Quick Facts at a Glance
- Recall Date
- August 29, 2025
- Hazard Level
- HIGH
- Brand
- ImaCor
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ImaCor
- Product type
- Ultrasound TEE Probe
- Model numbers
- CLT-010, UDI-DI 00861589000108, Lot 20261209
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 29, 2025
Reported by FDA DEVICE
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ImaCor Inc. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The ClariTEE CLT-010 is a miniaturized transesophageal echocardiography probe used with dedicated ultrasound systems.
Why This Is Dangerous
A reversed articulation could misdirect the probe tip during procedures, potentially compromising guidance during imaging.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Clinicians may need to pause procedures on affected patients and switch to alternative imaging devices.
Practical Guidance
How to identify if yours is affected
- Check UDI-DI 00861589000108 on the device and Lot 20261209.
- Verify model CLT-010 and association with ImaCor ZHH and Mobile Ultrasound.
- Cross-check with FDA recall Z-0038-2026.
Where to find product info
FDA recall page linked in enforcement report Z-0038-2026.
What timeline to expect
Refunds or replacements timelines are determined by ImaCor; expect several weeks.
If the manufacturer is unresponsive
- Escalate to hospital safety officer
- File a complaint with FDA if no response within a reasonable period
- Document all communications
How to prevent similar issues
- Verify UDI-DI before purchase
- Confirm device compatibility with imaging systems
- Keep recall contacts handy
- Register devices with vendor for updates
Documentation advice
Keep recall notice, photos of device label, and correspondence with ImaCor for records
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model: CLT-010. UDI-DI: 00861589000108. Lot number: 20261209. Quantity: 45 units. Distribution: US nationwide in SC, NJ, PA, FL, GA. Sold with ImaCor Mobile Ultrasound system, ImaCor ZHH.
Reported Incidents
No injuries or incidents have been reported in the data provided.
Key Facts
- Distributed across SC, NJ, PA, FL, GA
- High risk high-hazard defect
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
