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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97505

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
August 29, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
ImaCor Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0038-2026
Recall number
Z-0038-2026
Initiated
August 29, 2025
Classification
Class II
Status
Ongoing
Recalling firm
ImaCor Inc.
Quantity
45 units

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Production assembly error

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

Model CLT-010; UDI-DI 00861589000108; Lot number: 20261209.

Distribution pattern

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