FDA•CRITICAL
Medline HIP CDS-LF Convenience Kit
Medline recalls kits with Bupivacaine ampules over quality issues causing drug ineffectiveness.
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Medical Devices Recalls
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FDA•CRITICALMedline Anterior Hip KitMedline recalls anterior hip kits with Bupivacaine injection due to quality issues.
3 products
FDA•CRITICALAbiomed Impella Introducer SheathOscor recalls Abiomed Impella introducer sheaths (14Fr, 23Fr) due to leakage risk from sidearm and hub.
3 products
FDA•CRITICALTransvenous Pacing Electrode TrayArgon Medical recalls Transvenous Pacing Electrode Trays over non-sterile lidocaine ampules.
6 products
FDA•CRITICALAbiomed Impella RP Flex Introducer KitAbiomed recalls Impella RP Flex introducer kits over sheath leakage risk from manufacturing defects.
13 products
FDA•CRITICALReprocessed Electrophysiology and Ultrasound CathetersMedline is recalling reprocessed catheters due to residual particulate matter that may cause infection or embolism.
FDA•CRITICALMedtronic Harmony Delivery Catheter SystemMedtronic is recalling the Harmony Delivery Catheter System due to a manufacturing defect that may cause the distal tip to detach during use.
FDA•CRITICALDSAEK Pack-RX Surgical Convenience KitWindstone Medical recalls DSAEK Pack-RX kits due to contaminated alcohol prep pads.
4 products
FDA•CRITICALHillrom Volara Patient Circuit KitHillrom Volara circuit kits recalled over nebulizer cup leakage causing oxygen drops and ineffective treatment.
4 products
FDA•CRITICALHamilton Medical Ventilator Coaxial Breathing CircuitHamilton Medical is recalling ventilator coaxial breathing circuits due to a risk of valve membrane adhesion and inadequate ventilation.
FDA•CRITICALAbiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CPAbiomed recalls Impella CP introducer kit over thrombus risk.
4 products
FDA•CRITICALMedline Convenience KitsMedline recalls convenience kits with recalled lidocaine and bupivacaine injections due to supplier quality issues.
5 products
FDA•CRITICALGiraffe Stand-alone Infant Resuscitation System Blender KnobDatex-Ohmeda recalls Giraffe Infant Resuscitation System over blender knob that may cause incorrect oxygen delivery.
3 products
FDA•CRITICALImpella CP Set with SmartAssistAbiomed is recalling Impella CP Sets with SmartAssist due to a risk of low purge pressure that may interrupt mechanical circulatory support.
FDA•CRITICALParacentesis KitArrow recalls paracentesis kits over supplier drug quality issues that may cause serious injury.
51 products
FDA•CRITICALAbiomed Automated Impella ControllerAbiomed is recalling 30+ models of Impella Controllers due to a software error that may affect left ventricular support devices.
2 products
FDA•CRITICALDraeger Atlan A350 Anesthesia WorkstationDraeger recalls Atlan A350 anesthesia workstation over ventilator failure risk.
2 products
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.
- 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•CRITICALDesign Options Spinal TrayB. Braun recalls Design Options Spinal Trays due to potential quality issues in bupivacaine component.
6 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•CRITICALBD Spinal Tray with Quincke NeedleBD recalls Spinal Tray with Quincke Needle (Cat. 405609) due to quality issues in bupivacaine component.
10 products
FDA•CRITICALMedline Anesthesia TraysMedline recalls anesthesia trays containing Huons bupivacaine injection over data integrity and efficacy issues.
10 products
FDA•CRITICALOmnipod 5 PodsInsulet recalls Omnipod 5 Pods over insulin leakage risk that may cause high blood glucose, DKA, or HHS.
3 products
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•CRITICALRelayPro Thoracic Stent-Graft SystemBolton Medical is recalling 10+ models of the RelayPro Thoracic Stent-Graft System due to a risk of delivery system failure.
2 products
FDA•CRITICALArrow Edge Hemodialysis Catheterization KitArrow recalls hemodialysis kits over sheath introducer splitting failure risk.
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•CRITICALMedline Namic Angiographic Control Syringe KitsWindstone Medical is recalling Medline Namic Angiographic Control Syringe kits due to a risk of adapter disconnection and potential injury.
FDA•CRITICALNamic Angiographic ManifoldMedline recalls Namic Angiographic Manifolds (SKU 64038200) over particulate in fluid path.
14 products
FDA•CRITICALAmerican Contract Systems Coronary Angio PackAmerican Contract Systems is recalling Coronary Angio Packs due to a syringe adaptor defect that may cause disconnection and serious injury.
FDA•CRITICALMedical Action Industries Pack Cath BHHMedical Action Industries is recalling Pack Cath BHH kits due to a potential syringe adapter disconnection issue.
FDA•CRITICALHalyard CARDIAC CATH PACK KitAVID Medical recalls Halyard CARDIAC CATH PACK kits over risk of syringe adaptor disconnection.
10 products
FDA•CRITICALBeacon Tip Centimeter Sizing CatheterCook recalls Beacon Tip Centimeter Sizing Catheters due to risk of marker band cracking and device fragmentation.
3 products
FDA•CRITICALVOCSN V+Pro Respiratory SystemVentec is recalling VOCSN V+Pro respiratory systems (REF: PRT-01198-000, PRT-01185-000) due to potential oxygen leaks that may increase fire risk.
FDA•CRITICALIntuitive SureForm 30 Gray ReloadsIntuitive is recalling SureForm 30 Gray stapler reloads due to the risk of an incomplete staple line during surgical procedures.