FDA•CRITICAL
ENROUTE Transcarotid Neuroprotection System
Boston Scientific recalls ENROUTE Transcarotid Neuroprotection System over sheath tip separation risk.
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Medical Devices Recalls
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FDA•CRITICALElevaris Sodium Chloride Injection 10mL AmpuleSpectra Medical Devices recalls Elevaris Sodium Chloride Injection 10mL Ampules over sterility concerns.
FDA•LOWParagon 28 Navicular Cage Foot ImplantParagon 28 recalls Navicular Cage foot implant (Model 6123S R) due to elevated oxygen levels.
2 products
FDA•CRITICALBaxter Duo-Vent Solution SetBaxter recalls Duo-Vent Solution Set (1C8507) over air bubble risk in drip chamber and tubing.
FDA•LOWSyva Emit Tox Tricyclic Antidepressant Calibrator/ControlsSiemens recalls Syva Emit Tox Tricyclic Antidepressant Calibrator/Controls due to out-of-specification sodium azide concentration.
FDA•LOWSyva Emit Disopyramide AssaySiemens recalls Syva Emit Disopyramide Assay due to out-of-spec sodium azide concentration; risk of mild irritation.
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•CRITICALResmed Astral 100/150 VentilatorResMed recalls Astral 100/150 ventilators due to supercapacitor leakage that may interrupt ventilation.
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•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•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•CRITICALArrow Edge Hemodialysis Catheterization ProductArrow Edge hemodialysis catheterization product recalled: sheath introducer may not split, risking injury.
6 products
FDA•CRITICALNamic Angiographic ManifoldMedline recalls Namic Angiographic Manifolds (SKU 64038200) due to particulate in the fluid path.
14 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•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•LOWPALAMIX uno Mixing UnitHeraeus recalls PALAMIX uno mixing units: mixing rod may loosen in units over 17 months old; shelf life reduced to 1.5 years.
2 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- Device RecallFDA•CRITICALPhilips Respironics Trilogy Evo O2 Ventilator
Philips Respironics recalls Trilogy Evo O2 ventilators (SW 1.05.15.00) over delayed obstruction alarm.
4 products 
FDA•CRITICALCentrosFLO Hemodialysis CathetersMerit Medical recalls CentrosFLO Hemodialysis Catheters over sheath introducer defect that may cause hemorrhage and other serious complications.
5 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 USA recalls Flexible Cryoprobes because probes may rupture or burst during use.
4 products
FDA•LOWDatascope Cardiosave Battery Charging StationDatascope is recalling the Cardiosave battery charging station due to a screw defect in the left bay that prevents proper charging.
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
FDA•CRITICALOlympus High Flow Insufflation UnitOlympus is recalling the UHI-3 High Flow Insufflation Unit due to a software issue that may cause dangerous overpressure events.
3 products
FDA•LOWStraumann WB Impression Post Closed TrayStraumann is recalling WB Impression Post Closed Tray kits (L 13mm) due to incorrect magenta impression caps instead of brown.
FDA•CRITICALTRUE METRIX Blood Glucose Meter InstructionsTrividia recalls TRUE METRIX meter instructions over inadequate E-5 error guidance.
7 products