Use cautionMedical device recall · FDA · Published December 26, 2024
ROi CPS Newborn Kit Recall: Risk of Ineffective Ventilation
ROi CPS recalls newborn kits with Neo-Tee Resuscitator due to potential loss of positive pressure causing ineffective ventilation. Affected items have specific lot numbers and expiration dates.
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..
Take action
Contact the company
📍Recalling firmROi CPS LLC3000 E Sawyer Rd · Republic, MO 65738-2758
“ROi CPS Newborn Kit Recall: Risk of Ineffective Ventilation.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/53168-roi-cps-newborn-kit-recall-risk-of-ineffective-ventilation. Based on FDA recall #Z-1047-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1047-2025%22&limit=1).
ROi CPS LLC voluntarily recalled Newborn Kits containing Neo-Tee Resuscitators due to a potential loss of positive pressure impacting patient ventilation, according to the FDA. The agency announced the Class I recall on December 26, 2024.
Lot numbers: 104006 (Exp. 9/30/2026), 103486 (Exp. 8/31/2026)
Units affected: 414 kits
The hazard
The inline controller may use a spring out of specification, causing a loss of positive pressure that prevents the Neo-Tee Resuscitator and circuit from reaching required PIP and PEEP pressure ranges. This impacts effective patient ventilation.
Context
GovInfoNow's records show ROi CPS LLC has issued 27 other recalls since January 3, 2020. Recent brand recalls include medical convenience kits with Merit syringes on July 24, 2024, and Regard Kits with sterile packaging pin holes on June 17, 2024. Other recent recalls of similar products include Medline Hudson RCI Breathing Circuits (July 13, 2026), Draeger VentStar Resus Neo Neonatal Breathing Circuit (September 3, 2026), and Medline Breathing Circuits (July 13, 2026).
How to tell if you have this one
Check for lot numbers 104006 (expires 9/30/2026) or 103486 (expires 8/31/2026) on the kit's packaging. The kits are labeled as 'Newborn Kit containing Neo-Tee Resuscitator' for Labor and Delivery use.
Brand
ROi CPS
Product
regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Kit Lot Number
Look for lot numbers 104006 or 103486 on the kit's packaging to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in Missouri, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distribution was made to MO. There was no government/military/foreign distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Missouri.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1047-2025 (December 26, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1047-2025 to see it in context.
Plain-language summary written by qwen3:4b on September 23, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.