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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 67858

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

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Event summary

Timeline bucket
March 20, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medline Industries 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

Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict blood flow to a part of a patient's body.

Z-1649-2014
Recall number
Z-1649-2014
Initiated
March 20, 2014
Classification
Class II
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
2,860 bandages

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile.

Code information

Product Number: DYNJ05116A . Lot Number: 13LA1009.

Distribution pattern

Nationwide Distribution including AZ, CA, IA, IL, IN, KY, LA, MI, MS, NJ, NY, OH, PA, TX, and WA.