Z-2344-2023Class II

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

Name: Z-2344-2023 Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive...
Creator: Olympus Corporation of the Americas
Published: 2023-05-26
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-05-26 / Open, Classified / root cause: labeling and UDI

FDA source

Olympus Corporation of the Americas began a recall of Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories on 2023-05-26. FDA classified it as Class II and gives the reason as "Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2344-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-26
Posted: 2023-08-04
Recalling firm: OLYMPUS Corporation of the Americas
Product: Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Product code: FEB Accessories, Cleaning, For Endoscope
Reason for recall: Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Olympus issued two Urgent: Medical Device Corrective Action letters: (1) VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V (LF-V) TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-P (LF-P) (2)ENDOSCOPE REPROCESSOR Affected Models: OER-ProTM, OER-MiniTM and OER-EliteTM. Letters states reason for recall, health risk and action to take: Our records indicate that your facility has purchased one or more LF-V and LF-P scopes. (1)Olympus requests you to take the following actions: 1. Ensure all personnel are completely knowledgeable and thoroughly trained on the changes to the reprocessing instructions described in this letter. 2. If you are using OER for high level disinfection of your LF-V and LF-P, please transition to another compatible method of reprocessing as soon as possible. 3. Locate and replace any on-hand copies of the LF-V and LF-P Instructions for Use with the updated version. Obtain a copy of the updated IFU by accessing our Olympus Connect website: How to access the Instructions for Use a) Log in to www.OlympusConnect.com b) Select Product Support , then Instruction Manuals c) Navigate to the document entitled LF-V Instruction Manual and LF-P Instruction Manual If you require additional information about the updated Instruction for use, or need assistance with accessing Olympus Connect, please contact our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). The TAC department can assist you in answering questions on the new Instructions Manual and new steps. 4. If a Scope ID tag (MAJ-1545) is used with your LF-V and LF-P, please dispose of your MAJ-1545 since the LF-V and LF-P cannot be used with OERs. 5. Complete the enclosed response form and return to our recall partner, Sedgwick, via Email ([email protected]) or Fax (866-842-0470). For any questions about the acknowledgement form, please call the Sedgwick team at 888-912-7350. (2)Our records indicate that your facility has purchased one or more of the afore mentioned endoscope
Quantity in commerce: 1063 units
Distribution: Nationwide
Product codes and lots: UDI-DI: 04953170404047 Serial Numbers: 2201375 and the last 4 digits less than 1375

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2344-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2340-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-04
Z-2341-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-04
Z-2342-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-04
Z-2343-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-04
Z-2344-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-16	2023-08-04

Product code FEB

K201920Class IIEndoscope Reprocessor OER-EliteOlympus Medical Systems Corp. / cleared 2020-09-01

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)