FDA Device Recall Z-0038-2026: ImaCor Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0038-2026.

Recall Res Number

Z-0038-2026

Recalling Firm / Manufacturer

ImaCor Inc.

FEI Number

3006382185

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2025-08-29

Date Posted

2025-10-03

Date Terminated

N/A

Product Code

ITX

Event Number

97505

Product Quantity

45 units

Product Description ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.

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.

Action Details 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.

Distribution Pattern US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.

Code Information / Serial Numbers Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0038-2026

Recall Parameters & Description

Related Establishments / Registrations

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