Lower riskMedical device recall · FDA · Published April 23, 2021
CooperS: Koh Cup 3.5cm Model Recalled Due to Incorrect Packaging
CooperSurgical recalls Koh Cup 3.5cm model (P/N 34131-04) due to incorrect packaging. This model is not the required 3.0cm size and may cause improper use during vaginal procedures.
“CooperS: Koh Cup 3.5cm Model Recalled Due to Incorrect Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62740-coopers-koh-cup-3-5cm-model-recalled-due-to-incorrect. Based on FDA recall #Z-1686-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1686-2021%22&limit=1).
CooperSurgical, Inc. recalled The Ultem Polymeric Resin Koh Cup on April 23, 2021, according to the FDA. The device was incorrectly packaged with a 3.5cm cup instead of the required 3.0cm version.
How to tell if you have it
Brand: CooperSurgical
Product: The Ultem Polymeric Resin Koh Cup
Model Number: KCP-30-2
Lot Code: 280819
The hazard
The affected Koh Cups were incorrectly packaged with a 3.5cm Ultem Koh cup, P/N 34131-04, instead of the required 3.0cm Ultem Koh cup, P/N 34131-03.
Context
GovInfoNow's records show CooperSurgical, Inc. has issued 37 other recalls since October 6, 2017. Other recent recalls of similar products include the INCA Infant Nasal CPAP (August 11, 2026) and the Endosee System Convenience Kit (June 11, 2025). Additional recent recalls include the K-Systems R65 Trolley (November 15, 2024), Cook Rupsch-Uchida Liver Access Sets (November 26, 2025), W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis (May 22, 2026), and Cook Ring Transjugular Intrahepatic Access Sets (November 26, 2025).
How to tell if you have this one
Check the model number on the Koh Cup. The affected model is KCP-30-2 with lot number 280819. The incorrect size (3.5cm) was packaged instead of the required 3.0cm.
Brand
CooperSurgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Number
Look for the model number on the Koh Cup, which should be KCP-30-2 for the affected item.
Where it went and when
Where it was distributed
Distributed in 3 states.
Listed by the agency
Not listed
FDA distribution: “Domestic: UT, OH, DE” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Delaware, Ohio, Utah.
Recall timeline
FDA published this recall 40 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1686-2021 (April 23, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1686-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.