Neo-Tee Resuscitator Spring Defect May Impair Pediatric Ventilation
Mercury Medical is recalling the Neo-Tee T-Piece Resuscitator due to an undersized spring in the circuit flow controller that may prevent reaching proper pressure ranges, potentially impairing emergency ventilation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall, which carries a minimum severity rating of 4. The defect affects a critical emergency respiratory support device for pediatric patients, where failure to maintain proper pressure ranges could result in inadequate ventilation. Although no injuries or deaths have been reported, the documented malfunction of essential emergency equipment warrants a Severe classification.
Plain-English summary
Mercury Medical is recalling the Neo-Tee T-Piece Resuscitator, an emergency respiratory support device for pediatric patients, due to a manufacturing defect in the circuit flow controller.
The device's flow controller was manufactured with an undersized spring, which may prevent the resuscitator from reaching the full range of positive end-expiratory pressure (PEEP) and positive inspiratory pressure (PIP) settings. This failure could result in loss of positive pressure and impaired ventilation of the patient.
The affected resuscitators total 37,370 units across multiple part numbers and lot codes. They have been distributed nationwide in the United States and internationally to Canada, the United Kingdom, France, Spain, Italy, Netherlands, Switzerland, Hungary, United Arab Emirates, Saudi Arabia, and Hong Kong.
Healthcare providers using these devices should contact Mercury Medical for information about replacement units or remediation options.
The recalled product
- Product
- Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
- Manufacturer
- Mercury Enterprises, Inc. dba Mercury Medical
- Hazard
- ventilation-impairment
- positive-pressure-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part/UDI-DI/Lot: 1050805/10641043508053
- 30641043508057/2421450805
- 2423550805
- 2423650805
- 2426750805
- 1050808/10641043508084
- 30641043508088/2426450808
- 2426750808
- 2426850808
- 2429050808
- 2429350808
- 1050809/10641043508091
- 30641043508095/2426450809
- 2426750809
- 2429050809
- 2429150809
- 2429350809
- 2429750809
- 2429850809
- 2430050809
Distribution
Distributed nationwide across the United States.
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