CLASS II ONGOING Device recall · Reported 18 Dec 2019 · FDA Enforcement Report
Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish/each) recalled
Young Dental Manufacturing is recalling Oral-B, Practitioner Series, 5% Sodium Fluoride Varnish/each), distributed nationwide in the US. The recall was initiated on 30 Oct 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0661-2020
- FDA event ID
- 84249
- Recalling firm
- Young Dental Manufacturing, Earth City, MO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Oct 2019
- FDA classified
- 9 Dec 2019
- Reported
- 18 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 30 Oct 2019 | Recall initiated by company | |
| 9 Dec 2019 | Classified by FDA | +40 days |
| 18 Dec 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product shelf life may be shorter than that indicated on the label.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.
Nationwide IllinoisIndianaMarylandMississippiNew JerseyTennessee
Questions about this recall
Why was it recalled?
Product shelf life may be shorter than that indicated on the label.
Which lots are affected?
Batch 84702; Batch 72766
Where was it sold?
US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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