Exact FDA event identifier

Event 67442

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

Open FDA event record

Event summary

Timeline bucket: January 16, 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

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 ST. Circumcision Clamp, REF 32-1622, Size 1.3 cm, 1 Per Pack, Rx Only STERILE EO, distributed by DeRoyal Industries.

Z-1134-2014

Recall number: Z-1134-2014
Initiated: January 16, 2014
Classification: Class II
Status: Terminated
Recalling firm: DeRoyal Industries Inc
Quantity: 2504 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

out of specification

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Three lots of circumcision clamps were manufactured out of specification and as a result may not properly clamp at the surgical site completely.

Code information

lot numbers 33347799, 33444071, and 33423747

Distribution pattern

US Distribution to states of: NJ, AL, TX, WA, IL, OK, VA, FL, OR, and KS.