OraSure CVS Advanced Wart Remover Kit Recalled for Improper Sealing
OraSure Technologies is recalling CVS Advanced Wart Remover Kits because unit boxes were not properly sealed. The recall covers 23,400 units distributed in the US, Canada, and Brazil.
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 FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a packaging defect (improper sealing) with no reported injuries.
Plain-English summary
OraSure Technologies, Inc. is recalling the CVS Advanced Wart Remover Kit, Catalog Number 1001-0407. The product is an over-the-counter cryosurgical system indicated for the treatment of common warts and plantar warts. The recall involves 23,400 units with Lot Numbers 9214 and 9256.
The recall was initiated because unit boxes were not properly sealed. The affected products were distributed worldwide, including nationwide in the United States (specifically noting Rhode Island), as well as in Canada and Brazil.
Consumers who have this product should stop using it and contact the manufacturer for further instructions. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.
- Manufacturer
- OraSure Technologies, Inc.
- Hazard
- Affected units
- 23,400
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 (2)
- Lot Numbers: 9214
- 9256
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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