Inability for the guidewire to pass through the needles included with the catheter kits.
All Recalls
95,025 total recalls in our database
When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628
Medtronic Sofamor Danek USA
Nonconforming product; length of the product measured shorter than the labeled length.
iChemΒΏVELOCITY Urine Chemistry System-
Beckman Coulter
A defect in the SATA power adapter cable within the instruments computer has the potential risk for an electrical short that may lead to the following outcomes: charring and/or melting of the SATA adapter cable within the computers metal enclosure, smoke emanating from PC6, flames contained within PC6, or an inability to use the devices CD-ROM.
Failure to prime due to an assembly error
Siemens Cios Alpha VA20-mobile X-Ray system Material # 10308191 The Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications.
Siemens Medical Solutions USA
Main cable can be plugged or unplugged from the X10 connector which is part of the main unit (c-arm) at any time during clinical session. If the system displays the error message Err 16305 / 80, the unplugging of the main cable can cause an unsafe electrical voltage (125 V DC) at the X10 connector and result in an electrical shock if the user or other persons touch the contact pins of the X10 connector. These contact pins are accessible when the main cable is unplugged from the X10 connector
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2ΒΏC. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
da Vinci Xi Surgical System
Intuitive Surgical
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2ΒΏC. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Saline Flush Syringe compromised sterility due to holes in the packaging.
Failure to prime due to an assembly error
When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.
Genicon is providing updated IFU labeling to users to provide clarity on how to use the device for multiple specimen retrieval.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2ΒΏC. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Saline Flush Syringe compromised sterility due to holes in the packaging.
Saline Flush Syringe compromised sterility due to holes in the packaging.
Saline Flush Syringe compromised sterility due to holes in the packaging.
Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181
Edwards Lifesciences
Sterile catheter kit packaging compromised.
da Vinci X Surgical System
Intuitive Surgical
Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.
Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966).
Sunrise Medical (US)
Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits.