Exact FDA event identifier

Event 77519

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

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Event summary

Timeline bucket: June 07, 2017
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

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

DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control pressure.

Z-2639-2017

Recall number: Z-2639-2017
Initiated: June 07, 2017
Classification: Class II
Status: Terminated
Recalling firm: DeRoyal Industries Inc
Quantity: 426 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility

Code information

Lot Number 15125173

Distribution pattern

Nationwide Distribution to MD, NY, and IL