regard Item Number: 830106006 — Class I medical device recall Z-1047-2025
Ongoing recall by ROi CPS LLC, reported 2025-02-12. There is a potential for the Inline Controller to be using the spring out of specification causing a loss of p
| Recall number | Z-1047-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2024-12-26 |
| Classified | 2025-02-04 |
| Reported by FDA | 2025-02-12 |
| Quantity | 414 kits |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 10194717119074 |
| Lot numbers | 103486, 104006 |
| Model numbers | 830106006, LD01114F |
| Expiration dates | 2026-08-31, 2026-09-30 |
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..
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1047-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.