Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Brand
Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan
Lot Codes / Batch Numbers
UDI-DI 04953170305276 Serial Numbers 2270393, 2201027, 2201611, 2745407
Products Sold
UDI-DI 04953170305276 Serial Numbers 2270393, 2201027, 2201611, 2745407
Aizu Olympus Co., Ltd. 3 Chome 1-1 Niiderakita Aizuwakamatsu Japan is recalling GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE due to Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Recommended Action
Per FDA guidance
On October 16, 2023, the firm notified affected customers through URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect their inventory and identify affected devices. Affected devices should be quarantined and not used. Olympus Customer Solutions will contact customers by phone and email to arrange the return and repair of the affected product. If you require additional information, please do not hesitate to contact Olympus at 647-999-3203 or Cynthia.Ow@Olympus.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, KY, MA, NJ, NY, PA
Page updated: Jan 10, 2026