Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of Recalled by Pentax Medical Company Due to Pentax Medical Video Processor EPK-i5010 has been shipped...
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 Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and therapeutic access to the Upper Gastrointestinal Tract including but not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced via per orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Quantity: 819 units
Why Was This Recalled?
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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