FDA Device recall Z-0524-2021
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument
- FDA Device
- Class II
- terminated
- Published 2020-12-09
On 2020-12-09 the FDA classified a Class II recall of Regard - Product Usage: Obstetric Gynecologic specialized manual instrument by Roi Cps, citing labeling error, incorrect expiration date.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0524-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-10-12 |
| Published | 2020-12-09 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Roi Cps |
| Distribution | US |
Product
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
Reason
Labeling error, incorrect expiration date.
Identifiers
| code_info | Lot Numbers: 78483C, 79932C, 81043C, 82586C, 83090C. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0524-2021%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.