Lower riskMedical device recall · FDA · Published July 15, 2020
OraSure Pointts System Recall: Unsealed Boxes Risk Contamination
OraSure recalls Brazil-cataloged Pointts skin tag cryosurgical system (lot 9214, 9256) due to unsealed unit boxes. Consumers should check for unsealed packaging before use.
“OraSure Pointts System Recall: Unsealed Boxes Risk Contamination.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64716-orasure-pointts-system-recall-unsealed-boxes-risk-contamination. Based on FDA recall #Z-3003-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3003-2020%22&limit=1).
OraSure Technologies, Inc. recalled Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil (Catalog Number: 1001-0280) due to unit boxes not being properly sealed, the FDA said on July 15, 2020.
How to tell if you have it
Brand: OraSure
Product: Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil
Catalog Number: 1001-0280
Lot Numbers: 9214, 9256
The hazard
The recall involves unit boxes that are not properly sealed, according to the FDA.
Context
GovInfoNow's records show OraSure Technologies, Inc. has three other recalls on record since Dec. 20, 2017. Other recent recalls of similar products include Medline Convenience Kits Recall: Risk of Microbial Contamination from Packaging Wrinkles (June 12, 2026), Medline Convenience Kits Recall: Fungal Contamination Risk (Aug. 11, 2026) and Medical Convenience Kits with Contaminated Wipes Risk Infection (Aug. 10, 2026).
How to tell if you have this one
Check for the Brazil catalog number 1001-0280 on the box. Look for lot numbers 9214 or 9256. The product is an over-the-counter cryosurgical system for skin tags.
Brand
OraSure
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Terminated
Distribution
Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.
Recall number
Product, codes & lots
Quantity
Z-3001-2020
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.; Lot Numbers: 9214, 9256
23400 units
Z-3002-2020
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.; Lot Numbers: 9214
3000 units
Z-3003-2020
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.; Lot Numbers: 9214, 9256
23220 units
Based on the official FDA remedy
What to do — step by step
Check Box Seal
Inspect the unit box for proper sealing before use. If unsealed, stop using the product.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the state of Rhode Island and the countries of Canada, Brazil.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-3003-2020 (July 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3003-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.