Recall archive / FDA device enforcement
For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R — FDA record Z-2518-2023
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 Jul 20, 2023. 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
- For intraventricular indications mainly used for operations within the brain ventricles. Product Code: FF399R
- Reason
- Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
- Classification
- Class II
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 25 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2518-2023
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 | UDI-DI: 04038653065547 Lot Numbers: 52750146 52753381, 52756472, 52768317, 52805655, 52812596, 52816570, 52823878, 52830872. Serial Numbers: 4281,4282, 4284,4288, 4289,4291, 4308,4309, 4310, 4312, 4313,4336, 4340,4341, 4342,4402, 4411, 4412, 4413,4414, 4422,4439, 4447,4449, 4450 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of FL, ID, IL, MD, NC, NY, OR, RI, TX.
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
- Sep 13, 2023
- Recall initiation date
- Jul 20, 2023
- Center classification date
- Sep 6, 2023
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.