Summary
The FDA issued a Class II for Olympus OER-Mini by Aizu Olympus Co., Ltd.. Reason: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly traine.
Details
Source
Device Recall
External ID
Z-0874-2026
Action Date
2025-12-10
Status
Ongoing
Category
device
Product Description
Olympus OER-Mini
Lot/Code Info: Model: OER-Mini; UDI: 04953170331619; Serial #: All;
Quantity Affected: 6578 units
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.
Distribution
US Nationwide distribution.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-31
Company
Aizuwakamatsu
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 336 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Aizu Olympus Co., Ltd. has 31 FDA actions in our database, including 31 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aizu Olympus Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aizu Olympus Co., Ltd. have FDA actions?
Aizu Olympus Co., Ltd. has 31 FDA actions in our database, including 31 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0874-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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