Handpiece Headquarters: Medical Device Recall in 2019 - (Recall #: Z-0797-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: April 4, 2018

Date Posted: February 13, 2019

Recall Number: Z-0797-2019

Event ID: 81459

Reason for Recall:

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

Status: Ongoing

Product Quantity: 252 curing lights (rec'd by recalling firm; 142 were further dist)

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.

Voluntary or Mandated:

Voluntary: Firm initiated