Z-2447-2023Class II

The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC...

Name: Z-2447-2023 The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC...
Creator: Olympus Corporation of the Americas
Published: 2023-07-12
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2023-07-12 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of The Air/Water Valve is provided/used with the following Endoscopes: ULTRASONIC GASTROFIBERSCOPE, ULTRASONIC GASTROVIDEOSCOPE, ULTRASONIC COLONOVIDEOSCOPE... on 2023-07-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2447-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-12
Posted: 2023-08-23
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
Product code: FEB Accessories, Cleaning, For Endoscope
Reason for recall: 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.
FDA 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 [email protected].
Quantity in commerce: 29590 units
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI: 04953170355929. All lot numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2447-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2447-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-30	2023-08-23

Product code FEB

K103264Class IIEndoscope Reprocessor Oer-Pro Model Oer-ProOlympus Medical Systems Corporation / cleared 2011-02-23

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)