# FDA recall Z-3003-2020

> **OraSure Technologies, Inc.** · Class III · device recall initiated 2020-07-15.

## 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.

## Reason for recall

Unit boxes not properly sealed

## Distribution

Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.

## Key facts

- **Recall number:** Z-3003-2020
- **Recalling firm:** OraSure Technologies, Inc.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-15
- **Report date:** 2020-09-30
- **Termination date:** 2022-03-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bethlehem, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3003-2020

## Citation

> AI Analytics. FDA recall Z-3003-2020. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-3003-2020. Source: US FDA. Licensed CC0.

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