Exact FDA event identifier

Event 66608

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

Open FDA event record

Event summary

Timeline bucket: August 12, 2013
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) Surgical Eye Spears, REF 30-049, Sterile EO, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, MADE IN GUATEMALA cleaning of fluids from surgical site in or near the eye

Z-0275-2014

Recall number: Z-0275-2014
Initiated: August 12, 2013
Classification: Class II
Status: Terminated
Recalling firm: DeRoyal Industries Inc
Quantity: 726 cases (7242 units)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

labeled as being x-ray detectable, but contained

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

One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.

Code information

Lot Number 32794811

Distribution pattern

Nationwide Distribution