Manufacturer
33 recalls in our database name PENTAX of America Inc as the manufacturing or recalling firm.
Of the 33 recalls from PENTAX of America Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
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.
Pentax Medical EPK-i8020c video processors are recalled after reports of darkened images, smoke-like steam and a hot endoscope light guide that may cause thermal injury to the patient's mucous membrane. 144 units are affected.
Pentax of America is recalling 138 PENTAX Medical Video Upper GI Scopes due to a thermal injury risk. The light guide tip can become excessively hot during endoscopic procedures, potentially burning patient tissue.
Pentax EPK-i8020c video processors can overheat during endoscopic procedures, creating a risk of thermal burns to patient tissues. The light guide tip becomes hot and may cause injury to mucous membranes.
The PENTAX Medical Video Colonoscope (Model EC38-i20cL) can develop excessive heat at the tip during procedures, potentially causing thermal burns to patient tissue. Users reported dark images and steam-like smoke from the device.
Pentax is updating reprocessing instructions for over 28,000 colonoscopes and Upper GI scopes distributed nationwide between 2014 and 2021. Healthcare facilities should implement the updated procedures provided by the manufacturer.
Pentax Medical is updating reprocessing instructions for certain gastroscope and colonoscope models to ensure proper sterilization. Affected healthcare facilities should review and implement the updated instructions.
Pentax of America Inc. is recalling 108 Pentax Medical Video Duodenoscopes because the distal end cap may detach during procedures, posing risks of injury or aspiration.
Pentax of America Inc is recalling 39 units of the 9310HD Digital Video Capture Module due to a software issue that may copy patient exam videos to the wrong record.
Pentax of America Inc. is recalling 39 units of the 9372HD Digital Capture system due to a software issue that may copy exam videos to the wrong patient.
Pentax of America Inc is recalling one unit of the EC38-i10L Video Colonoscope because it was distributed in the USA without an approved 510(k).
Pentax of America Inc is recalling specific Pentax Video Colonoscopes because they were distributed in the USA without an approved 510K.
Pentax of America Inc is recalling 68 C2 CryoBalloon Pear Focal Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.
PENTAX of America Inc is recalling 4 C2 CryoBalloon Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.
Pentax of America Inc is recalling 157 C2 CryoBalloon Standard Focal Catheters because incorrect default doses and increments may be transmitted to the controller if the RFID tag is not correctly readable.
Pentax of America Inc is recalling 45 C2 CryoBalloon Controllers because the device fails to detect balloon overpressure during specific nitrous oxide applications, posing a risk of patient injury.
Pentax of America Inc is recalling 57 units of the C2 CryoBalloon Focal Catheter because a misaligned arrow may allow the catheter to detach from the controller during use.
Pentax of America Inc is recalling 559 Video Duodenoscopes to replace specific components and update inspection protocols to mitigate the potential risk of infection.
Pentax of America Inc is recalling 24 Video Cystoscopes because they lack required FDA premarket notification clearance.
Pentax of America Inc is recalling 116 ultrasound video gastroscopes because the instructions for use contain an error in the disinfection step.
Pentax of America Inc. is recalling 118 ultrasound video gastroscopes because the instructions for use contain an error in the disinfection step.
Pentax Medical is recalling 241 laryngeal strobe systems because isolation transformers were not always provided, posing a potential electrical safety risk.
Pentax Medical is recalling 241 units of 7245C, 7245C/E, and 7245D Computer Digital Video Systems because they may have been shipped without required 9175 isolation transformers.
Pentax Medical is recalling 241 laryngeal strobe systems because they were not always provided with required 9175 isolation transformers.
Pentax of America is recalling 241 units of 9310HD Digital Video Capture Modules because they were not always provided with required 9175 isolation transformers.
Pentax of America Inc. issued a field correction for two Video Duodenoscope models to investigate surface soiling on the suction cylinder and distal cap.
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
company
Source: Wikidata (Q503673), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.