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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "There is a potential for the Inline Controller to be using the spring out of specification causing a loss of positive pressure resulting in the Neo-Tee Resuscitator and/or Circuit will not reach the high and low ends of the PIP and PEEP…"
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
- Affected units
- 414
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:
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