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Pentax Medical Recalls
26 recalls on record · November 6, 2013 to August 3, 2016 · Medical Devices
Recalls by year
13
14
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 3, 2016Medical DevicesFDA
Pentax Medical Company recalls Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastroin
Hazard: 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.
August 3, 2016Medical DevicesFDA
Pentax Medical Company recalls Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualization of, and
Hazard: 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.
August 3, 2016Medical DevicesFDA
Pentax Medical Company recalls Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastroin
Hazard: 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.
August 3, 2016Medical DevicesFDA
Pentax Medical Company recalls Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointesti
Hazard: 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.
August 3, 2016Medical DevicesFDA
Pentax Medical Company recalls Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastroin
Hazard: 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.
August 3, 2016Medical DevicesFDA
Pentax Medical Company recalls Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastroin
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subs
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsyste
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy inc
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic acces
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. T
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. Th
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy inclu
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. Thi
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. Th
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy i
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. Thi
Hazard: 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.
July 6, 2016Medical DevicesFDA
Pentax Medical Company recalls Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This
Hazard: 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.
June 8, 2016Medical DevicesFDA
Pentax Medical Company recalls Video Duodenoscope
Hazard: Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.
August 27, 2014Medical DevicesFDA
Pentax Medical Company recalls PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Hazard: The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health.
July 30, 2014Medical DevicesFDA
Pentax Medical Company recalls EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope
Hazard: Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user.
November 6, 2013Medical DevicesFDA
Pentax Medical Company recalls PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Wat
Hazard: PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user.