OxyMask™ O2/EtCO2 Adult Mask with Microstream™ connector OM-2125-MDTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10620974002274), received between Nov 5, 2024 and Nov 5, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Low Readings” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K014211); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, THE UNIT HAD LOW READING OF 25-28MMHG WITH NO O2 SUPPLEMENTATION. IT WAS TESTED BY THE USER AND PLUGGED INTO A MODULE MONITOR WITH SAME RESULT THEN BETWEEN 15-20MMHG WITH O2 AT 10L/MIN AND 10MMHG WHEN O2 RUNNING AT 15L/MIN. ANOTHER TYPE OF DEVICE WAS USED TO CHECK ETCO2 READINGS, AND THE READING WAS 35-38MMHG. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20615490 ↗
• MalfunctionNov 5, 2024Unable to Obtain Readings; Low Readings; Unable to Obtain Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE GAVE NO READINGS. THE BASE LINE WAS RESET AND IT WAS SET AT 20MMHG. IT RESULTED A VALUE OF 15 THAT WAS VERY FAR OFF THE BASELINE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20613038 ↗
• MalfunctionNov 5, 2024Low Readings; Low Readings

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PATIENT HAD A PROCEDURAL SEDATION AND THE DEVICE WAS USED TO MEASURE END TIDAL CO2 AND TO PROVIDE OXYGEN TO THE PATIENT. THE READING OF THE ETCO2 WAS 10-11MMHG ON APPROXIMATELY 15L/MIN OF O2 AND WAS ALSO READING APNOEIA WHEN THE PATIENT WAS NOT APNOEIC. THE NURSE TRIED TURNING DOWN THE O2 TO ZERO AND MAKING SURE THE POSITION OF THE MASK WAS EXACT HOWEVER, THE READING DID NOT GET ANY MORE ACCURATE AND CONTINUED READING LOW. THE DEVICE WAS REMOVED AND REPLACED WITH A CAPNOLINE AND A HUDSON MASK WAS PLACED OVER THE TOP FOR ADDITIONAL O2 SUPPLEMENTATION. THIS WORKED WELL AND THE ETCO2 READING WERE APPROPRIATE. AT THE END OF THE PROCEDURE THE NURSE ATTEMPTED TO USE THE DEVICE AGAIN AND SHE REPORTED THAT THE READING WAS BETTER THE SECOND TIME AROUND AND THE WAVEFORM WAS PRESENT HOWEVER, THE ETCO2 READING WAS STILL BELOW NORMAL. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20611814 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K014211. One submission often covers many models, so check the product and lot details in each record.

• Z-1288-2018 · Oct 17, 2017 · Terminated
  Southmedic Oxygen Masks with EtCO2 sampling line part number OM-2125-8, 25 masks per case. Minimal contact, open oxygen delivery device for use with USP medical grade oxygen and f