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  1. Medical Device Recalls

The list below contains recalls that were issued in 2021.

2021 Medical Device Recalls

Device Name Date
Getinge/Datascope/Maquet Recalls Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pump (IABP) Due to Reports of Fluid Leaks 12/16/21
Arrow International Inc Recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr, Due to Risk of Separation 12/03/21
Ellume Recalls COVID-19 Home Test for Potential False Positive SARS-CoV-2 Test Results 11/10/21
Aligned Medical Solutions Doing Business as Windstone Medical Packaging, Inc. Recalls Custom Convenience Kits Due to Cardinal Health Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) Plunger Defect 11/09/21
Datascope/Getinge/Maquet Recalls Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs Due to Risk of Battery Failure 10/29/21
Zimmer Biomet Recalls ROSA One 3.1 Brain Application Due to Error in Software 10/29/21
Abbott Molecular, Inc. Recalls Alinity m SARS-CoV-2 AMP Kit and Alinity m Resp-4-Plex AMP Kit for Potential False Positive SARS-CoV-2 Test Results 10/14/21
DeRoyal Industries, Inc. Recalls Procedure Packs Containing Smiths Medical NORMOFLO Irrigation Warming Set Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers 10/06/21
Imperative Care Inc. Recalls ZOOM 71 Reperfusion Catheter Due to Risk of Breaks During Use 10/05/21
Medtronic Recalls Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks 10/05/21
Armstrong Medical Limited Recalls AMSORB PLUS PREFILLED G-CAN 1.0L Due to Reduced Gas Flow to Patients During Anesthesia 09/23/21
Cordis Recalls Super Torque MB Angiographic Catheter with Radiopaque Marker Bands Due to Potential for Marker Bands to Move or Dislodge   09/22/21
Medtronic Recalls Pipeline Flex Embolization Devices for Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device 09/20/21
Smiths Medical Recalls NORMOFLO Irrigation Fluid Warmers and Warming Sets Due to the Possibility of Harmful Levels of Aluminum Leaching into the Fluid Path of the Warmers 09/15/21
All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination (Updated 09/28/2021) 09/10/21
Bio-Medical Equipment Service Co. Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts 08/24/21
Cardinal Health Recalls Monoject Saline Flush Prefilled Syringes for Risk of Air Re-entering Syringe Leading to Air Embolism 08/23/21
Cardinal Health Recalls Argyle UVC Insertion Tray Due to Missing Instructions for Use for the Safety Scalpel N11 08/20/21
Medtronic Stops Distribution and Sale of HeartWare HVAD System Due to Risk of Neurological Adverse Events, Mortality, and Potential Failure to Restart 08/12/21
Baxter Healthcare Recalls Dose IQ Software Version 9.0.x, Used with Spectrum IQ Infusion Pumps, for Software Defect That May Improperly Configure Drug and Fluid Delivery 08/12/21
Boston Scientific Recalls INGENIO Family of Pacemakers and CRT-Ps Due to Risk of Transition to Safety Mode 08/06/21
Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum 08/05/21
Philips Respironics Recalls V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 Due to Risk of Receiving Reduced Oxygen 08/03/21
Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals 07/22/21
Philips Respironics Recalls Certain Ventilators and BiPAP Machines Due to Potential Health Risks from PE-PUR Sound Abatement Foam 07/22/21
Vero Biotech Recalls GENOSYL DS; Nitric Oxide Delivery System Due to Software Error 07/21/21
Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results 07/07/21
Medtronic Vascular Recalls Angiographic Guidewire Component Due to Being Non-sterile 07/02/21
Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results (Updated 09/28/2021) 07/01/21
Smiths Medical Recalls Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes for Skewed Graduated Marks on Syringe Barrel That May Cause Insulin Overdose or Underdose 06/25/21
Avid Medical Recalls Medical Convenience Kits for Risk of Fungal Contamination 06/25/21
DeRoyal Industries Recalls Surgical Procedure Packs for Mislabeled Lidocaine 06/25/21
Infusion Pump Repair Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts 06/15/21
Innova Medical Group Recalls Unauthorized SARS-CoV-2 Antigen Rapid Qualitative Test with Risk of False Test Results 06/10/21
The Biomed Guys Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts 06/02/21
Step-Har Medical Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts 05/28/21
Lepu Medical Technology Recalls SARS-CoV-2 Antigen Rapid Test Kit and Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) due to Risk of False Results 05/28/21
Medical Action Industries, Inc. 306 Recalls Medical Convenience Kits for Risk of Fungal (Aspergillus Penicillioides) Contamination 05/24/21
Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration 05/21/21
Abbott (formally known as "St. Jude Medical") Recalls Assurity™ and Endurity™ Pacemakers for Potential Moisture Ingress Causing Electrical Short and Reduced Battery Life 05/13/21
Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues 05/12/21
Pacific Medical Group (DBA Avante Health Solutions) Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts 04/30/21
Cordis Recalls Precise PRO Rx US Carotid System Due to Risk of Separation in Device During Use 04/23/21
Medtronic Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping Console for Possible Electrical Failure Causing the Pump to Stop 04/20/21
Tenacore Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly Due to Possible Cracked or Separated Bezel Repair Posts 04/19/21
CareFusion 303, Inc. Recalls BD Alaris Pump Module Model 8100 Due to Risk of Stuck or Unresponsive Keys 04/16/21
Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports 04/15/21
Smisson-Cartledge Biomedical, LLC Recalls ThermaCor 1200 Disposable Sets for Risk of Patient Contact to Aluminum 04/12/21
Medtronic Recalls Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy (CRT-Ds) Due to Risk of Shortened Battery Life 04/12/21
Medtronic Recalls Valiant Navion Thoracic Stent Graft System Due to Risk of Stent Fractures and Type III Endoleaks 04/09/21
ACIST Recalls Kodama Intravascular Ultrasound Catheter Due to Risk of Broken O-Ring Pieces Flushing into Arteries During Use 03/17/21
Combat Medical Systems, LLC, Recalls Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood Transfusion Set, Fresh Whole Blood Donor Set for Possible Broken or Bent Needles 03/12/21
Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped 03/01/21
Hillrom Recalls Liko Multirall 200 Overhead Lift Due to Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link 1 Strap Lock) to S65 Hook 02/22/21
Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit 02/19/21
Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures 02/02/21
Penumbra’s Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage 01/29/21



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