Z-1682-2021Class II

Pentax Medical Video Duodenoscope -

Name: Z-1682-2021 Pentax Medical Video Duodenoscope -
Creator: Pentax of America Inc
Published: 2021-04-21
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2021-04-21 / Terminated / root cause: manufacturing process

FDA source

Pentax of America Inc began a recall of Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization... on 2021-04-21. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1682-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-21
Posted: 2021-05-25
Terminated: 2024-02-05
Recalling firm: PENTAX of America, Inc.
Product: 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.
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
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
Root cause tag: manufacturing process
FDA root cause: Process design
Action: Pentax issued Urgent Medical Device Correction letter on 4/21/21 via USPS. Letter states reason for recall,health risk and action to take: We have updated our instructions for use (IFU) for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope. The warning section of the IFU has been updated to notify users of the associated risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure. In addition, the IFU has been updated to notify users of what immediate actions should be taken in case the event occurs. Please note that this documentation set is current as of this date. For updates, please refer to the PENTAX online IFU library at https://ifu.pentaxmedical.com. Customer Instructions: Please complete the enclosed Field Correction Response Form upon receipt of this package, and email to PENTAX at [email protected]. Adverse events experienced with the use of this product should be reported as soon as possible to PENTAX at [email protected]. PENTAX will issue additional communications as further information becomes available. If you have any questions regarding this action, please feel free to contact us at: : Tel: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: [email protected]
Quantity in commerce: 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.
Product codes and lots: All units

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1682-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1682-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-25

Product code FDT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)