Newborn Resuscitator Kit Recalled for Inline Spring Defect
414 newborn resuscitator kits (ROi CPS LLC) recalled for a potential spring defect in the Inline Controller that could prevent proper ventilation pressure in labor and delivery settings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class I medical device with no reported illnesses or injuries. The hazard is theoretical—improper ventilation pressure in a neonatal resuscitator—qualifying as a risk-of-harm product per the High severity criterion.
Plain-English summary
ROi CPS LLC is recalling 414 Newborn Kits (Item Number 830106006, LD01114F) containing the Neo-Tee Resuscitator. These kits are convenience units designed for use in labor and delivery settings for neonatal resuscitation.
The Inline Controller in these kits may have a spring that is out of specification. This defect could cause a loss of positive pressure, preventing the resuscitator and circuit from reaching the proper PIP (positive inspiratory pressure) and PEEP (positive end-expiratory pressure) ranges. As a result, the device may not provide effective ventilation to newborns requiring resuscitation.
The affected lots are: Lot 104006 (expires 9/30/2026) and Lot 103486 (expires 8/31/2026). Distribution was limited to Missouri. Healthcare facilities using these kits should immediately verify the lot numbers and remove any affected units from service until corrective action is confirmed.
Facilities should contact ROi CPS LLC for guidance on device replacement or repair.
The recalled product
- Product
- regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.
- Manufacturer
- ROi CPS LLC
- Hazard
- spring-defect
- pressure-loss
- ventilation-failure
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 (6)
- Lot number 104006
- Exp. 9/30/2026
- UDI (01)10194717119074(17)260930(10)104006
- and Lot number 103486
- Exp. 8/31/2026
- UDI (01)10194717119074(17)260831(10)103486.
Distribution
Distributed in 1 state:
- MO
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