FDA Medical Device Recalls (openFDA)
Pentax of America Inc: Pentax Video Colonoscope Model: EC38-i10L
- Recall number
- Z-1268-2020
- Recalling firm
- Pentax of America Inc
- Product
- Pentax Video Colonoscope Model: EC38-i10L
- Status
- Terminated
- Initiated
- 2020-01-03
- Posted
- not on file
- Terminated
- 2021-01-26
- Reason
- Distributed in the USA without an approved 510K
- Root cause
- Mixed-up of materials/components
- Action
- Pentax Medical contacted US Affected Customers by telephone to inform them of the pending action and to advise they quarantine the affected products Pentax issued URGENT MEDICAL DEVICE CORRECTIONAND REMOVAL Letter via UPS dated 1/3/20 states: reason for recall, health risk and action to take: Please quarantine the units your facility owns, complete the response form, and return it to PENTAX Medical using the e-mail address or fax number listed below. Upon return of the response form, PENTAX will contact your facility to arrange the return of the affected units. Loaner units will be supplied until this issue is resolved. Question contact: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: customeradvisories@pentaxmedical.com
- Quantity
- 1 unit
- Distribution
- NC, MA
- Lot, serial or model codes
- Serial Numbers:L110746
- 510(k) numbers
- ["K131855"]
- 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