CLASS I ONGOING Device recall · Reported 9 Oct 2024 · FDA Enforcement Report
Neo-Tee T-Piece Resuscitator recalled by Mercury Enterprises
Mercury Enterprises is recalling Neo-Tee T-Piece Resuscitator, distributed in Florida, Indiana, Michigan, Pennsylvania, South Carolina. The recall was initiated on 30 Aug 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0004-2025
- FDA event ID
- 95303
- Recalling firm
- Mercury Enterprises, Clearwater, FL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 30 Aug 2024
- FDA classified
- 2 Oct 2024
- Reported
- 9 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- CPAP & Ventilators
Timeline
| 30 Aug 2024 | Recall initiated by company | |
| 2 Oct 2024 | Classified by FDA | +33 days |
| 9 Oct 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
Product as listed by the FDA
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Where it was distributed
US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
Questions about this recall
Why was it recalled?
Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
Which lots are affected?
Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.
Where was it sold?
US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Mercury Enterprises
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Neo-Tee T-Piece Resuscitator recalled by Mercury Enterprises | Mercury Enterprises | Other | Nationwide |
| Device | CLASS II | Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit recalled | Mercury Enterprises | Device Malfunction | Nationwide |
Other CPAP & Ventilators recalls
All 554| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS I | Inca (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP recalled | CooperSurgical | Other | Nationwide |
| Device | CLASS II | Medline Hudson Rci, Dbd-circuit,Vent,Inspiratory,Heated,Neo recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Getinge Y Sensor Module, Servo-u, Servo recalled | Maquet Critical Care AB | Device Malfunction | Nationwide |
| Device | CLASS II | Biofire Respiratory Panel 2.1 (RP2.1) recalled by BioFire Diagnostics | BioFire Diagnostics | Other | Nationwide |