FDA Medical Device Recalls (openFDA)
Young Dental Manufacturing Co, LLC: 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.
- Recall number
- Z-0661-2020
- Recalling firm
- Young Dental Manufacturing Co, LLC
- 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.
- Status
- Open, Classified
- Initiated
- 2019-10-30
- Posted
- not on file
- Terminated
- not on file
- Reason
- Product shelf life may be shorter than that indicated on the label.
- Root cause
- Process control
- Action
- Notification by letter to be made to customer via certified mail. Customers are instructed to return or scrap the affected product. Multiple attempts will be made to contact customers. Returned product will be destroyed. For recall inquiries, contact 224-622-7191.
- Quantity
- Batch 84702 - 6500 units; Batch 72766 - 6500 units
- Distribution
- US Nationwide distribution in the states of MS, IN, MD, IL, TN, NJ, an ME.
- Lot, serial or model codes
- Batch 84702; Batch 72766
- 510(k) numbers
- ["K153334"]
- PMA numbers
- not on file
- Product code
- LBH
- Firm FEI
- 1941138
- Firm city
- Earth City
- Firm state
- MO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28