The Recall Desk
ModerateFDA (Devices)·Z-1268-2016·Announced 2016-04-06

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.

What this means for you

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.
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

Distributed nationwide across the United States.

The notice also names 24 states specifically: