Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ultrasound Bronchoscope Intended to provide optical visualization of 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
Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations
Quantity: 115 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