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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84249

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

Open FDA event record

Event summary

Timeline bucket
October 30, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Young Dental Manufacturing Co, 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

Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.

Z-0661-2020
Recall number
Z-0661-2020
Initiated
October 30, 2019
Classification
Class II
Status
Ongoing
Quantity
Batch 84702 - 6500 units; Batch 72766 - 6500 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product shelf life may be shorter than that indicated on the label.

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

Product shelf life may be shorter than that indicated on the label.

Code information

Batch 84702; Batch 72766

Distribution pattern

US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.