Pentax Medical Company

Complete recall history across all FDA and CPSC categories — 26 total recalls

Pentax Medical Company appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (26)

FDA medical device enforcement actions by Pentax Medical Company

Date Product Reason Class
Apr 6, 2016 Confocal GI Scope Product Usage: Intended to provide optical visualizatio... Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pen... Class II
Apr 6, 2016 Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, the... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Gastroscope Intended to provide optical visualization of and therapeutic acc... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Choledochoscope Intended to provide optical visualization of and therapeutic... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Confocal GI Scope Intended to provide optical visualization of an therapeuti... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Choledocho-Nephroscope Intended to provide optical visualization of and ther... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Duodenoscope Product Usage: Intended to provide optical visualization of ... Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pen... Class II
Apr 6, 2016 Cystoscope Intended to provide optical visualization of and therapeutic acce... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Ureteroscope Intended to provide optical visualization of and therapeutic ac... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not rest... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Gastroscope Product Usage: Intended to provide optical visualization of a... Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pen... Class II
Apr 6, 2016 Ultrasound Gastroscope Intended to provide optical visualization of, ultraso... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Ultrasound Bronchoscope Intended to provide optical visualization of, ultras... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Signmoidoscope Intended to provide optical visualization of, therapeutic acc... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Ultrasound Gastroscope Product Usage: Intended to provide optical visuali... Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pen... Class II
Apr 6, 2016 Laryngo Stroboscope Product Usage Intended to provide optical visualization ... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not ... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Colonoscope Product Usage: Intended to provide optical visualization of a... Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pen... Class II
Apr 6, 2016 Intubation Scope Intended to provide optical visualization of, therapeutic a... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Colonoscope Intended to provide optical visualization of and therapeutic acc... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Bronchoscope Intended to provide optical visualization of and therapeutic ac... Pentax has become aware that operational/cleaning accessories and therapeutic... Class II
Apr 6, 2016 Signmoidoscope Product Usage: Intended to provide optical visualization o... Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pen... Class II
Feb 22, 2016 Video Duodenoscope Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae ... Class II
Jul 17, 2014 PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve I... Class II
Jun 12, 2014 EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope... Aspiration needles used in combination with Ultrasound Gastroscopes can derai... Class II
Sep 16, 2013 PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lowe... PENTAX Medical has become aware of a product issue associated with the OF-B19... Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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