Important Safety Alerts

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Safety Alerts and Communications

Important Safety Alerts

Important Safety Alerts

Year:
2021
All
2021
2020
2019
2018
2017
2016
2015
2014
2013
2012
2011
2010
2009
2007
2006
2005
Month:
All
All
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Caption: Data Table
Posting Date Title
29 Dec 2021 29 Dec 2021Medical Device Safety Alert: Cooper Vision Hy-Care, All In One Light (AIOL), Refine One Step, Preservative Free Saline
24 Dec 2021 24 Dec 2021Medical Device Safety Alert: Medtronic Endurant II/IIs Stent Graft System
23 Dec 2021 23 Dec 2021Medical Device Safety Alert: ConvaTec AQUACEL FOAM ADH 10X10CM(1X10) EUR
20 Dec 2021 20 Dec 2021Medical Device Safety Alert: Medtronic NIM Trivantage EMG Endotracheal Tube
20 Dec 2021 20 Dec 2021Medical Device Safety Alert: Boston Scientific Jagtome RX, Hydratome RX, Dreamtome RX, Cannulating Sphincterotomes, and Jagtome Revolution RX
17 Dec 2021 17 Dec 2021Medical Device Safety Alert: Philips DigitalDiagnost 1.x, 2.x, 3.x, 4.x, BuckyDiagnost, EasyDiagnost, TraumaDiagnost, ProGrade, ProxiDiagnost N90, and CombiDiagnost R90 Radiography Systems
16 Dec 2021 16 Dec 2021Medical Device Safety Alert: Beckman Coulter AU/DxC AU Uric Acid [Reference: OSR6x98; All Lots]
14 Dec 2021 14 Dec 2021Medical Device Safety Alert: Boston Scientific AUTOLITH TOUCH EHL
13 Dec 2021 13 Dec 2021Medical Device Safety Alert: Bio-Rad ID‐DiaPanel Plus 6 (6x4 ml)
08 Dec 2021 08 Dec 2021Medical Device Safety Alert: Beckman Coulter AU/DxC AU Magnesium
07 Dec 2021 07 Dec 2021Medical Device Safety Alert: Medtronic HawkOne Directional Atherectomy System
01 Dec 2021 01 Dec 2021Medical Device Safety Alert: Meditech Kft Meditech ABPM-05 ambulatory blood pressure monitor
29 Nov 2021 29 Nov 2021Medical Device Safety Alert: Abbott Ultimum Hemostasis Introducer
26 Nov 2021 26 Nov 2021Medical Device Safety Alert: Philips MobileDiagnost wDR
25 Nov 2021 25 Nov 2021Medical Device Safety Alert: Medtronic Abre venous self-expanding stent system
18 Nov 2021 18 Nov 2021Medical Device Safety Alert: Medtronic Synergy Cranial and StealthStation Cranial
10 Nov 2021 10 Nov 2021Medical Device Safety Alert: Boston Scientific ROTAPRO Rotational Atherectomy System
04 Nov 2021 04 Nov 2021Medical Device Safety Alert: Medtronic Wireless Recharger
29 Oct 2021 29 Oct 2021Medical Device Safety Alert: Johnson and Johnson Surgical Vision iDESIGN Refractive Studio & CATALYS Precision Laser System
26 Oct 2021 26 Oct 2021Medical Device Safety Alert: Beckman Coulter COULTER 4C-ES Cell Controls
25 Oct 2021 25 Oct 2021Medical Device Safety Alert: Abbott Amplatzer Vascular Plug II
25 Oct 2021 25 Oct 2021Medical Device Safety Alert: Abbott 27mm Masters Mitral Standard Polyester Cuff Mechanical Heart Valve
21 Oct 2021 21 Oct 2021Medical Device Safety Alert: Boston Scientific Hurricane RX Biliary Balloon Dilatation Catheter
21 Oct 2021 21 Oct 2021Medical Device Safety Alert: Abbott Alinity s Systems
18 Oct 2021 18 Oct 2021Medical Device Safety Alert: Biomerieux BioFire Blood Culture Identification 2 (BCID2) Panel with BD BACTEC blood culture vials
15 Oct 2021 15 Oct 2021Medical Device Safety Alert: Medtronic Percept PC Implantable Neurostimulator (INS)
08 Oct 2021 08 Oct 2021Medical Device Safety Alert: Abbott ARCHITECT Systems
07 Oct 2021 07 Oct 2021Medical Device Safety Alert: Biomerieux API 50 CH
04 Oct 2021 04 Oct 2021Medical Device Safety Alert: Brightwake Algivon Honey Dressing and Activon Tube
29 Sep 2021 29 Sep 2021Medical Device Safety Alert: Medtronic Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation
29 Sep 2021 29 Sep 2021Medical Device Safety Alert: Biomerieux. VIDAS Immuno-Assays
29 Sep 2021 29 Sep 2021Medical Device Safety Alert: Beckman Coulter Stem – Kit Reagents 50 tests
28 Sep 2021 28 Sep 2021Medical Device Safety Alert: RaySearch Laboratories. RayStation, RayPlan
28 Sep 2021 28 Sep 2021Medical Device Safety Alert: Abbott EnSite X Display Workstation
20 Sep 2021 20 Sep 2021Medical Device Safety Alert: Philips Allura Xper, Allura Centron and UNIQ systems
16 Sep 2021 16 Sep 2021Medical Device Safety Alert: Beckman Coulter Inc. ACCESS SARS-CoV-2 IgG (1st IS)
16 Sep 2021 16 Sep 2021Medical Device Safety Alert: Cook Medical Inferior Vena Cava (IVC) Filters
15 Sep 2021 15 Sep 2021Medical Device Safety Alert: NuVasive Specialized Orthopedics Precice Bone Transport Nail
14 Sep 2021 14 Sep 2021Medical Device Safety Alert: Getinge MAQUET CARDIOSAVE hybrid and MAQUET CARDIOSAVE rescue
13 Sep 2021 13 Sep 2021Medical Device Safety Alert: Eco-Med Pharmaceutical, All Ultrasound Gels and Lotions
10 Sep 2021 10 Sep 2021Medical Device Safety Alert: Chalice Medical Ltd ParaTherm Heater/ Cooler
08 Sep 2021 08 Sep 2021Medical Device Safety Alert: bioMérieux MYLA SOFTWARE
08 Sep 2021 08 Sep 2021Medical Device Safety Alert: Beckman Coulter MicroScan Dried Gram Positive Combo and ID
31 Aug 2021 31 Aug 2021Medical Device Safety Alert: Medtronic DLP Left Heart Vent Catheters
27 Aug 2021 27 Aug 2021Medical Device Safety Alert: Maquet Cardiopulmonary GmbH HCU 40 Heater-Cooler Unit
27 Aug 2021 27 Aug 2021Medical Device Safety Alert: Philips HEARTSTART DEFIBRILLATION PADS
27 Aug 2021 27 Aug 2021Medical Device Safety Alert: Beckman Coulters Inorganic Phosphorus
24 Aug 2021 24 Aug 2021Medical Device Safety Alert: Boston Scientific Rezūm System
19 Aug 2021 19 Aug 2021Medical Device Safety Alert: Applied Medical Resources Corporation Alexis Contained Extraction System
19 Aug 2021 19 Aug 2021Medical Device Safety Alert: Smiths Medical Level 1 Fast Flow Fluid Warming System and Level 1 NORMOFLO Irrigation System
16 Aug 2021 16 Aug 2021Medical Device Safety Alert: Medtronic HeartWare Ventricular Assist Device (HVAD) System
16 Aug 2021 16 Aug 2021Medical Device Safety Alert: BioMérieux API 50 CH
12 Aug 2021 12 Aug 2021Medical Device Safety Alert: Boston Scientific Percuflex Plus Ureteral Stent
11 Aug 2021 11 Aug 2021Medical Device Safety Alert: Medline NAMIC MANIFOLD and STOPCOCKS
09 Aug 2021 09 Aug 2021Medical Device Safety Alert: BD PosiFlush Normal Saline Syringe
09 Aug 2021 09 Aug 2021Medical Device Safety Alert: Philips EPIQ Ultrasound Systems
06 Aug 2021 06 Aug 2021Medical Device Safety Alert: GS Elektromedizinische Geräte corpuls3 SLIM and corpuls3 Touch SLIM
04 Aug 2021 04 Aug 2021Medical Device Safety Alert: Abbott Alinity ci-series System Control Module (SCM)
04 Aug 2021 04 Aug 2021Medical Device Safety Alert: ConvaTec DuoDERM Extra Thin and DuoDERM CGF
23 Jul 2021 23 Jul 2021Medical Device Safety Alert: Boston Scientific TheraSphere Administration Sets
21 Jul 2021 21 Jul 2021Medical Device Safety Alert: Ethicon HARMONIC HD 1000i Shears
20 Jul 2021 20 Jul 2021Medical Device Safety Alert: Bio-Rad ID-Antigen Profile II
07 Jul 2021 07 Jul 2021Medical Device Safety Alert: Beckman Coulter HbA1c (Hemoglobin A1c) Reagent
05 Jul 2021 05 Jul 2021Medical Device Safety Alert: Kaluza C Software
24 Jun 2021 24 Jun 2021Medical Device Safety Alert: Roche Cobas u pack - International market only
21 Jun 2021 21 Jun 2021Medical Device Safety Alert: Beckman Coulter Access AMH Calibrators
21 Jun 2021 21 Jun 2021Medical Device Safety Alert: Ortho Clinical Diagnostics ORTHO VISION Analyzer for BioVue and ORTHO VISION Max Analyzer for BioVue
17 Jun 2021 17 Jun 2021Medical Device Safety Alert: Olympus Endocuff Vision
16 Jun 2021 16 Jun 2021Medical Device Safety Alert: Abbott Alinity c Activated Alanine Aminotransferase Reagent Kit (A‐ALT)
15 Jun 2021 15 Jun 2021Medical Device Safety Alert: BioFire FilmArray Pneumonia plus (PN plus) Panel
15 Jun 2021 15 Jun 2021Medical Device Safety Alert: Terumo Cardiovascular Terumo Advanced Perfusion System 1 – Electronic Patient Gas System (EPGS)
09 Jun 2021 09 Jun 2021Medical Device Safety Alert: Medtronic Stimloc Burr Hole Cover
09 Jun 2021 09 Jun 2021Medical Device Safety Alert: Boston Scientific Insufflation TRAPPER Exchange Device
07 Jun 2021 07 Jun 2021Medical Device Safety Alert: W.O.M. World of Medicine GmbH Aquilex Fluid Control System
04 Jun 2021 04 Jun 2021Medical Device Safety Alert: Boston Scientific INGENIO, VITALIO, and ADVANTIO pacemakers and INLIVEN, INTUA, and INVIVE cardiac resynchronization therapy pacemakers (CRT-Ps).
03 Jun 2021 03 Jun 2021Medical Device Safety Alert: BioMerieux VIDAS Anti-HBs Total II
28 May 2021 28 May 2021Medical Device Safety Alert: KARL STORZ Insufflation Filter
28 May 2021 28 May 2021Medical Device Safety Alert: Beckman Coulter MicroScan Gram Negative panels with Amoxicillin/ K Clavulanate (Aug) and Ampicillin/Sulbactam (A/S)
27 May 2021 27 May 2021Medical Device Safety Alert: Baxter Healthcare Y-Type irrigation set; Spike with Clearlink (valve); Fast flow Y-type Irrigation set; Secondary Medication Set, Y-Type Blood/Solution Infusion Set with Clearlink Injection Site, Luer Lock Adaptor; Solution Administration Set with Clearlink; Solution Administration Set; Light Sensitive Drugs Set; Vented Paclitaxel Set
24 May 2021 24 May 2021Medical Device Safety Alert: Teleflex FiberOptix Intra-Aortic Balloon (IAB) Catheter Kit, Ultra 8 IAB, UltraFlex IAB
21 May 2021 21 May 2021Medical Device Safety Alert: CAIR LGL Adapters with the C-Cure valve
20 May 2021 20 May 2021Medical Device Safety Alert: Beckman Coulter AU Creatine Kinase-MB (CK-MB) Reagent
20 May 2021 20 May 2021Medical Device Safety Alert: Lagis Enterprise Co. Ltd Metzenbaum Curved Scissors (EI-330S)
14 May 2021 14 May 2021Medical Device Safety Alert: QIAGEN NeuMoDx Cartridge
12 May 2021 12 May 2021Medical Device Safety Alert: bioMerieux MYLA V4.8.0/4.8.1 and MYLA V4.7.0/4.7.1
11 May 2021 11 May 2021Medical Device Safety Alert: Terumo HARVEST Platelet-Rich Plasma (PRP) Procedure Packs
10 May 2021 10 May 2021Medical Device Safety Alert: RaySearch Laboratories AB (publ) RayStation/RayPlan 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 2, including some service packs
05 May 2021 05 May 2021Medical Device Safety Alert: Johnson & Johnson GYNECARE INTERCEED 3INX4IN
05 May 2021 05 May 2021Medical Device Safety Alert: Terumo Cardiovascular Systems Sarns TCM and TCM II Cooling and Heating Systems; HX2 Temperature Management Systems
05 May 2021 05 May 2021Medical Device Safety Alert: Philips Continuous CT Fluoroscopy Digital Visual Interface (DVI) Ceiling Mount
03 May 2021 03 May 2021Medical Device Safety Alert: Philips Ingenia 1.5T, Ingenia 1.5T (S), Ingenia 1.5T CX, Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Ambition S, Ingenia Ambition X, Ingenia Elition S, Ingenia Elition X, Smartpath to dStream 1.5T and Smartpath to dStream for XR and 3.0T
26 Apr 2021 26 Apr 2021Medical Device Safety Alert: Beckman Coulter PK7400 Automated Microplate System
26 Apr 2021 26 Apr 2021Medical Device Safety Alert: Medtronic Covidien DAR airway products
26 Apr 2021 26 Apr 2021Medical Device Safety Alert: Beckman Coulter MicroScan Gram Negative panels with Mecillinam
23 Apr 2021 23 Apr 2021Medical Device Safety Alert: Boston Scientific ELUVIA Drug Eluting Vascular Stent System
20 Apr 2021 20 Apr 2021Medical Device Safety Alert: Beckman Coulter Access 25(OH) Vitamin D Total for use on Access 2 and Dxl
20 Apr 2021 20 Apr 2021Medical Device Safety Alert: Beckman Coulter IMMAGE Immunochemistry Systems IgE Immunoglobulin E Reagent
19 Apr 2021 19 Apr 2021Medical Device Safety Alert: BArjo Nimbus 4 & Nimbus Professional Mattress
16 Apr 2021 16 Apr 2021Medical Device Safety Alert: Boston Scientific Upsylon Y Mesh Kit with Colpassist Vaginal Positioning Device & Colpassist Vaginal Positioning Device
15 Apr 2021 15 Apr 2021Medical Device Safety Alert: Boston Scientific POLARSHEATH Steerable Sheath
15 Apr 2021 15 Apr 2021Medical Device Safety Alert: Ortho Clinical Diagnostics 0.8% Resolve Panel B
14 Apr 2021 14 Apr 2021Medical Device Safety Alert: Boston Scientific VICI and VICI RDS Venous Stent Systems
13 Apr 2021 13 Apr 2021Medical Device Safety Alert: Beckman Coulter Access Sensitive Estradiol
01 Apr 2021 01 Apr 2021Medical Device Safety Alert: Roche Diagnostics cobas 6800/8800 Systems Rack Tray
31 Mar 2021 31 Mar 2021Medical Device Safety Alert: Beckman Coulter Access Sensitive Estradiol
30 Mar 2021 30 Mar 2021Medical Device Safety Alert: Boston Scientific AMS 700 Spherical and Conceal Reservoir with InhibiZone
30 Mar 2021 30 Mar 2021Medical Device Safety Alert: Macherey-Nagel GmbH & Co. KG Medi-Test Combi 11
30 Mar 2021 30 Mar 2021Medical Device Safety Alert: Smiths Medical ACE MDI Spacer with Small Mask and Palm Cups (Large)
30 Mar 2021 30 Mar 2021Medical Device Safety Alert: Smiths Medical Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks, Tubing and LogiCal Kits
26 Mar 2021 26 Mar 2021Medical Device Safety Alert: Medtronic INTELLIS MODEL 97755 RECHARGER
24 Mar 2021 24 Mar 2021Medical Device Safety Alert: Medtronic VenaSeal Closure System
19 Mar 2021 19 Mar 2021Medical Device Safety Alert: Baxter Healthcare Colleague Single Channel CXE, Colleague Triple Channel CXE, EVO IQ LVP and EVO IQ SYR
16 Mar 2021 16 Mar 2021Medical Device Safety Alert: Abbott ASSURITY and ENDURITY pacemakers
16 Mar 2021 16 Mar 2021Medical Device Safety Alert: Boston Scientific EXALT Controller
15 Mar 2021 15 Mar 2021Medical Device Safety Alert: Beckman Coulter Access SARS-CoV-2 IgG II assay
12 Mar 2021 12 Mar 2021Medical Device Safety Alert: Becton Dickinson Infusion Sets for Alaris Pumps (GP, VP, CC, GW/GW800, SE, IVAC 590 series) and Gravity Infusion Sets & Connectors
11 Mar 2021 11 Mar 2021Medical Device Safety Alert: Teleflex Arrow OnControl Bone Lesion Biopsy System Tray
10 Mar 2021 10 Mar 2021Medical Device Safety Alert: Boston Scientific MAMBA 135 and MAMBA Flex 135 Microcatheters
09 Mar 2021 09 Mar 2021Medical Device Safety Alert: Baxter COLLEAGUE SINGLE CHANNEL CXE & COLLEAGUE TRIPLE CHANNEL CXE
09 Mar 2021 09 Mar 2021Medical Device Safety Alert: Abbott Amplatzer TorqVue LP (TVLP) System (80cm)
08 Mar 2021 08 Mar 2021Medical Device Safety Alert: Biotronik Implantable Cardioverter Defibrillators ("ICDs") and Cardiac Resynchronization Therapy Defibrillators ("CRT-Ds")
08 Mar 2021 08 Mar 2021Medical Device Safety Alert: Medtronic Covidien Signia Small Diameter Curved Tip Intelligent Reload
04 Mar 2021 04 Mar 2021Medical Device Safety Alert: Biosense Webster Irrigated Catheters
04 Mar 2021 04 Mar 2021Medical Device Safety Alert: Biosense Webster, CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath
03 Mar 2021 03 Mar 2021Medical Device Safety Alert: Medtronic HeartWare HVAD Power Cables, Monitor Data Cables, and Controller Ports, HeartWare HVAD System
03 Mar 2021 03 Mar 2021Medical Device Safety Alert: Hologic Panther Fusion Tube Trays
03 Mar 2021 03 Mar 2021Medical Device Safety Alert: Accuray CyberKnife System with Standard Treatment Couch
03 Mar 2021 03 Mar 2021Medical Device Safety Alert: Karl Storz Hysteromat E.A.S.I
02 Mar 2021 02 Mar 2021Medical Device Safety Alert: DePuy Synthes MBT & ATTUNE Tibial Bases (S+)
01 Mar 2021 01 Mar 2021Medical Device Safety Alert: Beckman Coulter Access AMH Calibrators
01 Mar 2021 01 Mar 2021Medical Device Safety Alert: Beckman Coulter IMMAGE Immunochemistry System APB Apolipoprotein B Reagent, IMMAGE Immunochemistry System LPAX Lipoprotein (a) Reagent, IMMAGE Immunochemistry System PAB Prealbumin Reagent
01 Mar 2021 01 Mar 2021Medical Device Safety Alert: BioMérieux VIDAS CMV IgM
24 Feb 2021 24 Feb 2021Medical Device Safety Alert: RaySearch Laboratories AB (publ) RayStation 4.5, 4.7, 4.9, 5, 6, 7, 8A, 8B, 9A, 9B, 10A, 10B, RayPlan 1, 2, 7, 8A, 8B, 9A, 9B, 10A, 10B, including some of the service packs
23 Feb 2021 23 Feb 2021Medical Device Safety Alert: Boston Scientific DC Bead, DC Bead M1, and DC Bead LUMI Radiopaque Microspheres
18 Feb 2021 18 Feb 2021Medical Device Safety Alert: Medtronic Valiant Navion Thoracic Stent Graft System
16 Feb 2021 16 Feb 2021Medical Device Safety Alert: In2Bones SAS-Pack 5 Shannon burrs
11 Feb 2021 11 Feb 2021Medical Device Safety Alert: Stryker SILVERGlide Non-Stick Precision Bipolar Forceps
11 Feb 2021 11 Feb 2021Medical Device Safety Alert: Steripack S.A Steriflush Prefilled 0.9% Sodium Chloride Syringes and Procedure Packs Containing Steriflush Prefilled 0.9% Sodium Chloride Syringes
09 Feb 2021 09 Feb 2021Medical Device Safety Alert: Maquet Heater-Cooler Unit HCU 40
08 Feb 2021 08 Feb 2021Medical Device Safety Alert: Boston Scientific 4G LATITUDE MIMIC Cell Adapter
04 Feb 2021 04 Feb 2021Medical Device Safety Alert: Baxter Prismaflex Control Unit
29 Jan 2021 29 Jan 2021Medical Device Safety Alert: BioFire Diagnostics BioFire FilmArray Blood Culture Identification (BCID) Panel and BioFire Blood Culture Identification 2 (BCID2) Panel used with BD BACTECTM Blood Culture Vials
25 Jan 2021 25 Jan 2021Medical Device Safety Alert: Getinge SERViNO and SoKINOX NO delivery and monitoring system
22 Jan 2021 22 Jan 2021Medical Device Safety Alert: ConvaTec AQUACEL Ag Dressing
21 Jan 2021 21 Jan 2021Medical Device Safety Alert: Sartorius Minisart NML / Ophthalsart
19 Jan 2021 19 Jan 2021Medical Device Safety Alert: Medtronic Strata II, Delta, and CSF-Flow Control Valves and Shunts
11 Jan 2021 11 Jan 2021Medical Device Safety Alert: Philips V680 Ventilators (Backup Battery)
11 Jan 2021 11 Jan 2021Medical Device Safety Alert: Philips Healthcare Philips V680 ventilators (Navigation Ring)
06 Jan 2021 06 Jan 2021Medical Device Safety Alert: Baxter ArtiSet Blood Tubing Sets (Product Codes: 955075, 955077)
04 Jan 2021 04 Jan 2021Medical Device Safety Alert: Beckman Coulter Access SARS-CoV-2 IgG Quality Control
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