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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

ā€‹ā€‹

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

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)

ā€‹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: Ć–ssur 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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