Mercury Medical is removing certain Neo-Tee T-Piece resuscitators from where they’re used or sold after a defect in the device’s controller was found to potentially prevent proper ventilation.


RT’s Three Key Takeaways:

  1. Ventilation Issue Identified – Mercury Medical is recalling the Neo-Tee T-Piece resuscitator due to a defective spring in the controller that may prevent the device from delivering adequate pressure for effective ventilation.
  2. FDA’s Most Serious Recall Classification – The FDA has classified this recall as its most serious type, warning that use of the affected devices could lead to low oxygen levels, slow heart rate, high carbon dioxide levels, or death in pediatric patients.
  3. Immediate Action Required – Mercury Medical has instructed customers to stop use, quarantine affected devices, and notify all personnel who may have used or distributed the recalled products.

Mercury Enterprises Inc, doing business as Mercury Medical, is recalling the Neo-Tee T-Piece resuscitator due to a small spring in the controller that may prevent the device from delivering the required pressure levels needed for effective ventilation. This issue could reduce positive pressure, affecting the patient’s breathing support.

This recall involves removing certain devices from where they are used or sold. The US Food and Drug Administration has identified this recall as the most serious type. The use of the affected product may cause serious adverse health consequences, including low oxygen levels, slow heart rate, lack of oxygen, high carbon dioxide levels, and death. There have been no reported injuries or death associated with this issue.

The Neo-Tee T-Piece resuscitator is a gas-powered emergency resuscitator intended to provide emergency respiratory support by means of a facemask or a tube inserted into a patient’s airway. It is intended for use with pediatric patients weighing less than 10kg (22lbs). The device is designed with an in-line flow controller in the circuit.

On Dec 5, 2024, Mercury Medical sent all affected customers an Urgent Field Safety Notice recommending the following actions:

  • Immediately check the inventory for affected product within the scope of this recall
  • Stop use and distribution and immediately quarantine the affected product.
  • Provide a copy of this recall notice to all customers who have received impacted product. Notify all personnel subject to using these devices.

Full list of affected devices:

Part NumberUnique Device IDLot Number(s)
105080510641043508053, 306410435080572421450805, 2423550805, 2423650805, 2426750805
105080810641043508084, 306410435080882426450808, 2426750808, 2426850808, 2429050808, 2429350808
105080910641043508091, 306410435080952426450809, 2426750809, 2429050809, 2429150809, 2429350809, 2429750809, 2429850809, 2430050809, 2430250809
105081010641043508107, 306410435081012426750810, 2429350810, 2429750810, 2429850810, 2430250810
105081110641043508114, 306410435081182426550811, 2426650811, 2426750811, 2429050811, 2429150811, 2429250811, 2429350811, 2429450811, 2429750811, 2429850811, 2429950811, 2430250811
105081410641043508145, 306410435081492426450814, 2426750814, 2429050814, 2429750814, 2430250814,
105083210641043508329, 306410435083232429050832, 242985083
105083910641043508398, 306410435083922430350839
105084010641043508404, 306410435084082429050840, 2429750840
105084110641043508411, 306410435084152429050841
105084210641043508428, 306410435084222426750842

Customers in the US with questions about this recall should contact Mercury Medical at 1-727-573-0088.