Cook Inc. Recalls Universa Soft Ureteral Stents Due to Wire Guide Loading Error
Cook Inc. is recalling Universa Soft Ureteral Stents because the wire guide may be incorrectly loaded, causing the stiff tip to be introduced into patients 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 involves a medical device defect that poses a risk of harm by introducing a stiff tip into a 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 Universa Soft Ureteral Stents. The recall covers specific Global Product Numbers and lot codes distributed domestically in the United States and internationally to numerous countries, including Australia, Canada, and the United Kingdom.
The recall was initiated 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 who have used these devices should contact Cook Inc. for further instructions on how to proceed. The source text does not report specific illnesses or injuries associated with this defect.
The recalled product
- Product
- Universa Soft Ureteral Stent, Global Product No. G49887 G49933 G49934 G49937 G49940 G49941 G49942 G49945 G49947 G49948 G49949 G49950 G49951 G49953 G49955 G49956 G49957 G49958 G49959 G49961 G53145 G53676 G53677 G53687 G53689 G53692 G53693 G53694 G53703…
- Manufacturer
- Cook Inc.
- Hazard
- 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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