FDA Device recall Z-0661-2020
Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the r…
- FDA Device
- Class II
- ongoing
- Published 2019-12-18
On 2019-12-18 the FDA classified a Class II recall of Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the r… by Young Dental Manufacturing, citing product shelf life may be shorter than that indicated on the label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0661-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-10-30 |
| Published | 2019-12-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Young Dental Manufacturing |
| Distribution | US |
Product
Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish, 500 units (40mL/each) - Product Usage: For dentinal hypersensitivity and for the reduction of post-operative sensitivity.
Reason
Product shelf life may be shorter than that indicated on the label.
Identifiers
| code_info | Batch 84702; Batch 72766 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0661-2020%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.