Device Recall
FDA•
Omnipod Insulin Delivery Pods
Insulet is recalling Omnipod insulin delivery pods due to a manufacturing issue that may result in the under-delivery of insulin.
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Medical Devices Recalls
Back to home ←- Device RecallFDA•Dexcom G7 Continuous Glucose Monitoring System
Dexcom is recalling G7 Continuous Glucose Monitoring System sensors that were identified as scrap and sold by a third party.
FDA•MODERATEDeRoyal Covaderm Plus Vascular Access DressingDeRoyal is recalling Covaderm Plus Vascular Access Dressing (Ref 46-406) due to a lack of sterility assurance.
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•CRITICALDraeger Atlan A350 Anesthesia WorkstationDraeger is recalling the Atlan A350 anesthesia workstation (Model 8211500) due to potential piston ventilator failure.
2 products
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.
FDA•MODERATENeptune Smart Docking StationStryker is recalling the Neptune Smart Docking Station (120V) due to missing safety testing and a potential electrical shock risk.
- Device RecallFDA•CRITICALIvenix Infusion System LVP Software
Fresenius Kabi is recalling Ivenix Infusion System LVP software due to a potential battery-health reporting error that may cause pump shutdown.
FDA•CRITICALB. Braun Spinal Needle Procedure KitsB. Braun is recalling various spinal needle procedure kits due to quality issues with the included Bupivacaine Hydrochloride injection.
3 products
FDA•CRITICALKayserBett IDA Pediatric Care BedKayserBetten is recalling IDA pediatric care beds due to an entrapment risk if hand controls are not locked while the child is unattended.
- Device RecallFDA•TRUE METRIX Blood Glucose Monitoring Systems
Trividia Health is recalling TRUE METRIX Blood Glucose Monitoring Systems due to missing instructions regarding E-5 error code symptoms.
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•CRITICALBD Spinal Tray with Bupivacaine HydrochlorideBecton Dickinson is recalling BD Spinal Trays (Catalog 405609) due to quality deficiencies in the included Bupivacaine Hydrochloride injection.
10 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•CRITICALRelayPro Thoracic Stent-Graft SystemBolton Medical is recalling 100+ variants of the RelayPro Thoracic Stent-Graft System due to a potential delivery system release failure.
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•CRITICALAbiomed Automated Impella ControllerAbiomed is recalling the Automated Impella Controller due to hardware issues that may cause motor control, startup, or power failures.
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•Aligned Medical Angio PackAligned Medical is recalling Angio Packs due to a risk of syringe adapter disconnection, which could lead to blood loss or infection.
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•CRITICALArrow Edge Hemodialysis Catheterization KitArrow International is recalling hemodialysis kits due to a defective sheath introducer that may cause injury during procedures.
6 products
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•CRITICALMedline Anesthesia TraysMedline is recalling anesthesia trays containing Huons Bupivacaine due to quality concerns, data integrity issues, and reduced efficacy.
7 products
FDA•MODERATEThermedx FluidSmart Urology Tube SetStryker is recalling the FluidSmart Urology Tube Set due to the distribution of nonconforming products.