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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86312

3 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 15, 2020
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
OraSure Technologies, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

3 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 3

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.

Z-3001-2020
Recall number
Z-3001-2020
Initiated
July 15, 2020
Classification
Class III
Status
Terminated
Quantity
23400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Unit boxes not properly sealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Unit boxes not properly sealed

Code information

Lot Numbers: 9214, 9256

Distribution pattern

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

device · product 2 of 3

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.

Z-3002-2020
Recall number
Z-3002-2020
Initiated
July 15, 2020
Classification
Class III
Status
Terminated
Quantity
3000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Unit boxes not properly sealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Unit boxes not properly sealed

Code information

Lot Numbers: 9214

Distribution pattern

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

device · product 3 of 3

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.

Z-3003-2020
Recall number
Z-3003-2020
Initiated
July 15, 2020
Classification
Class III
Status
Terminated
Quantity
23220 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Unit boxes not properly sealed

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Unit boxes not properly sealed

Code information

Lot Numbers: 9214, 9256

Distribution pattern

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

Field note

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