The Recall Desk

Manufacturer

Instrumed International, Inc.

38 recalls in our database name Instrumed International, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
38
Critical
0
Severe
0
Most recent
2014-12-17

Of the 38 recalls from Instrumed International, 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.

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.

26–38 of 38

  • LowFDA (Devices)·Z-0550-2015·2014-12-17

    Instrumed Recalls Gardner-Wells Traction Tongs for Regulatory Compliance

    Instrumed International is withdrawing 190 Gardner-Wells traction tongs because the company did not market them before September 26, 1976, failing to meet FDA pre-amendment requirements.

    Product
    Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold under the Millenium Surgical, Echo Instruments, Adler Instrument, Surgical Direct, Stealth Surgical, CareFusion, and Boss…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0534-2015·2014-12-17

    Instrumed Recalls Zipser Meatus Clamps Due to Regulatory Non-Compliance

    Instrumed International is withdrawing 81 Zipser Meatus Clamps because the company did not market the devices prior to 1976, failing to meet FDA requirements for pre-amendment devices.

    Product
    A zipser clamp is an instrument used to compress reduce blood flow to the penis and reduce pain and is sold under the Medline Industries, Boss Instruments, Millennium Surgical, Medetz Surgical, Surgical Direct, and Surgipro brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0548-2015·2014-12-17

    Instrumed Recalls Hudson Cranial Drill Sets for Regulatory Non-Compliance

    Instrumed International is withdrawing five Hudson cranial drill sets because the company failed to meet FDA requirements for marketing pre-amendment devices.

    Product
    Hudson cranial drill sets (w/ brace and 5 attachments) are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Symmetry Surgical, Medfix International, Stealth Surgical, and Boss Instruments brand names.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2728-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Caution Statements

    Instrumed International is recalling 71 reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2724-2014·2014-10-08

    Instrumed Recalls Reusable Laparoscopic Instruments for Updated Safety Instructions

    Instrumed International is recalling 3,093 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2727-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling 895 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2730-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Warnings

    Instrumed International is recalling reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2723-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Caution Statements

    Instrumed International is recalling 156 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2725-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling 83 reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2729-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling 15 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2722-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling reusable laparoscopic instruments to add caution statements regarding voltage limits and product life.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2721-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling 65 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2726-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling 122 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for…
    Category
    Medical Device
    Distribution
    Distributed nationwide