Insight Instruments, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0144-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 27, 2013

Date Posted: November 13, 2013

Recall Number: Z-0144-2014

Event ID: 66040

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.

Status: Terminated

Product Quantity: 10212

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.

Voluntary or Mandated:

Voluntary: Firm initiated