CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report

Urethral Dilator Set, Global Product No. G14185 recalled by Cook

Cook is recalling Urethral Dilator Set, Global Product No. G14185, distributed nationwide in the US. The recall was initiated on 4 Jan 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes8401849 8404945 8404946 8417702 8404946X

Quantity recalled13388 total

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-0971-2020
FDA event ID: 82026
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 4 Jan 2019
FDA classified: 4 Feb 2020
Reported: 12 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

4 Jan 2019	Recall initiated by company
4 Feb 2020	Classified by FDA	+396 days
12 Feb 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Product as listed by the FDA

Urethral Dilator Set, Global Product No. G14185

Where it was distributed

Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.

Nationwide

Questions about this recall

Is Urethral Dilator Set, Global Product No. G14185 recalled?

Yes. Cook recalled Urethral Dilator Set, Global Product No. G14185 on 4 Jan 2019. The recall is Class II and its status is Terminated. Recall number Z-0971-2020.

Why was it recalled?

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Which lots are affected?

8401849 8404945 8404946 8417702 8404946X

Where was it sold?

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 21 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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