The Recall Desk
HighFDA (Devices)·Z-0971-2020·Announced 2020-02-12

Cook Inc. Recalls Urethral Dilator Sets Due to Wire Guide Loading Error

Cook Inc. is recalling Urethral Dilator Sets because the wire guide may load incorrectly, causing a stiff tip to be introduced into the patient instead of a flexible one.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of physical injury from a stiff tip entering the patient, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cook Inc. is recalling 13,388 units of the Urethral Dilator Set, Global Product No. G14185. The recall is due to a potential defect where the wire guide may be incorrectly loaded into the wire guide holder. This error could result in the stiff tip of the wire guide being introduced into the patient instead of the intended flexible tip.

The affected products were distributed domestically across the United States and internationally to numerous countries, including Australia, Canada, Germany, Japan, and the United Kingdom. The recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare providers and patients should stop using the affected Urethral Dilator Sets immediately. Users should contact Cook Inc. for instructions on how to return the product for a refund or replacement.

The recalled product

Product
Urethral Dilator Set, Global Product No. G14185
Manufacturer
Cook Inc.
Category
Medical Device — Urological
Hazard
Affected units
13,388

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • 8401849 8404945 8404946 8417702 8404946X

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 20 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 20 products in this recall →

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Same hazard · physical injury

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