FDA Device recall Z-0004-2025
Neo-Tee T-Piece Resuscitator
- FDA Device
- Class I
- ongoing
- Published 2024-10-09
On 2024-10-09 the FDA classified a Class I recall of Neo-Tee T-Piece Resuscitator by Mercury Enterprises, citing manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0004-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-08-30 |
| Published | 2024-10-09 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Mercury Enterprises |
| Distribution | FL, IN, MI, PA, SC |
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.
Identifiers
| code_info | Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 105083…Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0004-2025%22
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