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Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combinat...

FDA Device Recall #Z-3068-2017 — Class II — May 23, 2017

Recall Summary

Recall Number Z-3068-2017
Classification Class II — Moderate risk
Date Initiated May 23, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Pentax of America Inc
Location Montvale, NJ
Product Type Devices
Quantity US: 116 units

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.

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.

Distribution Pattern

Nationwide

Lot / 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.

Other Recalls from Pentax of America Inc

Recall # Classification Product Date
Z-2329-2025 Class II Pentax Medical Video Processor; Model Number: ... Jul 16, 2025
Z-1236-2025 Class II PENTAX Medical Video Colonoscope- Intended to ... Jan 29, 2025
Z-1238-2025 Class II Pentax Medical Video Processor- Intended to be ... Jan 29, 2025
Z-1237-2025 Class II PENTAX Medical Video Upper GI Scope-Intended to... Jan 29, 2025
Z-2449-2021 Class II Gastroscope Family # 1-Gastroscopes without a W... Jul 14, 2021

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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