Pentax of America Inc: Medical Device Recall in 2017 - (Recall #: Z-3068-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video processor to provide images for observation, diagnosis, imaging, or therapy of the upper gastrointestinal tract from esophagus through duodenum.

Product Classification:

Class II

Date Initiated: May 23, 2017

Date Posted: August 30, 2017

Recall Number: Z-3068-2017

Event ID: 77380

Reason for Recall:

Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning detergent, should be used for this step.

Status: Terminated

Product Quantity: US: 116 units

Code Information:

H110516, H110619, H110635, H110643, H110624, A110407, A110411, H110507, A110352, A110444, A110417, A110419, H110493, H110494, H110522, H110584, H110586, H110590, H110591, H110559, A110471, A110474, A110355, A110359, H110606, H110566, H110568, H110498, H110503, H110509, H110510, H110637, H110560, H110514, A110427, A110372, A110438, H110587, H110598, H110600, A110439, A110440, A110443, A110450, A110448, A110451, A110453, H110542, H110569, A110445, A110454, H110565, A110356, A110357, H110592, H110593, H110595, A110346, H110508, A110461, H110620, H110623, H110641, H110642, H110613, A110460, A110380, A110463, H110577, A110457, A110401, H110610, H110611, H110502, H110511, H110518, H110519, H110578, H110557, H110561, A110422, A110432, H110512, H110626, H110628, H110629, H110633, H110634, H110539, H110544, A110341, A110418, H110596, H110604, A110387, A110388, H110601, H110615, H110571, H110574, H110599, H110506, A110350, A110398, H110575, A110449, A110360, A110363, A110368, H110554, H110515, H110567, A110410, A110414, A110485, H110553, H110563, H110589, A110376, A110384, H110549, H110564, H110556, H110536, H110646, H110533, H110543, A110458, A110459, A110383, H110538, H110499, A110344, A110345, A110348, A110452, A110391, A110475, A110483, A110486, A110488, A110477, A110479, A110480, A110481, A110482, A110375, A110406, A110470, A110429, A110435, H110618, A110393, A110394, A110447, A110462, A110466, H110555, H110631, H110636, H110639, H110524, H110525, H110526, H110530, H110531, H110532, H110534, H110535, A110476, A110416, A110420, A110379, A110381, A110385, A110484, A110492, H110640, H110579, H110581, H110572, H110573, A110425, A110431, A110441, A110442, H110517, A110426, A110433, A110434, A110353, H110614, H110616, A110464, A110465, H110520, H110523, H110550.

Distribution Pattern:

Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated