FDA (Devices) recall action 68725

Instrumed International, Inc. recalled 10 products on 2014-10-08

The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.

Products: 10
Announced: 2014-10-08
Critical: 0
Units: 4,504

Why these products were recalled

Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–10 of 10

ModerateFDA (Devices)··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
Distribution
45 states
ModerateFDA (Devices)··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
Distribution
45 states
ModerateFDA (Devices)··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
Distribution
45 states
ModerateFDA (Devices)··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
Distribution
45 states
ModerateFDA (Devices)··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
Distribution
45 states
ModerateFDA (Devices)··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
Distribution
45 states
ModerateFDA (Devices)··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
Distribution
45 states
ModerateFDA (Devices)··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
Distribution
45 states
ModerateFDA (Devices)··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
Distribution
45 states
ModerateFDA (Devices)··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
Distribution
45 states