Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.
23,306 detailed records are currently available in this category.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the…
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the…
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in…
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Drill guides might bend when axial forces are applied by surgeon during procedure and result in potential metal shavings due to friction with the drill bit.Risk to patients includes…
Fenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless steel fragments falling into the patient…
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
There is a risk of mis-association of patient demographic data for users who choose to report results manually when their Service Control Unit (SCU) is operating near capacity and are using…
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Treadmill malfunction: drive PCB can misread the signals and stop or reverse and then accelerate forward.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
