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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94756

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

Open FDA event record

Event summary

Timeline bucket
May 13, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Young Dental Manufacturing I, 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

Darby Prophylaxis Paste with 1.23% Fluoride Ion, Mint Coarse

Z-2143-2024
Recall number
Z-2143-2024
Initiated
May 13, 2024
Classification
Class II
Status
Ongoing
Quantity
534 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrectly labeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Part number 040032, Lot number, 248607 was incorrectly labeled as part number 045032

Code information

Unique Device Identifier (UDI)1: 00889813036273; Lot: 248607; Part number 040032 is the Young Dental part number. The Darby Dental Part Number (that is on the label) is 9518637.

Distribution pattern

US Nationwide distribution in the state of TN.