Recall Z-2761-2026
Olympus Corporation of the Americas · initiated July 7, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
Codes / lots: Model Number: OEV321UH. UDI-DI: 04953170418723. Serial Numbers: 7503474, 7503477, 7503479, 7503263, 7503264, 7503262, 7503261, 7503260, 7503259, 7503335.
Reason for recall
Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
FDA-determined cause: Nonconforming Material/Component
Action taken
On July 7, 2026, the firm issued "Urgent: Medical Device Correction" letters to consignees. Customers were informed of the product issue. While the identified 4K UHD LCD monitor may be used with VISERA S, VISERA ELITE III, EVIS X1, and EU-ME3 systems, the firm notes that the affected HDMI or DP connectors are more commonly used with the VISERA S video system center. Its use with the three other systems does not typically involve the affected HDMI or DP connectors. Customers are requested to examine their equipment, looking for the identified monitor model number and serial numbers listed in the customer letter. They should then acknowledge receipt of the letter through the firm's recall web portal. The firm will coordinate repair of the monitors. If customer needs to use the monitor prior to its repair, the firm recommends that a spare unit be available in case issues are encountered with the primary unit during use.
Details
- Recall number
- Z-2761-2026
- Initiated
- July 7, 2026
- Posted by FDA
- July 20, 2026
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- Quantity
- 10 units
- Distribution
- Worldwide - US Nationwide distribution in the states of OH, CA, NJ, FL and the country of Japan.
- Recalling firm
- Olympus Corporation of the Americas, Center Valley, PA