Regard Dressing Change Tray — Class II medical device recall Z-1542-2021
Terminated recall by ROi CPS LLC, reported 2021-05-19, distributed nationwide. ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package in
| Recall number | Z-1542-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2021-03-26 |
| Classified | 2021-05-07 |
| Reported by FDA | 2021-05-19 |
| Terminated | 2023-01-30 |
| Distributed | Nationwide (US) |
| Quantity | 272 trays |
| Reason classes | packaging |
| Lot numbers | 86356C, 86983C, 87081C |
Product
Regard Dressing Change Tray
Reason for recall
ChloraPrep applicators in the kit can grow organisms that can result in a breach of the applicators package integrity.
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-1542-2021. 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.