The Recall Desk
ModerateFDA (Devices)·Z-2580-2023·Announced 2023-09-20

Denture relining kit recalled for outer box labeling error

Keystone Industries is recalling 240 units of Henry Schein Hard Line Chairside Reline kits because the outer box is labeled as Soft Line, though the contents and instructions are correctly labeled.

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: This is an FDA Class II recall involving a minor labeling error on the outer box only; the actual product contents and instructions for use are correctly labeled. No illnesses or injuries have been reported, making this a low-risk packaging discrepancy.

Plain-English summary

Keystone Industries is recalling 240 units of the Henry Schein Hard Line Chairside Reline Kit (Item No. 570-0718, Keystone Item No. 0921940HS) with lot number 23B058B.

The outer box of the kit is labeled as "Soft Line Chairside Reline Kit" (Item No. 570-0717), creating a labeling discrepancy. However, the actual contents of the kit and the instructions for use enclosed with the kit are correctly labeled as Hard Line materials.

The affected kits were distributed nationwide to dental facilities in Illinois, Pennsylvania, Florida, Nevada, and Texas.

The recalled product

Product
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Manufacturer
Keystone Industries
Category
Medical Device — Dental relining material
Hazard
  • mis-labeling
  • product-misidentification

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 (1)

  • UDI: +H65857007171/$$325120723B058BP Lot Number: 23B058B

Distribution

Distributed nationwide across the United States.

Related recalls

Same category