Device recall: regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit…

Class I FDA enforcement event 96094. Recall start date: 26 Dec 2024. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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..

Class I, in the words of FDA

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

ROi CPS LLC started this device recall on 26 Dec 2024. The firm address in the FDA record is in Republic, MO. FDA put the recall in Class I. FDA event 96094 has 1 product record. The first FDA enforcement report date is 12 Feb 2025. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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

Recalling firm

ROi CPS LLC, Republic, MO.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 96094: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1047-2025	regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.	414 kits	Class I	Ongoing	12 Feb 2025

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Device events that started in 2024: 970
Share of these events in Class I: 11%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 28

Other events of the firm

Other FDA enforcement events of ROi CPS LLC
Initiated	Product (first record)	Type	Class	Records
24 Jul 2024	regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009	Device	Class II	1
17 Jun 2024	Regard Kit containing the Microtek decanter	Device	Class II	1
18 Dec 2023	regard Operative LAP, Item Number 800943001; surgical convenience kit	Device	Class I	1
20 Nov 2023	Regard Dressing change kit, Item Number 800026006	Device	Class I	1
21 Sep 2023	Regard CV PK, Item Numbers a) 880289014, b) 880289015; cardiovascular convenience kit	Device	Class II	1
11 Sep 2023	GS0008 2Y - Burn Pack - STL, Item Number 880082025	Device	Class II	1
22 Mar 2023	Sterile surgical convenience kits: 1. regard Item Number: 880405003, GS01011C - General Laparoscopy; 2. regard Item Numb	Device	Class II	8
20 Oct 2022	regard LAMINECTOMY, NU01140, Item Number 900940; neuro surgery convenience kit	Device	Class II	40
3 Jun 2022	Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV	Device	Class II	2
20 May 2022	regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.	Device	Class II	1

ROi CPS LLC: all 28 events

Official channels

FDA enforcement report Z-1047-2025The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 96094. https://recallregister.com/fda/i/96094/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Distribution was made to MO. There was no government/military/foreign distribution.
What quantity of product is in FDA event 96094?: The FDA record gives this quantity: 414 kits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2024 have the same class?: 11% of the 970 device events that started in 2024 are in Class I.