Oral-B — Class II medical device recall Z-0661-2020
Ongoing recall by Young Dental Manufacturing Co, LLC, reported 2019-12-18, distributed nationwide. Product shelf life may be shorter than that indicated on the label.
| Recall number | Z-0661-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Young Dental Manufacturing Co, LLC, Earth City, MO, United States |
| Recall initiated | 2019-10-30 |
| Classified | 2019-12-09 |
| Reported by FDA | 2019-12-18 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | 72766, 84702 |
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 for recall
Product shelf life may be shorter than that indicated on the label.
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-0661-2020. 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.