Regard NEWBORN KIT — Class II medical device recall Z-2167-2021
Terminated recall by ROi CPS LLC, reported 2021-08-11, distributed in MO. Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away
| Recall number | Z-2167-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2021-06-14 |
| Classified | 2021-07-30 |
| Reported by FDA | 2021-08-11 |
| Terminated | 2023-03-08 |
| Distributed | MO |
| Quantity | 608 units |
| Lot numbers | 71562J, 73679J, 74808J, 75222J |
| Model numbers | 830016010 |
Product
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.
Reason for recall
Instructions for use updated to include the following cautionary statement for the heel warmer, "Activate away from the user's face and away from the infant and others."
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-2167-2021. 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.