Z-2713-2017Class II

Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor)...

Name: Z-2713-2017 Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor)...
Creator: Pentax of America Inc
Published: 2017-01-17
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2017-01-17 / Terminated / root cause: design

FDA source

Pentax of America Inc began a recall of Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via... on 2017-01-17. FDA classified it as Class II and gives the reason as "Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2713-2017
Classification: Class II
Status: Terminated
Initiated: 2017-01-17
Posted: 2017-07-11
Terminated: 2018-03-08
Recalling firm: PENTAX of America, Inc.
Product: Video Duodenoscope These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: esophagus, stomach, duodenum, common bile, hepatic and cystic ducts.
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Pentax Medical, sent a "FIELD CORRECTION' letter dated January 17, 2017 to their affected customers via USPS Certified Mail. The letter described the product, problem and actions to be taken. The customers were instructed to immediately remove any affected product from use; follow product labeling; ensure all reprocessing personnel are knowledgeable and thoroughly trained on the instructions of Use for manual reprocessing of the devices; clean elevator recesses and follow all reprocessing instructions; and complete and return the FIELD CORRECTION RESPONSE FORM via a member of the PENTAX Service Department as part of an on-site-visit or Fax to: QA/RA Department at 201-799-4063 (alternate 201-391-4189) or a pdf copy to [email protected]. The firm will replace any affected product with its current generation model. If you have questions or request further information or assistance contact PENTAX Medical Customer Support at 1-800-431-5880 (8:30AM - 5:00PM, Monday-Friday, EST) or email: [email protected].
Quantity in commerce: 2,015 (US - 519 (ED-3490TK) and 5 (ED-3270K); OUS - 1,491)
Distribution: Worldwide Distribution-US (Nationwide) including states of: AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, PR, TN, TX, UT, VA, WA, WI, WV, WY;. and country of: CANADA.
Product codes and lots: Model Numbers: Ed-3490TK and ED-3270K

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2713-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2713-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-10

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)