FDA Device recall Z-0299-2023
regard MAJOR CRANI, NU00921E, Item Number 800716005
- FDA Device
- Class II
- terminated
- Published 2022-11-30
On 2022-11-30 the FDA classified a Class II recall of regard MAJOR CRANI, NU00921E, Item Number 800716005 by Roi Cps, citing surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0299-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-10-20 |
| Published | 2022-11-30 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | FL, LA, MO, NC |
Product
regard MAJOR CRANI, NU00921E, Item Number 800716005; neuro surgery convenience kit
Reason
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Identifiers
| code_info | UDI/DI 10174717110880, Lot Numbers: 91522, exp 2/7/2023; 91118, exp 10/18/2023; 91705, exp 12/30/2023; 92034, exp 1/26/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0299-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.