---
title: Olympus Corporation of the Americas — FDA recall record
license: CC0-1.0
source: openFDA drug & device recall enforcement records — U.S. FDA
---

# Olympus Corporation of the Americas — FDA recall record

The FDA recall enforcement history of Olympus Corporation of the Americas: 295 recalls (44 Class I), drug/device split, severity mix, recurring reasons, and ongoing count. RECORDED openFDA records, keyed by the exact firm name. Not a quality verdict or medical advice. CC0.

## Claims

### Olympus Corporation of the Americas has 295 FDA recalls on record (2023–2026)

**DERIVED.** Olympus Corporation of the Americas has 295 FDA recall enforcement records (0 drug, 295 device), of which 44 are Class I (the FDA's most-serious tier), 249 Class II, 2 Class III; 295 are ongoing. An AGGREGATED count of openFDA enforcement records keyed by firm name (occurred=true; adjudged=FALSE — the Atlas counted them, the FDA published the records).

Source: openFDA drug & device recall enforcement records — U.S. FDA — https://open.fda.gov/
Falsifier: occurred=TRUE: a faithful COUNT/SUM/total over the named record set that introduces NO modeling choice — it IS the case in the record. adjudged=FALSE: Atlas Commons computed the aggregate; openFDA drug & device recall enforcement records — U.S. FDA published the underlying records, NOT this figure. Re-count it from the named source to verify. Distinct from a median/ratio/index (which picks a population, weighting, denominator, or threshold — a constructed statistic → 'derived', occurred=FALSE) and from an authority-published total (→ 'recorded', adjudged=TRUE).

### A recall count is not a quality verdict

**INTERPRETATION.** A recall count is not a quality verdict — large firms recall more by volume and most recalls are voluntary; the Class I count and ongoing status are the signal, not the raw total. Keyed by the exact firm-name string (a large firm may file under variants; see the FDA recall database for the complete cross-variant record). Not medical advice.

Source: Drug & Device Safety Atlas L5 boundary (recall count ≠ quality verdict) — https://drug-device-safety-atlas.ryanjhunter.workers.dev/
Falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.

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Every claim above carries a four-status warrant (RECORDED / MODELED / DERIVED / INTERPRETATION) and a named source you can re-fetch — this is a research object, not a flat fact. Structured: `https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/firm/olympus-corporation-of-the-americas.jsonld`

## Data

### FDA recall summary — Olympus Corporation of the Americas

Aggregated counts of openFDA enforcement records keyed by firm name (occurred=true, adjudged=false — Atlas counted; FDA published the records). Source: openFDA.

| Metric | Value | Status |
| --- | --- | --- |
| Total recalls | 295 | aggregated |
| Drug recalls | 0 | aggregated |
| Device recalls | 295 | aggregated |
| Class I (most serious) | 44 | aggregated |
| Class II | 249 | aggregated |
| Class III | 2 | aggregated |
| Ongoing | 295 | aggregated |
| Year span | 2023–2026 | aggregated |
| Top reason #1 | Devices which did not undergo thermoforming could deform and lose performance. (30×) | aggregated |
| Top reason #2 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunct (23×) | aggregated |