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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91987

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

Open FDA event record

Event summary

Timeline bucket
March 20, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
DermLite 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

DERMLITE DL4W, REF: DL4W, Rx Only MD, CE

Z-1506-2023
Recall number
Z-1506-2023
Initiated
March 20, 2023
Classification
Class II
Status
Ongoing
Recalling firm
DermLite LLC
Quantity
32 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Incorrect labeling

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

Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling.

Code information

Lot # 7654, serial numbers DL4WGXXXX & DL4WBXXXX (1304-1353 and 1504); UDI-DI: (01) 0 8559970

Distribution pattern

Worldwide - US Nationwide distribution in the states of CA, AZ, TX, FL, NE, IA, MO, CO and the countries of Saudi Arabia, Australia, Spain.