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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68744

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

Open FDA event record

Event summary

Timeline bucket
June 04, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DeRoyal 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

2 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 2

DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.

Z-2124-2014
Recall number
Z-2124-2014
Initiated
June 04, 2014
Classification
Class II
Status
Terminated
Recalling firm
DeRoyal Industries Inc
Quantity
128 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.

Code information

Lot Numbers: 30674381, 30721925, 30733281, 31029711, 31442590, 31649363

Distribution pattern

Distributed in the states of MI, GA, OH, IL, MO, and IN.

device · product 2 of 2

DeRoyal Cardiac Hypothermia Tray, REF 50-9422.07, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Made in Guatemala

Z-2125-2014
Recall number
Z-2125-2014
Initiated
June 04, 2014
Classification
Class II
Status
Terminated
Recalling firm
DeRoyal Industries Inc
Quantity
230 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.

Code information

Lot Numbers: 30375680, 30515347, 30927691, 32922641, 33656541

Distribution pattern

Distributed in the states of MI, GA, OH, IL, MO, and IN.