FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
- Recall number
- Z-2676-2026
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the distal end of the insertion tube and around the forceps elevator; duodenoscope and accessories, flexible/rigid
- Status
- Open, Classified
- Initiated
- 2026-06-05
- Posted
- 2026-07-07
- Terminated
- not on file
- Reason
- Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.
- Root cause
- Device Design
- Action
- Olympus issued an UREGNT: MEDICAL DEVICE REMOVAL notice to it consignees on 6/5/2026 via 2nd day courier. The notice explained the issue, risk to heath, and requested the following be taken: "1. Examine your inventory for the previous design of the Single Use Distal Covers, model MAJ-2315 (see Fig.1-6 above and list of affected lot numbers). 2. All older versions of this product should be returned to Olympus and replaced with the newly designed version. " Transition to the newly designed version as soon as possible by placing an order through Customer Service at 1-800-848-9024, option 2. 3. Once you have received the new design of the MAJ-2315, stop using the previous design and set aside for return. " To return the older version, please contact Customer Service at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will issue a credit to your facility upon return of the previous design. 4. Olympus requests that you acknowledge receipt of this letter through our recall web portal: " Go to https://olympusamerica.com/recall " Enter the recall number "XXXX " Complete the form as instructed. " Please indicate in your response if you no longer have the device(s). 5. Please forward this notice to other users who may have the affected products if you have further distributed it." For additional information...
- Quantity
- 988700 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/DI: 04953170441271, Lot Numbers: H2530 or later
- 510(k) numbers
- K220587
- PMA numbers
- not on file
- Product code
- FDT
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- 3e6df46828c1
- Size
- 288213574 bytes
- Published
- 2026-10-06
- Read
- 2026-10-07T03:20:25.099Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-14
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06