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Pentax of America Recalls
33 recalls on record · September 28, 2016 to August 27, 2025 · Medical Devices
Recalls by year
16
17
18
19
20
21
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
November 30, 2016Medical DevicesFDA
Pentax of America Inc recalls Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation eq
Hazard: Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU or the dedicated reprocessing adaptor (for applicable models).
November 2, 2016Medical DevicesFDA
Pentax of America Inc recalls Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation eq
Hazard: PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
September 28, 2016Medical DevicesFDA
Pentax of America Inc recalls Pentax Video Bronchoscope Designed to be used with a Pentax Video Processor (including light source), documentation eq
Hazard: Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS.