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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Keystone Industries: Hard Line Chairside Reline Kits Recalled Due to Incorrect Outer Labeling

Agency Publication Date: September 12, 2023
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Summary

Keystone Industries is recalling 240 units of the Henry Schein Hard Line Chairside Reline Kit, a resilient acrylic denture relining material. The recall was initiated because the outer packaging was incorrectly labeled as a 'Soft Line' kit, although the internal components and instructions correctly identify it as a 'Hard Line' material. This labeling error could lead dental professionals to apply a hard relining material when a soft one was intended.

Risk

The use of a hard relining material instead of a soft one may cause discomfort, poor fit, or potential irritation to the patient's oral tissues if the clinician relies solely on the outer box label during selection.

What You Should Do

  1. Identify the affected product by checking the outer box for the name 'Soft Line Chairside Reline Kit' with Item Number 570-0717 (0921250HS).
  2. Confirm if the kit is part of the recall by looking for Lot Number 23B058B and UDI +H65857007171/$$325120723B058BP on the packaging.
  3. Compare the outer box label against the internal contents and Instructions for Use (IFU); the internal materials are correctly labeled as 'Hard Line' (Item No. 570-0718 / 0921940HS).
  4. Contact your healthcare provider or the manufacturer, Keystone Industries, at 1-800-333-3131 to discuss the labeling error and determine if the product should be returned or replaced.
  5. For further information or to report concerns, contact the FDA hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material
Model / REF:
KI Item No.: 0921940HS
Henry Schein Item No.: 570-0718
Recall #: Z-2580-2023
Lot Numbers:
23B058B

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92856
Status: Active
Manufacturer: Keystone Industries
Sold By: Henry Schein
Manufactured In: United States
Units Affected: 240 units
Distributed To: Illinois, Pennsylvania, Florida, Nevada, Texas

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.