FDA•CRITICAL
Epidural/Pain TQC Kit
Medical Action recalls its Epidural/Pain TQC Kit containing sodium chloride ampules over compromised sterility.
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FDA•CRITICALENROUTE Transcarotid Neuroprotection SystemBoston Scientific recalls ENROUTE Transcarotid Neuroprotection System over sheath tip separation risk.
2 products
FDA•CRITICALBMC Luna G3 APAPBMC recalls Luna G3 APAP (REF LG 3600) over 2024 warehouse rework.
FDA•CRITICALElevaris Sodium Chloride Injection 10mL AmpuleSpectra Medical Devices recalls Elevaris Sodium Chloride Injection 10mL Ampules over sterility concerns.
FDA•CRITICALBaxter Duo-Vent Solution SetBaxter recalls Duo-Vent Solution Set (1C8507) over air bubble risk in drip chamber and tubing.
FDA•CRITICALBoston Scientific Infinion CX Lead KitBoston Scientific recalls Infinion CX lead kits for SCS systems due to possible lead fracture at anchor site.
FDA•CRITICALHalyard Cardiac Cath Pack with Medline ManifoldAVID Medical recalls Halyard kits with Medline manifolds due to particulate risk.
3 products
FDA•CRITICALBD Needle Kit for Powered DriverBard Access recalls BD Powered Driver Needle Kits over obturator removal difficulty.
FDA•CRITICALAngiography Procedure Kit ManifoldsAngiography kit manifolds recalled due to particulate risk in blood circulation.
FDA•CRITICALResmed Astral 100/150 VentilatorResMed recalls Astral 100/150 ventilators due to supercapacitor leakage that may interrupt ventilation.
FDA•CRITICALMedline Anterior Hip KitMedline is recalling anterior hip kits containing Bupivacaine Hydrochloride in Dextrose Injection over quality issues.
4 products
FDA•CRITICALMedline HIP CDS-LF KitMedline is recalling specific lots of procedure kits containing Bupivacaine ampules due to a quality issue that could cause drug ineffectiveness.
4 products
FDA•CRITICALOscor Impella Introducer KitOscor recalls Abiomed Impella Introducer Kit (14F) due to sheath leakage risk.
3 products
FDA•CRITICALTransvenous Pacing Electrode TrayArgon recalls Transvenous Pacing Electrode Trays due to non-sterile lidocaine ampules in kits.
6 products
FDA•CRITICALAbiomed Impella RP Flex IntroducerAbiomed recalls Impella RP Flex introducers over 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 KitDSAEK Pack-RX kits recalled due to contaminated alcohol prep pads; stop use and contact firm.
4 products
FDA•CRITICALHillrom Volara System Patient Circuit KitBaxter recalls Hillrom Volara P.CIRCUIT KIT (REF M08085) due to nebulizer cup leakage causing 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 Impella CP Introducer KitAbiomed recalls Impella CP introducer kit (14 Fr x 13 cm) over thrombus risk.
4 products
FDA•CRITICALMedline CV Anesthesia Room Setup KitsMedline recalls CV Anesthesia Room Setup kits due to quality issues with included lidocaine and bupivacaine injections.
5 products
FDA•CRITICALGiraffe Stand-alone Infant Resuscitation SystemDatex-Ohmeda recalls Giraffe infant resuscitation systems over oxygen concentration risk.
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•CRITICALImpella Heart Pump Software RecallAbbott's Impella heart pumps may fail to restart after certain operational faults, posing a serious health risk to patients.
2 products
FDA•CRITICALParacentesis KitArrow International recalls paracentesis kits due to supplier quality issues with included injectables, risking serious injury.
51 products
FDA•CRITICALDraeger Atlan A350 Anesthesia WorkstationDraeger recalls Atlan A350 anesthesia workstation due to piston 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•CRITICALPencan Spinal Needle TraysB. Braun recalls Pencan spinal needle trays 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 over quality issues in bupivacaine component.
10 products
FDA•CRITICALMedline Anesthesia Trays with Huons BupivacaineMedline recalls anesthesia trays with Huons bupivacaine over quality and efficacy issues.
10 products
FDA•CRITICALOmnipod 5 PodsInsulet recalls Omnipod 5 Pods over cannula damage causing insulin leaks and under-delivery, risking 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•CRITICALBolton Medical Thoracic Stent-Graft Delivery SystemBolton Medical Inc. is recalling its Thoracic Stent-Graft delivery system due to a labeling update concerning disconnection of the proximal clasp from the outer control tube, which may prevent release of the stent-graft from the delivery system.
2 products
FDA•CRITICALArrow Edge Hemodialysis Catheterization ProductArrow Edge hemodialysis catheterization product recalled: sheath introducer may not split, risking injury.
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•CRITICALNamic Angiographic ManifoldMedline recalls Namic Angiographic Manifolds (SKU 64038200) due to particulate in the 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•CRITICALCook Centimeter Sizing CatheterCook recalls Centimeter Sizing Catheter (RPN N5.0-35-100-P-10S-PIG-CSC-20) over marker band cracking risk.
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 PacemakersBoston Scientific updates software for certain pacemakers and CRT-Ps due to bradycardia maintenance release.
3 products
FDA•CRITICALMedline Namic Angiographic Control SyringesWindstone recalls kits with Medline Namic RA Syringes over risk of adapter unwinding, which may cause disconnection and serious injury.
FDA•CRITICALB. Braun STREAMLINE Bloodline SetB. Braun recalls STREAMLINE bloodline sets for Dialog DR over arterial line air bubble risk.
6 products
FDA•CRITICALMedline Convenience Kits with Namic RA SyringesMedline recalls convenience kits with Namic RA syringes over risk of loose connection or disconnection during use.
25 products