Olympus Corporation of the Americas: The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5

Recall number

Z-2447-2023

Recalling firm

Olympus Corporation of the Americas

Product

The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE: GF-UC140P-AL5, GF-UCT140-AL5, GF-UE160-AL5, GF-UCT180, GF-UM20, GF-UM130, GF-UMQ130, GF-UM160, GF-UC160P-OL5, GF-UCT160-OL5

Status

Open, Classified

Initiated

2023-07-12

Posted

2023-08-23

Terminated

not on file

Reason

The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

Root cause

Under Investigation by firm

Action

Olympus issued Urgent Medical Device Field Corrective Action letter on July 12,2023. Letter states reason for recall, health risk and action to take: 1. Inspect your inventory for the referenced devices and identify any device with the model names specified above. Please check all areas of the hospital and include a copy of this letter and addendum with any of these devices remaining in inventory. 2. Carefully read the content of this Medical Device Field Corrective Action as well as the attached Addendum for valve inspection instructions and updated MAJ-1444 reprocessing instructions: Disinfect the MAJ-1444 in the OER by placing the MAJ-1444 individually in the washing case of the endoscope reprocessor, with no other accessories. Note: Steam sterilization (autoclaving) or manual high-level disinfection remain available options per the existing instruction for use. 3. Ensure all personnel are informed on valve inspection requirements and to cease use and dispose of any valves suspected of having an abnormality. 4. Olympus requests that you acknowledge receipt of this letter through the Olympus recall portal. a. Go to https://olympusamerica.com/recall b. Enter the file (recall) number: 0428 5. If you have further distributed this product, identify your customers, forward them this notification, and appropriately document your notification process. Actions to be taken by the company: Olympus is updating the MAJ-1444 Instructions for Use to reflect the information found in the attached addendum. MAJ-1444 valves will be shipped with the Addendum until the Instructions for Use are updated. Olympus requests that you report complaints, including any injuries associated with the use of MAJ-1444, to our Technical Assistance Center (TAC) at 1-800-848-9024 (option 1). For additional support concerning this matter, please contact Tara Safi, Field Corrective Actions Administrator, at Tara.Safi@Olympus.com.

Quantity

29590 units

Distribution

US Nationwide distribution.

Lot, serial or model codes

UDI-DI: 04953170355929. All lot numbers

510(k) numbers

K103264

PMA numbers

not on file

Product code

FEB

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 3e6df46828c1, published 2026-10-06

Copy