Z-0038-2026Class II

ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile...

Name: Z-0038-2026 ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile...
Creator: ImaCor Inc.
Published: 2025-08-29
License: https://open.fda.gov/license/

IMACOR, Inc / initiated 2025-08-29 / Open, Classified / root cause: manufacturing process

FDA source

ImaCor Inc. began a recall of ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH on 2025-08-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0038-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-08-29
Posted: 2025-10-03
Recalling firm: IMACOR, Inc
Product: ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
Product code: ITX Transducer, Ultrasonic, Diagnostic
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: ImaCor, Inc. notified consignees on 08/29/2025 via email. Consignees were instructed to Immediately discontinue use of the affected ClariTEE probes, quarantine all affected units in inventory, confirm receipt of this notice, return all affected units to ImaCor, and complete and return the response form.
Quantity in commerce: 45 units
Distribution: US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
Product codes and lots: Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0038-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0038-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-15	2025-10-03

Product code ITX

K220490Class IIImaCor Zura Handheld ZHH-010Imacor, Inc. / cleared 2022-04-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)