🏥 Medical Devices Class I - Dangerous
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
All Recalls
95,025 total recalls in our database
🏥 Medical Devices Class I - Dangerous
It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.
🏥 Medical Devices Class I - Dangerous
Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.
🏥 Medical Devices Class I - Dangerous
Intermittent communication due to inconsistent crimping of connectors onto cables.
The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life.
🏥 Medical Devices Class I - Dangerous
The Spanish and Swedish language versions of the IFU state that the assay can be tested with Plasma which is false and could result in biased results.
🏥 Medical Devices Class I - Dangerous
Saline Flush Syringe compromised sterility due to holes in the packaging.
🏥 Medical Devices Class I - Dangerous
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
🏥 Medical Devices Class I - Dangerous
The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.
🏥 Medical Devices Class I - Dangerous
There is a potential that an image from a previous patient study to show up in a later patient study. This may result in misdiagnosis of the correct patient.
🏥 Medical Devices Class I - Dangerous
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2¿C. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
🏥 Medical Devices Class I - Dangerous
Saline Flush Syringe compromised sterility due to holes in the packaging.
🏥 Medical Devices Class I - Dangerous
Saline Flush Syringe compromised sterility due to holes in the packaging.
PowerGlide ST Midline Catheter Maximal Barrier Kit-18 gauge,10 cm length Catalog Number: ST018101D
Becton Dickinson & Company
🏥 Medical Devices Class I - Dangerous
Iincorrectly packaged without the required lidocaine as labeled
🏥 Medical Devices Class I - Dangerous
Inability for the guidewire to pass through the needles included with the catheter kits.
🏥 Medical Devices Class I - Dangerous
Failure to prime due to an assembly error
The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.
🏥 Medical Devices Class I - Dangerous
When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.
Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein.
Merit Medical Systems
🏥 Medical Devices Class I - Dangerous
labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism.
🏥 Medical Devices Class I - Dangerous
Failure to prime due to an assembly error