FDA Device recall Z-2580-2023
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0…
- FDA Device
- Class II
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class II recall of Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0… by Keystone Industries, citing 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 IF….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2580-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-10 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Keystone Industries |
| Distribution | US |
Product
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Reason
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
Identifiers
| code_info | UDI: +H65857007171/$$325120723B058BP Lot Number: 23B058B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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All Keystone Industries recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2580-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.