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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

​​

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

October ​2025

FDA Recall: Blood Pressure Medicine, Prazosin Hydrochloride Capsules, Firm Amerisource Health Services LLC (PDF)

FDA Recall: Blood Pressure Medicine, Prazosin Hydrochloride Capsules, Firm Teva Pharmaceuticals, USA, Inc. (PDF)​​​​

September ​2025

FDA Recall: Mo-Vis BVBA IDM-Micro-R Electrical wheelchair component (PDF)​

FDA Recall: Medtronic Perfusion Systems (PDF)​​

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

August ​2025

FDA Recall: Thoratec LLC HeartMate (PDF)​

FDA Recall: Philips Respironic DreamStation Auto CPAP (PDF)

FDA Recall: Medline Industries, LP-Northfield Electrophysiology Catheter Models (PDF)​​

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

FDA Recall: Boston Scientific Corporation Watchman TruSeal Access (PDF)​

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

FDA Recall: Medline Industries, LP – Northfield Recalls Medline General Surgery Tray​ (PDF)​

FDA Recall: Baxter Novum Large Volume Pump (PDF)​​

FDA Recall: Ambu Spur Adult Resuscitator (PDF)​

FDA Recall: Fresenius Kabi USA, LLC LVP Primary Administration Set (PDF)

July ​2025

FDA Recall: Encore Medical EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 (PDF)​​

FDA Recall: Intersurgical I-View Video Laryngoscope (PDF)​​

FDA Recall: Hamilton Medical Breathing Circuit Set (PDF)​

FDA Recall: HeartSine Technologies SAM 350P, HeartSine SAM 360P, and HeartSine SAM 450P (PDF)​

FDA Recall: Draeger Bidirectionally Breathing System Filter (PDF)​

FDA Recall: Baxter Healthcare Baxter SIGMA Spectrum Infusion Pump (PDF)​

FDA Recall: Abiomed Automated Impella Controller (AIC) (PDF)​

FDA Recall: Edwards Lifesciences LLC FEM-FLEX II (PDF)

FDA Recall: Edwards Lifesciences LLC Optisite Arterial Cannula​ (PDF)

FDA Recall: Lumithera Inc., Valeda Light Delivery System (PDF)

FDA Recall: Medline Industries, LP – Northfield Medline Convenience Kits (PDF)

FDA Recall: Philips Respironics, Inc. BiPAP Ventilators (PDF)​​​​​​​

June ​2025

FDA Recall: Integra LifeSciences MicroMyst Applicators (PDF)​

FDA Recall: Given Imaging Ltd Recalls Bravo CF capsule delivery devic​e (PDF)​​

FDA Recall: Contamac Solutions, Inc. Nutrifill Physiologic formula, Contact Lens Insertion solution (PDF)​

FDA Recall: Natus Neurology OBM00002 OBM DAB (Digital Acquisition Box) (PDF)​

FDA Recall: Zyno Medical LLC Z-800 Infusion System (PDF)​​

FDA Recall: SunMed Holdings, LLC Broselow Pediatric Emergency Rainbow Tape (PDF)​

FDA Recall: Integra LifeSciences Corp. (NeuroSciences) Extended Tip Applicator (PDF)​

FDA Recall: Fresenius Kabi USA, LLC Ivenix Infusion System LVP Blood Products Administration Set (PDF)​

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

FDA Recall: Covidien Ivenix Infusion System LVP Blood Products Administration Set (PDF)​

FDA Recall: Balt USA, LLC Prestige Coil System (PDF)​

FDA Recall: Dexcom, Inc. Dexcom G7 iOS Application​ (PDF)​

FDA Recall: Beckman Coulter Mishima K.K. Sample Probe (PDF)

May ​2025

FDA Recall: Maquet Critical Care AB Recalls Servo-u Ventilator System​ (PDF)​

FDA Recall: Baxter Healthcare Hillrom LikoScale and Q-Link 13 component (PDF)​

FDA Recall: Beckman Coulter Ireland Inc., Apo B Reagent (PDF)​

FDA Recall: Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set (PDF)​

FDA Recall: SunMed Holdings Adult Manual Resuscitator with Medium Adult Mask (PDF)​​

FDA Recall: Pro-Med Instruments Gmbh DORO Easy-Connect Navigation Adaptor​ (PDF)

FDA Recall: Philips Microstream Advance Neonatal-Infant Intubated CO2 Filter Line and Related Products (PDF)

FDA Recall: Medline Kits containing Codman Disposable Perforator​ (PDF)

FDA Recall: Smith & Nephew, Inc., META-TAN LAG/Compression Screw Kit (PDF)​

FDA Recall: Copan Wasp PhenoMATRIX​ (PDF)

FDA Recall: LeMaitre Vascular Pruitt Occlusion Catheter, TufTex Over-the-Wire Embolectomy Catheter, and Pruitt Irrigation Occlusion Catheter (PDF)​​

FDA Recall: Ethicon Endo-Surgery Endopath Echelon Vascular White Reload (PDF)​

FDA Recall: C.R. Bard Lumen Esophagogastric Tamponade, Esophageal-Nasogastric, and Intragastric Linton Balloon Tubes (PDF)​

FDA Recall: Baxter Healthcare Novum IQ Large Value Pump Infusion System (PDF)​

FDA Recall: Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer (PDF)​​

FDA Recall: Meddev Corp Contour Gold Eyelid Weight​ (PDF)

FDA Recall: Baxter Healthcare Welch Allyn Life2000 Compressor/Welch Allyn Life2000 Ventilation System (PDF)​

FDA Recall: Vyaire Medical AirLife Infant Heated Wire Circuit​ (PDF)​

FDA Recall: Nipro Renal Soultions USA MedicaLyte Liquid Bicarbonate Concentrate (PDF)​

​FDA Recall: Medical Depot Inc., Go 2 DC Car Adapter (PDF)​

FDA Recall: Inari Medical-Oak Canyon Artix MT Thrombectomy Device (PDF)​

FDA Recall: Bard Issues Correction for EsophagogastricBalloon Tamponade Tubes​ ​​​

FDA Recall: Smiths Medical ASD, Inc. CADD-Solis HSPCA Pump, HPCA Ambulatory Infusion Pump, and VIP Ambulatory Infusion Pump​ (PDF)​

FDA Recall: Olympus Corporation of the Americas Soltive Pro SuperPulsed Laser System (PDF)​

FDA Recall: Integra LifeSciences Corp., Disposable Perforator and Craniotomy Kit (PDF)​​

FDA Recall: Bausch & Lomb Surgical Inc., enVista Monofocal, Aspire, and Envy Intraocular Lens (PDF)​

April​ ​2025

FDA Recall: Leica Biosystems Melbourne HistoCore Peloris 3​ (PDF)​

FDA Recall: Medtronic MiniMed, Inc. InPen Smart Insulin Pen​ (PDF)

FDA Recall: Radiometer Medical ApS ABL90 Flex and Flex Plus (PDF)​

FDA Recall: Medtronic Neuromodulation myPTM Software Application​ (PDF)​

FDA Recall: Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer (PDF)​

FDA Recall: Straumann USA TLX/TLC SP Guided Implant Drive (PDF)​​

FDA Recall: CareFusion 303, Inc., BD Pyxis Medflex (PDF)​

​FDA Recall: Waldemar Link GmbH & Co. KG Distal Femoral, Posterior Femoral, L-Shaped Femoral, and Tibial Augments (PDF)​

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

FDA Recall: Belmont Instrument LLC​ Procedure Kits (PDF)​

FDA Recall: GE Medical Systems China Co., Ltd. GE Healthcare Carestation (PDF)​

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

FDA Recall: Merit Medical Systems Inc., EsophyX Z+​ Fasteners (PDF)

FDA Recall: Conformis Inc., Restor3d Cordera Hip System (PDF)​​

FDA Recall: Stryker GmbH Guide Wire with Ruler Tube (PDF)​​

FDA Recall: Channel Medsystems Cerene Cryotherapy Device Thermal Ablation, Endometrial (PDF)​​

FDA Recall: BD Switzerland Sarl BD Connecta BD Luer-Lok 360​ (PDF)

FDA Recall: ZOLL Circulation Inc., AutoPulse NXT Resuscitation System (PDF, 1.2MB)​​

FDA Recall: Thoratec LLC HeartMate Mobile Power Unit (PDF)​​

FDA Recall: Tandem Diabetes Care Inc., Insulin Pump with Interoperable Technology (PDF)​

FDA Recall: Avanos Medical Inc., Ballard Closed Suction Catheters​ (PDF)

FDA Recall: Bard Access Systems Inc., BD 4 Fr Single-Lumen PowerPICC Catheters (PDF, 1.1MB)​​​

FDA Recall: Qapel Medical Inc., Hippo 072 Aspiration System (PDF)​

FDA Recall: Medline Industries, LP-Northfield Procedure Kits (PDF, 1.1MB)​​

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: Smiths Medical ASD, Inc., Capnocheck BCI Airway Adapter (PDF)​​

FDA Recall: Medline Industries Proxima Drapes Sterile Surgical Drapes​ (PDF)​

FDA Recall: Brainlab AG Origin Data Management​ (PDF)

FDA Recall: Orthofix U.S. Pillar SA Ti Spacer System (PDF)​​

FDA Recall: Oridion Medical 1987 Ltd. Microstream Sets​ (PDF)

FDA Recall: Remel Inc., Zebra Thermal Barcode Printer GX430t (PDF)​​

FDA Recall: Zimmer Orthopedics Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem, and Uncemented shoulder prosthesis​ (PDF)​

FDA Recall: Zimmer Inc., NexGen LPS Flex Knee Joint (PDF)​

FDA Recall: Waldemar Link GmbH & Co. KG Modular Stem Cylindrical, Tilastan (PDF)​​

FDA Recall: Baxter Healthcare Corporation Operating Table​ (PDF)

FDA Recall: Maquet Cardiovascular  VH-3010 Power Supply (PDF)​​

FDA Recall: Stryker Corp., Nasopore, Otopore Cylinder, and Hemopore Dressings​ (PDF)

FDA Recall: Medtronic MiniMed and Paradigm Insulin Pump (PDF)​​

FDA Recall: GE Healthcare Centricity Universal Viewer​ (PDF)

FDA Recall: CooperVision Inc., Stenfilcon A Contact Lens (PDF)​​

FDA Recall: Becton Dickinson BD BBL TB Stain Kit K (PDF)​​

FDA Recall: Qiagen Sciences LLC QIAstat-Dx Respiratory Panel Plus​ (PDF)

FDA Recall: ZOLL Medical Corporation Powerheart G5 AED​ (PDF)​

FDA Recall: Merge Healthcare Inc., VERICIS Merge Cardio (PDF)​

FDA Recall: Baxter Healthcare Corporation Progressa Bed Surfaces​ (PDF)​

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

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, 1.1MB)​

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: Philips Medical Systems Nederland B.V. Philips IntelliSpace Cardiovascular Software (PDF)​​

FDA Recall: New Medical Technologies Gmbh Integra Miltex Cryosolutions Cartridges (PDF)​

FDA Recall: Beckman Coulter Access 2 Immunoassay Analyzer (PDF, 1.1MB)​​

FDA Recall: Beckman Coulter Inc., Access Erythropoietin (PDF)

FDA Recall: Beckman Coulter Laboratory Systems Clinical Chemistry Analyzer (PDF)​

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, 1.2MB)​​

FDA Recall: Exactech Inc, AcuMatch XLE and Novation XLE (PDF, 1.3MB)​​

FDA Recall: XTANT Medical Holdings, Inc., Irix-A Integrated Lumbar Fusion System (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: Alphatec Spine, Inc. Non Sterile Implants/Convenience Kits Spinal Fusion Procedures​ (PDF, 1.3MB)​

FDA Recall: ALI Technologies Change Healthcare Cardiology Hemo and Hemodynamics software (PDF)

FDA Recall: Qualigen FastPack IP Sex Hormone Binding Globulin Immunoassay (PDF)​​

FDA Recall: Aerin Medical Inc., VivAer Stylus (PDF)​​

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, 1.2MB)​​

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, 1.2MB)​​

​December ​2024

FDA Recall: CareFusion 303, Inc. BD Pyxis Medstation​ Recall (PDF)​

FDA Recall: SeaSpine Orthopedics Daytona Small Stature CoCr Locking Cap (PDF)​

FDA Recall: Olympus Corporation of the Americas Duravent Silicone Ventilation Tube​ (PDF)​

FDA Recall: Noah Medical Galaxy System and Bronchoscope (PDF)​​

​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, 1.2MB)​​​

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, 1.1MB)​

FDA Recall: The Metrix Company Imed Products Imed EVA BAG (PDF, 1.1MB)

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, 1.1MB)

FDA Recall: Boston Scientific Corporation Polarx Fit Balloon Catheter ST US (2) (PDF, 1.1MB) ​​

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, 1.1MB)

FDA Recall: Baxter Healthcare Corporation MiniCap Extended Life PD Transfer Set with Twist Clamp (2) (PDF, 1.1MB)​​

October ​2024

FDA Recall: Beckman Coulter MMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent (PDF, 1.1MB)​

FDA Recall: Merit Medical Systems, Inc., Custom Inflation Kit​ (PDF, 1.2MB​)​

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: Datex-Ohmeda, Inc., GE Healthcare Giraffe Incubator Carestation CS1 (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, 1.1MB)​

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

FDA Recall: Maquet Cardiovascular, LLC., VasoView HemoPro Endoscopic Vessel Harvesting System (PDF, 1.1MB)

​FDA Recall: Datex-Ohmeda, Inc., Aespire 100​ (PDF, 1.2MB)

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, 1.2MB​​)​​

FDA Recall: Karl Storz Endoscopy Hopkins Telescope 6 (PDF, 1.1MB)

FDA Recall: Karl Storz Endoscopy Recalls Hopkins Telescope 6​ (2) (PDF, 1.1MB)​

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: Stryker Sustainability Solutions Disposable 5 Lead Cable And Lead Wire System (PDF)​​

FDA Recall: Merit Medical Systems Inc., K09/K09T Custom Manifold Kit (PDF)

FDA Recall: Merit Medical Systems Inc., K22C Vein Tray Angiography Kit (PDF)​

FDA Recall: Merit Medical Systems Inc., PC Pericardiocentesis Tray (PDF)

FDA Recall: Merit Medical Systems Inc., Prelude SNAP Introducer Catheter kit (PDF)​​​

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)

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