FDA Device recall Z-0251-2022
REGARD Core Biopsy Tray
- FDA Device
- Class II
- terminated
- Published 2021-11-24
On 2021-11-24 the FDA classified a Class II recall of REGARD Core Biopsy 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-0251-2022 |
| 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 Core Biopsy 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: 88004C, 87367C, 86986C, 83380C, 83062C, 82614C, 86178C and 85427C |
|---|
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-0251-2022%22
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