OraSure Technologies, Inc. Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
Brand
OraSure Technologies, Inc.
Lot Codes / Batch Numbers
Lot Numbers: 9214
Products Sold
Lot Numbers: 9214
OraSure Technologies, Inc. is recalling Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for ov due to Unit boxes not properly sealed. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Unit boxes not properly sealed
Recommended Action
Per FDA guidance
Orasure notified Distributors via email on 6/26/20 of the action to take re: the unsealed boxes. Rework to be performed by foreign Distributors and US product to be returned to the manufacturer for rework or scrap.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026