April​ ​2025

FDA Recall: PyrAmes Inc., Boppli Bedside Device Kit and Sensor Band (PDF)​

FDA Recall: Ethicon Endo Surgery, LLC PDS Plus VIO​ (PDF)​

FDA Recall: Draeger Inc., VentStar Flex 220, ID Circuit Flex 220, Anesthesia Circuit Kit, Flex EPA (PDF)​​

March ​2025

FDA Recall: Fujifilm Healthcare Americas Corporation Synapse PACS Software​ (PDF)​

FDA Recall: Premier Dental Products Solo Diamond -Large Invented Cone (PDF)​​

FDA Recall: Checkpoint Surgical Guardian Intraoperative Lead (PDF)​

FDA Recall: Immuno-Mycologics, Inc Recalls Candida ID Antigen (PDF)​

FDA Recall: B Braun Medical Inc., Introcan Safety 3 Closed IV Catheter (PDF)​​

​FDA Recall: Calyxo Inc., CVAC Aspiration System​ (PDF)​

FDA Recall: TruAbutment Inc., TruScan Body compatible with CONELOG 3.8 (PDF)​

FDA Recall: Smiths Medical ASD, Inc., Portex Endotracheal Tube (PDF)​​

FDA Recall: Medtronic Perfusion Systems Aortic Root Cannula (PDF)​​

FDA Recall: CareFusion 303, Inc., BD Alaris Systems Manager and BD Care Coordination Engine Infusion Adapter (PDF)​

FDA Recall: Integra LifeSciences Corp., Aurora Surgiscope System (PDF)​

FDA Recall: Micro Therapeutics Inc., Medtronic Pipeline Vantage Embolization Device (PDF)​​

FDA Recall: Baxter Sigma Spectrum Infusion System and Baxter Spectrum IQ Infusion System with Dose IQ Safety Software (PDF)​​

FDA Recall: Bard Peripheral Vascular Inc., Rotarex Atherectomy System (PDF)​

​February ​2025

FDA Recall: Smiths Medical ASD, Inc., ProPort Plastic Venous Access System (PDF)​​

FDA Recall: Medimaps Group TBS Osteo TBS iNsight​ (PDF)​

FDA Recall: Physio-Control Inc., Lifepak 15 V4/Masimo Rainbow Sensors (PDF)​

FDA Recall: Medline Industries, LP Convenience Kits for Various Procedures (PDF)​​

FDA Recall: Exactech Inc, AcuMatch XLE and Novation XLE (PDF)​​

​FDA Recall: Medicrea International Adaptive Spine Intelligence UNiD Spine Analyzer (PDF)​​

FDA Recall: KCI USA, INC. 3M V.A.C. VIA Negative Pressure Wound Therapy System and 3M Prevena Plus 125 Therapy Unit and System Kits​ (PDF)​

FDA Recall: Intelerad Medical Systems Incorporated IntelePACS InteleViewer (PDF)​

FDA Recall: Biosense Webster Inc., Varipulse Bi-Directional Ablation Catheter (PDF)​​

​FDA Recall: Philips Medical Systems Nederland B.V. Allura Xper Class I (PDF)

FDA Recall: Philips Medical Systems Nederland B.V. Allura Xper​ Class II (PDF)​

FDA Recall: Ethicon, LLC: Prolene Polypropylene Suture & Ethibond Excel Polyester Suture (PDF)​

FDA Recall: Dexcom Inc., Dexcom G6, Continuous Glucose Monitoring System (PDF)​​

FDA Recall: Biological, Bio52 HealthFirst Mail In Monitoring System​ (PDF)​​

FDA Recall: Terragene S.A. ASP Biotrace Auto Read 60 Steam BI Process Challenge Device (PDF)​​

FDA Recall: Ventec Life Systems, Inc., VOCSN Multi-Function Ventilators (PDF)

FDA Recall: Spectranetics Corporation Intact Vascular Tack Endovascular System​ (PDF)​​​

FDA Recall: Oxoid Limited Susceptibility Discs Levofloxacin (PDF)​​

FDA Recall: Integra LifeSciences Corp., MediHoney Wound & Burn Dressing Gel (PDF)​​

FDA Recall: Angel Medical Systems, Inc., The Guardian​ Sytem (PDF)​

FDA Recall: Max Mobility LLC Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial and Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial (PDF)​​

FDA Recall: Olympus Corporation of the Americas Single Use Guide Sheath Kits​ (PDF)​

FDA Recall: Fresenius Kabi USA, LLC., Ivenix Infusion System (IIS), LVP Software (PDF)

January 2025

FDA Recall: Zimmer Inc., NexGen LCCK Legacy Articular Surface with Locking Screw​ (PDF)​

FDA Recall: SIN Sistema de Implante Nacional S.A. Implant Epikut S Plus CM 16-Degrees (PDF)​​

FDA Recall: Elucent Medical Inc., EnVisio Patient Pad Transition Cushion​ (PDF)

FDA Recall: Hologic Inc. Panther Fusion GBS Assay (PDF)​

FDA Recall: Alcon Research LLC Monarch III D Delivery Cartridge​ (PDF)

FDA Recall: Medline Industries, LP-Northfield Arterial Line Products (PDF)​​

FDA Recall: NOA Medical Industries Inc., Behavioral Health hospital bed side rails (PDF)​

FDA Recall: Medtronic Navigation, Inc., Medtronic PIN (PDF)​​

FDA Recall: Olympus Corp., MAJ-891 Forceps/Irrigation Plug (PDF)​​

FDA Recall: Nuwellis Inc., Nuwellis AquaFlexFlow UF 500 Plus (PDF)​

FDA Recall: Mercury Enterprises, Inc., dba Mercury Medical Neo-Tee T-Piece Resuscitator (PDF)​​

FDA Recall: LivaNova USA, Inc. SenTiva Generators (PDF)​​

FDA Recall: Boston Scientific Corporation Accolade, Essentio, and Proponet DR Pacemaker, and Valitude CRT-P​ (PDF)​

FDA Recall: Baxter Healthcare Breathe Technologies, Inc., and Welch Allyn, Inc., Life2000 Ventilation System (PDF)​​

FDA Recall: Abiomed, Inc., Impella RP Flex with SmartAssist​ (PDF)

FDA Recall: Draeger Medical Systems, Inc., Infinity Central Station (PDF)​​

​December ​2024

​FDA Recall: Abbott Medical, The Merlin PCS 3650 programmer Model 3330​ (PDF)

FDA Recall: Angiodynamics Inc., Auryon Laser System 100-120 VAC (PDF)​

FDA Recall: Micro-X Ltd., Rover Mobile X-Ray System (PDF)​​

FDA Recall: Abbott Vascular Inc., 20/30 Priority Pack Accessory Kits (PDF)​​​

FDA Recall: Moximed, Inc., MISHA Knee System Implant (PDF)​​

FDA Recall: Mint Medical GmbH mint Lesion​ (PDF)

FDA Recall: Nova Biomedical Corp., StatStrip Glucose Hospital Meter System and StatStrip Glucose Ketone (mmol/L) Hospital Meter System (PDF)

FDA Recall: Medtronic Neurosurgery Exacta External Drainage and Monitoring System​ (PDF)

FDA Recall: Kirwan Surgical Products, LLC Ambler Surgical, Disposable, Optikon, and Walcott Bipolar Pencil​ (PDF)

FDA Recall: Cartiva Inc., Cartiva Synthetic Cartilage Implants​ (PDF)​

FDA Recall: Smith & Nephew Inc., Bioraptor Suture Anchors (PDF)​​​​

FDA Recall: Becton Dickinson & Co. BD BBL Sensi Disc Ampicillin 2 (PDF)

November 2024

FDA Recall: Bard Peripheral Vascular Inc., EVSRF Catheter (PDF)​​

FDA Recall: Enchroma Inc., EnChroma Safety Glasses (PDF)​​

​FDA Recall: American Surgical Company Neurological Sponges (PDF)

FDA Recall: Medline Industries Urine Collection Vhc and Clean Catch Kit (PDF)​

FDA Recall: Olympus Corporation of the Americas Cystoscope Outer Sheath​ (PDF)​

FDA Recall: Philips Respironics, Inc., Trilogy Evo Universal Ventilator (PDF)​

FDA Recall: The Metrix Company Imed Products Imed EVA BAG (PDF)

FDA Recall: The Metrix Company Secure 250 mL Empty EVA Container With 2 Ports and Secure 100 mL Empty EVA Container With 2 Ports (PDF)​

FDA Recall: Boston Scientific Corporation Polarx Balloon Catheter (PDF)

FDA Recall: Boston Scientific Corporation Polarx Fit Balloon Catheter ST US (2) (PDF) ​​

FDA Recall: Medline Industries, LP Lab Kit, SKU DYLAB1018​ (PDF)

FDA Recall: Baxter Healthcare Corporation MiniCap Extended Life PD Transfer Set with Twist Clamp (PDF)

FDA Recall: Baxter Healthcare Corporation MiniCap Extended Life PD Transfer Set with Twist Clamp (2) (PDF)​​

October ​2024

FDA Recall: Merit Medical Systems, Inc., Custom Inflation Kit​ (PDF)​

FDA Recall: Merit Medical Systems, Inc,. BasixTOUCH Inflation Device (PDF)​​

FDA Recall: Nihon Kohden America Inc.,  Adult/Pediatric Forehead Disposable SpO2 Sensor and Adult Ear Clip SpO2 Sensor (PDF)​​

​FDA Recall: Windstone Medical Packaging, Inc., Aligned Medical Septo Pack (PDF)​​

FDA Recall: Abbott Molecular, Inc., Abbott Alinity m HPV AMP Kit (PDF)​

FDA Recall: Datex-Ohmeda, Inc., GE Heathcare Giraffe (PDF)​

FDA Recall: Olympus Corporation of the Americas EZDilate Wire Guided Balloon (PDF)​​

​FDA Recall: Datex-Ohmeda, Inc., Aespire 100​ (PDF)

FDA Recall: Datex-Ohmeda, Inc., Aisys CS2 with Et Control (PDF)​​

FDA Recall: Microcare Medical Good Vibrations Ultrasonic Cleaner Solution (PDF)​​

FDA Recall: Datascope Corp., Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)​ (PDF)​

FDA Recall: Arrow International Inc., Arow Arterial Kits And Trays​ (PDF)​

FDA Recall: Percussionaire Corporation Ipv Therapy In-Line Valve (PDF)​

FDA Recall: Medtronic Minimed, Inc., Minimed 620g Insulin Pump (PDF)

FDA Recall: Mercury Enterprises, Inc., dba Mercury Medical Neo-Tee T-Piece Resuscitator​ (PDF)​

FDA Recall: Fresenius Kabi Usa, Llc Ivenix Infusion System (Iis), Lvp Software​ (PDF)​

September 2024

FDA Recall: Philips North America LLC., Recalls DIVA 24 Inch Widescreen LCD Touch Display (PDF)​​

FDA Recall: Karl Storz Endoscopy Hopkins Telescope 6 (PDF)

FDA Recall: Karl Storz Endoscopy Recalls Hopkins Telescope 6​ (2) (PDF)​

FDA Recall: Fisher & Paykel Healthcare, Ltd., PT301US Airvo 3 Respiratory Support Device (PDF)​​

FDA Recall: Healgen Scientific Llc., Healgen Series Reagent Strips For Urinalysis (PDF)​​

​FDA Recall: Smiths Medical Asd Inc., Cadd-Solis Vip Ambulatory Infusion Pumps​ (PDF)​

FDA Recall: Smiths Medical ASD Inc., Pediatric Tracheostomy Tube TTS Flextend Straight Neck (PDF)

​FDA Recall: Smiths Medical ASD Inc., Portex Bivona Tracheotomy Silicone Tube Standard Flextend Plus (PDF)​

FDA Recall: Abbott Diabetes Care, Inc., Freestyle Libre 3 Continuous Glucose Monitoring System (PDF)

August 2024

FDA Recall: Merit Medical Systems Inc., Rapid Response Waste Management System Kit (PDF)​​

FDA Recall: Olympus Corporation Of The Americas Everest Bipolar Cutting Forceps (PDF)​

FDA Recall: Drg International Inc., Salivary Testosterone Elisa Model (PDF)​​

FDA Recall: Covidien Mcgrath Mac Video Laryngoscope (PDF)

FDA Recall: Medline Industries, Lp -Northfield Medical Convenience Kits (PDF)​​​

July 2024

FDA Recall: Radiometer Medical Aps Abl800 Flex​ (PDF)

FDA Recall: Baxter Healthcare Live2000 Ventilator​ (PDF)​

​FDA Recall: Megadyne Mega Soft Reusable Patient Return Electrode (PDF)​

FDA Recall: Philips North America Sense XL Torso Coil for Intera and Achieva MR (PDF)​

June 2024

FDA Recall: Medtronic Navigation, Inc. O-arm O2 Imaging System (PDF)​​

FDA Recall: Stryker Neurovascular Synchro2 Guidewires (PDF)​​

FDA Recall: Stryker Neurovascular Synchro Guidewires​ (PDF)​

FDA Recall: Hamilton Medical C-6 Ventilators​ (PDF) 

FDA Recall: Zoll Medical Corporation Zoll 731 Ventilator Operator Guide (PDF)​

FDA Recall: Arrow International Intra-Aortic Balloon Series (PDF)​

May 2024 ​

FDA Recall: Mirion Technologies (Capintec), Inc., Captus 4000e Thyroid Uptake System (PDF)​​

FDA Recall: Wavi Co. Wavi Research EEG Desktop System (PDF)​​

FDA Recall: Medline Industries, LP -Northfield Medline Sub-G Endotracheal Tube With Subglottic Suctioning (PDF)​

FDA Recall: Fujifilm Healthcare Americas Corporation FDR Visionary Suite​ (PDF)​

FDA Recall: Route 92 Medical Inc., Neurovascular System (PDF)​​

FDA Recall: Johnson & Johnson Surgical Vision Inc.,  Vision reusable Laminar high flow irrigation sleeve and test chamber (PDF)​

​FDA Recall: Tandem Diabetes Care, Inc., Connect Mobile App​ (PDF)​

April 2024 

FDA Recall: Life Technologies Corporation Torrent Suite Dx Software​ (PDF)​

FDA Recall: Philips Respinonics Inc., Venitilator Software (PDF)

FDA Recall: Abbott Laboratories Architect Stat Myoglobin Reagent Kit​ (PDF)​

FDA Recall: Karl Storz Endoscopy Recalls Optical Scissor And Grasping Forceps​ (PDF)​

FDA Recall: Boston Scientific Corporation Obsidio Comformable Embolic (PDF)​

FDA Recall: Deroyal Industries Inc Recalls Geomed Custom Tracecarts​ (PDF)​

FDA Recall: Fresenius Medical Care Holdings, Inc., Stay-Safe (PDF)

FDA Recall: Sleepnet Corporation Vented And Non Vented Masks (PDF)

March 2024

FDA Recall: Fresenius Kabi Lvp Software​ (PDF)​

FDA Recall: Waldemar Link Gmbh & Co. Kg S​pii Model Lubinus​ (PDF)

FDA Recall: Biosense Webster, Inc., Carto Vizigo Bi-Directional Guiding Sheath​ (PDF)

FDA Recall: Angiodynamics, Inc., Mini Stick Max 4f (PDF)​

FDA Recall: Angiodynamics, Inc., Mini Stick Max 5f (PDF)​

FDA Recall: Smiths Medical Asd Inc., Pneupac Parapac Ventilator Kit (PDF)​

FDA Recall: Medos International Sarl Cerenovus Cerebase DA Guide Sheath​ (PDF)

FDA Recall: Thoratec Corp. Heartmate Ventricular Assist System (PDF)​​​

FDA Recall: Avanos Medical Inc., MIC* Gastric-Jejunal Feeding Tubes: ENFit Connectors and Endoscopic/Radiological Placement GJ-Tube (PDF)​​

FDA Recall: Canon Medical System, USA, Inc. MRI Systems Vantage Titan and Vantage Orian​ (PDF)​

February 2024

FDA Recall: Zimmer Surgical Inc., Skin Graft Carrier​ (PDF)

FDA Recall: Covidien Lp Absorbatack Absorbable Fixation Device (PDF)​

FDA Recall: Wipro Ge Healthcare Private Ltd. Recalls Incubator And Incubator Hood Models​ (PDF)​

FDA Recall: Cardinal Health Monoject Syringe And Monoject Luer-Lock Tip (PDF)​​

FDA Recall: Steris Corporation Dual Articulating Headrest​ (PDF)​

FDA Recall: Phillips Medical Systems CombiDiagnost (PDF)​​

FDA Recall: Microbiologics Inc., Enteric Pathogens Control Panel (PDF)​

FDA Recall: NeuroLogica Corporation Samsung Digital Diagnostic Mobile X-ray System​ (PDF)

FDA Recall: Maquet Medical Systems USA Bubble Sensor/​​BO-RF-32USA Rotaflow Centrifugal Pump (PDF)​​

FDA Recall: Origen Biomedical Inc. Accessory Sets Syringes (PDF)

FDA Recall: Balt Usa, LLC Neurovascular Embolization Device (PDF)​

FDA Recall: Heartsine Technologies Ltd. Samaritan Public Access Defibrillator (PDF)​

FDA Recall: Medtronic Minimed, Inc. Guardian 4 Glucose Sensor ​(PDF)

FDA Recall: Fujifilm Irvine Scientific Inc. Sperm Separation Media (PDF)​​

FDA Recall: Thoratec Corp. Heartmate Touch Communication System (PDF) 

FDA Recall: Philips North America Brightview Gamma Camera (PDF)

January 2024

FDA Recall: Acumed Llc. Ribloc U Plus 90 Instrument Primary Guide Assy, Low Profile Ref Rbl2320 (PDF)​​​

December 2023​

FDA Recall: ARJOHUNTLEIGH POLSKA Sp. Z.O.O. Arjo Medical Beds (PDF)​​

FDA Recall: BIOMET, INC., Biolox Ceramic​ (PDF)​

FDA Recall: Karl Storz Endoscopy Injection Needles​ (PDF)​

FDA Recall: Physio-Control, Inc. AC Power Adapter (PDF)​

FDA Recall: Nurse Assist LLC IV And Injectable Products (PDF)

​FDA Recall: Fresenius Kabi Ivenix Infusion System​ (PDF)

FDA Recall: ​Resmed Airtouch And Airfit Masks​ (PDF)​

FDA Recall: Phillips North America Panorama 1.0T HFO Magnetic Resonance System (PDF)​

FDA Recall: iiiIntegra Lifesciences Cerelink Extension Cable (PDF)

FDA Recall: B. Braun Medical Infusomat Administration Sets​ (PDF)​

FDA Recall: Maquet Medical CARDIOHELP​ (PDF)​

FDA Recall: Becton Dickinson (BD)/Carefusion 303 Alaris Infusion Pumps (PDF)​​

FDA Recall: Eitan Medical Ltd Sapphire Infusion Pumps​ (PDF)​

November 2023

​FDA Recall: Baxter Healthcare Corporation Novum IQ Syringe Infusion System (PDF)

FDA Recall: CareFusion 303 Bd Alaris PCU​ (PDF)

FDA Recall: Medtronic Navigation Stealthstation S8 Application Version 2.0 And 2.0.1 (PDF)

FDA Recall: Olympus Corporation Evis Bronchovideoscope Olympus BF Type​ (PDF)​

FDA Recall: Impedimed Limited Sozo Bilateral Arm L-Dex Software​ (PDF)

FDA Recall: Universal Meditech Diagnosus And ONTMO Pregnancy & Ovulation Tests​ (PDF)

FDA Recall: Universal Meditech Inc. Diagnosus One Step Ovulation And Menopausal Test Strips​ (PDF)​

FDA Recall: Universal Meditech Inc. Diagnosus Sars-Cov-2 Antibody (Igg/Igm) Test​ (PDF)

FDA Recall: Universal Meditech Inc. Lem Fertility Hcg Pregnancy Urine Test And Lh Ovulation Test(Strips)​ (PDF)

​FDA Recall: Universal Meditech PrestiBio Ketone and Urinalysis Test Strips​ (PDF)

FDA Recall: Universal Meditech Inc. Prestibio Ovulation And Pregnancy Strips​ (PDF)

FDA Recall: Universal Meditech Detec Hcg Pregnancy Urine Test Cassette Format​ (PDF)

FDA Recall: Universal Meditech Healthywiser Ph-Aware Ph 4.5 -9.0 Ph Test Strips​ (PDF)

​FDA Recall: Universal Meditech Healthywiser Uritest​ (PDF)

FDA Recall: Universal Meditech Ketofast Ketone Test Strips (PDF)

FDA Recall: Universal Meditech One Step Pregnancy And Ovulation Test​ (PDF)

​FDA Recall: Universal Meditech Am I Pregnant? One Step Hcg Pregnancy Test (PDF)

​FDA Recall: Universal Meditech Inc. To Life Hcg Pregnancy Urine Test Strips Format (PDF)​

FDA Recall: Universal Meditech Inc. Prestibio Breast Milk Alcohol Test Strip​ (PDF)​​

FDA Recall: Acclarent TruDi Navigation System (PDF)

FDA Recall: Cardinal Health 200 Monoject Syringe Luer-Lock Tip Soft Pack (PDF)

FDA Recall: Preat Corp Neodent Healing Abutment​ (PDF)​​

FDA Recall: Resmed Ltd. Astral 100 And Astral 150 Ventilators​ (PDF)

FDA Recall: B. Braun Medical Infusomat Large Volume Pump (PDF)

October 2023

​​FDA Recall: Abbott Laboratories Cell-Dyn Ruby And Abbott Cell-Dyn Sapphire (PDF)​​

FDA Recall: Tornier Stryker Tornier Augmented Glenoid Lateralized Baseplate​ (PDF)

FDA Recall: Medtronic Recalls Senight Connector Plug​ (PDF)​

FDA Recall: Eitan Medical Recalls Sapphire Infusion Pumps​ (PDF)

FDA Recall: Olympus Corporation Olympus High-Flow Insufflation Unit (PDF)​​

FDA Recall: Fresenius Medical Care 2008t Hemodialysis System (PDF)​​

FDA Recall: Ansell Healthcare Products Gammex Non-Latex Pi Green Surgical Gloves (PDF)​​

FDA Recall: Fresenius Medical Care Holdings 3 mL Syringe Luer Lock With Needle (PDF)

FDA Recall: Fresenius Medical Care Holdings 10 mL Syringe Luer Lock With Needle (PDF)​​

FDA Recall: Baxter Healthcare Epiphany Cardio Server E3 ECG Management System Servers (PDF)​

FDA Recall: Stryker Corporation Cinchlock Ss Knotless A​nchor Inserter (PDF)​

FDA Recall: Philips Respironics V60/V60 Plus Ventilator (PDF)​​​

​September 2023

​​FDA Recall: Remote Diagnostic Technologies Philips Tempus Pro Patient Monitor​ (PDF)

FDA Recall: Avanos Medical Recalls Coolief Rf Generator​ (PDF)

FDA Recall: B. Braun Medical Recalls Perifix¿/Epidural Anesthesia Set​ (PDF)

FDA Recall: Encore Medical Recalls DJO Surgical​ (PDF)

FDA Recall: GE Medical Systems Information Technologies Recalls Prucka 3 Amplifiers​ (PDF)​

FDA Recall: Hamilton Medical Hamilton-C1/T1/MR1​ (PDF)​

FDA Recall: Abbott Medical Recalls Implantable Pulse Genterator (Ipg)​ (PDF)

FDA Recall: Abbott Medical Recalls Infinity 7 Implantable Pulse Generator Ref 6662​ (PDF)

FDA Recall: Mallinckrodt Manufacturing LLC Recalls Mallinckrodt One-Way Valve​ (PDF)

FDA Recall: Medline Industries Recalls Hudson Rci Addipak Unit Dose Vials​ (PDF)​​

FDA Recall: Aomori Olympus Co. Olympus Distal Attachments (PDF)

FDA Recall: Cook Vandergrift Recalls Cook Lead Clipper​ (PDF)

FDA Recall: ​Paragon Vision Sciences Recalls I See And Fargo Ortho-K Lens ​(PDF)

FDA Recall: Philips Ultrasound Recalls 3D9-3v Transducer (PDF)

FDA Recall: Zimmer Recalls M/L Taper Hip Prosthesis Extended Offset​ (PDF)​​

FDA Recall: Accuray Incorporated The Upper Roller Bracket (PDF)

FDA Recall: Alphatec Spine Lif Amp (PDF)

FDA Recall: Beckman Coulter IVD (PDF)

FDA Recall: Datascope Cardiosave Intraaortic Balloon Pump For Autofilling Failure (PDF)

FDA Recall: ​​​Datascope Cardiosave Intraaortic Balloon Pump For Alarms During Therapy​ (PDF)

FDA Recall: Datascope Cardiosave Intraaortic Balloon Pump of Loss of Pumping (PDF)

FDA Recall: ​Datascope Cardiosave Intraaortic Balloon Pump For Device Charging (PDF)

FDA Recall: ​Oculus Optikgerate Pentacam for Insufficient Anti-Reflective Coating (PDF)

FDA Recall: ​Siemens Healthcare Diagnostics Epoc BGEM Test Card (PDF)

FDA Recall: Skytron Salus Surgical Table (PDF)​

​

Augu​s​t 2023

FDA Recall: Siemens Healthcare Diagnostics ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein​ (PDF)​

FDA Recall: Randox Laboratories Randox Liquid Urine Control Level 2​ (PDF)

FDA Recall: Smith & Nephew Trigen Trochanteric Antegrade Nail Lime (PDF)

FDA Recall: Invacare Corporation Dolomite Gloss Rollator (PDF)

FDA Recall: Biofire Diagnostics LLC Medical BioFire Respiratory Panel 2.1 (RP2.1) (PDF)

FDA Recall: Biofire Diagnostics Filmarray Pneumonia Panel (Pneumo) (PDF)

FDA Recall: Olympus Corporation Of The Americas -The Air/Water Valve Provided/Used With The Endoscopes (PDF)​

​FDA Recall: Draeger Medical Recalls Carina Subacute Care Ventilator​ (PDF)​

FDA Recall: Hamilton Medical Inc. HAMILTON-C1, C2, C3, T1 Ventilators​ (PDF)​

FDA Recall: Covidien Mahurkar Triple Lumen Acute Dialysis Catheter (PDF)​

July 2023

FDA Recall: Abiomed, Inc. Impella Intravascular Series (PDF)​

​FDA Recall: Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pump (PDF)

FDA Recall: Olympus Corporation of the Americas Bronchofiberscope and Bronchovideo Scope (PDF)​

FDA Recall: Abbott Amplatzer Steerable Delivery Sheat (PDF)

FDA Recall: Baxter Healthcare Corporation (PDF)

FDA Recall: Osteomed 1.6mm x 4mm Profile Zero Auto-Drive Screw (PDF)​

FDA Recall: HeartSine Technologies Ltd PAD-PAKs​ (PDF)​

FDA Recall: Draeger Medical, Inc. Oxylog 3000 Plus​ (PDF)​

FDA Recall: Full Vision Inc Trackmaster Treadmill​ (PDF)​​

FDA Recall: GE Healthcare Finland Oy TruSignal Ear Sensor​ (PDF)

FDA Recall: GE Healthcare Finland Oy TruSignal Sensor​ (PDF)​​

FDA Recall: Quidel Cardiovascular Inc., Quidel Triage Cardiac Panel​ (PDF)​

FDA Recall: Randox Laboratories Immunoassay Premium Control Tri Level​ (PDF)​

FDA Recall: ​Megadyne MEGA Series Patient Return Electrodes​ (PDF)

FDA Recall: Avante Health Solutions Philips Respironics V60 Ventilator​ (PDF)​​

FDA Recall: Beckman Coulter, Inc. Hybritech p2PSA Reagent​ (PDF)​​

FDA Recall: Teleflex Endotracheal Tube Rushelit and Magill Products (PDF)​​

FDA Recall: Teleflex Endotracheal Tubes Models - Slick Set, Flexi-Set, and Murphy​ (PDF)

June 2023

FDA Recall: Medtronic Recalls AMPLIA, BRAVA, CLARIA, COMPIA, EV, and VISIA Series of Implantable Cardioverter Defibrillators​ (PDF)​

FDA Recall: Medtronic Evera, Primo, Mirro, Cobalt, Crome And Viva Series Of Implantable Cardioverter Defibrillators And Cardiac Resynchronization Therapy Defibrillators (PDF)​​

FDA Recall: Karl Storz Endoscopy Sterilization Trays​ (PDF)

FDA Recall: Draeger Medical Systems, Inc. Softbed Resusciataire and/or Birthing Room Warmer with Scale (PDF)

FDA Recall: Helena Laboratories, Corp. Serrated Blade Applicator Kit​ (PDF)​​​

FDA Recall: LumiraDx SteriPack Sterile Polyester Spun Swab​ (PDF)​

FDA Recall: NOXBOX LTD NOxBOXi​ (PDF)​

FDA Recall: Boston Scientific Neuromodulation Corporation Superion Indirect Decompression System (PDF)​​

FDA Recall: Galt Medical Corporation Tearaway Introducer Kit​ (PDF)

FDA Recall: Ossur H / F Icelock Ratchet​ (PDF)​​

FDA Recall: Medtronic Navigation, Inc. StealthStation Cranial Software​ (PDF)​

FDA Recall: Bearcare Walnut Wearble Smart Thermometer (PDF)​​

FDA Recall: Abbott Ireland Limited Alinity i Anti-TPO Reagent Kit​ (PDF)

FDA Recall: Cytrellis Biosystems Cytrellis Ellacor System​ (PDF)​

FDA Recall: Medline Industries Procedure Packs (PDF)​

May 2023

FDA Recall: Immundiagnostik IDK Lactoferrin ELISA (PDF)​​

FDA Recall: Draeger Medical Ventstar Coax 180 (PDF)​​

FDA Recall: Draeger Medical Seattle PAP Plus And Breathing Circuit/Anesthesia Kits (PDF)​​

FDA Recall: ​ICU Medical Replacement Batteries For Plum 360, Plum A+, And Plum A+3 Infusion Systems (PDF)​​

FDA Recall: Bio-Rad Laboratories Bioplex 2200 (PDF)​​

FDA Recall: Technidata TDHisto/Cyto Software (PDF)​

FDA Recall: Cook Incorporated Blue Rhino G2-Multi Series Percutaneous Tracheostomy Products​ (PDF)​

FDA Recall: Cordis US Angiogard Rx / Xp Emboli Capture Guidewire System (PDF)

FDA Recall: Hamilton Medical - Hamilton C6 Ventilator (PDF)​

April 2023

​FDA Recall: Scientia Vascular Plato 17 Microcatheter (PDF)​​

FDA Recall: Fresenius Kabi Usa Ivenix Infusion System​ (PDF)​

FDA Recall: Philips Respironics Trilogy Series Ventilators (PDF)

FDA Recall: Philips Respironics, Inc., Philips DreamStation Auto BiPAP and CPAP (PDF)​​​​

FDA Recall: Abbott Diabetes Care Components of FreeStyle Libre Flash Glucose Monitoring Systems (PDF)​​

FDA Recall: Abbott Readers Used With The FreeStyle Libre, FreeStyle Libre 14 day, andFreeStyle Libre 2 Flash Glucose Monitoring Systems (PDF)

FDA Recall: Alcon Research Custom Pak Surgical Procedure Packs (PDF)​​

March 2023

FDA Recall: Preat Nobil Grip (PDF)​

FDA Recall: Datascope CardiosaveIntraaortic Balloon Pump (PDF)​

FDA Recall: CooperVision Biofinity XR Contact Lenses (PDF)​

FDA Recall: Med-Mizer MR600 and STS500 Patient Lifts (PDF)

FDA Recall: Baxter Healthcare Life2000 Ventilator Series Products (PDF)​

FDA Recall: Draeger Medical Recalls Anti-Asphyxia Valve and Standard Elbow for NovaStar TS​ (PDF)​

February 2023

FDA Recall: GE Healthcare MRI Software​ (PDF)​

FDA Recall: GE Medical Systems Israel Nuclear Medicine 600/800 Series Products (PDF)​

FDA Recall: Smiths Medical ASD CADD Administration Sets (PDF)​

FDA Recall: Universal Meditech Ventilators (PDF)

January 2023

FDA Recall: Cardiac Assist Lifesparc Controller and Accessories Kit (PDF)

FDA Recall: Datascope Cardiosave Hybrid & Rescue Intra-Aortic Balloon Pumps (IABP) (PDF)

FDA Recall: Philips Respironics Ventilators (PDF)

FDA Recall: Covidien Mahurkar Series Dialysis Catheters (PDF)

FDA Recall: Acumed LLC Acutrak Series Bone Hardware (PDF)

FDA Recall: Remington Medical Automatic Cutting Needle (PDF)

December 2022

FDA Recall: Alcon Research Custom Pak Surgical Procedure Pack (PDF)

FDA Recall: Caire, Inc. CAIRE Liberator Liquid Oxygen System Units (PDF)

FDA Recall: Remel Inc. Thermo SCIENTIFIC Sensititre Plate Gram Negative IVD AST (PDF)

FDA Recall: Dewei Medical Equipment DNA/RNA Preservation Kit (PDF)

FDA Recall: BioRAD Cytomegalovirus IgM In Vitro Diagnostic (PDF)

November 2022

FDA Recall: Kamiya Biomedical K-Assay for Performance (PDF)

FDA Recall: Whele Mighty Bliss Electric Heating Pad (PDF)

FDA Recall: Edwards Lifesciences Fogarty Arterial Embolectomy Catheters (PDF)

FDA Recall: Baxter Hillrom Centrella Hospital Bed and Accessories (PDF)

October 2022

FDA Recall: Teleflex Recalls Iso-Gard Filter S (PDF)

​Jiangsu Well Biotech Co., Ltd. Recalls COVID-19 Ag Rapid Test Devices (PDF)

September 2022

FDA Recall: Philips Respironics BiPAP Machines (PDF)

August 2022

FDA Recall: Getinge Maquet Critical Care Ab/Getinge Servo-u Ventilator System (PDF)

FDA Recall: Intera Oncology Recalls Intera 3000 Hepatic Artery Infusion Pump (PDF)

FDA Recall: Hamilton C6 Intensive Care Ventilator (PDF)

Extended Expiration Date: MaximBio COVID-19 Antigen Home Test

July 2022

FDA Recall: Link Bio Tibial Orthopedic Prosthesis (PDF)

FDA Recall: Haimen Shengbang Laboratory Equipment Viral Transport Container (PDF)

June 2022

FDA Recall: Heartware Ventricular Assist Device Battery (PDF)

FDA Recall: Medtronic Cardioverter Implantable Defibrillator (PDF)

FDA Recall: Abbott Hemoglobin Reagent for Archtect and Alinity (PDF)

FDA Recall: Bard Access Systems Intraosseous Needle and Driver (PDF)

FDA Recall: Baxter Healthcare Corporation Abacus TPN Calculation Software for Potential Medication Error (PDF)

FDA Recall: Integra Life Sciences Codman Cerelink ICP Monitor (PDF)

FDA Recall: North American Diagnostics Oral Rapid SARS-CoV-2 Rapid Antigen Test Kits (PDF)

FDA Recall: GE Healthcare Aisys and Avance Anesthesia Systems (PDF)

FDA Recall: Zeltiq Aesthetics Vacuum Applicator for Paradoxical Hyperplasia (PDF)

FDA Recall: Palindrome Precision Chronic Catheter (PDF)

FDA Recall: Illumina MiSeq Dx and NextSeq 550 Dx (PDF)

May 2022

FDA Recall: Cordis US Palmaz Genesis Transhepatic Biliary Stent (PDF)

FDA Recall: Drager Medical SafeStar 55 (PDF)

FDA Recall: Medtronic HeartWare HVAD System Batteries (PDF)

April 2022

FDA Recall: Karl Storz Endoscopy CMOS Video Cysto-Urethroscope (PDF)

FDA Recall: Karl Storz Endoscopy Flexible Ureteroscope (PDF)

FDA Recall: Karl Storz Endoscopy Nasopharyngolaryngoscope (PDF)

FDA Recall: Smiths Medical Medfusion Syringe Pump (PDF)

FDA Recall: GE Healthcare Backup Batteries for Carescape Ventilators (PDF)

FDA Recall: Baxter Inline Ventilator Adaptor (PDF) Updated

FDA Recall: Medtronic Cardioblate Gemini Irrigated RF Surgical Ablation System (PDF)

FDA Recall: Mesa Biotech Accula SARS-CoV-2 Test (PDF)

FDA Recall: Celltrion Recalls DiaTrust COVID-19 Ag Rapid Test (PDF)

March 2022

FDA Recall: Invacare TDX SP2 Powered Wheelchair (PDF)

FDA Recall: Accriva Diagnostics VerifyNow P2Y12 Test (PDF)

FDA Recall: Abbott Medical DragonFly OpStar Imaging Catheter (PDF)

FDA Recall: Draeger Software for Infinity CentralStation (PDF)

FDA Recall: Covidien Recalls Puritan Bennett 980 Series Ventilator (PDF)

FDA Recall: Medtronic Harmony Delivery Catheter, Part of Transcatheter Pulmonary Valve (TPV) System (PDF)

FDA Recall: Cub2 Bed Canopy System (PDF)

FDA Recall: GE Healthcare MRI Software (PDF)

February 2022

FDA Recall: Philips Respironics V60 Series Ventilators (PDF)

FDA Recall: Illumina NextSeq 550Dx (PDF)

FDA Recall: Abbott Alinity S Software (PDF)

FDA Recall: Brainlab ExacTrac Dynamic Software (PDF)

FDA Recall: Medtronic TurboHawk Plus Directional Atherectomy System (PDF)

January 2022

FDA Recall: Scleral Patch Grafts by CorneaGen (PDF)

FDA Recall: Sam Chest Seal Recalled for Packaging Error (PDF)

FDA Recall: LuSys COVID-19 Viral Antigen Tests (PDF)​