FDA•MODERATE
Covidien EndoStitch Polysorb Single Use Loading Unit
Covidien is recalling EndoStitch Polysorb loading units (170053, 170071) due to packaging holes that may compromise sterility.
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Medical Devices Recalls
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FDA•CRITICALIvenix Large Volume PumpFresenius Kabi is recalling Ivenix Large Volume Pumps due to potential touchscreen malfunctions caused by internal damage from drops or jarring.
- Device RecallFDA•MODERATEB. Braun CESK Northside Anesthesia Tray
B. Braun recalls CESK Northside Anesthesia Tray due to cracked adhesive tubing.
8 products 
FDA•MODERATECovidien Mon-a-Therm Esophageal StethoscopeCovidien recalls Mon-a-Therm Esophageal Stethoscope 400TM (REF 90042) due to lack of FDA clearance.
3 products
FDA•MODERATEExacta Mix Vented Micro-Volume InletBaxter is recalling Exacta Mix Vented Micro-Volume Inlet (Model H938175) due to incorrect filters that may cause flow and clinical issues.
FDA•CRITICALBD Spinal Tray with Quincke NeedleBD recalls Spinal Tray with Quincke Needle over quality issues in bupivacaine component.
10 products
FDA•MODERATECovidien Shiley Tracheostomy TubeCovidien is recalling Shiley Tracheostomy Tubes due to incorrect display box labeling.
FDA•MODERATEIvenix Infusion System Large Volume PumpFresenius Kabi is recalling the Ivenix Infusion System LVP due to a risk of the cassette loading lever breaking during use.
FDA•MODERATEGE HealthCare CARESCAPE Telemetry ServerGE HealthCare recalls CARESCAPE Telemetry Server V5 ATO over potential loss of ECG and SpO2 monitoring.
6 products
FDA•MODERATEMedtronic 1x4 Pocket Adaptor KitMedtronic recalls 1x4 Pocket Adaptor Kit (Model 64001) due to incorrect Use-By-Dates.
2 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•CRITICALMedline Anesthesia Trays with Huons BupivacaineMedline recalls anesthesia trays with Huons bupivacaine over quality and efficacy issues.
10 products
FDA•MODERATEPhilips Azurion System HDDPhilips recalls Azurion systems over aging HDDs that may cause loss of imaging or movement.
3 products
FDA•MODERATEHydroMARK Breast Biopsy Site MarkerDevicor Medical is recalling HydroMARK breast biopsy site markers due to incorrect inner package labeling.
FDA•CRITICALOmnipod 5 PodsInsulet recalls Omnipod 5 Pods over cannula damage causing insulin leaks and under-delivery, risking DKA.
3 products
FDA•MODERATEDexcom G7 Continuous Glucose Monitoring SystemDexcom is recalling stolen G7 sensors that were meant for destruction, posing risks of infection, sensor failure, and inaccurate readings.
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•CRITICALAbiomed Automated Impella ControllerAbiomed is recalling the Automated Impella Controller due to hardware issues that may cause motor control, startup, or power failures.
FDA•CRITICALBolton Medical Thoracic Stent-Graft Delivery SystemBolton Medical Inc. is recalling its Thoracic Stent-Graft delivery system due to a labeling update concerning disconnection of the proximal clasp from the outer control tube, which may prevent release of the stent-graft from the delivery system.
2 products
FDA•MODERATEPhilips Azurion Image Guided Therapy SystemsPhilips is recalling various Azurion systems due to potential mechanical wear in the Float Tabletop control module affecting table movement.
2 products
FDA•MODERATEPhilips Azurion X-ray Tube Cooling Unit Deaeration HosePhilips recalls Azurion systems: deaeration hose may leak oil, causing cooling failure and low-dose fluoroscopy lockout.
4 products
FDA•MODERATESilastic Foley CathetersC.R. Bard is recalling Silastic Brand Foley Catheters due to surface staining on the devices.
FDA•MODERATEGlobus Medical OneLIF Integrated FixationGlobus Medical is recalling OneLIF integrated fixation systems because some units may not meet shelf-life specifications, which could affect product performance.
2 products
FDA•MODERATEMedtronic GUNDRY Retrograde CannulaMedtronic recalls GUNDRY Retrograde Cannula over sterile barrier breach risk.
9 products
FDA•MODERATEICU Medical Oncology Extension SetICU Medical is recalling Oncology Extension Set REF: CL3960 due to a potential leak that could cause therapy interruption or hazardous exposure.
FDA•MODERATETangent Single Use Digital CatheterTangent Endoscopy is recalling single-use digital catheters due to potential fractures at the distal shaft tip.
FDA•MODERATESwan-Ganz Catheters (Multiple Models)Becton, Dickinson and Company is recalling multiple variants of its Swan-Ganz pulmonary artery catheters due to a potential risk of valve leakage that may affect the balloon inflation performance.
3 products
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.
- Device RecallFDA•MODERATEMedtronic SynchroMed Flex Infusion Mode A810 Software
Medtronic is recalling A810 software for SynchroMed pumps due to a display error that may cause incorrect or missed medication delivery.
2 products 
FDA•MODERATECodman CerebroFlo EVD CatheterIntegra LifeSciences is recalling the Codman CerebroFlo EVD Catheter due to out-of-specification endotoxin results.
FDA•CRITICALArrow Edge Hemodialysis Catheterization ProductArrow Edge hemodialysis catheterization product recalled: sheath introducer may not split, risking injury.
6 products
FDA•CRITICALOmnicell i.v.STATION Syringe LabelsOmnicell is recalling sterile syringe label stock for the i.v.STATION device due to a risk of mislabeled IV medication syringes.
FDA•MODERATEBARD Dynamic Deca Steerable CatheterBARD Dynamic Deca Steerable EP catheter recalled due to incomplete seals on sterile product.
26 products
FDA•MODERATEEdwards EVOQUE Tricuspid Delivery SystemEdwards Lifesciences is updating the labeling for the EVOQUE tricuspid delivery system to include a warning about potential functionality issues.
FDA•MODERATEZYMUTEST HIA IgG ELISA KitZYMUTEST HIA IgG ELISA kit lot FD1265 distributed with outdated flyer containing incorrect positive control values.
FDA•MODERATEPhilips Azurion Cable Hose CarrierPhilips is recalling Azurion imaging systems due to potential loosening or breakage of Cable Hose Carrier bolts and plastic parts.
FDA•MODERATEQuickVue Dipstick Strep A TestQuidel is recalling QuickVue Dipstick Strep A Test (REF 20108) due to risk of false positive results.
FDA•MODERATEThermedx FluidSmart Urology Tube SetStryker is recalling the FluidSmart Urology Tube Set (REF LL0006) due to the distribution of nonconforming products.
FDA•MODERATESelenia Dimensions Mammography SystemsHologic recalls Selenia Dimensions mammography systems over loose or broken internal bolts.
2 products
FDA•MODERATEDexcom G7 CGM iOS AppDexcom recalls G7 CGM iOS App (v2.9.0–2.11.2) over glucose alert delays that may cause missed hypo/hyperglycemic events.
4 products
FDA•MODERATEDiowave 250W Laser SystemDiowave 250W Laser System recalled; software update needed to correct power output exceeding FDA-cleared 60W limit.
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•MODERATERevolution Ascend CTGE HealthCare recalls Revolution Ascend CT over AW Server security vulnerability.
7 products
FDA•CRITICALNamic Angiographic ManifoldMedline recalls Namic Angiographic Manifolds (SKU 64038200) due to particulate in the fluid path.
14 products
FDA•MODERATEDonJoy IceMan Classic CubeDonJoy IceMan Classic Cube recalled due to broken connector interrupting cold therapy.
4 products
FDA•MODERATEOn-X Mitral Heart Valve with Conform-X Sewing RingOn-X is recalling Model ONXMC-25/33 Mitral Heart Valve due to incomplete testing before distribution.
FDA•MODERATEBioCera Fibers Bone Void FillerOrthorebirth recalls BioCera Fibers bone void filler (REFs ORB-0320C-KC, ORB-0310C-KC, ORB-0304C-KC, ORB-0302C-KC, ORB-0305D-KC) for out-of-spec.
2 products
FDA•MODERATEMedline Convenience KitsMedline is recalling Ancillary Pack-LF and Open Heart Anesthesia ICC-A kits due to potential issues with sterilization and packaging calibration.
58 products
FDA•MODERATEBioFire Joint Infection PanelBioFire is recalling the Joint Infection (JI) Panel due to contamination that may cause false positive test results.
- Device RecallFDA•MODERATEMint Lesion Software
Mint Medical is recalling Mint Lesion software versions 3.4.0–3.9.5 due to a risk of data loss or incorrect patient information linking.