Olympus ENDOEYE HD II Videoscope Image Discoloration Recall
Two Olympus ENDOEYE HD II Rigid Videoscope catalog numbers (WA50040A, WA50042A) have been recalled due to reports of pink or green image discoloration during use. The issue could require device exchange during surgery and potentially result in visual impacts or bleeding.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with potential for serious patient harm (mucosal injury or bleeding) if image discoloration occurs during a procedure. No actual illnesses or injuries have been reported; the hazard is theoretical but involves high-risk surgical procedures.
Plain-English summary
Olympus Corporation of the Americas has recalled two catalog numbers of the ENDOEYE HD II Rigid Videoscope (WA50040A and WA50042A) following reports of pink or green discoloration in the image displayed during surgical use.
If image discoloration occurs during a procedure, the device would need to be exchanged, potentially resulting in prolonged surgery. The visual impacts from the discoloration could potentially cause mucosal injury or bleeding.
A total of 1,418 units are affected by this recall: 561 units of catalog number WA50040A and 857 units of catalog number WA50042A. The devices are used with endoscopy and endoscopic surgery systems for procedures within thoracic, abdominal, and female reproductive cavities. The affected devices were distributed nationwide within the United States and worldwide.
The recalled product
- Product
- Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the…
- Manufacturer
- Olympus Corporation of the Americas
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: WA50040A: 04042761074964 WA50042A: 04042761074971 All Serial Numbers
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Olympus Corporation of the Americas
See all →- ModerateOlympus DisplayPort Cable Recalled for Video Dropout Risk
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Foroblique Telescope Recalled for Sterilization Labeling Discrepancy
FDA (Devices) · 2026-10-07
- ModerateOlympus M3 Gold Autoclavable Lateral Telescope 70 Recalled for Sterilization Labeling Discrepancies
FDA (Devices) · 2026-10-07
- ModerateOlympus Endoscopic Balloon Dilator Recalled for Incorrect Inflation Chart Label
FDA (Devices) · 2026-09-30
- SevereOlympus BiCOAG Hemostasis Probe Recall Due to Ceramic Tip Detachment Risk
FDA (Devices) · 2026-09-30
Similar recalls
- HighOlympus ENDOEYE HD II Video Telescopes Recalled Due to Overheating Tip
FDA (Devices) · 2015-12-16
- HighOlympus ENDOEYE Videoscope Recalled for Reprocessing Instructions Deviations
FDA (Devices) · 2024-01-17
- SevereOlympus Endoeye HD II Video Telescopes Recalled for Overheating Tip
FDA (Devices) · 2017-05-10
- HighOlympus ENDOEYE Flex Videoscope Recalled for Reprocessing Instruction Deviations
FDA (Devices) · 2024-01-17
- HighOlympus Ultrasound Endoscope Recall for Updated Cleaning Instructions
FDA (Devices) · 2020-12-09
- HighOlympus Recalls High Frequency Resection Electrodes Due to Wire Breakage
FDA (Devices) · 2017-07-05