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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87443

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

Open FDA event record

Event summary

Timeline bucket
February 15, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
CARESTREAM DENTAL, LLC

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

Carestream Dental CS 3600 Single Use Normal Tips, Catalog Number 5941216 - Product Usage: used to record the topographic characteristics of teeth or dental impressions in three dimensions.

Z-1268-2021
Recall number
Z-1268-2021
Initiated
February 15, 2021
Classification
Class II
Status
Terminated
Recalling firm
CARESTREAM DENTAL, LLC
Quantity
11400 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The mirror may become detached and fall from the unit

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The mirror may become detached and fall from the unit

Code information

All lot numbers

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of WA, MD, WV, NE, SC, NJ, FL, OH, CA, OR, LA, MO, NY, MI, MA, ID, TN, GA, MN, NC, PA, AZ, OK, IN and the country of Canada.