95,114 total recalls in our database
There is a remote potential for the sterile packaging of lots of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.
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.
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.
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.
Applied Medical Resources
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
Potential product mix-up. The recalling firm has determined that one unit of OsteoVation EX, 3cc that may not have been sterilized was inadvertently packaged as CranioSculpt C, 10cc.
The lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
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.
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
Loose silicone particulate was found to be present on the shaft of the silicone catheters.
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.
Baxter Healthcare
Prismaflex product code 114870 does not have FDA regulatory clearance and was inadvertently distributed.
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.
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
Becton Dickinson & Company
The kits contain surgical gowns which were subject to a recall by the supplier.
A software issue that may affect the analyzer's result accuracy.
Becton Dickinson & Company
The kits contain surgical gowns which were subject to a recall by the supplier.
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.
There is a remote potential for the sterile packaging of the transseptal guiding sheath to be compromised during shipping and handling. In the case that a packaging defect is not identified and the product is used in a patient, there may be a remote risk of infection.