Olympus Corporation of the Americas OES 4000 Hysteroscope, Model/Catalog Number: A4674A Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904
Products Sold
Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;
Olympus Corporation of the Americas is recalling OES 4000 Hysteroscope, Model/Catalog Number: A4674A due to The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyep. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.
Recommended Action
Per FDA guidance
On May 9, 2024, URGENT: MEDICAL DEVICE REMOVAL letters were sent to the consignee. Actions Required: Our records indicate that your facility has purchased one or more of the affected products. Therefore, Olympus requires you to take the following actions: 1. Carefully read the content of this notification. 2. Examine your inventory and identify the above listed device with serial number. 3. Please contact Customer Service at at 1-800-848-9024, option 2, to obtain a Return Material Authorization. Olympus will arrange for the return of your device to Olympus, and we will replace this device at no charge. 4. Olympus requests that you acknowledge receipt of this letter through the a. Go to https://olympusamerica.com/recall b. Enter the recall number "XXXX . c. Complete the form as instructed and include your account ID number: XXXXXXXX 5. If you have further distributed this product, identify your customers, and forward them this notification. Olympus requests that you report any complaints, including foggy image, to the Technical Assistance Center (TAC) at 1- 800-848-9024, option 1, and the FDA. Adverse events experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. Olympus fully appreciates your prompt cooperation in addressing this situation. If you require additional information, please do not hesitate to contact me directly by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026