The Recall Desk

Manufacturer

Insight Instruments, Inc.

3 recalls in our database name Insight Instruments, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2014-02-12

Of the 3 recalls from Insight Instruments, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

Which agencies issued them

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • ModerateFDA (Drugs)·D-1056-2014·2014-02-12

    Insight Instruments Recalls Cornea Coat Hydroxypropylmethylcellulose Syringes

    Insight Instruments is recalling Cornea Coat syringes because they were marketed without an approved NDA or ANDA.

    Product
    Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instruments, Inc., 2580 SE Willoughby Blvd., Stuart, FL 34994, USA. Tel: 772-219-9393.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0144-2014·2013-11-13

    Insight Instruments Recalls MLS Torpedo Mini-Light Ophthalmic Illuminator

    Insight Instruments is recalling MLS Torpedo Mini-Light Ophthalmic illuminators because the product was registered as a Class I device but is actually a Class II device requiring FDA clearance.

    Product
    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1281-2013·2013-05-22

    Insight Instruments Recalls M.I.S. Ophthalmic Cannulas Due to Misclassification

    Insight Instruments is recalling 776 M.I.S. Ophthalmic Cannulas distributed in Indiana and Illinois because the device was misclassified.

    Product
    Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the movement of the two surgical instruments inserted into the M.I.S. cannulas. The
    Category
    Medical Device
    Distribution
    2 states