FDA•CRITICAL
Draeger Atlan A350 Anesthesia Workstation
Draeger is recalling the Atlan A350 anesthesia workstation (Model 8211500) due to potential piston ventilator failure.
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Medical Devices Recalls
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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.
- 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•CRITICALB. Braun Spinal Needle Procedure KitsB. Braun is recalling various spinal needle procedure kits due to quality issues with the included Bupivacaine Hydrochloride injection.
3 products
FDA•CRITICALKayserBett IDA Pediatric Care BedKayserBetten is recalling IDA pediatric care beds due to an entrapment risk if hand controls are not locked while the child is unattended.
FDA•CRITICALBD Spinal Tray with Bupivacaine HydrochlorideBecton Dickinson is recalling BD Spinal Trays (Catalog 405609) due to quality deficiencies in the included Bupivacaine Hydrochloride injection.
10 products
FDA•CRITICALRelayPro Thoracic Stent-Graft SystemBolton Medical is recalling 100+ variants of the RelayPro Thoracic Stent-Graft System due to a potential delivery system release failure.
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 International is recalling hemodialysis kits due to a defective sheath introducer that may cause injury during procedures.
6 products
FDA•CRITICALMedline Anesthesia TraysMedline is recalling anesthesia trays containing Huons Bupivacaine due to quality concerns, data integrity issues, and reduced efficacy.
7 products
FDA•CRITICALCentimeter Sizing CatheterCook is recalling Centimeter Sizing Catheters due to a risk of marker band breakage that may cause vessel injury or life-threatening harm.
3 products
FDA•CRITICALMedline Namic Angiographic Control Syringe KitsWindstone Medical is recalling Angio Pack kits containing Medline Namic syringes due to a risk of adapter disconnection and potential injury.
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•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•CRITICALOmnicell i.v.STATION Syringe Label StockOmnicell is recalling i.v.STATION syringe label stock due to a risk of mislabeled syringes during the IV medication compounding process.
FDA•CRITICALMedline Namic Angiographic ManifoldMedline is recalling Namic Angiographic Manifolds due to the presence of particulate matter within the fluid path.
14 products
FDA•CRITICALBoston Scientific Essentio, Proponent, Accolade, and Altrua 2 PacemakersBoston Scientific is updating software for Essentio, Proponent, Accolade, and Altrua 2 pacemakers to address dual-chamber pacing issues.
3 products
FDA•CRITICALB. Braun Hemodialysis BloodlinesB. Braun is recalling Streamline Bloodline Sets for Dialog iQ machines due to a risk of air bubble accumulation in the arterial line.
6 products
FDA•CRITICALMedline Namic Angiographic Control Syringe KitsAmerican Contract Systems is recalling Medline Namic Angiographic Control Syringe kits due to a risk of syringe disconnection during use.
FDA•CRITICALMedical Action Industries Pack Cath BHHMedical Action Industries is recalling Pack Cath BHH kits due to a risk of syringe disconnection during use.
FDA•CRITICALHalyard Cardiac Cath Pack Syringe AdaptorAVID Medical is recalling Halyard Cardiac Cath Pack kits due to a risk of syringe adaptor disconnection during use.
10 products
FDA•CRITICALOmnipod 5 PodsInsulet is recalling Omnipod 5 Pods due to a cannula tear that can cause insulin leakage, leading to dangerous under-delivery of insulin.
FDA•CRITICALIntuitive SureForm 30 Gray ReloadsIntuitive Surgical is recalling SureForm 30 Gray Reloads (Ref 48230M-05, 48230M-06) due to the risk of an incomplete staple line.
FDA•CRITICALPhilips Respironics Trilogy Evo VentilatorPhilips Respironics is recalling Trilogy Evo ventilators (software v1.05.15.00) due to potential tidal volume delivery discrepancies.
4 products
FDA•CRITICALPhilips Respironics Trilogy Evo O2 VentilatorPhilips Respironics is recalling Trilogy Evo O2 ventilators running software version 1.05.15.00 due to a potential obstruction alarm delay.
4 products
FDA•CRITICALNAMIC Angiographic Syringe Convenience KitsMedline is recalling NAMIC angiographic syringe kits due to a risk of the rotating adaptor unwinding and disconnecting during use.
24 products
FDA•CRITICALAbiomed Impella Purge CassetteAbiomed is recalling Generation 1 purge cassettes sold individually and within Impella pump sets due to an increased risk of purge leaks.
2 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•CRITICALBaxter Volara Respiratory Therapy Blue Ventilator Adapter ModuleBaxter is correcting its Volara Respiratory Therapy Blue Ventilator Adapter Module (M07937) due to risks of oxygen desaturation or barotrauma in home care use.
FDA•CRITICALAbiomed Automated Impella ControllerAbiomed is recalling Automated Impella Controllers due to a potential delay in the "Purge System Blocked" alarm.
2 products
FDA•CRITICALCentrosFLO Hemodialysis CathetersMerit Medical is recalling 20+ models of CentrosFLO Hemodialysis Catheters due to a sheath design defect that may cause serious injury.
5 products
FDA•CRITICALErbe Flexible CryoprobeErbe is recalling Flexible Cryoprobes because they may rupture or burst during activation.
4 products
FDA•CRITICALTRUE METRIX Blood Glucose Meter Owner's BookletsTrividia Health is recalling TRUE METRIX meter manuals due to inadequate instructions for handling the E-5 error code.
7 products
FDA•CRITICALImpella RP Flex with SmartAssistAbiomed is recalling the Impella RP Flex with SmartAssist due to a potential malfunction of the differential pressure sensor.
3 products
FDA•CRITICALOlympus UHI-3 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