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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62432

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 02, 2012
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

1 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 1

Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.

Z-2080-2012
Recall number
Z-2080-2012
Initiated
July 02, 2012
Classification
Class II
Status
Terminated
Recalling firm
Beekley Corporation
Quantity
86,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Imaging artifact can occur on mammogram result

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

Imaging artifact can occur on mammogram result

Code information

Lot Numbers: 107657, 108150, 108833

Distribution pattern

International Distribution including Nationwide(USA), and the countries of Japan and Canada.