Class III — OraSure Technologies, Inc.
| Recalling firm | ORASURE TECHNOLOGIES, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Unit boxes not properly sealed |
| 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. |
| Quantity | 3000 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil. |
| Initiated | 2020-07-15 |
| Classified | 2020-09-23 |
| Terminated | 2022-03-14 |
| Recall number | Z-3002-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — OraSure Technologies, Inc. (Z-3002-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86312/
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