FDA•CRITICAL
Transvenous Pacing Electrode Tray
Argon Medical recalls pacing electrode trays over non-sterile lidocaine ampules.
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Medical Devices Recalls
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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•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•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•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•CRITICALArrow Edge Hemodialysis Catheterization KitArrow recalls hemodialysis kits over sheath introducer splitting failure risk.
6 products
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•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•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 duo / PALAMIX unoHeraeus recalls PALAMIX duo and uno mixing units due to risk of mixing rod loosening in units over 17 months old.
2 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- 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•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 Owner's BookletsTrividia Health recalls TRUE METRIX meter booklets over inadequate E-5 error code instructions that may delay treatment.
7 products