Z-1071-2024Class II

Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be...

Name: Z-1071-2024 Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be...
Creator: Olympus Corporation of the Americas
Published: 2023-12-08
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-12-08 / Open, Classified / root cause: design

FDA source

Olympus Corporation of the Americas began a recall of Single Use Distal Cover MAJ-2315 Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover the... on 2023-12-08. FDA classified it as Class II and gives the reason as "Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in...". 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-1071-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-08
Posted: 2024-02-09
Recalling firm: OLYMPUS Corporation of the Americas
Product: Single Use Distal Cover 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
Product code: FDT Duodenoscope And Accessories, Flexible/Rigid
Reason for recall: Single Use Distal Cover MAJ-2315 may unexpectedly detach from the duodenoscope during use result include the risk of mucosal injury, tissue damage, bleeding, perforation, or obstruction due to retained distal cover in the gastrointestinal tract that would require urgent medical intervention for removal, and/or burns from the use an uncovered duodenoscope distal end. Detachment of a distal cover in the oral cavity may result in aspiration, airway obstruction, or respiratory distress and would require immediate medical intervention for removal.
Root cause tag: design
FDA root cause: Device Design
Action: Olympus issued Urgent: Medical Device Corrective Action letter on December 8, 2023. Letter states reason for recall, health risk and action to take: Our records indicate that you have purchased the MAJ-2315 Distal Covers. Olympus requires you to take the following action: 1. Please ensure that all Olympus TJF-Q190V duodenoscope users at your facility are knowledgeable on MAJ-2315 distal cover attachment and attachment verification to ensure the safe use of these devices. 2. Please ensure that the reference guide (Appendix) is distributed to all parties at your facility who will be involved in the process of attaching the MAJ-2315 distal cover. 3. Olympus requests that you acknowledge receipt of this letter and provide a contact for in-servicing. Complete the enclosed response form and return it to our recall partner, Sedgwick, via e-mail at [email protected] or by fax at 866-534-0018. For any questions about the acknowledgement form, please call the Sedgwick team at 888-216-7307. 4. An Olympus representatives will be contacting you to schedule an upcoming on-site, in-service training at your user facility on MAJ-2315 distal cover attachment and attachment verification to ensure the safe use of these devices. 5. If you have distributed these devices outside your facility, please provide a copy of this letter to those facilities immediately. Olympus requests that you report complaints, including mucosal injuries, distal cover detachment and/or cracks, and adverse events, to our Technical Assistance Center (TAC) at 1-800-848-9024, option 1. Adverse events experienced with the use of this product may also be reported to the Food and Drug Administration MedWatch Adverse Event Reporting program either online, by regular mail or by fax. If you require additional information, please do not hesitate to contact me directly at (647) 999-3203 or at [email protected].
Quantity in commerce: 24300 units (box of 20 pieces)
Distribution: US Nationwide distribution.
Product codes and lots: UDI: 04953170441271 All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1071-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1071-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09

Product code FDT

K220587Class IIEvis Exera III Duodenovideoscope Olympus TJF-Q190VOlympus Medical Systems Corp. / cleared 2022-05-11

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)