regard MAJOR CRANI — Class II medical device recall Z-0299-2023
Terminated recall by ROi CPS LLC, reported 2022-11-30, distributed in FL, LA, MO, NC. Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
| Recall number | Z-0299-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi CPS LLC, Republic, MO, United States |
| Recall initiated | 2022-10-20 |
| Classified | 2022-11-23 |
| Reported by FDA | 2022-11-30 |
| Terminated | 2026-04-01 |
| Distributed | FL, LA, MO, NC |
| Quantity | 146 units |
| Lot numbers | 91118, 91522, 91705, 92034 |
| Model numbers | 800716005 |
| Expiration dates | 2023-02-07, 2023-10-18, 2023-12-30, 2024-01-26 |
Product
regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit
Reason for recall
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
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-0299-2023. 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.