The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0797-2019·Announced 2019-02-13

Handpiece Headquarters Recalls Henry Schein CU 1000 Halogen Curing Lights

Handpiece Headquarters is recalling 252 Henry Schein CU 1000 Halogen Curing Lights because the tip became too hot, causing heat sensations in patients.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (excessive heat causing patient sensation) where specific injury reports are not detailed, fitting the High severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Handpiece Headquarters is recalling 252 Henry Schein CU 1000 Halogen Curing Lights, Catalog 900-4542. The product is a curing light used in dentistry, and the labeling did not provide specific details for intended use. The devices were distributed by Henry Schein Inc. in Melville, NY.

The recall was initiated because the tip of the curing light was too hot, which caused a heat sensation in patients. The affected units have serial numbers ranging from 17C0001 to 17C0252. Of the 252 units recalled by the firm, 142 were further distributed.

Distribution was worldwide, including nationwide in the United States across numerous states and territories, as well as to military/government entities and specific countries including Johannesburg, Panama, Suriname, and Trinidad. Patients or dental professionals who have used these devices should contact their healthcare provider or the recalling firm for further instructions.

The recalled product

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.
Manufacturer
Handpiece Headquarters
Category
Medical Device — Dental Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Serial #17C0001 to #17C0252

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

Related recalls

Same hazard · burn injury

See all →

Similar recalls