Pointts sistema de ellmlnact! — Class III medical device recall Z-3003-2020
Terminated recall by OraSure Technologies, Inc., reported 2020-09-30, distributed nationwide. Unit boxes not properly sealed
| Recall number | Z-3003-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OraSure Technologies, Inc., Bethlehem, PA, United States |
| Recall initiated | 2020-07-15 |
| Classified | 2020-09-23 |
| Reported by FDA | 2020-09-30 |
| Terminated | 2022-03-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA |
| Quantity | 23,220 units |
| Lot numbers | 9214, 9256 |
| Model numbers | 1001-0280 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3003-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.