Z-1861-2016Class II

Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection

Name: Z-1861-2016 Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
Creator: Fujifilm Medical Systems U.S.A., Inc.
Published: 2015-12-23
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2015-12-23 / Terminated

FDA source

Fujifilm Medical Systems U.S.A., Inc. began a recall of Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection on 2015-12-23. FDA classified it as Class II and gives the reason as "This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1861-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-23
Posted: 2016-05-31
Terminated: 2018-01-18
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
FDA root cause: Other
Action: Fujifilm issued a urgent field correction/Tracking/Verification form on 12/23/2015.
Quantity in commerce: 98 units
Distribution: Nationwide Distribution.
Product codes and lots: All distribution dates :3/2003-4/2016

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1861-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1860-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1861-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1862-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1863-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31
Z-1864-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-08	2016-05-31

Product code FDT

K944759Class II200 Series Gastro-Intestinal Video SystemFujinon, Inc. / cleared 1995-04-11

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)