# FDA recall Z-0797-2019

> **Handpiece Headquarters** · Class II · device recall initiated 2018-04-04.

## 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.

## Reason for recall

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

## 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.

## Key facts

- **Recall number:** Z-0797-2019
- **Recalling firm:** Handpiece Headquarters
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-04-04
- **Report date:** 2019-02-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Placentia, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0797-2019

## Citation

> AI Analytics. FDA recall Z-0797-2019. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0797-2019. Source: US FDA. Licensed CC0.

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