Regard — Class II medical device recall Z-0524-2021
Terminated recall by ROi CPS LLC, reported 2020-12-09, distributed nationwide. Labeling error, incorrect expiration date.
| Recall number | Z-0524-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2020-10-12 |
| Classified | 2020-12-02 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2021-05-13 |
| Distributed | Nationwide (US) |
| Quantity | 220 kits |
| Reason classes | labeling |
| Lot numbers | 78483C, 79932C, 81043C, 82586C, 83090C |
Product
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Reason for recall
Labeling error, incorrect expiration date.
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-0524-2021. 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.