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  1. Medical Device Recalls

The list below contains recalls that were issued in 2022.

2022 Medical Device Recalls

Device Name Date
Medtronic Recalls HeartWare HVAD System Batteries Due to Battery Failure 06/23/22
Baxter Healthcare Corporation Recalls Volara System For Risk Of Respiratory Distress In Ventilated Patients During Home Use 06/23/22
Draeger, Inc Recalls SafeStar 55 Breathing System Filters for Possible Obstructions That May Block Oxygen Flow To Patients 06/21/22
Woodside Acquisitions Inc. Recalls Oral Rapid SARS-CoV-2 Antigen Rapid Test Kits and Joysbio SARS-CoV-2 Antigen Rapid Test Kits (Colloidal Gold) That Are Not Authorized, Cleared, or Approved by the FDA 06/09/22
Medtronic Recalls HVAD Pump Implant Kit for Pump Weld Defect 06/08/22
Philips Respironics Recalls All V60 and V60 Plus Ventilators for Power Issue that May Cause Ventilator to Stop with or without Alarms 06/03/22
Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm 06/02/22
ArjoHuntleigh Polska Recalls Sara Plus Floor Lift for Risk of Smoke or Fire When Lift Is Used with Depleted Battery 05/27/22
Abbott Medical Recalls Dragonfly OpStar Imaging Catheter for Potential Loose Catheter Marker Band That May Cause Patient Harm 05/26/22
Avanos Medical Recalls Cortrak*2 Enteral Access System for Risk of Misplaced Enteral Tubes Could Cause Patient Harm 05/13/22
SML Distribution LLC Recalls Skippack Medical Lab COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA 05/10/22
Mesa Biotech, Inc., Recalls Certain Accula SARS-CoV-2 Tests for Risk of False Positives Caused by Contamination 05/09/22
Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Which May Have Been Distributed to Unauthorized, Non-CLIA-Certified Users 04/28/22
Medtronic Recalls Harmony Delivery Catheter, Part of Transcatheter Pulmonary Valve (TPV) System, for Risk of Capsule Break During Use 04/26/22
Celltrion USA Recalls Certain Point of Care DiaTrust COVID-19 Ag Rapid Test Kits Labeled for Research Use Only 03/23/22
Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm 03/21/22
SD Biosensor Recalls STANDARD Q COVID-19 Ag Home Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results 03/16/22
Celltrion USA Recalls Certain Point of Care Celltrion DiaTrust COVID-19 Ag Rapid Tests for False Positive Test Results and Unauthorized Shelf Life 03/15/22
LuSys Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests Because They Are Not Authorized, Cleared, or Approved by the FDA 03/14/22
Baxter recalls SIGMA Spectrum Infusion Pumps with Master Drug Library (Version 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software (Version 9) due to the risk of not alarming for repeated upstream occlusion events 03/11/22
Medtronic Recalls TurboHawk Plus Directional Atherectomy System Due to Risk of Tip Damage During Use 03/09/22
Arrow International, LLC (Subsidiary of Teleflex Inc.) Recalls the Arrow-Trerotola Percutaneous Thrombolytic Device Due to Risk of Tip Damage During Use 02/23/22
E25Bio Recalls COVID-19 Direct Antigen Rapid Tests That Are Not Authorized, Cleared, or Approved by the FDA and May Give False Results 02/18/22
BASE10 Genetics Recalls RNAstill MTM Specimen Collection Kits That Are Not Authorized, Cleared, or Approved by the FDA, May Give False Results, and Require Special Training for Safe Handling 02/17/22
Vyaire Medical Recalls bellavista 1000 and 1000e Series Ventilators Due to Issues with Software Configurations 02/17/22
Empowered Diagnostics Recalls COVID-19 Tests due to Risk of False Results 01/28/22
Philips Respironics Recalls Certain Trilogy EVO Ventilators for Potential Health Risks from PE-PUR Foam 01/26/22
Medtronic Inc. Recalls HawkOne Directional Atherectomy System Due to Risk of Tip Damage During Use 01/21/22
Getinge USA Sales, LLC Recalls the Vaporizer Sevoflurane Maquet Filling for Flow Family Anesthesia Systems Due to a Risk of Harmful Chemical Exposure 01/19/22
Cardiovascular Systems, Inc Recalls WIRION Embolic Protection Device Due to Complaints of Filter Breakage During Retrieval 01/10/22
Medtronic Recalls Synergy Cranial and StealthStation S7 Cranial Software Due to Potential Risk of Inaccurate Biopsy Depth Gauge Cycle View 01/06/22
Covidien, LP Recalls Puritan Bennett 980 Series Ventilator Due to Manufacturing Assembly Error 01/03/22

 

 

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