Class I - Dangerous
Failure to prime due to an assembly error
ðĨ
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
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.
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
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.
Class I - Dangerous
Failure to prime due to an assembly error
Class I - Dangerous
When strain relief is lost at the stand side of the Stand MVS Trolley Cable, over time one or more electrical contacts could break due to pulling, twisting, or dropping of the connector. If this happens, live parts may be exposed (230 V) and/or the video signal can be lost.
Saline Flush Syringe compromised sterility due to holes in the packaging.
The firm received complaints that the EMPOWR Acetabular Impactor Balls were fracturing/cracking during impaction which could cause debris to migrate or be left in the joint space.
Saline Flush Syringe compromised sterility due to holes in the packaging.
Class I - Dangerous
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2ÂŋC. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Insufflation tubing to be used with varies insufflator units. REF 031200-10; REF 031322-10; REF 031532-10; REF 031622-10
Karl Storz Endoscopy
Class I - Dangerous
The sterile single-use tubing may contain higher ethylene oxide (EO) residues than the acceptable level.
Class I - Dangerous
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2ÂŋC. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Class I - Dangerous
False positive reaction on the reagent.
Class I - Dangerous
Failure to prime due to an assembly error
The firm received complaints on five devices from one specific lot where the stent dislodged from the balloon delivery system prior to deployment. Use of affected product may lead to increased procedural time and additional intervention to remove a stent that dislodged within an unintended location.
There is potential for a white paper-type residue attached to the catheter.
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.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2ÂŋC. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment
Class I - Dangerous
Inability for the guidewire to pass through the needles included with the catheter kits.
Temperature sensing catheters failed to meet the established calibrated temperature sensing tolerance of +/- 0.2ÂŋC. Failure to correctly measure patient body temperatures could lead to an incorrect diagnosis and insufficient treatment