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 KitOscor recalls Abiomed Impella Introducer Kits (REF 0052-3025) due to sheath leakage risk.
3 products
FDA•CRITICALTransvenous Pacing Electrode TrayArgon Medical recalls pacing electrode trays over non-sterile lidocaine ampules.
6 products
FDA•CRITICALABIOMED Impella RP Flex Introducer SheathAbiomed recalls Impella RP Flex pump sets over introducer sheath leakage risk.
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 System P.CIRCUIT KITBaxter recalls Hillrom VOLARA P.CIRCUIT KIT (REF M08085) over nebulizer cup leakage that may cause oxygen drop 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•CRITICALSpinal Needle Procedure KitsB. Braun recalls spinal needle kits over potential quality issues with 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 cannula defect causing insulin leaks, risking high blood glucose and DKA.
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•CRITICALCentimeter Sizing CatheterCook recalls Centimeter Sizing Catheter over marker band cracking risk that may cause vessel injury or death.
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.
FDA•CRITICALAIDBAG First Aid Kits with McKesson TRUE Metrix PRONorth American Rescue is recalling AIDBAG first aid kits with McKesson TRUE Metrix PRO glucose meters over E-5 error code software defect risking treatment delays.
2 products
FDA•CRITICALBoston Scientific ACCOLADE/ESSENTIO/PROPONENT/ALTRUA 2 PacemakersBoston Scientific expands pacemaker software advisory to include CRT-P and DR-EL devices; SMR6 update addresses dual-chamber pacing issues.
3 products
FDA•CRITICALB. Braun Streamline Bloodline SetB. Braun recalls Streamline Bloodline Sets for Dialog over air bubble risk.
6 products
FDA•CRITICALMedline Convenience Kits with Namic RA SyringesMedline recalls convenience kits with Namic RA syringes due to risk of loose connection or disconnection during use.
25 products- Device RecallFDA•CRITICALPhilips Respironics Trilogy Evo Ventilator
Philips Respironics recalls Trilogy Evo ventilators over delayed obstruction alarm.
4 products 
FDA•CRITICALCentrosFLO Hemodialysis CathetersMerit Medical recalls 80+ CentrosFLO hemodialysis catheter variants over sheath introducer splitting defect.
5 products
FDA•CRITICALBaxter Volara Ventilator Adapter ModuleBaxter is issuing a correction for the Volara Respiratory Therapy system adapter module to prevent oxygen desaturation and lung injury.
FDA•CRITICALAbiomed Impella Purge CassetteAbiomed is recalling Generation 1 purge cassettes due to an increased risk of purge leaks.
2 products
FDA•CRITICALAbiomed Automated Impella ControllerAbiomed is recalling Automated Impella Controllers due to a potential delay in the "Purge System Blocked" alarm.
2 products- Device RecallFDA•CRITICALPhilips Respironics Trilogy Evo Ventilator
Philips Respironics recalls Trilogy Evo ventilators over tidal volume discrepancy with non-pneumatic nebulizers.
4 products 
FDA•CRITICALHandy Solutions Neck & Shoulders Heating PadHandy Solutions Neck & Shoulders Heating Pad (Model 25607) may overheat and cause burns if folded or placed under the body.
FDA•CRITICALErbe Flexible CryoprobeErbe recalls Flexible Cryoprobes (REF 20402-401) due to rupture/burst risk.
4 products
FDA•CRITICALOmnipod 5 PodsInsulet is recalling Omnipod 5 Pods due to a cannula defect that can cause insulin under-delivery and severe health risks.
FDA•CRITICALImpella RP Flex with SmartAssistAbiomed recalls Impella RP Flex with SmartAssist due to sensor drift risk.
3 products