Olympus Corporation of the Americas: Olympus Single Use Distal Cover Model Number MAJ-2315 used with EVIS EXERA III Duodenovideoscope TJF-Q190V; Item code: Catalogue #N5786100

Recall number

Z-1613-2023

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

Status

Open, Classified

Initiated

2023-04-18

Posted

2023-05-19

Terminated

not on file

Reason

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

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

309278 pieces

Distribution

US Nationwide.

Lot, serial or model codes

UDI-DI: 04953170403019; Item code: Catalog N5786100 Lots Lower than H2530

510(k) numbers

["K193182"]

PMA numbers

not on file

Product code

FDT

Firm FEI

2429304

Firm city

Center Valley

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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