Henry Schein CU 1000 Halogen Curing Light — Class II medical device recall Z-0797-2019
Ongoing recall by Handpiece Headquarters, reported 2019-02-13, distributed nationwide. Tip of the curing light was too hot causing a heat sensation in the patients.
| Recall number | Z-0797-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Handpiece Headquarters, Placentia, CA, United States |
| Recall initiated | 2018-04-04 |
| Classified | 2019-02-04 |
| Reported by FDA | 2019-02-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | PA, TT |
| Serial numbers | 17C0001, 17C0252 |
| Model numbers | 900-4542 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0797-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.