FDA Device recall Z-1686-2021
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator
- FDA Device
- Class II
- ongoing
- Published 2021-06-02
On 2021-06-02 the FDA classified a Class II recall of The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator by Coopersurgical, citing the affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1686-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-23 |
| Published | 2021-06-02 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Coopersurgical |
| Distribution | DE, OH, UT |
Product
The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
Reason
The affected Koh Cup were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of a 3.0cm Ultem Koh cup, P/N 34131-03 as required.
Identifiers
| code_info | Lot 280819 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1686-2021%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.