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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98035

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

Open FDA event record

Event summary

Timeline bucket
November 25, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Ferndale Laboratories, 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

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

Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: No

Z-1005-2026
Recall number
Z-1005-2026
Initiated
November 25, 2025
Classification
Class II
Status
Ongoing
Quantity
24589

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Butyrate tube cracks during actuation, rendering product unusable.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Butyrate tube cracks during actuation, rendering product unusable.

Code information

Lot Code: Lot 24161B Expiration Date 10-31-2029 DI Number 00304960523488 UPC/GTIN-12 3040960523488

Distribution pattern

Worldwide distribution - US Nationwide and the country of UK.