Olympus Corporation of the Americas has recalled 14,093 units of its UroPass Ureteral Access Sheath Sets because the device's dilator tips can become brittle and break. These medical devices are used during surgical procedures to help insert endoscopes and other tools into the ureter. Exposure to ultraviolet (UV) radiation can weaken the material, potentially causing the tips to break off while still inside a patient's body or while being handled in their packaging.
If a dilator tip breaks during a surgical procedure, it could lead to internal tissue injury or require additional medical steps to retrieve the broken fragment. While no injuries have been reported in the provided data, the defect creates a risk of complications during sensitive urological surgeries.
Quantity: 14,093 units. Consists of a hydrophilic coated outer sheath and an inner tapered dilator.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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