FDA Medical devices recall ·
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use… recall
- Recall number
- Z-0231-2025
- Date
- (initiated September 16, 2024)
- Company / brand
- ImaCor Inc.
50 Jericho Tpke Ste 105, Jericho, NY, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 73 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
Why was it recalled?
Epoxy used to seal the edge of the transducer into its paddle exceeded specification. This variability could attenuate the ultrasound signal with a potential impact on the quality of images obtained from the probes.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI - Primary - 00861589000108 Lot numbers: 20250509 and 20250823
Distribution
FL ,GA, NJ, TN
States: Florida Georgia New Jersey Tennessee
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0231-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.