Regard Dressing change kit — Class I medical device recall Z-0596-2024
Terminated recall by ROi CPS LLC, reported 2024-01-10, distributed nationwide. ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was
| Recall number | Z-0596-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2023-11-20 |
| Classified | 2024-01-03 |
| Reported by FDA | 2024-01-10 |
| Terminated | 2024-08-05 |
| Distributed | Nationwide (US) |
| Quantity | 1,830 units |
| UPC / GTIN / UDI-DI | 10194717107873 |
| Lot numbers | 94270, 94435, 94769, 95508, 96961, 97081, 97405, 97591, 98283 |
| Model numbers | 800026006 |
Product
Regard Dressing change kit, Item Number 800026006
Reason for recall
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
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-0596-2024. 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.