CLASS II ONGOING Device recall · Reported 2 Jun 2021 · FDA Enforcement Report
The Ultem Polymeric Resin Koh Cup is a non- sterile recalled
CooperSurgical is recalling The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator, distributed in Delaware, Ohio, Utah. The recall was initiated on 23 Apr 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1686-2021
- FDA event ID
- 87849
- Recalling firm
- CooperSurgical, Trumbull, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Apr 2021
- FDA classified
- 26 May 2021
- Reported
- 2 Jun 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 23 Apr 2021 | Recall initiated by company | |
| 26 May 2021 | Classified by FDA | +33 days |
| 2 Jun 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Domestic: UT, OH, DE
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot 280819
Where was it sold?
Domestic: UT, OH, DE
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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