FDA•MODERATE
DeRoyal Covaderm Plus Vascular Access Dressing
DeRoyal is recalling Covaderm Plus Vascular Access Dressing (Ref 46-406) due to a lack of sterility assurance.
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Medical Devices Recalls
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FDA•MODERATEMedtronic Deep Brain Stimulation Pocket Adaptor KitMedtronic is recalling Deep Brain Stimulation Pocket Adaptor Kits (Models 64001 and 64002) due to incorrect Use-By-Dates on the packaging.
2 products
FDA•MODERATENeptune Smart Docking StationStryker is recalling the Neptune Smart Docking Station (120V) due to missing safety testing and a potential electrical shock risk.
FDA•MODERATEPhilips Azurion and Allura Imaging SystemsPhilips is recalling Azurion and Allura imaging systems due to hard disk drive failure that may cause loss of functionality or data.
2 products
FDA•MODERATEHiResolution Bionic Ear SystemAdvanced Bionics is recalling the HiRes Ultra 3D CI HiFocus Mid Scala cochlear implant due to an incorrect shelf-life expiration date.
FDA•MODERATEBD Pyxis MedStation 4000 Fingerprint ScannerCareFusion 303 is recalling the BD Pyxis MedStation 4000 medication cabinet due to a fingerprint scanner overheating burn risk.
8 products
FDA•MODERATEPhilips Azurion Image-Guided Therapy SystemsPhilips is recalling various Azurion image-guided therapy systems due to potential table movement issues caused by control module wear.
2 products- FDA•MODERATEPhilips Azurion X-Ray Tube Cooling Unit
Philips is recalling X-ray tube cooling units in Azurion systems due to hose degradation and potential oil leakage.
4 products 
FDA•MODERATEPhaseOne Antimicrobial Solution SprayerOculus Technologies is recalling PhaseOne Antimicrobial Solution due to sprayer spring corrosion that may contaminate the product.
FDA•MODERATEAligned Medical Fluids KitWindstone Medical Packaging is recalling the Aligned Medical AMS16835 Fluids Kit due to a supplier recall of the included Lidocaine injection.
FDA•MODERATEHydroMARK Breast Biopsy Site MarkerDevicor Medical is recalling HydroMARK breast biopsy site markers due to incorrect inner package labeling.
- Device RecallFDA•MODERATEGE HealthCare CARESCAPE Telemetry Server V5
GE HealthCare is recalling CARESCAPE Telemetry Server V5 units due to a risk of losing ECG and SpO2 monitoring capabilities.
6 products 
FDA•MODERATECASE v7.0 Cardiac Testing SystemGE Medical Systems is recalling the CASE v7.0 Cardiac Testing System due to a risk of electrical sparking and potential paper ignition.
FDA•MODERATEMedrad Avanta Injection System Tube SetsBayer is recalling Avanta Multi-Patient Administration Tube Sets due to a connection issue that may cause procedure interruptions.
FDA•MODERATEDa Vinci 5 NIR Handheld CameraIntuitive Surgical is recalling the da Vinci 5 NIR handheld camera system due to a risk of unintentional activation during surgery.
FDA•MODERATEOneLIF Interbody CageNovapproach Spine is recalling 60+ variants of OneLIF Interbody Cages due to a risk of inserter attachment failure during surgical procedures.
2 products
FDA•MODERATESilastic Foley CathetersC.R. Bard is recalling Silastic Brand Foley Catheters due to surface staining on the devices.
FDA•MODERATECovidien Mon-a-Therm Esophageal StethoscopeCovidien is recalling Mon-a-Therm Esophageal Stethoscopes with Temperature Sensors because the devices lack FDA clearance.
3 products
FDA•MODERATEArvis Hip & Knee 3.0 Instrument Set ComponentsKico Knee Innovation is recalling Arvis Hip & Knee 3.0 instrument components over potential wear or corrosion on the magnet face.
2 products
FDA•MODERATESharpoint Microsurgical KnifeSurgical Specialties Corporation is recalling mislabeled Sharpoint microsurgical knives that contain 3.0mm blades instead of 2.2mm.
FDA•MODERATEBioFire Joint Infection PanelBioFire is recalling the Joint Infection (JI) Panel due to potential contamination that may cause false positive test results.
FDA•MODERATEExacta Mix Vented Micro-Volume InletBaxter is recalling Exacta Mix Vented Micro-Volume Inlets (Model H938175) due to incorrect filters that may cause clinical complications.
FDA•MODERATEMedtronic GUNDRY Retrograde CannulaMedtronic is recalling GUNDRY Retrograde Cannula catheters due to a potential sterile barrier breach that may compromise device sterility.
9 products
FDA•MODERATEMAC 5 Resting ECG Analysis SystemsGE is recalling MAC 5 A4 and A5 ECG systems due to a software error that may incorrectly associate clinical data with the wrong patient.
FDA•MODERATEShimadzu Medical Systems X-Ray and Angiography GeneratorsShimadzu is recalling 20+ models of X-ray and angiography systems due to a contactor defect that may keep power active when switched off.
FDA•MODERATECovidien Shiley Tracheostomy TubeCovidien is recalling Shiley Tracheostomy Tubes (REF 6FEN) due to incorrect display box labeling.
FDA•MODERATECovidien EndoStitch Polysorb Single Use Loading UnitCovidien is recalling EndoStitch Polysorb loading units (models 170053 and 170071) due to a compromised sterile barrier.
FDA•MODERATEPhilips Achieva and MR 7700 MR Elastography SystemsPhilips is recalling MR Elastography systems (models 782130, 781196, 781296) due to a software error that can cause inaccurate stiffness values.
19 products
FDA•MODERATEDexcom G7 CGM iOS AppDexcom is recalling G7 CGM iOS app versions 2.9.0–2.11.2 due to a software defect that may delay glucose alerts and readings.
4 products
FDA•MODERATEPhysio-Control LIFEPAK DefibrillatorsPhysio-Control is recalling various LIFEPAK defibrillators due to missing performance inspection documentation that may impact device therapy.
FDA•MODERATELUCAS Chest Compression SystemJolife AB is recalling LUCAS 2, 3, and 3.1 chest compression systems due to missing service documentation.
2 products
FDA•MODERATEHalyard Purezero Ultraviolet Nitrile Exam GlovesHalyard is recalling Purezero Ultraviolet Nitrile Exam Gloves due to a failure to meet chemical permeation performance specifications.
FDA•MODERATECodman CerebroFlo EVD CatheterIntegra LifeSciences is recalling the CerebroFlo EVD Catheter due to out-of-specification endotoxin results.
FDA•MODERATEBard Dynamic Deca Steerable Electrophysiology CatheterStryker is recalling the Bard Dynamic Deca Steerable Electrophysiology Catheter due to incomplete sterile packaging seals.
26 products
FDA•MODERATEMedline Eye Tray-LF Convenience KitMedline is recalling Eye Tray-LF kits containing mislabeled Cardinal Health syringes that may lead to incorrect insulin dosing.
FDA•MODERATEThermedx FluidSmart Urology Tube SetStryker is recalling the FluidSmart Urology Tube Set due to the distribution of nonconforming products.
FDA•MODERATESelenia Dimensions Mammography SystemsHologic is recalling 15+ models of Selenia Dimensions Mammography Systems due to a risk of loose, missing, or broken internal bolts.
2 products- Device RecallFDA•MODERATEMedtronic SynchroMed Flex Infusion Mode A810 Software
Medtronic is recalling A810 software for SynchroMed pumps due to a display error that can cause incorrect or failed infusion delivery.
2 products 
FDA•MODERATESwan-Ganz CathetersBecton, Dickinson and Company is recalling 15+ models of Swan-Ganz Catheters due to a risk of hub leakage or breakage.
3 products
FDA•MODERATEBD GasPak EZ Gas Generating Pouch SystemsBecton Dickinson is recalling BD GasPak EZ CO2 and Campy Gas Generating Pouch Systems due to insufficient carbon dioxide production.
2 products
FDA•MODERATEQuickVue Dipstick Strep A TestQuidel is recalling QuickVue Dipstick Strep A Test (REF 20108) due to risk of false positive results.
FDA•MODERATELVIS Intraluminal Support DeviceMicroVention recalls LVIS Intraluminal Support Devices (REF 214022-CAS, 214518-CAS, 213517-CAS) due to dimensional nonconformance risking vessel injury or thrombosis.
FDA•MODERATEDePuy Synthes Attune Revision Hinge Femoral ComponentDePuy Synthes is recalling the Attune Revision Hinge Femoral component due to a potential compromise of the sterile barrier.
9 products
FDA•MODERATEGrace Medical Stapes ProsthesisGrace Medical is recalling the Titanium/Fluoroplastic Piston Stapes Prosthesis due to incorrect functional length listed on the labeling.
FDA•MODERATEepoc BGEM BUN Test CardSiemens is recalling epoc BGEM BUN Test Cards due to the risk of inaccurate pH and carbon dioxide results that may lead to incorrect treatment.
FDA•MODERATEPhilips Bridge Prep KitMerit Medical Systems is recalling the Philips Bridge Prep Kit due to potential catheter resistance during use.
4 products
FDA•MODERATEda Vinci X and Xi Surgical System Universal Surgical ManipulatorIntuitive Surgical is recalling the USM arm sub-assembly for da Vinci X and Xi systems due to a risk of internal screw breakage.
2 products
FDA•MODERATEOne Step 10A In Vitro Diagnostic TestDFI is recalling the One Step 10A in vitro diagnostic test due to a lack of required FDA premarket clearance or approval.
7 products
FDA•MODERATEi-STAT Blood Gas CartridgesAbbott is recalling i-STAT EG7+, EG6+, and G3+ cartridges due to inaccurate blood gas results that may lead to incorrect clinical decisions.
3 products
FDA•MODERATEBiofire Spotfire Respiratory/Sore Throat PanelBioFire is recalling the Spotfire Respiratory/Sore Throat Panel due to the risk of false negative results and control failures.