Duodenoscope recallZ-2277-2016 · Pentax Medical Company · initiated Apr 6, 2016
Class II Terminated All recalls posted in July 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 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
Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States.
FDA root cause category: Device Design
What the company is doing
Pentax Medical sent an "Urgent Field Correction Letter and Response Form" dated April 6, 2016 via Certified Mail to their affected customers. The recall letter identified the product, problem and action to be taken by customer. The customer is asked to complete the response form even if the customers does not have any OS-H2/OS-H4 water bottles to discard. If customer needs assistance in completing the response form, they can contact their local sales representative. For questions regarding the recall, customers can contact Mr. Paul Silva, Pentax Americas Recall Coordinator at: (800) 431-5880 ext. 2064, from (8:30 am - 5:00 pm, Monday - Friday, EST), via fax: (201) 799-4063 or via email to: [email protected].
Recall details
- Recall number
- Z-2277-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 6, 2016
- Posted by the FDA
- Jul 23, 2016
- Recalling firm
- Pentax Medical Company
- Quantity
- 433 units
- Product code
- FDT
- FDA submissions
- K963056
- Distribution
- US Nationwide Distribution
Product description
Duodenoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Code information (models, lots, serial numbers)
Model #'s FD-34V and ED-3490TK
Other devices under the same FDA submission
1 device cleared under K963056 — 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 OF-B121Hoya Corporation · duodenoscope and accessories, flexible/rigid1 report
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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