Class I - Dangerous
The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.
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Infusion Pumps
🏥 Medical Devices • 4,350 recalls
The gel-filled Gel-E Donut and Squishon product line has received a number of complaints about visible mold. The mold detected was determined to be Cladosporium and Penicillium Fungi, which are commonly found molds.
Class I - Dangerous
Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation.
Brainlab Navigation Software Spine & Trauma 3D 2.0/2.1 offers automatic registration of intraoperatively acquired CT image data sets. To enable automatic registration, the software requires the gantry position of the scanner. The gantry position can either be entered manually or submitted automatically from the CT scanner. If automatic gantry communication is available, the so-called "
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
Beevers Manufacturing & Supply
Class I - Dangerous
Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the US FDA.
Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
Gambro Renal Products, Incorporated
Class I - Dangerous
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Class I - Dangerous
Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause the inability to unload patient data.
Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
Siemens Medical Solutions USA
Class I - Dangerous
A safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.
CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.
The following defects have been identified for data loaded with Patient Data Manager version 2.0 (including subversions 2.0.0, 2.0.1 and 2.0.2): 1) When loading non-square pixel image data with PDM 2.0, the data set is not correctly transferred and displayed in the corresponding Brainlab navigation or planning software. When a data set is loaded, the pixels of the data set are sorted in order to
Class I - Dangerous
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Class I - Dangerous
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
Class I - Dangerous
Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product.
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Terumo Cardiovascular Systems
Class I - Dangerous
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Terumo Cardiovascular Systems
Class I - Dangerous
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.
Class I - Dangerous
There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.
Class I - Dangerous
One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use.
Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
Siemens Medical Solutions USA
Class I - Dangerous
An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. In special scenarios within the Structure Operations function the system did not store the selected name from the list of predefined names. After reloading of the data, this structure name had been changed by the system. Additionally, a performance issue was addressed where import of DI
Class I - Dangerous
Bottles did not provide positive signals within the time frame of the quality control specification for one of two strains of Streptococcus pneumoniae.
During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead.