Has Olympus Corporation of the Americas had other FDA enforcement actions?

Yes. Argus HQ has recorded 21 total FDA actions tied to Olympus Corporation of the Americas: 0 warning letters, 21 recalls, 0 approval records, and 0 Form 483 inspection citations.

What kind of FDA record is this?

This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-22; Argus observed and indexed it on 2026-07-28.

Where can I verify this record directly with FDA?

The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

.hq

fda_recall · device_recall · high

Olympus Corporation of the Americas — Class II recall: Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.

Name: FDA Recall Record — Olympus Corporation of the Americas
Creator: Argus HQ
Published: 2026-07-22
License: https://argushq.ai/methodology

Event date: 2026-07-22 00:00:00Z
Observed: 2026-07-28 04:20:57Z
Source ID: Z-2721-2026
Payload hash: 7d5baac7abb27485911556ff…

Summary

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. Status: Ongoing.

Entities

Olympus Corporation of the Americas

View source record ↗

Frequently asked questions

Has Olympus Corporation of the Americas had other FDA enforcement actions?: Yes. Argus HQ has recorded 21 total FDA actions tied to Olympus Corporation of the Americas: 0 warning letters, 21 recalls, 0 approval records, and 0 Form 483 inspection citations.
What kind of FDA record is this?: This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2026-07-22; Argus observed and indexed it on 2026-07-28.
Where can I verify this record directly with FDA?: The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Olympus Corporation of the Americas — Class II recall: Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-olympus-corporation-of-the-americas-z-2721-2026

MLA

"Olympus Corporation of the Americas — Class II recall: Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-olympus-corporation-of-the-americas-z-2721-2026.

Chicago

Argus HQ Research. "Olympus Corporation of the Americas — Class II recall: Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.." Digital Empire Holdings LLC. Accessed July 28, 2026. https://argushq.ai/events/fda-recall-olympus-corporation-of-the-americas-z-2721-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_olympus_corporation_of_the_americas_z_2721_2026_2026,
  title = {Olympus Corporation of the Americas — Class II recall: Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A.},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-olympus-corporation-of-the-americas-z-2721-2026},
  note = {Accessed: July 28, 2026}
}

Informational only. Not legal, financial, or medical advice.