N/A M1091365VSRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10190752135697), received between Oct 31, 2024 and May 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).

3 other recalls 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE T PIECE NEONATAL PATIENT CIRCUIT KITS WERE NOT REGISTERING A PEEP PRESSURE. NO HARM OR INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094981 ↗
• MalfunctionOct 31, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED, DURING AN ATTEMPT TO DO POSITIVE PRESSURE VENTILATION (PPV) WITH T-PIECE, [THE MEDICAL PROVIDER(S)] COULD NOT GET PRESSURE HIGH ENOUGH TO WORK AND DELIVER PROPERLY TO THE BABY. RESPIRATORY THERAPIST X 2 AND REGISTERED NURSE PRESENT. INSTEAD USED A MANUAL BAGGER AND WORKED ON BABY. THERE WAS A REPORTED DELAY IN CRITICAL CARE; HOWEVER, NO INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 20583819 ↗

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-0821-2025 · Dec 10, 2024 · Open, Classified
  Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
• Z-0004-2025 · Aug 30, 2024 · Open, Classified
  Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
• Z-0639-2016 · Oct 22, 2015 · Terminated
  Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit. The Neo-Tee T-Piece Resuscitator is a gas powered emergency resuscitator intended to provide emergency respiratory