Recall archive / FDA device enforcement
OES 4000 Hysteroscope, Model/Catalog Number: A4674A — FDA record Z-2029-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 18, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- OES 4000 Hysteroscope, Model/Catalog Number: A4674A
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2029-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model/Catalog Number: A4674A, UDI-DI: 04042761006361, Serial Number: 805904; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the state of NY.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 12, 2024
- Recall initiation date
- Apr 18, 2024
- Center classification date
- Jun 6, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.