Regard — Class II medical device recall Z-0469-2022
Terminated recall by ROi CPS LLC, reported 2022-01-19, distributed nationwide. Kits lacks rubber latex warning label.
| Recall number | Z-0469-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2021-11-30 |
| Classified | 2022-01-10 |
| Reported by FDA | 2022-01-19 |
| Terminated | 2023-08-07 |
| Distributed | Nationwide (US) |
| Quantity | 195 kits |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 10194717110804, 10194717112730 |
| Lot numbers | 89090D, 89378 |
| Model numbers | 8800313004, 8800313005 |
| Expiration dates | 2023-07-15, 2023-08-05 |
Product
Regard, T AND A - Rogers, sterilized convenience kits
Reason for recall
Kits lacks rubber latex warning label.
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-0469-2022. 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.