Z-0797-2019Class II

Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. -

Name: Z-0797-2019 Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. -
Creator: Handpiece Headquarters
Published: 2018-04-04
License: https://open.fda.gov/license/

Handpiece Headquarters / initiated 2018-04-04 / Open, Classified / root cause: manufacturing process

FDA source

Handpiece Headquarters began a recall of 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... on 2018-04-04. FDA classified it as Class II and gives the reason as "Tip of the curing light was too hot causing a heat sensation in the patients". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0797-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-04-04
Posted: 2019-02-04
Recalling firm: Handpiece Headquarters
Product: 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.
Product code: EBZ Activator, Ultraviolet, For Polymerization
Reason for recall: Tip of the curing light was too hot causing a heat sensation in the patients.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The initial letter was issued via regular mail on 4/4/2018 by the parent company of the recalling firm. It explained the reason for recall and requested the consignee to immediately cease distribution or use of the product and to return it.
Quantity in commerce: 252 curing lights (rec'd by recalling firm; 142 were further dist)
Distribution: 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.
Product codes and lots: Serial #17C0001 to #17C0252

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0797-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0797-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-02-13	2019-02-04

Product code EBZ

K060646Class IIBlue Luxcer Curing Light, Models M-830, M-835 and M-855Monitex Industrial Co., Ltd. / cleared 2006-04-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)