OraSure Pointts Skin Tag Removal System Recalled for Unsealed Boxes
OraSure Technologies is recalling Pointts skin tag removal systems because unit boxes were not properly sealed. The recall affects 23,220 units distributed in the US, Canada, and Brazil.
What this means for you
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 by definition is unlikely to cause adverse health consequences. The issue is a packaging defect (unsealed boxes) rather than a direct safety hazard like contamination or malfunction.
Plain-English summary
OraSure Technologies, Inc. is recalling 23,220 units of the Pointts over-the-counter cryosurgical system for the treatment of skin tags. The recall is due to unit boxes that were not properly sealed. The affected product is identified by Catalog Number 1001-0280 and Lot Numbers 9214 and 9256.
The recalled products were distributed worldwide, including nationwide in the United States (specifically noting Rhode Island), Canada, and Brazil. The FDA has classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers who have purchased this product should stop using it and contact OraSure Technologies, Inc. for instructions on how to return the product or obtain a refund.
The recalled product
- 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.
- Manufacturer
- OraSure Technologies, Inc.
- Hazard
- Affected units
- 23,220
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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