Z-3002-2020Class III

Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 -

Name: Z-3002-2020 Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 -
Creator: OraSure Technologies, Inc.
Published: 2020-07-15
License: https://open.fda.gov/license/

OraSure Technologies, Inc. / initiated 2020-07-15 / Terminated

FDA source

OraSure Technologies, Inc. began a recall of Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of... on 2020-07-15. FDA classified it as Class III and gives the reason as "Unit boxes not properly sealed". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3002-2020
Classification: Class III
Status: Terminated
Initiated: 2020-07-15
Posted: 2020-09-23
Terminated: 2022-03-14
Recalling firm: OraSure Technologies, Inc.
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.
Product code: GEH Unit, Cryosurgical, Accessories
Reason for recall: Unit boxes not properly sealed
FDA 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 in commerce: 3000 units
Distribution: Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.
Product codes and lots: Lot Numbers: 9214

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3002-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3001-2020	Class III	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-23
Z-3002-2020	Class III	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-23
Z-3003-2020	Class III	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-23

Product code GEH

K023487Class IIHistofreezer Wart Removal System or Other Proprietary NameOraSure Technologies, Inc. / cleared 2003-03-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)