FDA Device recall Z-2685-2024
Regard Kit containing the Microtek decanter
- FDA Device
- Class II
- ongoing
- Published 2024-08-28
On 2024-08-28 the FDA classified a Class II recall of Regard Kit containing the Microtek decanter by Roi Cps, citing decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2685-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-17 |
| Published | 2024-08-28 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Roi Cps |
| Distribution | US |
Product
Regard Kit containing the Microtek decanter
Reason
Decanters may have pin holes and tears in sterile packaging that cannot be identified visually.
Identifiers
| code_info | Item Number: 830099009; UDI: 10194717116677; Lot number's 99206 (Expiration Date: 2024-09-15) and 100633 (Expiration Date: 2024-09-15) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2685-2024%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.