🏥 Medical Devices • 7,015 recalls
Resource Optimization & Innovation
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Resource Optimization & Innovation
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Resource Optimization & Innovation
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Resource Optimization & Innovation
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Resource Optimization & Innovation
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Resource Optimization & Innovation
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Resource Optimization & Innovation
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Resource Optimization & Innovation
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Arrow International
Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products.
Resource Optimization & Innovation
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
Disposable Reflective Marker Spheres (DRMS) for Brainlab Image Guided Surgery (IGS) Systems: DRMS spheres may separate at the mid-point where the two halves of the sphere are sealed together.
Bard Access Systems
Bard Access Systems is recalling marketing brochures for the PowerPICC¿ and PowerPICC¿ SOLO¿ catheters due to incorrect indication for use contained in the brochure.
Zien Medical Technologies
Cracks were discovered in the PET tray of a small population of sterile product. These cracks create a risk of loss of sterile barrier for the product. Sampling and root cause analysis indicated that the risk could extend throughout the lots manufactured from September 2014-July 2015. This led to the decision to recall the product.
Resource Optimization & Innovation
Surgical kits contain a surgical scrub product which may be chemically contaminated and lack sterility assurance.
Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration
There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.
Two cables within the console were inadvertently twisted during manufacturing. The individual wires within the cables may break and/or contact one another where the cables terminate into two connectors. When these wires break or contact one another (i.e., short), various types of malfunction may occur with the console. One type of malfunction may result in unexpected aspiration increase.
In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.
Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for distributing a device without FDA clearance or approval.
In certain circumstances involving select da Vinci Si Single-Site instruments, the jaws of grip actuated instruments may become fixed in a closed position.