Complete FDA and NHTSA recall records dated in May 2020.
These records include useful source details for the selected month.
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.
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.
Damaged ESD bags used for storing components in Processor PCA Replacement Kits
There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
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 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.
Possible mis-labeling of the device with incorrect serial number labels which may result in a patient's misdiagnosis.
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
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.
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 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.
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…
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.
A software issue that may affect the analyzer's result accuracy.
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
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.
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.
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.
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.
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 lot number on the pediatric orthopedic implant driver instrument handle does not match the lot number on the label.
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.
Failure of cardiovascular clips to provide sufficient occlusion of the vessel.
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.
