Exact FDA event identifier

Event 80558

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

Event summary

Timeline bucket: June 13, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Beekley Corporation

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

O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.

Z-2830-2018

Recall number: Z-2830-2018
Initiated: June 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Beekley Corporation
Quantity: 3,384,024 pieces in total.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is a potential for imaging artifact to mimic calcifications on patient's mammograms

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for imaging artifact to mimic calcifications on patient's mammograms

Code information

REF 791 - Lot Numbers: 05311802 03051802 03271802 04191801 04031801 04241801 04231801 03291802 04021801 02271801 05291802 03081801 03091801 05111801 05251801 04091801 02201801 02231801 02071801 02091801 03161802 03231801 02131801 05031801 03011801 03291801 04301801 05171801 04161801 04261801 02051801 04051801 03201801 03221801 02151801 03221802 02021801 05231802 05021801 04191802 05291801 04301802 05211802 02191802 REF 791S - Lot Numbers: 03191801 02221802

Distribution pattern

Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.

device · product 2 of 3

S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.

Z-2831-2018

Recall number: Z-2831-2018
Initiated: June 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Beekley Corporation
Quantity: 3,384,024 pieces in total.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is a potential for imaging artifact to mimic calcifications on patient's mammograms

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for imaging artifact to mimic calcifications on patient's mammograms

Code information

REF 777 - Lot Numbers: 02281802 05301801 04041801 04211801 03301801 05101802 05241801 02191801 03151801 03281801 04281801 02131802 REF 777S - Lot Numbers

Distribution pattern

Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.

device · product 3 of 3

TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to skin for marking and identifying moles in mammography.

Z-2832-2018

Recall number: Z-2832-2018
Initiated: June 13, 2018
Classification: Class II
Status: Terminated
Recalling firm: Beekley Corporation
Quantity: 3,384,024 pieces in total.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

There is a potential for imaging artifact to mimic calcifications on patient's mammograms

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a potential for imaging artifact to mimic calcifications on patient's mammograms

Code information

REF 782 - Lot Numbers: 05311801 05211801 02221801 04181802 03051801 03071802 04181804 05081801 03131801 02121801 03301802 05141801 03141801 05101801 03271801 05161801 02161801 03021802 04111801 05011801 05171802 02211801 04051802 04271801 04251801 05161802 03141802 05181801 04121801 05221802 04161802 04171801 04181803 05301802 04241802 05011802 02271802 02271803 02071802 02261802 02261803 05291803 REF 782S - Lot Numbers: 02221801 03271801 04121801 REF 783 - Lot Numbers: 04131801 03071801 02281801 03121801 05151801 04101801 05041801 03021801 05181803 02081801 03261801 05221801 02061801 04181801 04201801 05071801 03161801 04061801 05181802 04231802 03091802 03171801 REF 783S - Lot Numbers: 02221801 04021801 REF 784 - Lot Numbers: 05231801 03061801 02261801 03211801 02141801 03211802 05091801 04261802 REF 784S - Lot Numbers: 02221801 04021801 04121801 REF 785 Lot Numbers: 05111801 04191801 REF 785S Lot Numbers: 04021801 04121801

Distribution pattern

Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.