Every recall we track for Pentax of America Inc — 18 in all — plus the complaints and injury reports the public filed about them.
Pentax recalls EPK-i8020c medical video processors after users reported reddish images and hot light guides causing potential mucous membrane burns during endoscopy.
Pentax recalls specific medical colonoscopes due to potential thermal injury from reddish images during use. Affected models include EC38-i20cL with listed serial numbers. Stop using immediately to avoid mucous membrane burns.
Pentax recalls specific medical endoscopes due to risk of thermal injury to mucous membranes during procedures. The device may emit hot light guides and cause reddish/dark images. Affected models include EG29-i20c with listed serial numbers.
Pentax recalls EPK-i8020c video processors used with endoscopes due to rare reddish image and potential thermal injury to patient mucous membranes during procedures.
Pentax recalls specific video colonoscope models (EC-2990Li to EC38-i10L) sold 2014-2021 due to updated reprocessing instructions. Owners should check model numbers and contact Pentax for details.
Pentax recalls certain gastroscopes made between April 2014 and May 2021 that lack a water jet channel, which could lead to improper cleaning and infection risks.
Pentax recalls ED34-i10T2 duodenoscopes due to risk of distal end cap detaching during procedures, potentially causing mucosal injury or aspiration. Affected units may require immediate action.
Pentax recalls 9310HD Digital Video Capture Modules with software version 3.4.0+ that may copy exam videos between patients during follow-up reviews. Affected units have specific computer serial numbers listed.
Pentax recalls 9372HD Digital Capture systems with version 1.1.0+ where exam videos could be copied between patients during follow-up reviews. Affected units have specific computer serial numbers listed.
Pentax recalls specific cryosurgical catheters due to potential incorrect dose transmission if RFID tags aren't properly read by controllers. This could affect medical procedures involving endoscopic ablation of Barrett's esophagus.
Pentax recalls specific model cryo-balloon catheters due to potential incorrect dose transmission if RFID tag is unreadable by controller. Affected units include certain lot numbers from 2018.
Pentax recalls C2 CryoBalloon Controller software v1.18.258 due to potential balloon overpressure during nitrous oxide use, risking tissue injury. Affected units sold with specific reference numbers.
Pentax recalls specific models of cryosurgical catheters due to potential incorrect dose transmission to the controller, which could affect treatment safety. Affected units include certain lot numbers from 2018.
Pentax recalls C2 CryoBalloon Focal Catheter (REF FG-1009) due to potential detachment from controller during surgery. Affected units have specific lot codes.
Pentax recalls ED-3490TK duodenoscopes due to potential infection risk from outdated design. Replace with updated model per manufacturer instructions.
