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

Yes. Argus HQ has recorded 29 total FDA actions tied to Olympus Corporation of the Americas: 0 warning letters, 29 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 2026-09-30; Argus observed and indexed it on 2026-10-06.

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 EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Num…

Name: FDA Recall Record — Olympus Corporation of the Americas
Creator: Argus HQ
Published: 2026-09-30
License: https://argushq.ai/methodology

Event date: 2026-09-30 00:00:00Z
Observed: 2026-10-06 04:20:26Z
Source ID: Z-3216-2026
Payload hash: ab606dd88c0ca550cb314df3…

Summary

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, 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 29 total FDA actions tied to Olympus Corporation of the Americas: 0 warning letters, 29 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 2026-09-30; Argus observed and indexed it on 2026-10-06.
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 EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Num…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-olympus-corporation-of-the-americas-z-3216-2026

MLA

"Olympus Corporation of the Americas — Class II recall: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Num…." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/events/fda-recall-olympus-corporation-of-the-americas-z-3216-2026.

Chicago

Argus HQ Research. "Olympus Corporation of the Americas — Class II recall: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Num…." Digital Empire Holdings LLC. Accessed October 6, 2026. https://argushq.ai/events/fda-recall-olympus-corporation-of-the-americas-z-3216-2026.

BibTeX

@misc{argushq_argushq_ai_events_fda_recall_olympus_corporation_of_the_americas_z_3216_2026_2026,
  title = {Olympus Corporation of the Americas — Class II recall: Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Num…},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/events/fda-recall-olympus-corporation-of-the-americas-z-3216-2026},
  note = {Accessed: October 6, 2026}
}

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