Z-0318-2017Class II

Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source)...

Name: Z-0318-2017 Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source)...
Creator: Pentax of America Inc
Published: 2016-08-15
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2016-08-15 / Terminated / root cause: labeling and UDI

FDA source

Pentax of America Inc began a recall of Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device... on 2016-08-15. FDA classified it as Class II and gives the reason as "PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0318-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-15
Posted: 2016-10-26
Terminated: 2019-04-23
Recalling firm: PENTAX of America, Inc.
Product: Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the upper digestive tract including the esophagus, stomach and duodenum.
Product code: FDS Gastroscope And Accessories, Flexible/Rigid
Reason for recall: PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Pentax sent as "Urgent Field Correction" and Field Correction Response Form dated August 15, 2016 to their affected customers.
Quantity in commerce: 3,436 (US) and 14,488 (OUS)
Distribution: US Nationwide and Japan
Product codes and lots: EG-1690K, EG-2490K, EG-279oI, EG-2790K, EG-2990K, EG-2990K, EG-349oK and EG-3890TK

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0318-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0318-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-02	2016-10-26

Product code FDS

K131902Class IIPentax Video Upper G.i. Scopes (Eg Family)Pentax Medical Company / cleared 2014-04-10

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)