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Food and Drug Branch

 FDB Home Page

 Contact

Main Telephone:

(800) 495-3232

 

Email:

FDBMedDevice@cdph.ca.gov 

Address (Courier Delivery):

California Department of Public Health - Food and Drug Branch

1500 Capitol Ave, MS 7602

Sacramento, CA 95814

 

Address (Non-Courier Delivery):

California Department of Public Health - Food and Drug Branch

P.O. Box 997435, MS 7602

Sacramento, CA 95899

​​

Device Recalls

Information regarding device recalls and links to other device recall information may be found below.

For any questions, please contact us using the information on the left or email us as the following address: FDBMedDevice@cdph.ca.gov.

 Device Specific Recall Information

July 2024

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

May 2024 ​

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: 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)

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: Össur 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)


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