Z-2448-2021Class II

Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet...

Name: Z-2448-2021 Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet...
Creator: Pentax of America Inc
Published: 2021-07-14
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2021-07-14 / Open, Classified / root cause: design

FDA source

Pentax of America Inc began a recall of Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li... on 2021-07-14. FDA classified it as Class II and gives the reason as "Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2448-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-07-14
Posted: 2021-09-10
Recalling firm: PENTAX of America, Inc.
Product: Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models: EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, EC34-i10L, EC38-i10L; Colonoscope Family # 2-Pentax Video Colonoscopes with Two Instrument Channels and a Water Jet Channel Model: EC-3890TLK
Product code: FDF Colonoscope And Accessories, Flexible/Rigid
Reason for recall: Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
Root cause tag: design
FDA root cause: Device Design
Action: Pentax issued Urgent Medical Device Correction letter via UPS mailing on 7/14/21. Letter states reason for recall, health risk and action to take (USB drive along with the enclosed instruction sheet enclosed). Letter states: PENTAX separated the EC and EG rIFUs into 5 separate rIFUs . The grouping will allow the following for reprocessing personnel: " Eliminate the need to identify optional configurations of instrument channels and water jet channels " Simplify the instructions and graphics in the individual rIFUs Please replace any previous versions of rIFUs with the most current revision. Please note that this documentation set is current as of this date. For future 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]. Questions regarding this action, please feel free to contact us at: o Tel: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) o Fax: 201-799-4063 (alternate 201-391-4189) o Email: [email protected]
Quantity in commerce: 28849 units Total
Distribution: Nationwide
Product codes and lots: All devices distributed by Pentax in the US between April 2014 and May 2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2448-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2448-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-10
Z-2449-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-10

Product code FDF

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)