Olympus Corporation of the Americas: Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube

Recall number

Z-2341-2023

Recalling firm

Olympus Corporation of the Americas

Product

Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube

Status

Open, Classified

Initiated

2023-05-26

Posted

2023-08-04

Terminated

not on file

Reason

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

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 (Olympus6538@sedgwick.com) 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

686 units

Distribution

Nationwide

Lot, serial or model codes

UDI-DI: 04953170051098 All serial numbers

510(k) numbers

["K221631"]

PMA numbers

not on file

Product code

EOQ

Firm FEI

2429304

Firm city

Center Valley

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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