ROi CPS LLC: Medical Device Recall in 2025 - (Recall #: Z-1047-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

Product Classification:

Class I

Date Initiated: December 26, 2024

Date Posted: February 12, 2025

Recall Number: Z-1047-2025

Event ID: 96094

Reason for Recall:

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 pressure ranges impacting effective ventilation of the patient..

Status: Ongoing

Product Quantity: 414 kits

Code Information:

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 Pattern:

Distribution was made to MO. There was no government/military/foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated