE DEVICE WAS NOT PUT INTO PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24898898 ↗
• MalfunctionApr 13, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE SUCTION TO PULL THE GAS INTO THIS MONITOR IS NO LONGER WORKING ON THE MULTIGAS UNIT.. HE STATED THEY ARE SEEING GAS NOT AVAILABLE. THEY SWAPPED THIS ONE OUT WITH A SPARE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24867010 ↗
• MalfunctionApr 13, 2026Gas Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIGAS UNIT RECEIVED A DEVICE ERROR MESSAGE WHILE IN PATIENT USE. NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24857573 ↗
• MalfunctionApr 1, 2026Display or Visual Feedback Problem; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT THIS MULTIGAS UNIT DISPLAYED A "GAS DEVICE ERROR" MESSAGE. THE ISSUE WAS DISCOVERED DURING SETUP. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756141 ↗
• MalfunctionMar 31, 2026Display or Visual Feedback Problem; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT THIS MULTIGAS UNIT DISPLAYED AN "EXTERNAL DEVICE FAILURE" ERROR MESSAGE. THE ISSUE WAS FOUND DURING SETUP. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747039 ↗
• MalfunctionMar 15, 2026Display or Visual Feedback Problem; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT THIS MULTIGAS UNIT DISPLAYED AN AIRWAY BLOCKED ERROR MESSAGE. THE ISSUE WAS DISCOVERED DURING SETUP. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601623 ↗
• MalfunctionMar 15, 2026Display or Visual Feedback Problem; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT THIS MULTIGAS UNIT DISPLAYED A GAS MODULE ERROR MESSAGE. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601620 ↗
• MalfunctionMar 15, 2026Display or Visual Feedback Problem; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT THIS MULTIGAS UNIT DISPLAYED A GAS MODULE ERROR MESSAGE. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24601605 ↗
• MalfunctionMar 6, 2026Unable to Obtain Readings; Output Problem

  THE CUSTOMER REPORTED THAT THE MULTIGAS UNIT GAVE A "GAS DEVICE ERROR" MESSAGE AND GAVE NO GAS READINGS. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533425 ↗
• MalfunctionMar 4, 2026Unable to Obtain Readings; Output Problem

  THE CUSTOMER REPORTED THAT THE MULTIGAS UNIT DID NOT DISPLAY A CO2 READING ON THE MONITOR WHILE IN PATIENT USE. THEY TRIED CHANGING OUT THE WATER TRAP, BUT THE ISSUE PERSISTED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24510183 ↗
• MalfunctionFeb 19, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTI-GAS UNIT WAS GIVING AN EXTERNAL DEVICE FAILURE ERROR. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24397136 ↗
• MalfunctionFeb 19, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTI-GAS UNIT WAS PROVIDING A EXTERNAL DEVICE FAILURE ERROR MESSAGE. THEY TRIED A NEW SAMPLING LINE AND A NEW WATER TRAP, BUT THERE WAS NO CHANGE. THIS ISSUE FOLLOWS THE GAS MODULE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24396070 ↗
• MalfunctionFeb 19, 2026Unable to Obtain Readings; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  THE MONITOR TECH REPORTED THAT THE MULTIGAS UNIT WOULD NOT TAKE A READING WHILE IN PATIENT USE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24389194 ↗
• MalfunctionFeb 19, 2026Pumping Problem

  THE CUSTOMER REPORTED THAT THIS MULTIGAS UNIT'S MOTOR APPEARS TO BE STRUGGLING AND GETTING VERY LOUD. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24388710 ↗
• MalfunctionFeb 11, 2026Display or Visual Feedback Problem; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT THIS MULTIGAS UNIT DISPLAYED A CHECK DEVICE ERROR MESSAGE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24314844 ↗
• MalfunctionFeb 10, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTI GAS UNIT WAS NOT GIVING READINGS WHEN CONNECTED TO A BEDSIDE MONITOR. THIS WAS DISCOVERED DURING A CASE, SO TROUBLESHOOTING WAS LIMITED BEFORE SWAPPING OUT THE UNIT. THEY TRIED SWAPPING CABLES WITH NO CHANGE. CUSTOMER SWAPPED THIS GAS UNIT WITH ANOTHER ONE AND DATA CAME ACROSS IMMEDIATELY, ISSUE APPEARS TO BE WITH THIS UNIT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310168 ↗
• MalfunctionFeb 6, 2026Gas Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE PUMP MOTOR FOR THE MULTIGAS UNIT WAS LOUD AND HAD INCONSISTENT PRESSURE WHILE IN PATIENT USE. NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24284807 ↗
• MalfunctionFeb 5, 2026Display or Visual Feedback Problem; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT THIS MULTIGAS UNIT DISPLAYED A GAS LINE BLOCKED ERROR MESSAGE. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269418 ↗
• MalfunctionJan 29, 2026Gas Output Problem

  THE CUSTOMER REPORTED THAT THIS MULTIGAS UNIT STOPPED WORKING, THE ISSUE WAS DISCOVERED AFTER THE CASE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24209609 ↗
• MalfunctionJan 26, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIGAS UNIT WILL NOT RUN, AND THERE IS A GAS LINE BLOCKED ERROR MESSAGE. THEY CAN HEAR THE PUMP RUN, THEN IT STOPS AND AN ERROR MESSAGES "GAS LINE BLOCKED" POPS UP ON THE BSM DISPLAY. CUSTOMER ALSO STATES THAT WHEN THE PUMP IS RUNNING, IT SOUNDS TERRIBLE, LIKE THE PUMP IS STRUGGLING. THE CUSTOMER VERIFIED THERE ARE NOT BLOCKED GAS LINES, THE UNIT IS RUNNING TO THE OPEN AIR, NO LINE CONNECTED AT ALL, AND THE ERROR MESSAGE STILL APPEARS AND THE PUMP STILL SOUNDS LIKE IT IS STRUGGLING. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24185651 ↗
• MalfunctionJan 22, 2026Display or Visual Feedback Problem; Image Display Error/Artifact

  THE CUSTOMER REPORTED THAT THIS MULTIGAS UNIT DISPLAYED A GAS DEVICE ERROR MESSAGE. THE UNIT WAS NOT IN PATIENT USE AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24145979 ↗
• MalfunctionJan 21, 2026Output Problem

  THE BIOMEDICAL ENGINEER (BME) REPORTED THAT THE MULTIGAS UNIT WAS GIVING A LINE BLOCK ERROR UPON POWERING IT ON, THEN IT PROGRESSED TO A GAS DEVICE FAILURE ERROR. THE CUSTOMER VERIFIED THAT THE LINES ARE CLEAR AND UNKINKED. THE CUSTOMER TRIED USING A BRAND-NEW WATER TRAP AND EVEN TRIED RUNNING WITHOUT A WATER-TRAP FOR TESTING AND NOTHING YIELDED ANY CHANGE IN BEHAVIOR. NOT IN PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24141485 ↗