Cook Inc. Recalls Universa Firm Ureteral Stents Due to Loading Error
Cook Inc. is recalling Universa Firm Ureteral Stents because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into the patient instead of the flexible tip.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 the hazard involves a risk of physical harm (introduction of a stiff tip) where specific injury reports are not detailed in the source text, fitting the 'High' criteria for risk-of-harm products.
Plain-English summary
Cook Inc. is recalling the Universa Firm Ureteral Stent, identified by Global Product Numbers G49864 through G49888. The recall involves 13,388 total units that were distributed domestically across the United States and internationally to numerous countries, including Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom.
The recall is being issued because the wire guide may be incorrectly loaded into the wire guide holder. This error can lead to the stiff tip of the wire guide being introduced into the patient instead of the intended flexible tip.
Healthcare providers and patients should contact Cook Inc. for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
- Manufacturer
- Cook Inc.
- Affected units
- 13,388
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.
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