regard Operative LAP — Class I medical device recall Z-0620-2024
Terminated recall by ROi CPS LLC, reported 2024-01-24, distributed in LA. Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
| Recall number | Z-0620-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2023-12-18 |
| Classified | 2024-01-12 |
| Reported by FDA | 2024-01-24 |
| Terminated | 2024-10-03 |
| Distributed | LA |
| Quantity | 345 units |
| UPC / GTIN / UDI-DI | 10194717111863 |
| Lot numbers | 94792, 95613, 96003, 96845 |
| Model numbers | 800943001 |
Product
regard Operative LAP, Item Number 800943001; surgical convenience kit
Reason for recall
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
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-0620-2024. 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.