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

Olympus OER-Elite recalled by Aizu Olympus Co

Aizu Olympus 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, 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
Device type: Other Medical Devices

Timeline

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

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

Other products in this recall event

2 other products · FDA event 97849

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025	CLASS II	Olympus OER-Pro recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
10 Dec 2025	CLASS II	Olympus OER-Mini recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide

More recalls from Aizu Olympus

All 31

Reported	Class	Recall	Company	Reason	Where
10 Dec 2025Device	CLASS II	Olympus OER-Mini recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
10 Dec 2025Device	CLASS II	Olympus OER-Pro recalled by Aizu Olympus Co	Aizu Olympus	Other	Nationwide
6 Dec 2023Device	CLASS II	Gif-hq190, Evis Exera Iii Gastrointestinal Videoscope recalled	Aizu Olympus	Other	6 states
6 Dec 2023Device	CLASS II	Gif-h190, Evis Exera Iii Gastrointestinal Videoscope recalled	Aizu Olympus	Other	6 states
6 Dec 2023Device	CLASS II	Cf-hq190l Evis Exera Iii Colonovideoscope recalled by Aizu Olympus Co	Aizu Olympus	Other	6 states

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