Use caution Medical device recall · FDA · Published April 10, 2023

Henry Schein Denture Relining Kit Recall: Mislabeling Hazard

Keystone Industries recalls Henry Schein Hard Line Chairside Reline Kits due to mislabeling on the outer box. Check your kit details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2580-2023Medical device Henry Schein ›

Use caution until it’s fixed

The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly labeled as Hard Line materials

Take action

Contact the company

Recalling firmKeystone Industries480 S Democrat Rd · Gibbstown, NJ 08027-1239

✎ GovInfoNow plain-language explainer

Keystone Industries is recalling specific units of the Henry Schein Hard Line Chairside Reline Kit because the outer packaging was incorrectly labeled as a Soft Line Kit. The actual contents and instructions inside are correct for the Hard Line material, but the external labeling error could cause confusion during use. This recall affects 240 units distributed in Illinois, Pennsylvania, Florida, Nevada, and Texas. Read more at govinfonow.com/recall/58593-henry-schein-hard-line-chairside-reline-kit-mislabeled-as-soft.

Source Summary by GovInfoNow · govinfonow.com/recall/58593-henry-schein-hard-line-chairside-reline-kit-mislabeled-as-soft · Updated October 13, 2026 · FDA enforcement record: FDA #Z-2580-2023

Cite this page

“Henry Schein Denture Relining Kit Recall: Mislabeling Hazard.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/58593-henry-schein-hard-line-chairside-reline-kit-mislabeled-as-soft. Based on FDA recall #Z-2580-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2580-2023%22&limit=1).

Keystone Industries voluntarily recalled Henry Schein Hard Line Chairside Reline kits due to labeling errors, the FDA said on April 10, 2023. The outer boxes were mislabeled as Soft Line material while containing Hard Line contents.

How to tell if you have it

Brand: Henry Schein
Product: Hard Line Chairside Reline Kit
KI Item No.: 0921940HS
Henry Schein Item No.: 570-0718
Lot Number: 23B058B
Distribution: US Nationwide, including IL, PA, FL, NV, TX

The hazard

The Hard Line Chairside Reline Kit was labeled as Soft Line Chairside Reline Kit on the outer box. The contents and enclosed instructions were correctly labeled as Hard Line materials.

Context

GovInfoNow's records show Keystone Industries has five other recalls since July 21, 2023. Recent Keystone recalls include a May 21, 2026 topical anesthetic gel recall for defective containers and a Nov. 14, 2024 quality anesthetic gel recall for CGMP deviations. Other recent recalls of similar products include Henry Schein Structur 2 SC Resin Cartridge Refills (July 9, 2026) and Henry Schein Grandio Dental Capsules (July 9, 2026).

How to tell if you have this one

Look for the Henry Schein Hard Line Chairside Reline Kit with KI Item No. 0921940HS and Henry Schein Item No. 570-0718. Check the UDI code +H65857007171/$$325120723B058BP and Lot Number 23B058B on the packaging. The outer box may incorrectly state 'Soft Line Chairside Reline Kit' with item numbers 570-0717 and 0921250HS.

Brand
Henry Schein
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Verify Kit Contents
Check the UDI, lot number, and internal instructions to confirm you have the Hard Line kit despite the outer box label.
Contact Manufacturer
Reach out to Keystone Industries for further instructions on how to handle the mislabeled product.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 5 states.

FDA distribution: “US Nationwide distribution in the states of IL, PA, FL NV, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Illinois, Nevada, Pennsylvania, Texas.

Recall timeline

FDA published this recall 5 months after the firm started it.

Apr 10, 2023Firm started the recall
Sep 12, 2023FDA classified it Class II
Sep 20, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/58593-henry-schein-hard-line-chairside-reline-kit-mislabeled-as-soft">Henry Schein Denture Relining Kit Recall: Mislabeling Hazard (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2580-2023 (April 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2580-2023 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.