FDA•MODERATE
GSP Neonatal GALT Kit
The GSP Neonatal GALT Kit is recalled due to reduced on-board stability, which may cause test failures and delays in patient results.
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Medical Devices Recalls
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FDA•MODERATEFletcher CT/MR Shielded Applicator SetElekta recalls Fletcher CT/MR Shielded Applicator Set over risk of intrauterine tube tip detachment.
3 products
FDA•MODERATEKlowen Custom Orthodontic SolutionKlowen is recalling the Custom Orthodontic Solution, model CIAS-800033, due to a defect that may cause incorrect bracket placement.
FDA•MODERATEAtellica CH Enzymatic Hemoglobin A1c AssaySiemens is recalling the Atellica CH Enzymatic Hemoglobin A1c assay (Material No. 11097536) due to potential for inaccurate patient results.
FDA•MODERATEMiniMed 780G Insulin PumpMedtronic is recalling MiniMed 780G Insulin Pumps due to a software error that can cause the device to unexpectedly stop delivering insulin.
FDA•MODERATEMedline Convenience KitsMedline recalls convenience kits with Covidien Mon-a-Therm probes due to distribution error.
3 products
FDA•MODERATEFresenius 5008X Blood Tubing SetsFresenius is recalling 5008X blood tubing sets due to potential connection errors between the tubing and the 5008X CAREsystem.
FDA•MODERATEIntracept Access InstrumentsBoston Scientific is recalling Intracept Access Instruments due to a potential sterile barrier breach that could lead to severe infection.
FDA•MODERATEEnovis EMPOWR 3D Knee InsertEncore Medical is recalling the EMPOWR 3D Knee Insert (11L 14MM) due to a packaging discrepancy involving incorrect product sizes.
2 products
FDA•MODERATEMasimo Radius VSM ECG Set and NIBP CuffMasimo recalls Radius VSM ECG Sets and NIBP Cuffs over false alarms and skin irritation risks.
2 products
FDA•MODERATEAquacel Ag Surgical SP DressingConvaTec is recalling Aquacel Ag Surgical SP dressings because they were manufactured with a thickness exceeding specifications.
FDA•MODERATEOlympus Single Use Distal CoverOlympus is replacing the previous design of the MAJ-2315 Single Use Distal Cover used with the EVIS EXERA III Duodenovideoscope.
FDA•MODERATEA.T.S. 4000 TS Tourniquet Dual HoseZimmer Surgical recalls A.T.S. 4000 TS Tourniquet Dual Hoses over sterility breach risk.
2 products
FDA•MODERATEGore TAG Thoracic Branch Endoprosthesis Side Branch ComponentGore is recalling 30+ models of the TAG Thoracic Branch Endoprosthesis Side Branch Component due to a risk of catheter separation.
2 products
FDA•CRITICALReprocessed Electrophysiology and Ultrasound CathetersMedline is recalling reprocessed catheters due to residual particulate matter that may cause infection or embolism.
FDA•MODERATEBard Acute Drainage TraysBard recalls Acute Drainage trays due to deficient lidocaine ampoules from supplier.
20 products
FDA•MODERATEMedline Gravity SetMedline is recalling gravity sets labeled "Not for Human Use" that were inadvertently shipped to the U.S. market.
FDA•CRITICALMedtronic Harmony Delivery Catheter SystemMedtronic is recalling the Harmony Delivery Catheter System due to a manufacturing defect that may cause the distal tip to detach during use.
FDA•MODERATESolar GI System Water PerfusionLaborie is recalling Solar GI System configurations due to moisture accumulation that may affect pressure measurement performance.
FDA•MODERATECovidien Shiley Disposable Decannulation PlugCovidien is recalling 12+ models of Shiley Disposable Decannulation Plugs due to incorrect labeling regarding DEHP content.
2 products
FDA•MODERATEZeiss Intrabeam Spherical ApplicatorZeiss is recalling the 1.5 cm Intrabeam Spherical Applicator (REF 304534-6000-557) due to failure to meet manufacturing specifications.
FDA•MODERATESiemens ARTIS icono Ceiling SuspensionSiemens is recalling the ARTIS icono ceiling suspension (Model 11328100) because monitor attachment screws may loosen over time.
FDA•CRITICALDSAEK Pack-RX Surgical Convenience KitWindstone Medical recalls DSAEK Pack-RX kits due to contaminated alcohol prep pads.
4 products- Device RecallFDA•MODERATERayCare 2024A SP1 Oncology Information Systems
RaySearch recalls RayCare 2024A SP1 over beam set delivery note data loss risk.
2 products 
FDA•CRITICALHillrom VOLARA System P.CIRCUIT KITBaxter recalls Hillrom VOLARA P.CIRCUIT KIT (REF M08085) over nebulizer cup leakage that may cause oxygen drop and ineffective treatment.
4 products- Device RecallFDA•MODERATEMedela ENFit Enteral Extension Set
Medela is recalling ENFit Enteral Extension Sets due to incorrect connectors that may cause delivery delays or misconnections.
FDA•MODERATEAccuray Cyberknife Xchange Robotic Collimator ChangerAccuray is recalling the Xchange Robotic Collimator Changer for the Cyberknife system due to a risk of the collimator falling from its housing.
FDA•MODERATEARTIS icono biplaneSiemens recalls ARTIS icono biplane over potential loss of detector lift movement.
3 products
FDA•MODERATEAccuray Cyberknife Xchange Robotic Collimator ChangerAccuray is recalling the Cyberknife Xchange Robotic Collimator Changer due to a risk of the component falling from its housing.
FDA•MODERATECRE Pro Wireguided Dilatation BalloonBoston Scientific recalls CRE Pro Wireguided Dilatation Balloons over potential sterile pouch breach.
12 products
FDA•MODERATEIntelliCuff Portable Cuff Pressure ControllerThe IntelliCuff pressure controller may fail to maintain cuff pressure due to a system leakage error, causing the motor to run continuously.
FDA•MODERATEPilling Wecksorb NeurospongesTeleflex is recalling Pilling Wecksorb Neurosponges and Neurosponge Strips due to potential out-of-specification levels of endotoxins.
2 products
FDA•MODERATEBaxter Adapter for Head PositioningBaxter is recalling the Adapter for Head Positioning due to a risk of the accessory becoming loose and moving during patient positioning.
FDA•MODERATERemel GC Agar BaseRemel is recalling GC Agar Base plates due to a risk of reduced or no recovery of Neisseria gonorrhoeae strains.
FDA•CRITICALHamilton Medical Ventilator Coaxial Breathing CircuitHamilton Medical is recalling ventilator coaxial breathing circuits due to a risk of valve membrane adhesion and inadequate ventilation.
FDA•MODERATEMedline Arterial Access TraysMedline recalls arterial access kits with Huons lidocaine ampules over quality issues.
19 products
FDA•MODERATEATTUNE Revision Hinge Knee Hinge Housing ComponentsDepuy Synthes recalls ATTUNE Revision Hinge Knee Hinge Housing Components due to packaging adhesion that may compromise sterility.
4 products
FDA•MODERATEMedacta Shoulder System Short Monobloc Stem BroachesMedacta is recalling Short Monobloc Stem Broaches for the Shoulder System due to a risk of humerus fracture during surgery.
FDA•MODERATEMedline Convenience Kits with Swan-Ganz CathetersMedline recalls convenience kits with Swan-Ganz catheters over leak/breakage risk.
9 products
FDA•MODERATEMentor Luer Lok 10cc SyringesMentor is recalling a lot of 10cc Luer Lok syringes that were distributed after their expiration date.
FDA•MODERATEIntera 3000 Hepatic Artery Infusion PumpBoston Scientific recalls Intera 3000 pump over drug pathway leakage risk.
FDA•MODERATEMedline Convenience Kits with 10mL Polycarbonate SyringesMedline recalls convenience kits with 10mL syringes over unapproved design changes.
23 products
FDA•CRITICALAbiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CPAbiomed recalls Impella CP introducer kit over thrombus risk.
4 products
FDA•MODERATEPhilips Telemetry Monitor 5500Philips is recalling Telemetry Monitor 5500 units due to a potential reset error that prevents connection to the central monitoring system.
FDA•MODERATEPersona Revision Femoral Distal AugmentZimmer is recalling the Persona Revision Femoral Distal Augment (model 42-5572-066-10) due to a packaging error.
- Device RecallFDA•MODERATEThuvera Laser Console
IPG Medical is recalling the Thuvera Laser Console due to a software anomaly that may cause a false error code 5018 display.
FDA•CRITICALMedline Convenience KitsMedline recalls convenience kits with recalled lidocaine and bupivacaine injections due to supplier quality issues.
5 products
FDA•MODERATEGE Healthcare AW Server 3.2 ext.6.5GE Healthcare is recalling the AW Server 3.2 ext.6.5 image processing system due to a software error that may display the wrong patient's data.
FDA•MODERATEOctopus Evolution Tissue StabilizerMedtronic recalls Octopus Evolution Tissue Stabilizer over incorrect tubing assembly.
3 products
FDA•MODERATESurgify Halo 3.0 mm Extendable DrillSurgify Halo 3.0 mm Extendable drill recalled over burr breakage risk during spinal surgery.
19 products