June 2024
FDA Recall: Arrow International Intra-Aortic Balloon Series (PDF)ā
May 2024 ā
FDA Recall: Johnson & Johnson Surgical Vision Inc., Vision reusable Laminar high flow irrigation sleeve and test chamber (PDF)ā
āFDA Recall: Tandem Diabetes Care, Inc., Connect Mobile Appā (PDF)ā
April 2024
FDA Recall: Abbott Laboratories Architect Stat Myoglobin Reagent Kitā (PDF)ā
FDA Recall: Karl Storz Endoscopy Recalls Optical Scissor And Grasping Forcepsā (PDF)ā
FDA Recall: Boston Scientific Corporation Obsidio Comformable Embolic (PDF)ā
FDA Recall: Deroyal Industries Inc Recalls Geomed Custom Tracecartsā (PDF)ā
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 Softwareā (PDF)ā
FDA Recall: Waldemar Link Gmbh & Co. Kg Sāpii Model Lubinusā (PDF)
FDA Recall: Biosense Webster, Inc., Carto Vizigo Bi-Directional Guiding Sheathā (PDF)
FDA Recall: Angiodynamics, Inc., Mini Stick Max 4f (PDF)ā
FDA Recall: Angiodynamics, Inc., Mini Stick Max 5f (PDF)ā
FDA Recall: Smiths Medical Asd Inc., Pneupac Parapac Ventilator Kit (PDF)ā
FDA Recall: Medos International Sarl Cerenovus Cerebase DA Guide Sheathā (PDF)
FDA Recall: Thoratec Corp. Heartmate Ventricular Assist System (PDF)āāā
FDA Recall: Avanos Medical Inc., MIC* Gastric-Jejunal Feeding Tubes: ENFit Connectors and Endoscopic/Radiological Placement GJ-Tube (PDF)āā
FDA Recall: Canon Medical System, USA, Inc. MRI Systems Vantage Titan and Vantage Orianā (PDF)ā
February 2024
FDA Recall: Zimmer Surgical Inc., Skin Graft Carrierā (PDF)
FDA Recall: Covidien Lp Absorbatack Absorbable Fixation Device (PDF)ā
FDA Recall: Wipro Ge Healthcare Private Ltd. Recalls Incubator And Incubator Hood Modelsā (PDF)ā
FDA Recall: Cardinal Health Monoject Syringe And Monoject Luer-Lock Tip (PDF)āā
FDA Recall: Steris Corporation Dual Articulating Headrestā (PDF)ā
FDA Recall: Phillips Medical Systems CombiDiagnost (PDF)āā
FDA Recall: Microbiologics Inc., Enteric Pathogens Control Panel (PDF)ā
FDA Recall: NeuroLogica Corporation Samsung Digital Diagnostic Mobile X-ray Systemā (PDF)
FDA Recall: Maquet Medical Systems USA Bubble Sensor/āāBO-RF-32USA Rotaflow Centrifugal Pump (PDF)āā
FDA Recall: Origen Biomedical Inc. Accessory Sets Syringes (PDF)
FDA Recall: Balt Usa, LLC Neurovascular Embolization Device (PDF)ā
FDA Recall: Heartsine Technologies Ltd. Samaritan Public Access Defibrillator (PDF)ā
FDA Recall: Medtronic Minimed, Inc. Guardian 4 Glucose Sensor ā(PDF)
FDA Recall: Fujifilm Irvine Scientific Inc. Sperm Separation Media (PDF)āā
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)āāā
December 2023ā
FDA Recall: ARJOHUNTLEIGH POLSKA Sp. Z.O.O. Arjo Medical Beds (PDF)āā
FDA Recall: BIOMET, INC., Biolox Ceramicā (PDF)ā
FDA Recall: Karl Storz Endoscopy Injection Needlesā (PDF)ā
FDA Recall: Physio-Control, Inc. AC Power Adapter (PDF)ā
FDA Recall: Nurse Assist LLC IV And Injectable Products (PDF)
āFDA Recall: Fresenius Kabi Ivenix Infusion Systemā (PDF)
FDA Recall: āResmed Airtouch And Airfit Masksā (PDF)ā
FDA Recall: Phillips North America Panorama 1.0T HFO Magnetic Resonance System (PDF)ā
FDA Recall: iiiIntegra Lifesciences Cerelink Extension Cable (PDF)
FDA Recall: B. Braun Medical Infusomat Administration Setsā (PDF)ā
FDA Recall: Maquet Medical CARDIOHELPā (PDF)ā
FDA Recall: Becton Dickinson (BD)/Carefusion 303 Alaris Infusion Pumps (PDF)āā
FDA Recall: Eitan Medical Ltd Sapphire Infusion Pumpsā (PDF)ā
November 2023
āFDA Recall: Baxter Healthcare Corporation Novum IQ Syringe Infusion System (PDF)
FDA Recall: CareFusion 303 Bd Alaris PCUā (PDF)
FDA Recall: Medtronic Navigation Stealthstation S8 Application Version 2.0 And 2.0.1 (PDF)
FDA Recall: Olympus Corporation Evis Bronchovideoscope Olympus BF Typeā (PDF)ā
FDA Recall: Impedimed Limited Sozo Bilateral Arm L-Dex Softwareā (PDF)
FDA Recall: Universal Meditech Diagnosus And ONTMO Pregnancy & Ovulation Testsā (PDF)
FDA Recall: Universal Meditech Inc. Diagnosus One Step Ovulation And Menopausal Test Stripsā (PDF)ā
FDA Recall: Universal Meditech Inc. Diagnosus Sars-Cov-2 Antibody (Igg/Igm) Testā (PDF)
FDA Recall: Universal Meditech Inc. Lem Fertility Hcg Pregnancy Urine Test And Lh Ovulation Test(Strips)ā (PDF)
āFDA Recall: Universal Meditech PrestiBio Ketone and Urinalysis Test Stripsā (PDF)
FDA Recall: Universal Meditech Inc. Prestibio Ovulation And Pregnancy Stripsā (PDF)
FDA Recall: Universal Meditech Detec Hcg Pregnancy Urine Test Cassette Formatā (PDF)
FDA Recall: Universal Meditech Healthywiser Ph-Aware Ph 4.5 -9.0 Ph Test Stripsā (PDF)
āFDA Recall: Universal Meditech Healthywiser Uritestā (PDF)
FDA Recall: Universal Meditech Ketofast Ketone Test Strips (PDF)
FDA Recall: Universal Meditech One Step Pregnancy And Ovulation Testā (PDF)
āFDA Recall: Universal Meditech Am I Pregnant? One Step Hcg Pregnancy Test (PDF)
āFDA Recall: Universal Meditech Inc. To Life Hcg Pregnancy Urine Test Strips Format (PDF)ā
FDA Recall: Universal Meditech Inc. Prestibio Breast Milk Alcohol Test Stripā (PDF)āā
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 Abutmentā (PDF)āā
FDA Recall: Resmed Ltd. Astral 100 And Astral 150 Ventilatorsā (PDF)
FDA Recall: B. Braun Medical Infusomat Large Volume Pump (PDF)
October 2023
āāFDA Recall: Abbott Laboratories Cell-Dyn Ruby And Abbott Cell-Dyn Sapphire (PDF)āā
FDA Recall: Tornier Stryker Tornier Augmented Glenoid Lateralized Baseplateā (PDF)
FDA Recall: Medtronic Recalls Senight Connector Plugā (PDF)ā
FDA Recall: Eitan Medical Recalls Sapphire Infusion Pumpsā (PDF)
FDA Recall: Olympus Corporation Olympus High-Flow Insufflation Unit (PDF)āā
FDA Recall: Fresenius Medical Care 2008t Hemodialysis System (PDF)āā
FDA Recall: Ansell Healthcare Products Gammex Non-Latex Pi Green Surgical Gloves (PDF)āā
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)āā
FDA Recall: Baxter Healthcare Epiphany Cardio Server E3 ECG Management System Servers (PDF)ā
FDA Recall: Stryker Corporation Cinchlock Ss Knotless Aānchor Inserter (PDF)ā
FDA Recall: Philips Respironics V60/V60 Plus Ventilator (PDF)āāā
āSeptember 2023
āāFDA Recall: Remote Diagnostic Technologies Philips Tempus Pro Patient Monitorā (PDF)
FDA Recall: Avanos Medical Recalls Coolief Rf Generatorā (PDF)
FDA Recall: B. Braun Medical Recalls PerifixĀæ/Epidural Anesthesia Setā (PDF)
FDA Recall: Encore Medical Recalls DJO Surgicalā (PDF)
FDA Recall: GE Medical Systems Information Technologies Recalls Prucka 3 Amplifiersā (PDF)ā
FDA Recall: Hamilton Medical Hamilton-C1/T1/MR1ā (PDF)ā
FDA Recall: Abbott Medical Recalls Implantable Pulse Genterator (Ipg)ā (PDF)
FDA Recall: Abbott Medical Recalls Infinity 7 Implantable Pulse Generator Ref 6662ā (PDF)
FDA Recall: Mallinckrodt Manufacturing LLC Recalls Mallinckrodt One-Way Valveā (PDF)
FDA Recall: Medline Industries Recalls Hudson Rci Addipak Unit Dose Vialsā (PDF)āā
FDA Recall: Aomori Olympus Co. Olympus Distal Attachments (PDF)
FDA Recall: Cook Vandergrift Recalls Cook Lead Clipperā (PDF)
FDA Recall: āParagon Vision Sciences Recalls I See And Fargo
Ortho-K Lens ā(PDF)
FDA Recall: Philips Ultrasound Recalls 3D9-3v Transducer (PDF)
FDA Recall: Zimmer Recalls M/L Taper Hip Prosthesis Extended Offsetā (PDF)āā
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: āāāDatascope Cardiosave Intraaortic Balloon Pump For Alarms During Therapyā (PDF)
FDA Recall: Datascope Cardiosave Intraaortic Balloon Pump of Loss of Pumping (PDF)
FDA Recall: āDatascope Cardiosave Intraaortic Balloon Pump For Device Charging (PDF)
FDA Recall: āOculus Optikgerate Pentacam for Insufficient Anti-Reflective Coating (PDF)
FDA Recall: āSiemens Healthcare Diagnostics Epoc BGEM Test Card (PDF)
FDA Recall: Skytron Salus Surgical Table (PDF)ā
ā
Auguāsāt 2023
FDA Recall: Siemens Healthcare Diagnostics ADVIA Chemistry Urinary/Cerebrospinal Fluid Proteinā (PDF)ā
FDA Recall: Randox Laboratories Randox Liquid Urine Control Level 2ā (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)ā
āFDA Recall: Draeger Medical Recalls Carina Subacute Care Ventilatorā (PDF)ā
FDA Recall: Hamilton Medical Inc. HAMILTON-C1, C2, C3, T1 Ventilatorsā (PDF)ā
FDA Recall: Covidien Mahurkar Triple Lumen Acute Dialysis Catheter (PDF)ā
July 2023
FDA Recall: Abiomed, Inc. Impella Intravascular Series (PDF)ā
āFDA Recall: Datascope Corp. Cardiosave Rescue Intra-Aortic Balloon Pump (PDF)
FDA Recall: Olympus Corporation of the Americas Bronchofiberscope and Bronchovideo Scope (PDF)ā
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)ā
FDA Recall: HeartSine Technologies Ltd PAD-PAKsā (PDF)ā
FDA Recall: Draeger Medical, Inc. Oxylog 3000 Plusā (PDF)ā
FDA Recall: Full Vision Inc Trackmaster Treadmillā (PDF)āā
FDA Recall: GE Healthcare Finland Oy TruSignal Ear Sensorā (PDF)
FDA Recall: GE Healthcare Finland Oy TruSignal Sensorā (PDF)āā
FDA Recall: Quidel Cardiovascular Inc., Quidel Triage Cardiac Panelā (PDF)ā
FDA Recall: Randox Laboratories Immunoassay Premium Control Tri Levelā (PDF)ā
FDA Recall: āMegadyne MEGA Series Patient Return Electrodesā (PDF)
FDA Recall: Avante Health Solutions Philips Respironics V60 Ventilatorā (PDF)āā
FDA Recall: Beckman Coulter, Inc. Hybritech p2PSA Reagentā (PDF)āā
FDA Recall: Teleflex Endotracheal Tube Rushelit and Magill Products (PDF)āā
FDA Recall: Teleflex Endotracheal Tubes Models - Slick Set, Flexi-Set, and Murphyā (PDF)
June 2023
FDA Recall: Medtronic Recalls AMPLIA, BRAVA, CLARIA, COMPIA, EV, and VISIA Series of Implantable Cardioverter Defibrillatorsā (PDF)ā
FDA Recall: Medtronic Evera, Primo, Mirro, Cobalt, Crome And Viva Series Of Implantable Cardioverter Defibrillators And Cardiac Resynchronization Therapy Defibrillators (PDF)āā
FDA Recall: Karl Storz Endoscopy Sterilization Traysā (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 Kitā (PDF)āāā
FDA Recall: LumiraDx SteriPack Sterile Polyester Spun Swabā (PDF)ā
FDA Recall: NOXBOX LTD NOxBOXiā (PDF)ā
FDA Recall: Boston Scientific Neuromodulation Corporation Superion Indirect Decompression System (PDF)āā
FDA Recall: Galt Medical Corporation Tearaway Introducer Kitā (PDF)
FDA Recall: Ossur H / F Icelock Ratchetā (PDF)āā
FDA Recall: Medtronic Navigation, Inc. StealthStation Cranial Softwareā (PDF)ā
FDA Recall: Bearcare Walnut Wearble Smart Thermometer (PDF)āā
FDA Recall: Abbott Ireland Limited Alinity i Anti-TPO Reagent Kitā (PDF)
FDA Recall: Cytrellis Biosystems Cytrellis Ellacor Systemā (PDF)ā
FDA Recall: Medline Industries Procedure Packs (PDF)ā
May 2023
FDA Recall: Immundiagnostik IDK Lactoferrin ELISA (PDF)āā
FDA Recall: Draeger Medical Ventstar Coax 180 (PDF)āā
FDA Recall: Draeger Medical Seattle PAP Plus And Breathing Circuit/Anesthesia Kits (PDF)āā
FDA Recall: āICU Medical Replacement Batteries For Plum 360, Plum A+, And Plum A+3 Infusion Systems (PDF)āā
FDA Recall: Bio-Rad Laboratories Bioplex 2200 (PDF)āā
FDA Recall: Technidata TDHisto/Cyto Software (PDF)ā
FDA Recall: Cook Incorporated Blue Rhino G2-Multi Series Percutaneous Tracheostomy Productsā (PDF)ā
FDA Recall: Cordis US Angiogard Rx / Xp Emboli Capture Guidewire System (PDF)
FDA Recall: Hamilton Medical - Hamilton C6 Ventilator (PDF)ā
April 2023
āFDA Recall: Scientia Vascular Plato 17 Microcatheter (PDF)āā
FDA Recall: Fresenius Kabi Usa Ivenix Infusion Systemā (PDF)ā
FDA Recall: Philips Respironics Trilogy Series Ventilators (PDF)
FDA Recall: Philips Respironics, Inc., Philips DreamStation Auto BiPAP and CPAP (PDF)āāāā
FDA Recall: Abbott Diabetes Care Components of FreeStyle Libre Flash Glucose Monitoring Systems (PDF)āā
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)āā
March 2023
FDA Recall: Preat Nobil Grip (PDF)ā
FDA Recall: Datascope CardiosaveIntraaortic Balloon Pump (PDF)ā
FDA Recall: CooperVision Biofinity XR Contact Lenses (PDF)ā
FDA Recall: Med-Mizer MR600 and STS500 Patient Lifts (PDF)
FDA Recall: Baxter Healthcare Life2000 Ventilator
Series Products (PDF)ā
FDA Recall: Draeger Medical Recalls Anti-Asphyxia Valve and Standard Elbow for NovaStar TSā (PDF)ā
February 2023
FDA Recall: GE Healthcare MRI Softwareā (PDF)ā
FDA Recall: GE Medical Systems Israel Nuclear Medicine 600/800 Series Products (PDF)ā
FDA Recall: Smiths Medical ASD CADD Administration Sets (PDF)ā
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)
āJiangsu 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)
December 2021
FDA Recall: Nobel Biocare NobelReplace Endosseus Root-Form Implant (PDF)
FDA Recall: Celltrion DiaTrust COVID-19 Tests (PDF)
FDA Recall: Vyaire Medical Bellavista 100 Ventilator (PDF)
FDA Recall: Xtant Medical X060-0270 Axle Interspinous Fusion System (PDF)
FDA Recall: Baxter Spectrum Infusion Pumps (PDF)
FDA Recall: Empowered Diagnostics COVID-19 Tests (PDF)
November 2021
FDA Recall: Siemens Medical Solutions Acuson Ultrasound Imaging System and Software (PDF)
FDA Recall: Tapemark Iontopatch On-the-Go Patch Therapy, Transdermal Iontophoretic Drug Delivery System (PDF)
FDA Recall: Velano Vascular PIVO Blood Collection Device (PDF)
FDA Recall: Diasorin Molecular Simplexa Direct Amplification Disc Kit (PDF)
FDA Recall: Reflexion RXM1000 for Dosage Discrepancy Error (PDF)
FDA Recall: Ćssur Updates Instructions-Miami J Select Collar (PDF)
FDA Recall: Cardiovascular Systems WIRION Embolic Protection System (PDF)
FDA Recall: Medtronic Synergy Cranial and StealthStation S7 Cranial Software (PDF)
FDA Recall: Activbody-Activ 5 Tiny Gym and ActivForce2 (PDF)
FDA Recall: Cook Flexor Check-Flo Introducer (PDF)
FDA Recall: Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR | Multiple Product Codes (PDF)
FDA Recall: Cordis Flex Biliary Stent (PDF)
FDA Recall: Biocheck T4 EIA Kit (PDF)
FDA Recall: Implant Direct Legacy 2 Dental Implant (PDF)
FDA Recall: Instrumentation Laboratory (PDF)
FDA Recall: Intuitive Sterile Drapes (PDF)
FDA Recall: Ellume COVID-19 Home Test (PDF)
FDA Recall: All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. (PDF)
FDA Recall: GORE Cardioform Septal Occluders (PDF)
FDA Recall: Smiths Medical Endotracheal Tubes (PDF)
FDA Recall: Karl Storz Endoscopy (PDF)
FDA Recall: 3M Redot Electrode (PDF)
FDA Recall: Siemens Healthcare EUA for SARS-CoV-2 Antigen Assays (PDF)
October 2021
FDA Recall: Medtronic Perfusion Systems Custom Perfusion Kits (PDF)
FDA Recall: Medtronic Vascular Endurant Series Stent (PDF)
FDA Recall: Ortho Clinical Booklet Correction for Documentation of Vitros Immunodiagnostic Products Anti-HBc IgM Controls (PDF)
FDA Recall: Smith and Nephew EVOS Self-Tapping Locking Screw (PDF)
FDA Recall: GE Centricity Universal Viewer Zero Footprint Client (PDF)
FDA Recall: BioFire-Blood Culture Identification Panel (PDF)
FDA Recall: X-Strahl X-Ray and Photoelectric Therapy Systems (PDF)
FDA Recall: Olympus Pneumoliner Devices (PDF)
FDA Recall: GE Healthcare Recalls MRI Software (PDF)
FDA Recall: Medtronic sterile single-use blades (PDF)
FDA Recall: Stradis Healthcare (PDF)
FDA Recall: BD-Bard Misbrands Biopsy Needle (PDF)
FDA Recall: Zimmer Biomet-ROSA One 3.1 Brain Application (PDF)
FDA Recall: Datascope/Getinge/Maquet Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs (PDF)
FDA Recall: Siemens Healthcare Diagnostics, Inc.-Ancillary Reagant Packs (PDF)
FDA Recall: DiaSorin Molecular LLC-Simplexa COVID-19 Positive Control Pack (PDF)
FDA Recall: LimaCorporate Self-tapping Titanium Alloy Bone Screw (PDF)
September 2021
FDA Recall: Becton Dickinson Infusion Therapy Systems Recalls BD Nexiva (PDF)
FDA Recall: Fujifilm Irvine Scientific Vit Kit-Freeze (PDF)
FDA Recall: Permobil TiLite Wheelchairs, Models: Aero Z, and ZRA (PDF)
FDA Recall: Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit (PDF)
August 2021
FDA Recall: Smiths Medical ASD Devices Employing Fast Flow Fluid Warming and Irrigation System Disposables (PDF)
FDA Recall: Imperative Care Inc., -Zoom 71 Reperfusion Catheter (PDF)
July 2021
FDA Recall: Cordis Super Torque MB Angiographic Catheter with Radiopaque Marker Bands (PDF)
June 2021
Phillips Respironics CPAP, BiPAP, and Ventilator Recall (PDF)
FDA Recall: Skytron Bracket Flatscreen, Revision 2 & 3, Model: FS32 (PDF)
May 2021
FDA Recall: Ortho Clinical Vitros Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (PDF)
February 2021
FDA Recall: Bio-RAD BioPlex 2200 Syphilis Total and RPR Kit (PDF)