FDA•MODERATE
Bicarby Dialysate
Fresenius Medical Care is recalling Bicarby Dialysate due to a luer-lock leak issue that poses a slip and fall hazard.
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Medical Devices Recalls
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FDA•MODERATEPlum Solo Precision IV PumpICU Medical recalls Plum Solo IV Pump over soft limit alert failure.
3 products
FDA•MODERATETDC VELOCE 23G Two Dimensional CutterD.O.R.C. recalls TDC VELOCE 23G cutter over loose outer knife risk.
3 products
FDA•MODERATEEXCOR Pediatric VAD Blood Pump PU ValvesBerlin Heart is recalling EXCOR Pediatric VAD Blood Pump PU Valves due to an expiration date mismatch that could delay surgical procedures.
FDA•MODERATESporeTraq Mail-In Spore Testing ServiceSporeTraq Mail-In Spore Testing Service recalled due to incorrect incubation process; model 1023780.
4 products
FDA•MODERATESiemens ARTIS pheno X-ray SystemSiemens recalls ARTIS pheno X-ray system over dose display error.
2 products
FDA•MODERATESharpoint Microsurgical KnifeSurgical Specialties Corporation is recalling Sharpoint microsurgical knives mislabeled as 2.2mm when they are actually 3.0mm.
FDA•MODERATEGrace Medical Stapes ProsthesisGrace Medical is recalling the Titanium/Fluoroplastic Piston Stapes Prosthesis due to incorrect functional length listed on the labeling.
FDA•MODERATEDa Vinci 5 NIR Handheld CameraIntuitive Surgical is recalling the da Vinci 5 NIR handheld camera system due to a risk of unintentional illumination activation.
2 products
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•MODERATEAligned Medical Fluids KitWindstone Medical Packaging is recalling Aligned Medical AMS16835 Fluids Kits due to a supplier recall of the included Lidocaine injection.
FDA•MODERATEGE MAC 5 A4 and A5 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•MODERATEBD Pyxis MedStation 4000 Fingerprint ScannerBD Pyxis MedStation 4000 recalled: fingerprint scanner may overheat, causing burns.
8 products
FDA•MODERATEMedrad Avanta Injection System Tube SetsBayer is recalling Avanta Multi-Patient Administration Tube Sets due to a fit issue that may cause connection instability during use.
FDA•MODERATEArvis Hip & Knee 3.0 Instrument SetKico recalls Arvis Hip & Knee 3.0 Instrument Set over magnet face wear/corrosion.
2 products
FDA•MODERATEShimadzu X-Ray Systems High Voltage GeneratorShimadzu recalls X-ray systems over generator contactor weld risk; full model list on FDA page.
2 products
FDA•MODERATEPhaseOne Antimicrobial Solution SprayerOculus Technologies is recalling PhaseOne Antimicrobial Solution due to sprayer spring corrosion that may contaminate the product.
FDA•MODERATECASE v7.0 Cardiac Testing SystemGE Medical is recalling the CASE v7.0 Cardiac Testing System due to a risk of electrical sparking at the printer head.
FDA•MODERATEHiRes Ultra 3D CI HiFocus Mid Scala Cochlear ImplantAdvanced Bionics is recalling the HiRes Ultra 3D CI HiFocus Mid Scala cochlear implant due to an incorrect shelf-life expiration date.
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•MODERATECovidien EndoStitch Polysorb Single Use Loading UnitCovidien is recalling EndoStitch Polysorb loading units (170053, 170071) due to packaging holes that may compromise sterility.
- 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•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•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•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•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•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.