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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices

Neo-Tee T-Piece Resuscitators Recalled for Ventilation Pressure Failure

Agency Publication Date: January 10, 2025
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Summary

Mercury Medical is recalling approximately 37,370 Neo-Tee T-Piece Resuscitators used for pediatric emergency respiratory support. These gas-powered devices contain an undersized spring in the circuit flow controller that may prevent the resuscitator from reaching the required high and low pressure ranges (PIP and PEEP). This defect can cause a loss of positive pressure, which prevents the device from effectively ventilating the patient during an emergency. No injuries have been reported to date.

Risk

The undersized spring can cause the device to fail to reach or maintain critical ventilation pressure levels. This failure impacts the effective ventilation of pediatric patients, potentially leading to respiratory distress or insufficient oxygenation during life-saving procedures.

What You Should Do

  1. This recall affects Neo-Tee T-Piece Resuscitators used for pediatric emergency respiratory support, involving multiple part numbers and batch lots.
  2. Check your medical equipment for Part Numbers: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, or 1050842.
  3. To confirm if your specific units are affected, check the UDI-DI and lot numbers printed on the device label or packaging. See the Affected Products section below for the full list of affected codes.
  4. Stop using the recalled devices immediately and remove them from clinical service.
  5. Contact Mercury Medical or your medical device distributor to arrange for the return, replacement, or correction of your affected resuscitators.
  6. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support
Model / REF:
1050805
1050808
1050809
1050810
1050811
1050814
1050832
1050839
1050840
1050841
1050842
Lot Numbers:
2421450805
2423550805
2423650805
2426750805
2426450808
2426750808
2426850808
2429050808
2429350808
2426450809
2426750809
2429050809
2429150809
2429350809
2429750809
2429850809
2430050809
2430250809
2426750810
2429350810
2429750810
2429850810
2430250810
2426550811
2426650811
2426750811
2429050811
2429150811
2429250811
2429350811
2429450811
2429750811
2429850811
2429950811
2430250811
2426450814
2426750814
2429050814
2429750814
2430250814
2429050832
242985083
2430350839
2429050840
2429750840
2429050841
2426750842
UDI:
10641043508053
30641043508057
10641043508084
30641043508088
10641043508091
30641043508095
10641043508107
30641043508101
10641043508114
30641043508118
10641043508145
30641043508149
10641043508329
30641043508323
10641043508398
30641043508392
10641043508404
30641043508408
10641043508411
30641043508415
10641043508428
30641043508422

Quantity affected: 37,370 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95967
Status: Active
Manufacturer: Mercury Enterprises, Inc. dba Mercury Medical
Sold By: Mercury Medical; Medical device distributors
Manufactured In: United States
Units Affected: 37370
Distributed To: Pennsylvania, Florida, Indiana, Wisconsin, Maine, South Carolina, Wyoming, Idaho, Montana, Texas, Michigan, Louisiana, Mississippi, Arkansas, West Virginia, Maryland, Kentucky, New Jersey, Washington, California, Georgia, Missouri, Massachusetts, North Carolina, Nevada, Tennessee, Virginia, Oklahoma, North Dakota, Minnesota, Alabama, Hawaii, Utah, New York, Arizona, Illinois, Ohio, Iowa, Nebraska, Connecticut, Alaska, Oregon

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.