OraSure Personelle OTC Skin Tag Remover Recalled for Improperly Sealed Boxes
OraSure Technologies is recalling 3,000 units of Personelle OTC Skin Tag Remover because unit boxes were not properly sealed.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a packaging defect (improperly sealed boxes) with no reported injuries or illnesses.
Plain-English summary
OraSure Technologies, Inc. is recalling 3,000 units of the Personelle OTC Skin Tag Remover (Catalog Number: 1001-0314, Lot Number: 9214). The product is an over-the-counter cryosurgical system indicated for the treatment of skin tags.
The recall was initiated because the unit boxes were not properly sealed. The affected products were distributed worldwide, including in the United States (nationwide, including Rhode Island), Canada, and Brazil.
Consumers who have purchased this product should stop using it and contact the manufacturer for further instructions.
The recalled product
- 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.
- Manufacturer
- OraSure Technologies, Inc.
- Hazard
- Affected units
- 3,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers: 9214
Distribution
Part of a larger recall action
This product is one of 3 recalled by OraSure Technologies, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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