Other Medical Devices

Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Smiths Medical has become aware that the drawing on the Instructions for Use (IFU) on certain yellow striped CADD¿ Administration Sets (part number 21-7339-24), incorrectly represent the actual filter size of the product. Although the text description on the IFU correctly identifies the product to include a 0.2 micron filter, the illustration on the IFU identifies the filter size as 2.0 microns.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

A complaint was received on January 1, 2017 stating the pigtail on line 2 of the oxygenator was assembled to the port where the yellow cap and the clear cap remained on the center port.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

Aesculap Implant Systems LLC is recalling the Minop Trocar due to the possibility it may have sharp edges on the distal end which may lead to the abrasion of the insulation when removing the electrode.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.

AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.

"Roche Diagnostics Corp. initiated a voluntary correction because a rack crash may occur on the Cobas 8100 bi-directional reformatter (BRF) and uni-directional reformatter (URF) modules with software version 02-xx, only when rack buffering is activated and the rack buffer is completely full. This issue can lead to sample spillage, posing a potential risk to operators / laboratory staff due to exposure to potentially infectious material, cross-contamination of samples in the affected racks and erroneous results due to sample carry-over."

During an FDA inspection it was found that the firm claims unapproved therapy and medical claims on product information and website.