Z-0643-2018Class II

Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments...

Name: Z-0643-2018 Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments...
Creator: Pentax of America Inc
Published: 2018-02-13
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2018-02-13 / Terminated / root cause: design

FDA source

Pentax of America Inc began a recall of Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These instruments are intended to provide optical visualization of... on 2018-02-13. FDA classified it as Class II and gives the reason as "The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic...". 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-0643-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-13
Posted: 2018-02-20
Terminated: 2020-10-09
Recalling firm: PENTAX of America, Inc.
Product: Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) 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: The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy.
Root cause tag: design
FDA root cause: Device Design
Action: Pentax Medical sent an Urgent Medical Device Correction/Removal letter dated February 7, 2018, to the United States Customers. The consignee letter includes a customer response form and a revised operator manual with the added recommended periodic maintenance. The letter requests the return of the form which includes an accounting of the devices (by serial number) owned by the facility. The firm is to contact the consignee to arrange return of the affected units and to provide loaner devices as needed. For further questions, please call 1 (800) 431-5880 ext. 2064.
Quantity in commerce: 559
Distribution: USA (nationwide) Distribution to the states of including Puerto Rico : AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, WV and WY, and the District of Columbia.
Product codes and lots: All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0643-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0643-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-28	2018-02-20

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)