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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81459

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

Open FDA event record

Event summary

Timeline bucket
April 04, 2018
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Handpiece Headquarters

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

Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry. The labeling did not provide specific details for intended use. Distributed by Henry Schein Inc., Melville, NY.

Z-0797-2019
Recall number
Z-0797-2019
Initiated
April 04, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Handpiece Headquarters
Quantity
252 curing lights (rec'd by recalling firm; 142 were further dist)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tip of the curing light was too hot causing a heat sensation in the patients.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tip of the curing light was too hot causing a heat sensation in the patients.

Code information

Serial #17C0001 to #17C0252

Distribution pattern

Worldwide distribution including US nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, and WV, and to Guam. There was also military/government distribution, and countries of Johannesburg, Panama, Suriname, and Trinidad.