Z-1686-2021Class II

The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of...

Name: Z-1686-2021 The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of...
Creator: CooperSurgical, Inc.
Published: 2021-04-23
License: https://open.fda.gov/license/

CooperSurgical, Inc. / initiated 2021-04-23 / Open, Classified / root cause: labeling and UDI

FDA source

CooperSurgical, Inc. began a recall of 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... on 2021-04-23. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1686-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-04-23
Posted: 2021-05-26
Recalling firm: CooperSurgical, Inc.
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
Product code: HEW Culdoscope (And Accessories)
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 04/30/2021, Cooper Surgical issued an Urgent Medical Device Removal notice to customers via letter notifying them Cooper Surgical is issuing this recall due to a labeling discrepancy with respect to the cup size, where a 3.5cm Ultem Cup was placed in the Product rather than a 3.0cm Ultem Cup as indicated by the Part Number on the packaging label.
Quantity in commerce: 6 boxes or 12 units
Distribution: Domestic: UT, OH, DE
Product codes and lots: Lot 280819

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1686-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1686-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-06-02	2021-05-26

Product code HEW

K954311Class IIKoh Colpotomizer SystemCooperSurgical, Inc. / cleared 1996-11-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)