Z-1613-2023Class II

Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V...

Name: Z-1613-2023 Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V...
Creator: Olympus Corporation of the Americas
Published: 2023-04-18
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-04-18 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100 on 2023-04-18. FDA classified it as Class II and gives the reason as "The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1613-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-18
Posted: 2023-05-19
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: The Single Use Distal Cover MAJ-2315 may cause mucosal injury and/or become detached from the endoscope during use. Consequences of a detached cover could include the risk of aspiration, inhalation, or obstruction that will require urgent removal, and/or burns from an uncovered distal end.
Root cause tag: design
FDA root cause: Device Design
Action: An URGENT - Medical Device Recall notification letter dated 4/18/23 was sent to customers. Instructions for Use: Correct application and inspection of the distal cover before the procedure is critical. In addition, inspection of the distal end after the procedure is also important. Olympus representatives are available to provide additional support and training. Please contact your local Olympus facility to further discuss. Action Required: Our records indicate that you have purchased or may use the MAJ-2315 Distal Covers with the original design. Olympus requires you to take the following action: 1. Immediately locate and no longer use the MAJ-2315 with the original design. The original design can be identified by the item code (below) or by lot numbers less than H2530. The image below depicts the area where the lot number is identified. The lot number is on the Carton box and Pack. Model: MAJ-2315 Item code: N5786100 Lot number: Lower than H2530 2. Contact our Olympus Customer Service Team at 1-800-848-9024, option 2. Olympus will issue a Return Material Authorization to return any affected product at no charge to you. Olympus will issue a credit to your facility upon return of affected product. 3. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a) Go to https://olympusamerica.com/recall b) Enter the recall number: 0423 c) Complete the form as instructed. 4. If you have distributed these devices outside your facility, please notify your customers of this matter immediately. Your notification to your customers may be enhanced by including a copy of this letter. Olympus requests that you report complaints, including mucosal injuries, distal cover detachment and adverse events, to Olympus. Please report complaints to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1, to report complaints. Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration
Quantity in commerce: 309278 pieces
Distribution: US Nationwide.
Product codes and lots: UDI-DI: 04953170403019; Item code: Catalog N5786100 Lots Lower than H2530

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1613-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1613-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-05-31	2023-05-19

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)