Z-2029-2024Class II

OES 4000 Hysteroscope, Model/Catalog Number: A4674A

Name: Z-2029-2024 OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Creator: Olympus Corporation of the Americas
Published: 2024-04-18
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2024-04-18 / Open, Classified

FDA source

Olympus Corporation of the Americas began a recall of OES 4000 Hysteroscope, Model/Catalog Number: A4674A on 2024-04-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2029-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-04-18
Posted: 2024-06-06
Recalling firm: OLYMPUS Corporation of the Americas
Product: OES 4000 Hysteroscope, Model/Catalog Number: A4674A
Product code: HIH Hysteroscope (And Accessories)
Reason for recall: 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.
FDA root cause: Process change control
Action: 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 [email protected]
Quantity in commerce: 1 unit
Distribution: US Nationwide distribution in the state of NY.
Product codes and lots: Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2029-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2029-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-06

Product code HIH

K897003Class IIOlympus HysteroresectoscopeOlympus Corp. / cleared 1990-03-16

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)