Resp-O2 Pressure Line Adaptor, 22 mm OD x 22 mm ID Connections 34513Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840117340305), received between Jun 2, 2026 and Jun 2, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 2, 2026Manufacturing, Packaging or Shipping Problem

  FIRST EVENT 19-DEC-2025 IN THE INITIAL INCIDENT, THE PATIENT WAS ON A TRACHEOSTOMY COLLAR AND HAD BEEN PLACED ON A NEW AIRWAY CARE SETUP, WHICH INCLUDED THE PRESSURE LINE ADAPTER. AFTER BEING PLACED ON THIS SETUP, HE PATIENTS'S OXYGEN SATURATION LEVELS DECLINED. ALTHOUGH THE PATIENT IS NORMALLY OFF THE VENTILATOR, THE DESATURATION REQUIRED PLACEMENT ON A VENTILATOR FOR APPROXIMATELY TWELVE HOURS. SECOND EVENT 17-FEB-2026 A SECOND OCCURENCE WAS IDENTIFIED THIS WEEK, THE SAME PATIENT WAS INVOLVED. A RESPIRATORY THERAPIST NOTED BACK PRESSURE ON THE HUMIDIFIER, AND THE WATER BOTTLE WAS EXPANDING. THIS PROMPTED FURTHER INVESTIGATION, WHICH REVEALED AN OCCLUDED ADAPTOR. THE REPORT ISSUE INVOLVES THE ELBOW OF THE ADAPTOR. AT THIS LOCATION, PLASTIC MATERIAL WAS FOUND FULLY OCCLUDING THE TURN WITHIN THE ADAPTOR. NOTE: DYNAREX WAS NOT CONTACTED ABOUT THE FIRST EVENT AND WAS NOT AWARE OF IT UNTIL THE SECOND EVENT WAS REPORTED TO OUR ATTENTION. INCIDENT LOCATION: (B)(6). CONTACT: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360209 ↗