Class II — Handpiece Headquarters
| Recalling firm | Handpiece Headquarters |
|---|---|
| Registered facility | Handpiece Headquarters - HPR Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Tip of the curing light was too hot causing a heat sensation in the patients. |
| 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. |
| Quantity | 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. |
| Initiated | 2018-04-04 |
| Classified | 2019-02-04 |
| Recall number | Z-0797-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Handpiece Headquarters (Z-0797-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81459/
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