Z-0873-2026Class II

Olympus OER-Pro

Name: Z-0873-2026 Olympus OER-Pro
Creator: Aizu Olympus Co., Ltd.
Published: 2025-10-31
License: https://open.fda.gov/license/

Aizu Olympus Co., Ltd. / initiated 2025-10-31 / Open, Classified

FDA source

Aizu Olympus Co., Ltd. began a recall of Olympus OER-Pro on 2025-10-31. FDA classified it as Class II and gives the reason as "Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0873-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-31
Posted: 2025-12-02
Recalling firm: Aizu Olympus Co., Ltd.
Product: Olympus OER-Pro
Product code: FEB Accessories, Cleaning, For Endoscope
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.
FDA root cause: Under Investigation by firm
Action: On October 31, 2025 URGENT Medical Device Safety Alert letters were sent to customers. Actions to be taken: 1. Olympus reminds users to follow the Warnings/Cautions and inspections outlined in all Olympus Endoscope Reprocessor Operation Manuals which are important to reduce the potential risk of fire to the device. 2. Carefully read the content of the notification. 3. Check your inventory for the reference devices and identify any in your inventory. 4. Ensure all personnel are completely knowledgeable and thoroughly aware of the contents of the letter. 5. Acknowledge receipt through the provided information. 6. Forward this notice if any affected product was further distributed.
Quantity in commerce: 6578 units
Distribution: US Nationwide distribution.
Product codes and lots: Model: OER-Pro; UDI: 04953170258589; Serial #: All;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0873-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0872-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-10	2025-12-02
Z-0873-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-10	2025-12-02
Z-0874-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-10	2025-12-02

Product code FEB

K103264Class IIEndoscope Reprocessor Oer-Pro Model Oer-ProOlympus Medical Systems Corporation / cleared 2011-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)