FDA Device recall Z-0797-2019
Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry
- FDA Device
- Class II
- ongoing
- Published 2019-02-13
On 2019-02-13 the FDA classified a Class II recall of Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing light for use in dentistry by Handpiece Headquarters, citing tip of the curing light was too hot causing a heat sensation in the patients.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0797-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2018-04-04 |
| Published | 2019-02-13 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Handpiece Headquarters |
| Distribution | US |
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
Tip of the curing light was too hot causing a heat sensation in the patients.
Identifiers
| code_info | Serial #17C0001 to #17C0252 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0797-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.