thejoe Pentax Medical Company

Pentax Medical Company: 26 FDA recall reports

Every medical device recall the FDA has published for Pentax Medical Company. The fault, and how the agency graded it.

26Reports

1Class I

0Ongoing

2016-08-03Most recent

1 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	25
Class I	1

By year reported

Year	Reports
2013	1
2014	2
2016	23

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lowe

Z-2280-2016 · Class II · reported 2016-08-03 · Terminated

Why it was 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.
Product: Signmoidoscope Product Usage: Intended to provide optical visualization of, therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: US Nationwide Distribution
How much: N/A

Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lowe

Z-2275-2016 · Class II · reported 2016-08-03 · Terminated

Why it was 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.
Product: Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: US Nationwide Distribution
How much: 12,412 units

Ultrasound Gastroscope Product Usage: Intended to provide optical visualization of, ultrasonic Visualizati

Z-2279-2016 · Class II · reported 2016-08-03 · Terminated

Why it was 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.
Product: 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.
Where it went: US Nationwide Distribution
How much: 819 units

Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Uppe

Z-2278-2016 · Class II · reported 2016-08-03 · Terminated

Why it was 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.
Product: Gastroscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: US Nationwide Distribution
How much: 10,074 units

Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gas

Z-2277-2016 · Class II · reported 2016-08-03 · Terminated

Why it was 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.
Product: Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: US Nationwide Distribution
How much: 433 units

Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to th

Z-2276-2016 · Class II · reported 2016-08-03 · Terminated

Why it was 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.
Product: Confocal GI Scope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: US Nationwide Distribution
How much: 17 units

Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial

Z-2065-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 4,195 units

Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal

Z-2068-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Colonoscope Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 12,412 units

Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate r

Z-2072-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Intubation Scope Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 1,220 units

Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissue

Z-2080-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 96 units

Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Up

Z-2073-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Laryngo Stroboscope Product Usage Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 206 units

Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestina

Z-2075-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Signmoidoscope Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 1,596 units

Ultrasound Bronchoscope Intended to provide optical visualization of, ultrasonic visualization of and therape

Z-2076-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: 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
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 115 units

Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeu

Z-2077-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Ultrasound Gastroscope Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 819 units

Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues an

Z-2079-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 405 units

Ureteroscope Intended to provide optical visualization of and therapeutic access to the Urinary Track. This a

Z-2078-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: 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.
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 32 units

Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This ana

Z-2070-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Cystoscope Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 120 units

Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal C

Z-2066-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Choledocho-Nephroscope Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 126 units

Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal

Z-2069-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Confocal GI Scope Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 17 units

Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This

Z-2067-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Choledochoscope Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 50 units

Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal

Z-2071-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Gastroscope Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 9,669 units

Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Air

Z-2074-2016 · Class II · reported 2016-07-06 · Terminated

Why it was 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.
Product: Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations
Where it went: Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
How much: 215 units

Video Duodenoscope

Z-1835-2016 · Class II · reported 2016-06-08 · Terminated

Why it was recalled: Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.
Product: Video Duodenoscope
Where it went: Nationwide
How much: 423 units

PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve

Z-2290-2014 · Class II · reported 2014-08-27 · Terminated

Why it was recalled: 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.
Product: PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
Where it went: Worldwide Distribution - US Distribution including the states of CA, CO, IN, KS and ID., and the countries of Asia, Canada, Europe and Japan.
How much: 98 units US; 1108 units OUS

EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gas

Z-2116-2014 · Class II · reported 2014-07-30 · Terminated

Why it was recalled: 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.
Product: EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.
Where it went: US Nationwide Distribution
How much: 531 units

Class I

PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided wi

Z-0084-2014 · Class I · reported 2013-11-06 · Terminated

Why it was recalled: 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.
Product: PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation.
Where it went: Nationwide Distribution including Arizona, California, Florida, Idaho, Indiana, Kansas, Maryland, Missouri, Missippi, North Carolina, New York, Pennsylvania, Virginia, Wisconsin and Wyoming.
How much: 76 units

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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