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High RiskFDA
Arrow International Inc
Arrow OnControl Bone Lesion Biopsy System Tray-11 ga 10 cm Access/13 ga 14 cm Biopsy, Product Code: 9464-VC-006 (US) Product Code: 9464-...
Medical Devices·3,756 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pac...
Cardiac Devices·98 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·670 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ve...
Cardiac Devices·0 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK ILIVIA 7, VR-T DF4 ProMRI, REF 404626, UDI: 04035479142131 - Product Usage: intended to provide ventricular tachycardia pacing...
Cardiac Devices·779 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK ITREVIA 7, VR-T DF-1, REF 393040, UDI: 04035479129552 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·499 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK IPERIA 7,VR-T, DX, DF-1, ProMRI, REF 393032, UDI: 04035479129477 - Product Usage: intended to provide ventricular tachycardia p...
Cardiac Devices·3,832 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 VR-T, DF-4, REF 383580, UDI: 04035479125363 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·323 affected·Mar 8, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·674 affected·Mar 5, 2021
High RiskFDA
Boston Scientific Corporation
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in ...
Surgical Devices·52 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·8 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·15 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·132 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·33 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·0 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·195 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·185 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·1 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·27 affected·Mar 5, 2021
High RiskFDA
Covidien
Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083...
Surgical Devices·59,828 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·43 affected·Mar 5, 2021
High RiskFDA
Howmedica Osteonics Corp.
Trial Cutting Guide for Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System, prosthesis, knee, patellofemorotibia...
Medical Implants·113 affected·Mar 5, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
Medical Devices·1,452 affected·Mar 5, 2021
High RiskFDA
Roi Cps Llc
Regard, Item Number 830067009, custom cardiovascular procedure kit
Medical Devices·16 affected·Mar 4, 2021
High RiskFDA
Arjohuntleigh Magog, Inc.
Maxi Sky 1000 (Arjo) and V10 (BHM) Bariatric Ceiling Rail - Mounted Lift with measuring function
Medical Devices·62 affected·Mar 4, 2021
High RiskFDA
P-chip Corporation
p-Chip Wand Reader
Medical Devices·329 affected·Mar 3, 2021
High RiskFDA
Raysearch Laboratories Ab
RayCare 3B (3.1.0.60341) - Product Usage: Intended Use Oncology information system that supports healthcare professionals in delivering c...
Medical Devices·1 affected·Mar 3, 2021
High RiskFDA
Direct Rx
Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA, NDC 619...
Oral Drugs·17 affected·Mar 2, 2021
High RiskFDA
Ferring Pharmaceuticals Inc
Menopur 75 IU, (menotropins for injection), packaged as a) 5 single dose vials of Menotropins for injection, 5 single dose vials of 0.9% ...
Injectable Drugs·1,155,601 affected·Mar 2, 2021
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 10461894, 10470625 - Product Usage: The Behr...
Diagnostic Devices·1,547 affected·Mar 2, 2021
High RiskFDA
Terumo Cardiovascular Systems Corporation
Consist of a distal connection mechanism (either standard Terumo Ball Quick Connect or Terumo Shaft Quick Connect), an articulating arm w...
Medical Devices·12 affected·Mar 2, 2021
High RiskFDA
Cellex
Cellex qSARS-Cov-2 Antigen Rapid Test, 25 tests/box, submitted as EUA202955 "declined to issue"
Medical Devices·44,821 affected·Mar 1, 2021
High RiskFDA
Abiomed, Inc.
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems ...
Medical Devices·4,463 affected·Mar 1, 2021
High RiskFDA
Hitachi Medical Systems America Inc
Ultrasonic pulsed doppler imaging system - Product Usage: intended for use by trained personnel (doctor, Sonographer, etc.) for the diagn...
Cardiac Devices·1 affected·Mar 1, 2021
High RiskFDA
James Leckey Design Ltd
MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.
Medical Devices·2,719 affected·Mar 1, 2021
High RiskFDA
B&g Sweet Heat Peppers
B&G Sweet Heat Pepper Dip, Ready To Eat, Refrigerated, packaged in 10 oz, semi-rigid plastic container. UPC 7 42832 07566 4. Product lab...
Dairy·43 affected·Feb 27, 2021
High RiskFDA
J & J Distributing Company
tastebuds Taco Platter, Net Wt. 26oz. (738g), UPC 0 38232 31683 5; Net Wt. 15.8oz (448g), UPC 0 38232 33235 4, Distributed By H. Brooks &...
Food·371 affected·Feb 26, 2021
High RiskFDA
J & J Distributing Company
Haug Fresh Mini 7 Layer Dip Tray, Net Wt. 22oz (624g), UPC 6 10014 16414 0, Packed and Distributed by J&J Distributing, St Paul Mn 55103
Food·371 affected·Feb 26, 2021
High RiskFDA
J & J Distributing Company
Taco Dip [Kwik Trip], Net Wt. 8oz (227g), UPC 0 38232 36091 3, Distributed By H. Brooks & Co. Mpls MN 55112
Food·371 affected·Feb 26, 2021
High RiskFDA
J & J Distributing Company
Fresh Thyme Taco Dip, Net Wt. 10oz (283g), UPC 8 41330 12368 3
Food·371 affected·Feb 26, 2021
High RiskFDA
J & J Distributing Company
tastebuds Taco Dip, Net Wt. 9oz (255g), UPC 0 38232 31612 5, Distributed By H. Brooks & Co Mpls MN 55112
Food·371 affected·Feb 26, 2021
High RiskFDA
Taylor Farms Northwest, Llc
Item #140804, Egg Salad Croissant Sandwich, Refrigerated, packaged in clear plastic clamshell container. Ready to Eat product sold in foo...
Dairy·701 affected·Feb 26, 2021
High RiskFDA
J & J Distributing Company
Haug Fresh Taco Tray, Net Wt. 29 oz. (823g), UPC 6 10014 16416 4; Net Wt. 16 oz (454g), UPC 6 10014 16383 9; Net Wt. 16 oz (454g), UPC 6 ...
Food·371 affected·Feb 26, 2021
High RiskFDA
J & J Distributing Company
Earthgrown Mini Taco Dip, Net Wt. 8oz. (227g), UPC 6 10014 22341 0, Packed By J&J Distributing Inc. 653 Rice St, St Paul, MN 55103
Food·371 affected·Feb 26, 2021
High RiskFDA
J & J Distributing Company
Caribou Coffee Turkey Sandwich, Net Wt. 9.0oz. (255g)
Meat & Poultry·371 affected·Feb 26, 2021
High RiskFDA
J & J Distributing Company
Taco Platter [Kwik Trip], Net Wt. 15.8oz (448g), UPC 0 38232 36090 6, Distributed By H. Brooks & Co. Mpls MN 55112
Food·371 affected·Feb 26, 2021
High RiskFDA
The Quaker Oats Company
Quaker Rice Crisps Sweet Barbecue Flavor, 3.03 oz. bag, UPC 0 30000 31984 0
Food·4,550 affected·Feb 26, 2021
High RiskFDA
J & J Distributing Company
tastebuds Layered Fiesta Taco Dip, Net Wt. 9 oz. (255g), UPC 0 38232 31611 8, Distributed By H. Brooks & Co Mpls MN 55112
Food·371 affected·Feb 26, 2021