Z-0638-2022Class II

OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus...

Name: Z-0638-2022 OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus...
Creator: Olympus Corporation of the Americas
Published: 2021-12-13
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2021-12-13 / Terminated / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope... on 2021-12-13. FDA classified it as Class II and gives the reason as "The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0638-2022
Classification: Class II
Status: Terminated
Initiated: 2021-12-13
Posted: 2022-02-11
Terminated: 2023-12-26
Recalling firm: OLYMPUS Corporation of the Americas
Product: OER-Elite Endoscope Reprocessor-for use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes, their accessories, and endoscope reprocessor accessories
Product code: FEB Accessories, Cleaning, For Endoscope
Reason for recall: The detergent and alcohol tank tubing may have been incorrectly assembled in the OER-Elite. If the tubing is incorrectly assembled, alcohol will be dispensed instead of detergent for the cleaning cycle and detergent will be dispensed instead of alcohol for the alcohol cycle, resulting in a ineffective endoscope reprocessing and patient exposure to residual detergent
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Olympus issued Urgent Medical Device Correction letter dated 12/13/21. Letter states reason for recall, health risk and action to take: 1. Please immediately perform an inspection of your installed OER-Elite units as described in the Attachment 1 Alcohol Rinse Inspection . If you require assistance, please contact your local Endoscopy Support Specialist (ESS). 2. If the inspection check does not pass, stop using the OER-Elite and endoscopes reprocessed with that OER-Elite. Contact Olympus TAC at 1-800-848-9024, option 1 for further instruction. If the inspection check passes, you may continue to use your OER-Elite. 3. Access the Olympus recall portal to indicate that you have received this notification and to report the results of the inspection. Go to https://olympusamerica.com/recall. Enter the recall number "0404" and provide your contact information as indicated in the portal. An Olympus Endoscopy Support Specialist (ESS) will reach out to you to schedule an on-site inspection of the OER-Elite detergent and alcohol tubing assembly for final confirmation. If you do not know your local ESS, please contact our Olympus TAC at 1-800-848-9024 to connect you with your local ESS. In addition, if you have further distributed this product, please reach out to those facilities and notify them at once of this field action and appropriately document your notification process. Your notification to your customers may be enhanced by including a copy of this field action notification letter. If you require additional information, please do not hesitate to contact me at [email protected].
Quantity in commerce: 295 units
Distribution: Nationwide
Product codes and lots: All serial numbers. UDI: 04953170404047

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0638-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0638-2022	Class II	Terminated	Voluntary: Firm initiated	2022-02-23	2022-02-11

Product code FEB

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)