Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 13, 2019
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.
Tip of the curing light was too hot causing a heat sensation in the patients.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Handpiece Headquarters recalled Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing ligh… - a moderate-severity action.
Henry Schein CU 1000 Halogen Curing Light, Catalog 900-4542. - Product Usage: Curing ligh… was recalled by Handpiece Headquarters in February 13, 2019. Reason: Tip of the curing light was too hot causing a heat sensation in the patients.. Check the official notice for the remedy. Verify recall #Z-0797-2019 with the FDA Devices before acting.
The recall
Handpiece Headquarters issued this moderate-severity FDA Devices recall-Tip of the curing light was too hot causing a heat sensation in the patients..
- Moderate
- severity level
- Class II
- classification
- February 13, 2019
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0797-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0797-2019) was formally reported on February 13, 2019, with the manufacturer initiating the action on April 4, 2018. It is classified under Moderate severity (Class II), with a current status of Ongoing. Handpiece Headquarters is listed as the recalling firm, operating out of Placentia, CA. Federal records list the affected scope as 252 curing lights (rec'd by recalling firm; 142 were further dist).
The documented reason for this recall is: Tip of the curing light was too hot causing a heat sensation in the patients. Distribution data in the federal record shows the product reached: 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…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
252 curing lights (rec'd by recalling firm; 142 were further dist)
Related Recalls
6
0 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0797-2019 |
| Date reported | February 13, 2019 |
| Date initiated | April 4, 2018 |
| Recalling firm | Handpiece Headquarters |
| Firm location | Placentia, CA |
| Affected scope | 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… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0797-2019) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Handpiece Headquarters. Units affected: 252 curing lights (rec'd by recalling firm; 142 were further dist).
Why was this product recalled? ▼
Tip of the curing light was too hot causing a heat sensation in the patients.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 13, 2019. Severity: Moderate. Recall number: Z-0797-2019.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0797-2019) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 13, 2019. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.