# FDA recall Z-1047-2025

> **ROi CPS LLC** · Class I · device recall initiated 2024-12-26.

## Product

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

## 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..

## Distribution

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

## Key facts

- **Recall number:** Z-1047-2025
- **Recalling firm:** ROi CPS LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-26
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Republic, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1047-2025

## Citation

> AI Analytics. FDA recall Z-1047-2025. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1047-2025. Source: US FDA. Licensed CC0.

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