Neo-Tee T-Piece Resuscitator 10-50811Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10641043508114), received between Dec 5, 2017 and Jan 7, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

2 FDA recall records name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K093913); 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.

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. 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 ↗

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.

• MalfunctionJan 7, 2026

  WOULD NEVER ALLOW YOU TO SET A PEEP [POSITIVE END-EXPIRATORY PRESSURE]. TRIED SEVERAL DIFFERENT RADIANT WARMERS TO MAKE SURE, FLOW WAS SET TO 10LPM, ABLE TO GET A PIP [PEAK INSPIRATORY PRESSURE] LEVEL SET, BUT WHEN YOU TURN THE DIAL FOR PEEP IT STAYS AT 0 AND WILL NOT ALLOW FOR PEEP SO UNABLE TO GIVE CPAP [CONTINUOUS POSITIVE AIRWAY PRESSURE] TO NEWBORN INFANT. I TRIED SEVERAL WITH THIS LOT NUMBER AND THREE OF THEM WOULD NOT SET THE PEEP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23988450 ↗
• MalfunctionApr 9, 2020Device Slipped

  THE MANOMETER FALLS OUT OF THE PATIENT CIRCUIT, THERE IS NOTHING HOLDING IT IN PLACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9943310 ↗
• MalfunctionDec 5, 2017Device Operates Differently Than Expected

  UNABLE TO SET PIP OR PEEP ON DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7082183 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093913. One submission often covers many models, so check the product and lot details in each record.

• Z-0004-2025 · Aug 30, 2024 · Open, Classified
  Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.