Recall archive / FDA device enforcement
ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultraso... — FDA record Z-0038-2026
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 Aug 29, 2025. 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
- ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
- Reason
- Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex rather than retroflex, and vice versa.
- Classification
- Class II
- Recalling firm
- ImaCor Inc.
- Quantity
- 45 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0038-2026
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 CLT-010; UDI-DI 00861589000108; Lot number: 20261209. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
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
- Oct 15, 2025
- Recall initiation date
- Aug 29, 2025
- Center classification date
- Oct 3, 2025
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.