Skip to main content
CriticalFDA
Sanit Technologies, Llc Dba Durisan
Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free, packaged in a) 18 mL Net C...
Drugs·8,609,863 affected·Mar 10, 2021
High RiskFDA
Remel Inc
Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in ...
Medical Devices·19 affected·Mar 10, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Ysio X.pree, Model Number: 11107464 - Product Usage: A Digital X-Ray System generate Xray images from the whole body including the skull...
Medical Devices·12 affected·Mar 10, 2021
RecallFDA
Cardinal Health Inc.
Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc.,...
Injectable Drugs·48 affected·Mar 9, 2021
High RiskFDA
Icu Medical Inc
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045...
Drugs·425,628 affected·Mar 9, 2021
CriticalFDA
Kareem Mart Inc
Kareem Chef Halva 1lb and 2lb sizes in plastic tub
Food·1,320 affected·Mar 8, 2021
RecallFDA
New Generation Wellness Inc.
Live Better vegan vitamin d-3 by CVS Health, 50 mcg (2000 IU), 40 tablets in blue PET jar, Distributed by: CVS Pharmacy, Inc. one CVS Dri...
Supplements·16,477 affected·Mar 8, 2021
High RiskFDA
Quirch Foods
Yellowfin Tuna portions Frozen IVP-CO Treated, Net WT 20 LBS, Size 1 LB.
Seafood·55 affected·Mar 8, 2021
CriticalFDA
Kareem Mart Inc
Kareem Chef Halva with Chocolate 1lb size in plastic tub
Snacks & Candy·600 affected·Mar 8, 2021
CriticalFDA
Kareem Mart Inc
Kareem Chef Halva with Pistachio 1lb and 2lb sizes in plastic tub
Food·2,412 affected·Mar 8, 2021
High RiskFDA
Akorn, Inc.
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech...
Oral Drugs·8,183 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·1,000 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing an...
Cardiac Devices·3,664 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia paci...
Cardiac Devices·702 affected·Mar 8, 2021
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
RecallFDA
Teva Pharmaceuticals Usa
Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01
Drugs·1,416 affected·Mar 4, 2021
High RiskFDA
Roi Cps Llc
Regard, Item Number 830067009, custom cardiovascular procedure kit
Medical Devices·16 affected·Mar 4, 2021
CriticalFDA
Covidien, Lp
Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
Medical Devices·5,928 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
CriticalFDA
Covidien, Lp
Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
Medical Devices·15,298 affected·Mar 4, 2021
High RiskFDA
P-chip Corporation
p-Chip Wand Reader
Medical Devices·329 affected·Mar 3, 2021
CriticalFDA
Carefusion 303, Inc.
BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Part...
Medical Devices·160,300 affected·Mar 3, 2021
CriticalFDA
Medtronic Perfusion Systems
Medtronic Bio-Console 560 Extracorporeal Blood Pumping Console, Model Numbers: 560BC, 560BC1, 560BCS, 560BCS1, R560BCS1. Used in cardio...
Medical Devices·387 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
CriticalFDA
Canteen Inc. Dba Mg Foods, Inc.
MG Foods TURKEY & PROVOLONE BLT ON A BUTTERY CROISSANT, Net Wt. 8.1oz (229g), MG Foods Charlotte, NC 28208, UPC 1 00000 50065 1
Dairy·65 affected·Mar 2, 2021
CriticalFDA
Canteen Inc. Dba Mg Foods, Inc.
FRESH TO YOU Turkey Swiss & Cranberry Mayo Pita, Net Wt. 9oz (255g), MG Foods Charlotte, NC 28208, UPC MGF9804
Meat & Poultry·6 affected·Mar 2, 2021