Olympus Corporation of the Americas: Medical Device Recall in 2022 - (Recall #: Z-1275-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum). Model: GIF-HQ190

Product Classification:

Class II

Date Initiated: April 22, 2022

Date Posted: June 29, 2022

Recall Number: Z-1275-2022

Event ID: 90232

Reason for Recall:

Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when replacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications

Status: Ongoing

Product Quantity: 8 units

Code Information:

UDI-DI: 04953170305276 Serial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545

Distribution Pattern:

US Nationwide distribution in the states of AL, FL, NC, NY.

Voluntary or Mandated:

Voluntary: Firm initiated