Food, drugs, devices › Aizu Olympus Co., Ltd.
Device recall: Olympus OER-Elite
Aizu Olympus Co., Ltd. (Aizuwakamatsu) initiated this device recall on 31 Oct 2025; FDA lists 3 product records under event 97849, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 85% of the 945 device enforcement events initiated in 2025 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Aizu Olympus Co., Ltd. has 4 enforcement events on this register, with a median of 5 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aizu Olympus Co., Ltd., Aizuwakamatsu, Japan.
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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0872-2026 | Olympus OER-Elite | 6578 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0873-2026 | Olympus OER-Pro | 6578 units | Class II | Ongoing | 10 Dec 2025 |
| Z-0874-2026 | Olympus OER-Mini | 6578 units | Class II | Ongoing | 10 Dec 2025 |
Context
Other enforcement events for Aizu Olympus Co., Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 16 Oct 2023 | CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE | Device | Class II | 5 |
| 25 Sep 2023 | Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, | Device | Class II | 22 |
| 20 Jul 2022 | EVIS EXERA III Bronchovideoscope | Device | Class II | 1 |
All 4 events for Aizu Olympus Co., Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.