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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80157

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

Open FDA event record

Event summary

Timeline bucket
April 17, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Tactical Medical Solutions, 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

BLAST Bandage, sterile.

Z-2538-2018
Recall number
Z-2538-2018
Initiated
April 17, 2018
Classification
Class II
Status
Terminated
Quantity
1,097 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.

Code information

Lot 0617

Distribution pattern

Domestic distribution to AL, AP, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MO, MS, NC, ND, NM, NY, OH, PA, SC, TX, VA, WI. International distribution to Austria, Canada, France, Kenya, Latvia, Netherlands, New Zealand, Poland, Singapore, South Africa, Switzerland, Turkey, United Kingdom.