Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture… — Class II medical device recall Z-2580-2023
Ongoing recall by Keystone Industries, reported 2023-09-20, distributed nationwide. The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0
| Recall number | Z-2580-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Industries, Gibbstown, NJ, United States |
| Recall initiated | 2023-04-10 |
| Classified | 2023-09-12 |
| Reported by FDA | 2023-09-20 |
| Distributed | Nationwide (US) |
| Quantity | 240 units |
| Reason classes | labeling |
| Lot numbers | 23B058B |
| Model numbers | 0921940HS, 570-0718 |
Product
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2580-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.