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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65098

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

Open FDA event record

Event summary

Timeline bucket
April 30, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
American Optisurgical 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

FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.

Z-1505-2013
Recall number
Z-1505-2013
Initiated
April 30, 2013
Classification
Class II
Status
Terminated
Recalling firm
American Optisurgical Inc
Quantity
63 individual applicators

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incomplete seal
Sterility assurance reason.sterility_assurance · v1.0.0
lack of 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

American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual unit packaging.

Code information

Lot Numbers 07912-06 12912-04

Distribution pattern

Nationwide Distribution-USA (nationwide) including the states of AZ, CA, FL, GA, IL, KS, MA, MI, NC, NJ, OH, PA, TN, TX, VA, and WI.