Z-0819-2012

EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of (via a video monitor)...

Name: Z-0819-2012 EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of (via a video monitor)...
Creator: Pentax Medical Company
Published: 2011-09-30
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2011-09-30 / Terminated / root cause: manufacturing process

FDA source

Pentax Medical Company began a recall of EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper... on 2011-09-30. The reason FDA records is "The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope". 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-0819-2012
Status: Terminated
Initiated: 2011-09-30
Posted: 2012-01-20
Terminated: 2012-11-27
Recalling firm: PENTAX of America, Inc.
Product: EE- Series Video Esophagoscopes, EE-1580K. Intended to provide optical visualization of (via a video monitor) and therapeutic access to, the Upper Gastrointestinal Track.
Product code: EOX Esophagoscope (Flexible Or Rigid)
Reason for recall: The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Pentax sent an "Urgent: Device Recall - Stop Use Immediately" letter/return response form to their customers on 9/30/2011. The letter identified the affected product and asked customers to immediately discontinue the use of their endoscope(s). Customers were to contact PENTAX at 1-800-736-8293 to schedule the return of the affected product(s). The reason for the recall was also explained, and the letter stated that there will be no charge for shipping, evaluation, or repair of the products. Customers can request loaner instruments, if necessary.
Quantity in commerce: one unit
Distribution: Nationwide Distribution.
Product codes and lots: EE-1580K A110273

Product code EOX

K961564Class IIEg-2940, Video GastroscopePentax Precision Instrument Corp. / cleared 1996-07-09

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)