Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-1071-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: December 8, 2023

Date Posted: February 21, 2024

Recall Number: Z-1071-2024

Event ID: 93732

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.

Status: Ongoing

Product Quantity: 24300 units (box of 20 pieces)

Code Information:

UDI: 04953170441271 All lot numbers

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated