95,114 total recalls in our database
Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.
W L Gore & Associates
The incorrect label was placed on both the primary and secondary package.
May exhibit increased levels of artifacts which could be difficult to distinguish from gram positive cocci, increased levels of artifacts could result in a false-positive Gram stain
Howmedica Osteonics
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
Howmedica Osteonics
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
Three products requiring refrigerated storage conditions were incorrectly stored outside of approved temperature ranges. Using these temperature abused products may result in misdiagnosis of the patient.
hearing performance degradation due to body-fluid entering the device.
Foreign material near or along the edge of the hydrogel adhesive within the pouch packaging
Applied Medical Resources
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe tray, the updated Basic User Guide will reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining.
The Aleutian Anatomically Narrow Lordotic Spreader was manufactured as two pieces welded together which has been associated with the spreader tip breaking off during the procedure.
Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).
Howmedica Osteonics
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
Howmedica Osteonics
The Stryker Restoration Anatomic Shell (RAS) may fall off its post within its inner packaging which can result in the device loose in the package with coating debris.
Vertebral hydraulic assemblies has incorrect expiration date printed on the labels.The product's shelf-life is two (2) years, but the expiration date printed on the labels is five (5) years.The affected product will begin expiring in March 2020. Using product beyond the validated shelf-life may result in (1) product not functioning as intended and/or (2) a delay in procedure or the need for the procedure to be rescheduled.
hearing performance degradation due to body-fluid entering the device.
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.
Medline identified that there may be a potential for voids in the packaging seal and loss of sterility on the outside of the foil pouch.