Z-2269-2018Class II

Olympus JF-140F duodenoscopes (Model NumberJF-140F)

Name: Z-2269-2018 Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Creator: Olympus Corporation of the Americas
Published: 2018-05-11
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2018-05-11 / Terminated / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Olympus JF-140F duodenoscopes (Model NumberJF-140F) on 2018-05-11. FDA classified it as Class II and gives the reason as "Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2269-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-11
Posted: 2018-06-21
Terminated: 2020-05-05
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus JF-140F duodenoscopes (Model NumberJF-140F)
Product code: FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Reason for recall: Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Firm is extending recall to the user level Letters will be sent on May, 11, 2018 via overnight mail to customers Follow-up phone calls to consignees to offer training on new reprocessing instructions No action can be taken with hospitals that are no longer in business
Quantity in commerce: 994
Distribution: Nationwide
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2269-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2269-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-21
Z-2270-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-27	2018-06-21

Product code FET

K853585Class IIOlympus Evs-Endoscopic Video Image & Data SysOlympus Corp. / cleared 1986-01-21

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)