HIGH

ImaCor Recalls Miniaturized TEE Probe Due to Assembly Error

ImaCor recalled 45 units of the ClariTEE Miniaturized TEE probe on August 29, 2025, due to a production assembly error. The defect may cause the probe to articulate incorrectly, posing a risk to patient safety. Healthcare providers and patients must stop using the device immediately.

Quick Facts at a Glance

Recall Date
August 29, 2025
Hazard Level
HIGH
Brand
ImaCor
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

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

Product Details

The recalled product is the ClariTEE Miniaturized TEE probe, Model Number CLT-010. It was distributed nationwide in South Carolina, New Jersey, Pennsylvania, Florida, and Georgia. The recall affects 45 units.

The Hazard

A production assembly error can lead to reversed articulation. When the lever is moved forward, the probe tip may anteflex instead of retroflex, risking improper usage.

Reported Incidents

No injuries or incidents have been reported as of the recall date. The risk is classified as high due to the potential for misuse.

What to Do

Stop using the probe immediately. Follow recall instructions provided by ImaCor and contact your healthcare provider for guidance.

Contact Information

For more information, contact ImaCor Inc. via email as per the recall notification. Visit the FDA recall page at the provided URL.

Key Facts

  • Model: CLT-010
  • Recalled quantity: 45 units
  • Recall date: August 29, 2025
  • Distribution states: SC, NJ, PA, FL, GA
  • Hazard: Reversed articulation risk
View Original Recall on FDA - Medical Devices

Get Alerts for Health & Personal Care Recalls

Get notified about recalls in categories you care about.

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeUltrasound Probe
Sold At
Multiple Retailers

Product Details

Brand
ImaCor
Model Numbers
CLT-010
UDI-DI 00861589000108
Lot number: 20261209
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

Related Recalls

HIGH

Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]

CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

SUCRALFATE
CGMP Deviations:
Read more