Pelton & Crane Recalls Helios Track Mounted Dental Lights
Pelton & Crane is recalling 156 Helios HL3T and HLT track mounted dental lights because they were missing two set screws during initial installation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves missing hardware (set screws) during installation, which is a mechanical defect without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Pelton & Crane / Marus / DCI Equipment / KaVo is recalling 156 units of Helios HL3T and HLT Track Mounted Dental Lights. These products are intended for use by dental professionals to illuminate the oral cavity during examinations and procedures.
The recall was initiated after the firm received two customer complaints from local Pelton & Crane distributors. The complaints indicated that the Helios 3000 track mounted dental lights were missing two 8/32x3/16 set screws during the initial installation of the dental light.
The affected units were distributed nationwide in the United States in the states of AZ, AR, CA, CO, CT, FL, IA, ID, IL, IN, MA, MI, MN, NJ, NY, NC, OH, OR, PA, TN, TX, UT, VA, and WI, as well as in Canada. Specific model and serial numbers are listed in the official recall documentation.
The recalled product
- Product
- Helios HL3T and HLT Track Mounted Dental Lights Product Usage: The product is intended for use by dental professionals to illuminate the oral cavity while performing examinations and dental procedures.
- Manufacturer
- Pelton & Crane / Marus / DCI Equipment / KaVo
- Hazard
- Affected units
- 156
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Model/Serial No. - HLT-5535
- 5543
- 5536
- 5537
- 5538
- 5556
- 5540
- 5541
- 5545
- 5546
- 5515
- 5500
- 5503
- 5520
- 5521
- 5547
- 5548
- 5549
- 5550
- 5551
Distribution
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