FDA Medical Device Recalls (openFDA)
Pentax of America Inc: 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
- Recall number
- Z-2448-2021
- 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
- Status
- Open, Classified
- Initiated
- 2021-07-14
- Posted
- not on file
- Terminated
- not on file
- Reason
- Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families
- 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 customeradvisories@pentaxmedical.com. 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: customeradvisories@pentaxmedical.com
- Quantity
- 28849 units Total
- Distribution
- Nationwide
- Lot, serial or model codes
- All devices distributed by Pentax in the US between April 2014 and May 2021
- 510(k) numbers
- ["K131855","K181084","K210485"]
- PMA numbers
- not on file
- Product code
- FDF
- Firm FEI
- 1000080301
- Firm city
- Montvale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28