Class I - Dangerous
The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers.
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Class I - Dangerous
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Cushing burrs are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Medfix International and Stealth Surgical brand names.
Instrumed International
Class I - Dangerous
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Class I - Dangerous
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Hudson cerebellar extensions are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments brand name.
Instrumed International
Class I - Dangerous
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Class I - Dangerous
PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.
Class I - Dangerous
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Class I - Dangerous
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
BD Insyte Autoguard may have potential damage along the body of the catheter.
Hudson braces are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Teleflex Medical, Boss Instruments, Symmetry Surgical, and CareFusion brand names.
Instrumed International
Class I - Dangerous
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Class I - Dangerous
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Some of the intermediate boxes within lot 140417-3, were labeled as P8, a French Size 8 pediatric catheter but actually contain P10, French Size 10 pediatric catheters. Trying to use a P10 catheter for bladder drainage, where P8 catheters have been prescribed, may result in acute urinary retention; and, forced attempts to insert the French Size 10 catheter lead to urethral trauma.
Class I - Dangerous
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Class I - Dangerous
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
The product has been identified to contain an incorrect curette type.
Amerigel Post-op Surgical Kits Wound management
Amerx Health Care
Class I - Dangerous
Formulation deviation
Class I - Dangerous
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Class I - Dangerous
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Class I - Dangerous
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Some specific lots of Selector Tubing may potentially leak irrigation fluid during use if not placed on the Selector handpiece in a specific manner.