FDA Device recall Z-0250-2022
REGARD Basic Cataract tray
- FDA Device
- Class II
- terminated
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class II recall of REGARD Basic Cataract tray by Roi Cps, citing povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0250-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-10 |
| Published | 2021-11-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Roi Cps |
| Distribution | US |
Product
REGARD Basic Cataract tray
Reason
Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.
Identifiers
| code_info | Lots numbers: 88797G, 88392G, 87844G, 86422G and 83645F |
|---|
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-0250-2022%22
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