Recall archive / FDA device enforcement
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support. — FDA record Z-0004-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Aug 30, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
- Reason
- Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
- Classification
- Class I
- Recalling firm
- Mercury Enterprises, Inc. dba Mercury Medical
- Quantity
- 1,300 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0004-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Oct 9, 2024
- Recall initiation date
- Aug 30, 2024
- Center classification date
- Oct 2, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.