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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66040

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

Open FDA event record

Event summary

Timeline bucket
June 27, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Insight Instruments, 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

MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.

Z-0144-2014
Recall number
Z-0144-2014
Initiated
June 27, 2013
Classification
Class II
Status
Terminated
Recalling firm
Insight Instruments, Inc.
Quantity
10212

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance.

Code information

Part Number Lot Number Expiration 11007 M52934 04/2013 11017 M53017 04/2013 11007 M55285 07/2013 11007 M55869 08/2013 11007 M58610 12/2013 11007 M59575 02/2014 11007 M61781 05/2014

Distribution pattern

Worldwide Distribution - USA (nationwide) including AZ, CA, FL, IN, MA, MD, TX, and WA and Internationally to Czech Republic, Germany, Netherlands, Spain, Switzerland, and Turkey.