🏥 Medical Devices • 6,839 recalls
Intuitive Surgical
Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
Intuitive Surgical
Revised instructions for users of the da Vinci S, Si and Si-e systems with additional information regarding sterile adapter engagement and instrument installation.
Distribution of an unapproved device into interstate commerce.
Edwards Lifesciences
Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
The product has a Lithium Heparin contaminant which could adversely affect coagulation results potentially causing erroneous lab results.
Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.
Software design error in IMPAX CV 7.8 SU3
Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
Stryker received reports from the field indicating that the handle detached from the cam of the Baseplate Impactor/Extractor Assembly.
Baseline pulmonary capillary wedge (PCW) pressure values from IMPAX CV Reporting Cardiac Catheterization module were not correctly transferring into the hospital's electronic health record (EHR) system.
Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.
Advanced Sterilization Products
The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
Dual Tip Marker has inconsistent ink flow on the black permanent ink side.
LEEP RediKit Products (for use in Loop Electrosurgical Excision Procedures) have Xylocaine (Lidocaine) HCL (2%) listed on the tray lid label but this is not included in the contents of the kit, which contained Polocaine (Mepivacaine) HCL (3%) instead (which was not listed on the tray label).
The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. Firm is in the process of updating the labeling for these products. In the meantime, when choosing an alternative contrast medium, health care providers are instructed to select a contrast
Advanced Sterilization Products
The recall was initiated because Advanced Sterilization Products (ASP) has determined that the STERRAD 100NX and STERRAD 200 Sterilization Systems may emit an odor or smell into the surrounding environment that is not typical to normal operating conditions.
The Dens Instrument Set has been designed to facilitate the anterior internal fixation of the Dens (odontoid process). There are currently no screws specifically indicated to treat Dens fractures via anterior screw fixation therefore the affected product will be removed.
An issue with the plunger rod seal was identified where the seal had the potential to migrate inside the pump case top during slow rate/ high back pressure infusions.
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic has identified an issue with a specific lot of the Archer 0.035 inch (0.89mm) Super Stiff Guidewire, model ARCSJ200W, where the PTFE (Teflon) coating has the potential to separate from the wire during in-vivo use.