FDA•MODERATE
Allia IGS 7 Pulse Angiographic X-ray System
GE HealthCare recalls Allia IGS 7 Pulse X-ray systems over electrical shock risk to service personnel.
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Medical Devices Recalls
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FDA•MODERATEBicarby DialysateFresenius Medical Care is recalling Bicarby Dialysate due to a luer-lock leak issue that poses a slip and fall hazard.
FDA•MODERATEPlum Solo Precision IV PumpICU Medical recalls Plum Solo IV Pump (40001-0401) over soft limit alert failure that may cause under- or over-delivery.
3 products
FDA•MODERATETDC VELOCE 23G Two Dimensional CutterD.O.R.C. recalls TDC VELOCE 23G cutter over loose outer knife complaints.
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 spore testing service recalled due to incorrect incubation process.
4 products
FDA•CRITICALDraeger Atlan A350 Anesthesia WorkstationDraeger recalls Atlan A350 anesthesia workstation over ventilator failure risk.
2 products
FDA•MODERATESharpoint Microsurgical KnifeSurgical Specialties Corporation is recalling Sharpoint microsurgical knives mislabeled as 2.2mm when they are actually 3.0mm.
FDA•CRITICALKayserBett IDA Pediatric Care BedKayserBett is recalling the IDA pediatric care bed due to an entrapment risk if the hand control is not locked while the child is unattended.
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.
- 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•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 ES Tower REF: 352 Medication CabinetBD Pyxis MedStation cabinets recalled due to fingerprint scanner overheating risk of first-degree 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•CRITICALDesign Options Spinal TrayB. Braun recalls Design Options Spinal Trays due to potential quality issues in bupivacaine component.
6 products
FDA•MODERATEArvis Hip & Knee 3.0 Instrument SetKico Knee recalls Arvis Hip & Knee 3.0 Instrument Set due to wear/corrosion on magnet face of V-Block and Trackers.
2 products
FDA•MODERATEShimadzu X-Ray and Angiography SystemsShimadzu is recalling 20+ models of X-ray and angiography systems due to a power-off failure caused by welding electromagnetic contactors.
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 Stethoscope with Temperature Sensor 400TMCovidien recalls Mon-a-Therm Esophageal Stethoscope 400TM over lack of FDA clearance for temperature probe.
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 (Cat. 405609) due to 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•MODERATEMedtronic Pocket Adaptor KitMedtronic recalls Pocket Adaptor Kits Models 64001 and 64002 due to incorrect Use-By-Date labels.
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 TraysMedline recalls anesthesia trays containing Huons bupivacaine injection over data integrity and efficacy issues.
10 products
FDA•MODERATEPhilips Azurion System HDDPhilips recalls Azurion/Allura systems due to HDD aging that may cause loss of imaging or data.
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 insulin leakage risk that may cause high blood glucose, DKA, or HHS.
3 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•CRITICALAbiomed Automated Impella ControllerAbiomed is recalling the Automated Impella Controller due to hardware issues that may cause motor control, startup, or power failures.
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 UnitPhilips recalls Azurion systems over cooling unit hose degradation that may cause oil leakage and force low-dose mode.
4 products
FDA•MODERATESilastic Foley CathetersC.R. Bard is recalling Silastic Brand Foley Catheters due to surface staining on the devices.
FDA•MODERATEOneLIF Interbody CageNovapproach Spine is recalling 60+ variants of OneLIF Interbody Cages due to a potential failure of the straight-inserter attachment.
2 products
FDA•MODERATEMedtronic GUNDRY Retrograde CannulaMedtronic recalls GUNDRY Retrograde Cannula 13FR 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 CatheterBD recalling 20+ Swan-Ganz Catheter models over hub leak/break risk; full model list on FDA page.
3 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 KitArrow recalls hemodialysis kits over sheath introducer splitting failure risk.
6 products
FDA•MODERATEBARD EP XT Steerable CatheterStryker recalls BARD EP XT and Dynamic Deca steerable catheters over incomplete sterile seals.
26 products