Olympus Corporation of the Americas recall records

323 reported ongoing

327 records in this archive. Latest source date Aug 18, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories

Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.

Official source for POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Elec...
FDA device enforcement

Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit designed for displaying graphical information in color.

Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.

Class IIReported ongoing

Distribution: Worldwide - US Nationwide distribution in the states of OH, CA, NJ, FL and the country of Japan.

Official source for Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered visual display unit d...
FDA device enforcement

Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4

Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, El Salvador, Germany, Honduras, Hong...

Official source for Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4
FDA device enforcement

Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideoscope TJF-Q190V- designed to be attached to Olympus duodenovideoscopes to cover t...

Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA III Duodenovideos...
FDA device enforcement

Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.

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.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Japan, EU, and Latin America.

Official source for Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb. Model Number: 194.
FDA device enforcement

OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included with the Olympus OER-ELITE.

Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Hong Kong, Japan, South Korea and Taiwan.

Official source for OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2110. May be included...

Reasons in these listed records

  • Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
  • Potential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
  • Potential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
  • Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers.

These examples come from this result page and are not a ranking of every recall reason.

Checking Olympus Corporation of the Americas

Is there a recall on olympus corporation of the americas right now?

This archive contains 327 records, including 323 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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