CLASS II ONGOING Device recall · Reported 16 Aug 2023 · FDA Enforcement Report

Olympus Endoscope Reprocessor OER-Elite-For use recalled

Olympus Corporation of the Americas is recalling Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection, distributed nationwide in the US. The recall was initiated on 26 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 04953170404047 Serial Numbers: 2201375 and the last 4 digits less than 1375

Quantity recalled1063 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2344-2023
FDA event ID: 92633
Recalling firm: Olympus Corporation of the Americas, Center Valley, PA
Classification: Class II
Status: Ongoing
Recall initiated: 26 May 2023
FDA classified: 4 Aug 2023
Reported: 16 Aug 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

26 May 2023	Recall initiated by company
4 Aug 2023	Classified by FDA	+70 days
16 Aug 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide

Questions about this recall

Is Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection recalled?

Yes. Olympus Corporation of the Americas recalled Olympus Endoscope Reprocessor OER-Elite-For use in cleaning and high-level disinfection on 26 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2344-2023.

Why was it recalled?

Which lots are affected?

UDI-DI: 04953170404047 Serial Numbers: 2201375 and the last 4 digits less than 1375

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Olympus Corporation of the Americas

All 415

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Powerseal (in diameter) (long), Curved Jaw Sealer & Divider recalled	Olympus Corporation of the Americas	Labeling Errors	Nationwide
29 Jul 2026Device	CLASS II	Olympus 4K UHD LCD Monitor recalled by Olympus Corporation of the	Olympus Corporation of the Americas	Other	Nationwide
29 Jul 2026Device	CLASS II	Olympus High Flow Insufflation Unit - UHI recalled	Olympus Corporation of the Americas	Other	Nationwide
22 Jul 2026Device	CLASS II	Olympus Toomey Evacuator 50cc with Adaptor recalled	Olympus Corporation of the Americas	Sterility	Nationwide
22 Jul 2026Device	CLASS II	Olympus Glass Body for 194 Ellik Evacuator recalled	Olympus Corporation of the Americas	Foreign Material	Nationwide

Other Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Sterility	Nationwide