CLASS II ONGOING Device recall · Reported 10 Dec 2025 · FDA Enforcement Report

Olympus OER-Elite recalled by Aizu Olympus Co

Aizu Olympus Co is recalling Olympus OER-Elite, distributed nationwide in the US. The recall was initiated on 31 Oct 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel: OER-Elite; UDI: 04953170404047; Serial #: All;
Quantity recalled6578 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0872-2026
FDA event ID
97849
Recalling firm
Aizu Olympus Co, Aizuwakamatsu
Classification
Class II
Status
Ongoing
Recall initiated
31 Oct 2025
FDA classified
2 Dec 2025
Reported
10 Dec 2025
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

31 Oct 2025Recall initiated by company
2 Dec 2025Classified by FDA+32 days
10 Dec 2025Published in enforcement report+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Product as listed by the FDA

Olympus OER-Elite

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Olympus OER-Elite recalled?

Yes. Aizu Olympus Co recalled Olympus OER-Elite on 31 Oct 2025. The recall is Class II and its status is Ongoing. Recall number Z-0872-2026.

Why was it recalled?

Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

Which lots are affected?

Model: OER-Elite; UDI: 04953170404047; Serial #: All;

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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