FDA Medical devices recall ·
Neo-Tee T-Piece Resuscitator recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0004-2025
- Date
- (initiated August 30, 2024)
- Company / brand
- Mercury Medical
11300 49th St N, Clearwater, FL, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1,300 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.
Why was it recalled?
Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Part Number: 1050805; UDI/DI: 10641043508053, 30641043508057; Lot Numbers: 2417650805, 2417750805. Part Number: 1050832; UDI/DI: 10641043508329, 30641043508323; Lot Numbers: 2423550832, 2417850832.
Distribution
US distribution to MI, FL, SC, PA, IN. International distribution to Albania.
States: Florida Indiana Michigan Pennsylvania South Carolina
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0004-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.