Z-1292-2021Class II

Duodenoscope and accessories, flexible/rigid -

Name: Z-1292-2021 Duodenoscope and accessories, flexible/rigid -
Creator: Olympus Corporation of the Americas
Published: 2021-01-28
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2021-01-28 / Terminated

FDA source

Olympus Corporation of the Americas began a recall of Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo... on 2021-01-28. FDA classified it as Class II and gives the reason as "Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1292-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-28
Posted: 2021-03-22
Terminated: 2024-03-13
Recalling firm: OLYMPUS Corporation of the Americas
Product: Duodenoscope and accessories, flexible/rigid - Product Usage: used with an Olympus video system center, light source, documentation equipment, monitor, Endo Therapy accessories (such as biopsy forceps), and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: Olympus Medical Systems Corporation (OMSC) has received complaints of mucosal injury associated with the forceps elevator region of the TJF-Q190V duodenoscope, including the distal cover (model MAJ- 2315).
FDA root cause: Under Investigation by firm
Action: On 2/5/2021, Olympus issued Urgent Device Correction notices to customers via letter informing them Olympus has identified an increase in the number of complaints from customers reporting that mucosal tissue was found within the single-use distal cover, MAJ-2315, after withdrawing the TJF-Q190V duodenoscope from the patient. In the reported complaints, the user facilities have reported mucosal injuries in the esophagus, stomach, and duodenum. Olympus is thoroughly investigating the root cause or causes of these reported events. This notice included information that may reduce the potential occurrence of similar incidents.
Quantity in commerce: 1564 devices total (Domestic: 627 devices, Foreign: 937 devices)
Distribution: Worldwide distribution - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Japan, Europe, Australia.
Product codes and lots: Model: TJF-Q190V

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1292-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1292-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-31	2021-03-22

Product code FDT

K193182Class IIEvis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. / cleared 2020-01-17

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)