Z-2761-2026Class II

Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for...

Name: Z-2761-2026 Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for...
Creator: Olympus Corporation of the Americas
Published: 2026-07-07
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2026-07-07 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color on 2026-07-07. FDA classified it as Class II and gives the reason as "Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2761-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-07
Posted: 2026-07-20
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 10 units
Distribution: Worldwide - US Nationwide distribution in the states of OH, CA, NJ, FL and the country of Japan.
Product codes and lots: Model Number: OEV321UH. UDI-DI: 04953170418723. Serial Numbers: 7503474, 7503477, 7503479, 7503263, 7503264, 7503262, 7503261, 7503260, 7503259, 7503335.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2761-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2761-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-29	2026-07-20

Product code GCJ

K220069Class II4K UHD LCD Monitor OEV321UHOlympus Medical Systems Corp. / cleared 2022-03-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)