EE- Series Video Esophagoscopes, EE-1580K recallZ-0819-2012 · Pentax Medical Company · initiated Sep 30, 2011
Terminated All recalls posted in January 2012
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 Medical Company 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
The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.
FDA root cause category: Employee error
What the company is doing
Pentax sent an "Urgent: Device Recall - Stop Use Immediately" letter/return response form to their customers on 9/30/2011. The letter identified the affected product and asked customers to immediately discontinue the use of their endoscope(s). Customers were to contact PENTAX at 1-800-736-8293 to schedule the return of the affected product(s). The reason for the recall was also explained, and the letter stated that there will be no charge for shipping, evaluation, or repair of the products. Customers can request loaner instruments, if necessary.
Recall details
- Recall number
- Z-0819-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 30, 2011
- Posted by the FDA
- Jan 20, 2012
- Recalling firm
- Pentax Medical Company
- Quantity
- one unit
- Product code
- EOX
- FDA submissions
- K961564
- Distribution
- Nationwide Distribution.
Product description
EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track.
Code information (models, lots, serial numbers)
EE-1580K A110273
Other devices under the same FDA submission
1 device cleared under K961564 — 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 EE-1580KHoya Corporation · Gastroscope and accessories, flexible/rigid7 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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