Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.
Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Atrium Medical
Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Atrium Medical
Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Class I - Dangerous
Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension.
Class I - Dangerous
On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. I
Class I - Dangerous
Drug flow rates exceeding programmed flow rates.
Class I - Dangerous
Drug flow rates exceeding programmed flow rates.
Class I - Dangerous
Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field
Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images
Class I - Dangerous
King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex.
Class I - Dangerous
Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss.
Class I - Dangerous
Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant.
Class I - Dangerous
Drug flow rates exceeding programmed flow rates.
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
Maquet Cardiovascular Us Sales
Class I - Dangerous
The manufacturer has conducted a review of the results of product testing performed during the last twelve months and has identified specific lots of product which may not meet specifications for bond strength on the inlet and/or outlet connector.
Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The ear prosthesis is implantable and indicated for hearing loss.
Medtronic Xomed
Class I - Dangerous
One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.
Medical device used in cardiovascular procedures is defective.
GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (Gems Visualization ToolKit) Viewer, the MR Product can generate image headers with non-unique series identifiers, which when exported to some PACS systems, results in the series being associated wit