Exact FDA event identifier

Event 95179

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

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Event summary

Timeline bucket: July 26, 2024
Product types: Device
Classifications: Class III
Statuses: Ongoing
Recalling firm wording: Carbon Medical Technologies, 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

BiomarC EX Fiducial Marker System, Catalog Number 040165

Z-3161-2024

Recall number: Z-3161-2024
Initiated: July 26, 2024
Classification: Class III
Status: Ongoing
Recalling firm: Carbon Medical Technologies, Inc.
Quantity: 25 boxes of 3 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This recall has been initiated due to a failure to provide an MRI Insert that is to be provided to the patient.

Code information

UDI/DI 00850002461305, Lot Number 2112355B

Distribution pattern

US Nationwide distribution in the state of TN.