Skip to content

Olympus Corporation of the Americas

Also registered as Olympus Corporations of the Americas

United StatesFDA applicant, unverified

Devices
2
FDA recalls
423331 ongoing since 2021 (332 open in total)
1 open since before 2021

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Olympus Corporation of the Americas makes

Olympus Corporation of the Americas manufactures flexible cysto-nephroscope systems, including the VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2 and VA2, designed for endoscopic visualization of the urinary tract and kidneys. These devices support diagnostic and therapeutic procedures in urology, such as stone removal and tissue biopsy.

The company’s products fall under FDA Class II devices and are authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

FDA recalls423

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 423 recalls initiated by Olympus Corporation of the Americas, the earliest on 2015-08-21 and the most recent on 2026-08-27. By recorded status: 332 ongoing and 91 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 3
  • 2018 39
  • 2019 3
  • 2020 18
  • 2021 19
  • 2022 21
  • 2023 90
  • 2024 58
  • 2025 82
  • 2026 81

9 initiated before 2017

Showing the 10 most recent of 423 recalls.

  • 2026

    • 27 Aug 2026 Z-3329-2026 Class II Ongoing While in the high-power operating mode, a video dropout/blackout may occur when using a particular accessory cable. Distribution: Worldwide distribution - US Nationwide and the country of Poland.
    • 24 Aug 2026 Z-3299-2026 Class II Ongoing There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. Distribution: International distribution to the country of Japan. Submission number: K890328
    • 24 Aug 2026 Z-3300-2026 Class II Ongoing There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert. Distribution: International distribution to the country of Japan. Submission number: K890328
    • 19 Aug 2026 Z-3216-2026 Class II Ongoing Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm, Distribution: International distribution in the country of Japan.
    • 19 Aug 2026 Z-3244-2026 Class II Ongoing Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU. Submission number: K123319
    • 19 Aug 2026 Z-3245-2026 Class II Ongoing Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU. Submission number: K123319
    • 19 Aug 2026 Z-3246-2026 Class II Ongoing Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU. Submission number: K123319
    • 19 Aug 2026 Z-3247-2026 Class II Ongoing Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU. Submission number: K123319
    • 18 Aug 2026 Z-3035-2026 Class II Ongoing Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. Distribution: Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union,…
      Full distribution text Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
      Submission number: K212643
    • 7 Jul 2026 Z-2761-2026 Class II Ongoing Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities. Distribution: Worldwide - US Nationwide distribution in the states of OH, CA, NJ, FL and the country of Japan. Submission number: K220069
Show the 25 most recent of 423 recalls

  • 2026

    • 16 Jun 2026 Z-2776-2026 Class II Ongoing Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases. Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Bolivia, Brazil, Canada, Chile, China, Colombia,…
      Full distribution text Worldwide distribution - US Nationwide and the countries of Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Germany, Honduras, Hong Kong, India, Ireland, Japan, Korea, Malaysia, Mexico, Myanmar, New Zealand, Paraguay, Peru, Russia, Singapore, Sri Lanka, Taiwan, Thailand, United Kingdom, Uruguay, Vietnam.
      Submission number: K243527
    • 5 Jun 2026 Z-2676-2026 Class II Ongoing Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers. Distribution: US Nationwide distribution. Submission number: K220587
    • 5 May 2026 Z-2718-2026 Class II Ongoing Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
    • 5 May 2026 Z-2719-2026 Class II Ongoing Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
    • 5 May 2026 Z-2720-2026 Class II Ongoing Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America. Submission number: K890328
    • 5 May 2026 Z-2721-2026 Class II Ongoing Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.
    • 25 Mar 2026 Z-1898-2026 Class II Ongoing Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan. Submission number: K201920
    • 25 Mar 2026 Z-1899-2026 Class II Ongoing Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan. Submission number: K201920
    • 25 Mar 2026 Z-1900-2026 Class II Ongoing Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan. Submission number: K201920
    • 25 Mar 2026 Z-1901-2026 Class II Ongoing Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan. Submission number: K201920
    • 25 Mar 2026 Z-1902-2026 Class II Ongoing Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan. Submission number: K201920
    • 25 Mar 2026 Z-1903-2026 Class II Ongoing XXX Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan. Submission number: K201920
    • 25 Mar 2026 Z-1904-2026 Class II Ongoing Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan. Submission number: K201920
    • 25 Mar 2026 Z-1905-2026 Class II Ongoing Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan. Submission number: K201920
    • 25 Mar 2026 Z-1906-2026 Class II Ongoing Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan. Submission number: K201920

Frequently asked questions

How many devices does Olympus Corporation of the Americas have in the registry?

The registry currently lists 2 devices for Olympus Corporation of the Americas. Devices recorded under merged duplicate company entries are counted once.

Which registries list Olympus Corporation of the Americas's devices?

Among its 2 most recently registered devices, Olympus Corporation of the Americas has devices listed in FDA 510(k) (2 devices).

What risk classes do Olympus Corporation of the Americas's devices fall under?

Among its 2 most recently registered devices, the classes recorded for Olympus Corporation of the Americas's devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Olympus Corporation of the Americas?

FDA recall records list 423 recalls initiated by Olympus Corporation of the Americas, the most recent initiated on 27 Aug 2026. 332 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Olympus Corporation of the Americas in the registry?

The most recently registered devices listed for Olympus Corporation of the Americas include VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700; VISERA ELITE III LED LIGHT SOURCE OLYMPUS CLL-S700; 4K CAMERA HEAD OLYMPUS CH-S700-XZ-EA and VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE VA2, VISERA CYSTO-NE.

Generated automatically from registry data and not verified by a human reviewer.