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-0553-2015·2014-12-17
Instrumed Recalls Titanium Fixation Screws for Regulatory Compliance Issues
Instrumed International is withdrawing 22 springloaded titanium fixation screws from the market because the devices were not marketed prior to 1976 and do not meet FDA pre-amendment requirements.
Product
Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and are sold under the Millennium Surgical, Boss Instruments, Stealth Surgical, and CareFusion brand name
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0549-2015·2014-12-17
Instrumed Recalls Galt Trephines for Regulatory Compliance Issues
Instrumed International is withdrawing Galt trephines because the company did not market them prior to September 26, 1976, failing to meet FDA pre-amendment requirements.
Product
Galt trephines are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion brand name.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0558-2015·2014-12-17
Instrumed Recalls 23 Schiotz Tonometers for Regulatory Non-Compliance
Instrumed International is withdrawing 23 Schiotz tonometers because the devices do not meet FDA requirements for pre-amendment marketing.
Product
Tonometers are manual devices intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea) and
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 manip
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 manip
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 manip
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 manip
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 manip
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 manip
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 manip
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 manip
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 manip
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 manip
Category
Medical Device
Distribution
Distributed nationwide