The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.
Take action
Contact the company
📍Recalling firmPentax of America Inc3 Paragon Dr · Montvale, NJ 07645-1782
“Pentax ED-3490TK Duodenoscope Recall: Infection Risk from Design Flaw.” GovInfoNow, updated August 28, 2026. https://govinfonow.com/recall/71967-pentax-ed-3490tk-duodenoscope-recall-infection-risk-from-design-flaw. Based on FDA recall #Z-0643-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0643-2018%22&limit=1).
Pentax of America Inc recalled Pentax Video Duodenoscope Model ED-3490TK units nationwide to mitigate infection risk, the FDA said on Feb. 13, 2018. The recall affects 559 devices distributed across the U.S. and Puerto Rico.
How to tell if you have it
Brand: Pentax
Product: Pentax Video Duodenoscope Model ED-3490TK
UDI of design: 04961333232420
Quantity: 559 units
The hazard
The duodenoscopes are being recalled to replace the forceps elevator mechanism, O-rings, and distal end covering to align with an updated design. This action aims to provide an updated periodic inspection in the Operation Manual to mitigate the potential risk of infection in flexible endoscopy.
Context
GovInfoNow's records show Pentax of America Inc has 10 other recalls on record since July 13, 2017. Other recent recalls include a Pentax EPK-i8020c Medical Video Processor recall (July 16, 2025) and a Pentax Medical Colonoscope recall (Jan. 29, 2025). Similar product recalls include an Olymp Single Use Distal Cover recall for Duodenovideoscopes (June 5, 2026) and a Wilson-Cook Instinct Plus Endoscopic Clipping Device recall (March 3, 2026).
How to tell if you have this one
Check for the model ED-3490TK on the instrument. The recall includes all units with the UDI design code 04961333232420.
Brand
Pentax
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Recalled Model
Look for the model ED-3490TK on the instrument and the UDI design code 04961333232420.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 37 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “USA (nationwide) Distribution to the states of including Puerto Rico : AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and WY, and the District…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0643-2018 (February 13, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0643-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.