# FDA recall Z-0661-2020

> **Young Dental Manufacturing Co, LLC** · Class II · device recall initiated 2019-10-30.

## 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.

## Distribution

US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.

## Key facts

- **Recall number:** Z-0661-2020
- **Recalling firm:** Young Dental Manufacturing Co, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-10-30
- **Report date:** 2019-12-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Earth City, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0661-2020

## Citation

> AI Analytics. FDA recall Z-0661-2020. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-0661-2020. Source: US FDA. Licensed CC0.

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