🏥 Medical Devices Class I - Dangerous
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
All Recalls
95,102 total recalls in our database
Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are blocked and can only be reactivated by a field service engineer.
Omnera 400T Digital Radiographic System
Arcoma AB
🏥 Medical Devices Class I - Dangerous
There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).
CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+, and/or 19+) in whole blood Part Number: 7900001
Menarini Silicon Biosystems
🏥 Medical Devices Class I - Dangerous
High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples
🏥 Medical Devices Class I - Dangerous
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
🏥 Medical Devices Class I - Dangerous
Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton
🏥 Medical Devices Class I - Dangerous
The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.
🏥 Medical Devices Class I - Dangerous
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for children and adolescents.
Ossur Americas
🏥 Medical Devices Class I - Dangerous
Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot.
🏥 Medical Devices Class I - Dangerous
When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."
🏥 Medical Devices Class I - Dangerous
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
Radiometer Medical ApS
🏥 Medical Devices Class I - Dangerous
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
🏥 Medical Devices Class I - Dangerous
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
🏥 Medical Devices Class I - Dangerous
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
NaturaLyte 2301 2K 3.0 Ca 1 Mg Gal, Model No. 08-2301-3
Fresenius Medical Care Holdings
🏥 Medical Devices Class I - Dangerous
The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.
syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows: (1) Artis pheno Model Number:10849000 (2) Artis icono biplane Model Number: 11327600 (3) Artis icono floor Model Number: 11327700
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in inappropriate treatment, even if the incorrect visualization is obvious.
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level II
Chromsystems Instruments & Chemicals GmbH
🏥 Medical Devices Class I - Dangerous
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.
🏥 Medical Devices Class I - Dangerous
Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton
🏥 Medical Devices Class I - Dangerous
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
John Deere X380 and X390 Lawn Tractors
Deere & Company, of Moline, Illinois
🏠 Consumer Products Class II - Moderate
The wheel hubs were not manufactured to specifications and can fail, causing the tractor to lose braking and propulsion, posing crash and injury hazards.