Neo-Tee T-Piece Resuscitator 10-50805Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's 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, 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.

Recalls naming this device

1. Dec 10, 2024Class IOpen, Classified

   Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.

   Z-0821-2025 · Root cause: Process change control · Recall details · FDA record ↗

2. Aug 30, 2024Class IOpen, Classified

   Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

   Z-0004-2025 · Root cause: Process control · Recall details · FDA record ↗

3. Oct 22, 2015Class IITerminated

   Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient.

   Z-0639-2016 · Root cause: Device Design · Recall details · FDA record ↗