PlainRecordsClariTEE Miniaturized TEE probe…
- Reason
- 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.
- Status
- Ongoing
- Distribution
- US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
- Enforcement report date
- Oct. 15, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- ImaCor Inc.
- Product
- ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH.
- Reason
- 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.
- Distribution pattern
- US Nationwide distribution in the states of South Carolina, New Jersey, Pennsylvania, Florida, and Georgia.
- Quantity
- 45 units
- Codes and lots
- Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.
- Recall started
- Aug. 29, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Transducer, Ultrasonic, Diagnostic
- Root cause (FDA)
- Process control
- What the company told customers
- 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.
- Recall number
- Z-0038-2026
What this record is about
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“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.”ClariTEE Miniaturized TEE probe. Model Number: CLT-010. Ultrasound miniaturized TEE probe for use with Mobile Ultrasound, ImaCor model ZHH., FDA enforcement report, 2025-10-15. The caption is the record's own words.
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FDA device name: Transducer, Ultrasonic, Diagnostic
Distributed in (FDA's record): Florida Georgia New Jersey Pennsylvania South Carolina and nationwide
This recall among the others
- FDA's enforcement report came 47 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- ImaCor: 1 other recall or notice on this site in the three years before this one (from Oct. 16, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-0038-2026. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-0038-2026, Oct. 15, 2025. "ClariTEE Miniaturized TEE probe." PlainRecords, https://plainrecords.com/recall/device/z-0038-2026/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections