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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 74927

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

Open FDA event record

Event summary

Timeline bucket
August 11, 2016
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

Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.

Z-2678-2016
Recall number
Z-2678-2016
Initiated
August 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
DeRoyal Industries Inc
Quantity
26 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.

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

The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.

Code information

Lot Number 40259236

Distribution pattern

Distributed in LA and TN.

device · product 2 of 2

DeRoyal (R) CYSTO TRAY PGYBK REF 89-3076.08, Rx Only, STERILE,EO; Custom surgical kit. O,

Z-2679-2016
Recall number
Z-2679-2016
Initiated
August 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
DeRoyal Industries Inc
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.

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

The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.

Code information

Lot Number 40004006

Distribution pattern

Distributed in LA and TN.