Stop using nowMedical device recall · FDA · Published April 21, 2021
Pentax Medical Duodenoscope Recall: Risk of Distal End Cap Detachment
Pentax recalls ED34-i10T2 duodenoscopes due to risk of distal end cap detaching during procedures, potentially causing mucosal injury or aspiration. Affected units may require immediate action.
IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result in unforseen events such as mucosal injury, lacerations, or bleeding of the patient. Detachment of the distal end cap (OE-A63) into the oral cavity of the patient may also result in aspiration
Take action
Contact the company
📍Recalling firmPentax of America Inc3 Paragon Dr · Montvale, NJ 07645-1782
“Pentax Medical Duodenoscope Recall: Risk of Distal End Cap Detachment.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62750-pentax-medical-duodenoscope-recall-risk-of-distal-end-cap-detachment. Based on FDA recall #Z-1682-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1682-2021%22&limit=1).
Pentax of America Inc. recalled Pentax Medical Video Duodenoscopes, model ED34-i10T2, due to the risk of the distal end cap detaching during procedures, according to the FDA on April 21, 2021.
How to tell if you have it
Brand: Pentax
Product: Pentax Medical Video Duodenoscope
Model Number: ED34-i10T2
Quantity: 108 units
The hazard
The recall addresses the risk of the distal end cap (OE-A63) unexpectedly becoming detached during a procedure, which can result in mucosal injury, lacerations, bleeding, or aspiration into the patient's oral cavity. The company updated the Instructions for Use to notify users of these risks and immediate actions.
Context
GovInfoNow's records show Pentax of America Inc. has had 10 other recalls on record since July 13, 2017. Other recent recalls include a Pentax EPK-i8020c Medical Video Processor recall on July 16, 2025, and a Pentax Medical Colonoscope recall on Jan. 29, 2025. Similar product recalls in the sector include Tangent Endoscopy Catheters recalled on March 23, 2026, and Olymp Single Use Distal Cover recalled on June 5, 2026.
How to tell if you have this one
Check for the model number ED34-i10T2 on the duodenoscope. The recall applies to all units manufactured for medical use.
Brand
Pentax
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately cease using the ED34-i10T2 duodenoscope if you have it, as detachment can cause serious injury.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 10 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, Washington, D.C.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, District of Columbia, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas.
Recall timeline
FDA terminated this recall 2.8 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-1682-2021 (April 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1682-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.