Z-1267-2020Class II

Pentax Video Colonoscope Model: EC34-i10L

Name: Z-1267-2020 Pentax Video Colonoscope Model: EC34-i10L
Creator: Pentax of America Inc
Published: 2020-01-03
License: https://open.fda.gov/license/

PENTAX of America, Inc. / initiated 2020-01-03 / Terminated

FDA source

Pentax of America Inc began a recall of Pentax Video Colonoscope Model: EC34-i10L on 2020-01-03. FDA classified it as Class II and gives the reason as "Distributed in the USA without an approved 510K". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1267-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-03
Posted: 2020-02-19
Terminated: 2021-01-26
Recalling firm: PENTAX of America, Inc.
Product: Pentax Video Colonoscope Model: EC34-i10L
Product code: FDF Colonoscope And Accessories, Flexible/Rigid
Reason for recall: Distributed in the USA without an approved 510K
FDA 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: [email protected]
Distribution: NC, MA
Product codes and lots: Serial Numbers: L110300, L110301, L110303, L110306

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1267-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1267-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19
Z-1268-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-26	2020-02-19

Product code FDF

K131855Class IIPentax Video Colonoscopes (Ec Family)Pentax Medical Company / cleared 2014-04-09

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)