FDA Medical Device Recalls (openFDA)
OraSure Technologies, Inc.: Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
- Recall number
- Z-3003-2020
- Recalling firm
- OraSure Technologies, Inc.
- Product
- Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
- Status
- Terminated
- Initiated
- 2020-07-15
- Posted
- not on file
- Terminated
- 2022-03-14
- Reason
- Unit boxes not properly sealed
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 23220 units
- Distribution
- Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.
- Lot, serial or model codes
- Lot Numbers: 9214, 9256
- 510(k) numbers
- ["K023487"]
- PMA numbers
- not on file
- Product code
- GEH
- Firm FEI
- 3004142665
- Firm city
- Bethlehem
- Firm state
- PA
- 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