Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ureteroscope Intended to provide optical visualization of and therapeutic access Recalled by Pentax Medical Company Due to Pentax has become aware that operational/cleaning accessories and...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Pentax Medical Company directly.
Affected Products
Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Quantity: 32 units
Why Was This Recalled?
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Where Was This Sold?
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
About Pentax Medical Company
Pentax Medical Company has 26 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report