2021-12-01 Arrow -Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7R by Teleflex Incorporated: Class I Recall - Due to Inner Lumen Detaching From the Device’s Basket (FDA)
2021-11-12 Updates on Philips Respironics CPAP, BiPAP, and Ventilator Recall (FDA)
2021-11-10 Custom Convenience Kits by Aligned Medical Solutions: Class I Recall - Due to Monoject Flush Prefilled Syringe (0.9% Sodium Chloride) Plunger Defect (FDA)
2021-11-02 ROSA One 3.1 Brain Application by Zimmer Biomet: Class I Recall - Due to Error in Software (FDA)
2021-11-02 Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump (IABP) Battery Packs by Datascope/Getinge/Maquet: Class I Recall - Due to Risk of Battery Failure (FDA)
2021-10-19 Transseptal Needle and Transseptal Needle with Catheter by Cook Medical Due to Complaints of Rust on the Products (FDA)
2021-10-07 Imperative Care Inc. Recalls ZOOM 71 Reperfusion Catheter Due to Risk of Breaks During Use (FDA)
2021-10-07 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 (FDA)
2021-10-05 Medtronic Recalls Remote Controllers Used with Paradigm and 508 MiniMed Insulin Pumps for Potential Cybersecurity Risks (FDA)
2021-09-23 Cordis Recalls SUPER TORQUE MB Angiographic Catheter with Radiopaque Marker Bands Due to Potential for Marker Bands to Move or Dislodge (FDA)
2021-09-20 Medtronic Recalls Pipeline Flex Embolization Devices for Risk of Delivery System Fractures During Placement, Retrieval, or Movement of Device (FDA)
2021-09-15 Eight Medical International Recalls Recirculator 8.0 Disposable Lavage Kits due to Potential Exposure to High Levels of Aluminum (FDA)
2021-09-15 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 (FDA)
2021-08-25 Baxter Issues Urgent Medical Device Correction for All Spectrum IQ Infusion Pumps to Reinforce Important Safety Information Regarding Best Practices for Customer-Initiated IT Network Updates (FDA)
2021-08-25 Alaris Infusion Pump Module 8100 Bezel by Bio-Medical Equipment Service: Class I Recall - Due to Possible Cracked or Separated Bezel Repair Posts (FDA)
2021-08-20 Argyle UVC Insertion Tray by Cardinal Health: Class I Recall - Due to Missing Instructions for Use for the Safety Scalpel N11 (FDA)
2021-08-12 Dose IQ Software Version 9.0.x, Used with Spectrum IQ Infusion Pumps by Baxter Healthcare: Class I Recall - Due to Software Defect That May Improperly Configure Drug and Fluid Delivery (FDA)
2021-08-12 Recirculator 8.0 Disposable Lavage Kits by Eight Medical International: Class I Recall - Due to Potential Exposure to High Levels of Aluminum (FDA)
2021-08-09 INGENIO Family of Pacemakers and CRT-Ps by Boston Scientific: Class I Recall - Due to Risk of Incorrect Transition to Safety Mode (FDA)
2021-08-05 Recirculator 8.0 Disposable Lavage Kits by Eight Medical International: Class I Recall - Due to Potential Exposure to High Levels of Aluminum (FDA)
2021-08-04 V60 and V60 Plus Ventilators Equipped with High Flow Therapy Software Versions 3.00 and 3.10 by Philips Respironics: Class I Recall - Due to Risk of Receiving Reduced Oxygen (FDA)
2021-08-04 BD Alaris System Software by BD: BD to Begin Remediation - Because Infusion Pump May Not Operate as Expected (FDA)
2021-07-21 GENOSYL DS; Nitric Oxide Delivery System by Vero Biotech - Due to Software Error (FDA)
2021-07-08 Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results (FDA)
2021-07-02 Medtronic Vascular Recalls Angiographic Guidewire Component Due to Being Non-sterile (FDA)
2021-07-02 Magellan Diagnostics Recalls LeadCare II, LeadCare Plus, and LeadCare Ultra Blood Lead Tests Due to Risk of Falsely Low Results (FDA)
2021-06-28 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 (FDA)
2021-06-25 Avid Medical Recalls Medical Convenience Kits for Risk of Fungal Contamination (FDA)
2021-06-21 Smiths Medical Issues Worldwide Notification Regarding the Recall of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe With Skewed Graduation Markings (FDA)
2021-06-16 Infusion Pump Repair Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts (FDA)
2021-06-16 Philips Issues a Recall Notification* to Mitigate Potential Health Risks Related to the Sound Abatement Foam Component in Certain Sleep and Respiratory Care Devices (FDA)
2021-05-24 Medical Action Industries, Inc. 306 Recalls Medical Convenience Kits for Risk of Fungal (Aspergillus Penicillioides) Contamination (FDA)
2021-05-21 Boston Scientific Corporation Recalls VICI VENOUS STENT System and VICI RDS VENOUS STENT System for Potential of Stent Migration (FDA)
2021-05-13 Abbott (formally known as “St. Jude Medical”) Recalls Assurity™ and Endurity™ Pacemakers for Potential Moisture Ingress Causing Electrical Short and Reduced Battery Life (FDA)
2021-05-12 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 (FDA)
2021-04-30 Pacific Medical Group (DBA Avante Health Solutions) Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts (FDA)
2021-04-23 Cordis Recalls Precise PRO Rx US Carotid System Due to Risk of Separation in Device During Use (FDA)
2021-04-21 Tenacore LLC Issues Nationwide Recall of Tenacore’s Replacement for the Front Bezel Assembly of the CareFusion Alaris 8100 Infusion Pump Module (FDA)
2021-04-20 Medtronic Perfusion Systems Recalls Bio-Console 560 Extracorporeal Blood Pumping Console for Possible Electrical Failure Causing the Pump to Stop (FDA)
2021-04-19 Tenacore Recalls Alaris Pump Bezel Assembly and Alaris Infusion Pumps repaired with Bezel Assembly Due to Possible Cracked or Separated Bezel Repair Posts (FDA)
2021-04-19 CareFusion 303, Inc. Recalls BD Alaris Pump Module Model 8100 Due to Risk of Stuck or Unresponsive Keys (FDA)
2021-04-15 Medtronic Recalls HeartWare HVAD Battery Cables, Data Cables, Adapter Cables and Controller 2.0 Ports Due to Risk of Damage to Controller Ports (FDA)
2021-04-12 ThermaCor 1200 Disposable Sets by Smisson - Cartledge Biomedical: Class I Recall - Due to Risk of Patient Contact to Aluminum (FDA)
2021-04-09 Valiant Navion Thoracic Stent Graft System by Medtronic: Class I Recall - Due to Risk of Stent Fractures and Type III Endoleaks (FDA)
2021-04-12 Evera, Viva, Brava, Claria, Amplia, Compia, and Visia Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy by Medtronic: Due to Risk of Shortened Battery Life (FDA)
2021-03-25 ChloraPrep, 3 mL Applicator by BD: Expanded Recall - Due to Potential Aspergillus penicillioides contamination (FDA)
2021-03-25 Affinity Pixie Oxygenator and Cardiotomy/Venous Reservoir with Balance Biosurface by Medtronic: Class I Recall - Due to Possible High Levels of Endotoxins (FDA)
2021-03-17 Kodama Intravascular Ultrasound Catheter by ACIST: Class I Recall - Due to Risk of Broken O-Ring Pieces Flushing into Arteries During Use (FDA)
2021-03-20 Valkyrie LTOWB Collection, Valkyrie LTOWB Administration, Low Titer Type O FWB Transfusion Set, Fresh Whole Blood Transfusion Set, Fresh Whole Blood Donor Set by Combat Medical Systems: Class I Recall - Due to Possible Broken or Bent Needles (FDA)
2021-03-02 HVAD Pump Implant Kits by Medtronic: Class I Recall - Due to Delayed or Failed Restart After the Pump is Stopped (FDA)
2021-02-24 Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System (FDA)
2021-02-22 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 (FDA)
2021-02-11 Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures (FDA)
2021-02-10 Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error (FDA)
2021-02-01 Penumbra's Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers (FDA)
2021-01-29 Penumbra's Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage (FDA)
2021-01-13 Boston Scientific Announces LOTUS Edge™ Aortic Valve System Voluntary Recall and Product Discontinuation (FDA)