Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 2, 2021
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Pentax of America Inc recalled Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic de… - a moderate-severity action.
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic de… was recalled by Pentax of America Inc in June 2, 2021. Reason: IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope ha…. Check the official notice for the remedy. Verify recall #Z-1682-2021 with the FDA Devices before acting.
The recall
Pentax of America Inc issued this moderate-severity FDA Devices recall-IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope ha….
- Moderate
- severity level
- 108 units
- affected scope
- Class II
- classification
- June 2, 2021
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1682-2021 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1682-2021) was formally reported on June 2, 2021, with the manufacturer initiating the action on April 21, 2021. It is classified under Moderate severity (Class II), with a current status of Terminated. Pentax of America Inc is listed as the recalling firm, operating out of Montvale, NJ. Federal records list the affected scope as 108 units.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, Washington, D.C.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
108 units
Related Recalls
6
3 from same agency
Product description
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.
Reason for recall
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1682-2021 |
| Date reported | June 2, 2021 |
| Date initiated | April 21, 2021 |
| Recalling firm | Pentax of America Inc |
| Firm location | Montvale, NJ |
| Affected scope | 108 units |
| Distribution | US Nationwide distribution in the states of Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, Washington, D.C. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1682-2021) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number: ED34-i10T2.. Recalled by Pentax of America Inc. Units affected: 108 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 2, 2021. Severity: Moderate. Recall number: Z-1682-2021.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of Alabama, California, Louisiana, Maryland, Michigan, Missouri, New Jersey, North Carolina, Pennsylvania, Texas, Washington, D.C..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1682-2021) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported June 2, 2021. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.