Olympus Corporation of the Americas — FDA Enforcement History

FDA action counts

Risk pattern analysis

Argus HQ analysis — not an FDA finding

This section is Argus HQ analysis, not an FDA finding. Olympus Corporation of the Americas has 16 separate FDA recalls on file, more than a single isolated recall event. A pattern across multiple FDA touchpoints does not by itself establish that any specific product currently poses a risk; it reflects only the frequency of FDA engagement with this company as recorded in Argus HQ's database. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures. This page reflects only the FDA event types Argus HQ currently tracks -- FDA Warning Letters, recalls, drug and biologic approvals, and Form 483 inspection observations -- and will update automatically as new FDA records are observed.

Enforcement history

On 2026-04-29, Argus HQ recorded a FDA recall for Olympus Corporation of the Americas, rated "high" severity in Argus HQ's classification: Olympus Corporation of the Americas — Class II recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-05… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Olympus Corporation of the Americas, rated "high" severity in Argus HQ's classification: Olympus Corporation of the Americas — Class II recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2114… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Olympus Corporation of the Americas, rated "high" severity in Argus HQ's classification: Olympus Corporation of the Americas — Class II recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-05… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Olympus Corporation of the Americas, rated "high" severity in Argus HQ's classification: Olympus Corporation of the Americas — Class II recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2111 An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Olympus Corporation of the Americas, rated "high" severity in Argus HQ's classification: Olympus Corporation of the Americas — Class II recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Olympus Corporation of the Americas, rated "high" severity in Argus HQ's classification: Olympus Corporation of the Americas — Class II recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2330… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Olympus Corporation of the Americas, rated "high" severity in Argus HQ's classification: Olympus Corporation of the Americas — Class II recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Olympus Corporation of the Americas, rated "high" severity in Argus HQ's classification: Olympus Corporation of the Americas — Class II recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-05… An FDA recall record reflects a firm removing or correcting a product already in distribution because it does not meet FDA requirements. On 2026-04-29, Argus HQ recorded a FDA recall for Olympus Corporation of the Americas, rated "high" severity in Argus HQ's classification: Olympus Corporation of the Americas — Class II recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2117… An FDA recall record reflects a firm removing or correcting a product already.

Frequently asked questions

What is the most recent FDA action on file for Olympus Corporation of the Americas?

July 29, 2026. Argus HQ ingests new FDA enforcement records daily.

Has Olympus Corporation of the Americas had product recalls?

Yes, 23 recalls on file. See the full history below for each one.

Is this FDA enforcement data for Olympus Corporation of the Americas official?

Every record links directly to its primary FDA.gov source. Argus HQ aggregates and structures public FDA data; the verbatim FDA record is always the source of truth.

How many FDA actions has Olympus Corporation of the Americas had?

Argus HQ has recorded 16 FDA events for Olympus Corporation of the Americas: 0 warning letters, 16 recalls, 0 approvals, and 0 Form 483 inspection observations. Argus HQ ingests these records directly from FDA's own public enforcement and approval databases rather than from company disclosures.

Related enforcement actions

• Olympus Corporation of the Americas — Class II recall: Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 →
• Olympus Corporation of the Americas — Class II recall: Olympus 4K UHD LCD Monitor. Model Number: OEV321UH. An electrically powered v… →
• Olympus Corporation of the Americas — Class II recall: Olympus Glass Body for 194 Ellik Evacuator. Model Number: 190A. →
• Olympus Corporation of the Americas — Class II recall: Olympus Toomey Evacuator 30cc with Adaptor. Model Number: 188. →
• Olympus Corporation of the Americas — Class II recall: Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb… →
• Olympus Corporation of the Americas — Class II recall: Olympus Toomey Evacuator 50cc with Adaptor. Model Number: 188A. →
• Olympus Corporation of the Americas — Class II recall: Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA… →
• Olympus Corporation of the Americas — Class II recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2118… →
• Olympus Corporation of the Americas — Class II recall: OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2138… →
• Olympus Corporation of the Americas — Class II recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-05… →

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