The Recall Desk

Manufacturer

Pentax Medical Company

26 recalls in our database name Pentax Medical Company as the manufacturing or recalling firm.

What the numbers show

Total
26
Critical
0
Severe
2
Most recent
2016-08-03

Of the 26 recalls from Pentax Medical Company we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (8%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 26

  • ModerateFDA (Devices)·Z-2279-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling Video Processor EPK-i5010 units because they were shipped with a water bottle assembly not cleared for use 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, Smal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2278-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use 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 introdu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2276-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling Video Processor EPK-i5010 units shipped with a water bottle assembly not cleared for US use.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2280-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use 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 introd
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2277-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2275-2016·2016-08-03

    Pentax Medical Video Processor Recalled for Uncleared Water Bottle Assembly

    Pentax Medical is recalling the EPK-i5010 Video Processor because it was shipped with a water bottle assembly not cleared for use 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2076-2016·2016-07-06

    Pentax Ultrasound Bronchoscopes Recalled for Lodged Accessories Risk

    Pentax Medical is recalling 115 Ultrasound Bronchoscopes because operational and therapeutic accessories can become lodged in the 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 acc
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2065-2016·2016-07-06

    Pentax Medical Recalls Bronchoscopes Due to Lodged Accessories

    Pentax Medical is recalling 4,195 bronchoscopes because operational and cleaning accessories can become lodged in the 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
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2073-2016·2016-07-06

    Pentax Laryngo Stroboscope Recalled Due to Lodged Accessories Risk

    Pentax Medical Company is recalling 206 Laryngo Stroboscopes because operational and therapeutic accessories can become lodged in the 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 introd
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2072-2016·2016-07-06

    Pentax Intubation Scope Recall Due to Lodged Accessories in Instrument Channel

    Pentax Medical Company is recalling 1,220 intubation scopes because operational and therapeutic accessories can become lodged in the 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
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2066-2016·2016-07-06

    Pentax Choledocho-Nephroscope Recalled Due to Lodged Accessories in Instrument Channel

    Pentax Medical is recalling 126 Choledocho-Nephroscope units because operational and therapeutic accessories can become lodged in the 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, K
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2067-2016·2016-07-06

    Pentax Choledochoscope Recall Due to Potential Instrument Channel Lodging

    Pentax Medical is recalling 50 units of FCP-8P and FCP-9P choledochoscopes because accessories and therapeutic devices may become lodged in the 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 w
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2071-2016·2016-07-06

    Pentax Recalls 9,669 Gastroscope Units Due to Lodged Accessories

    Pentax Medical is recalling 9,669 gastroscope units because operational or cleaning accessories can become lodged in the 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 w
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2068-2016·2016-07-06

    Pentax Medical Recalls Colonoscopes Due to Lodged Accessories

    Pentax Medical is recalling 12,412 colonoscopes because operational and cleaning accessories can become lodged in the 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 in
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2080-2016·2016-07-06

    Pentax Small Bowel Scope Recall Due to Lodged Accessories

    Pentax Medical Company is recalling 96 Small Bowel Scopes because operational and cleaning accessories can become lodged in the 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 adul
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2078-2016·2016-07-06

    Pentax Medical Recalls Ureteroscopes Due to Lodged Accessories Risk

    Pentax Medical is recalling 32 ureteroscopes because operational accessories may become lodged in the 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 indicati
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2070-2016·2016-07-06

    Pentax Cystoscopes Recalled Due to Risk of Lodged Accessories in Instrument Channel

    Pentax Medical Company is recalling 120 cystoscopes because operational and therapeutic accessories can become lodged in the 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 consist
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2074-2016·2016-07-06

    Pentax Naso-Pharyngo-Laryngoscope Recall Due to Lodged Accessories

    Pentax Medical Company is recalling 215 Naso-Pharyngo-Laryngoscopes because operational and therapeutic accessories can become lodged in the 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 th
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2069-2016·2016-07-06

    Pentax Confocal GI Scope Recall Due to Lodged Accessories

    Pentax Medical is recalling 17 Confocal GI Scopes because operational and therapeutic accessories can become lodged in the 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
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2075-2016·2016-07-06

    Pentax Sigmoidoscopes Recalled Due to Risk of Lodged Accessories

    Pentax Medical Company is recalling 1,596 sigmoidoscopes because operational and therapeutic accessories can become lodged in the 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 rectu
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2077-2016·2016-07-06

    Pentax Ultrasound Gastroscope Recall Due to Lodged Accessories

    Pentax Medical Company is recalling ultrasound gastroscopes because operational and therapeutic accessories can become lodged in the 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 a
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2079-2016·2016-07-06

    Pentax Medical Recalls Esophagoscopes Due to Lodged Accessories Risk

    Pentax Medical is recalling 405 esophagoscopes because operational accessories can become lodged in the 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 an
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1835-2016·2016-06-08

    Pentax Medical Recalls Video Duodenoscopes Due to CRE Infection Reports

    Pentax Medical is recalling 423 Video Duodenoscopes nationwide after reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.

    Product
    Video Duodenoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2290-2014·2014-08-27

    Pentax Endoscope Gas/Water Valve Recall Due to Instructions for Use Risk

    Pentax Medical Company is recalling OF-B130 and OF-B194 Gas/Water Feeding Valves because failure to follow the Instructions for Use may cause a potential risk to health.

    Product
    PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-2116-2014·2014-07-30

    Pentax Ultrasound Gastroscopes Recalled Due to Aspiration Needle Derailment Risk

    Pentax Medical is recalling 531 ultrasound gastroscopes because aspiration needles may derail from the accessory elevator, posing a risk of patient injury.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

PENTAX Medical Company (United States)

company in Montvale, United States

Country
United States
Founded
1979

Official website

Source: Wikidata (Q30284361), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.