Pentax Video Gastroscope is intended to be used with a… recallZ-0318-2017 · Pentax of America Inc · initiated Aug 15, 2016
Class II Terminated All recalls posted in October 2016
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Pentax of America Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
FDA root cause category: Labeling Change Control
What the company is doing
Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.
Recall details
- Recall number
- Z-0318-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 15, 2016
- Posted by the FDA
- Oct 26, 2016
- Recalling firm
- Pentax of America Inc
- Quantity
- 3,436 (US) and 14,488 (OUS)
- Product code
- FDS
- FDA submissions
- K131902
- Distribution
- US Nationwide and Japan
Product description
Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach and duodenum.
Code information (models, lots, serial numbers)
EG-1690K, EG-2490K, EG-279oI, EG-2790K, EG-2990K, EG-2990K, EG-349oK and EG-3890TK
Other devices under the same FDA submission
16 devices cleared under K131902 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- PENTAX EG27-i10Hoya Corporation · Gastroscope and accessories, flexible/rigid261 reports
- PENTAX EG-2990iHoya Corporation · Gastroscope and accessories, flexible/rigid156 reports
- PENTAX EG29-i10Hoya Corporation · Gastroscope and accessories, flexible/rigid130 reports
- PENTAX EG29-i10Hoya Corporation · Gastroscope and accessories, flexible/rigid125 reports
- PENTAX EG-2790iHoya Corporation · Gastroscope and accessories, flexible/rigid113 reports
- PENTAX EG-1690KHoya Corporation · Gastroscope and accessories, flexible/rigid54 reports
- PENTAX EG-2990KHoya Corporation · Gastroscope and accessories, flexible/rigid44 reports
- PENTAX EG-2790KHoya Corporation · Gastroscope and accessories, flexible/rigid29 reports
- PENTAX EG-2490KHoya Corporation · Gastroscope and accessories, flexible/rigid25 reports
- PENTAX EG-3890TKHoya Corporation · Gastroscope and accessories, flexible/rigid19 reports
- PENTAX EG-2990iHoya Corporation · Gastroscope and accessories, flexible/rigid16 reports
- PENTAX EG-3490KHoya Corporation · Gastroscope and accessories, flexible/rigid10 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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