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High RiskFDA
Biopsybell S.r.l.
10 GAUGE DIRECT UNILATERAL STYLET(1 X DIAMOND 1 X BEVEL), CODE INTVM-DSSKBD
Medical Devices·625 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
10G DIRECT WORKING CANNULA BEVEL TIP 15CM, CODE INTVM-DWCB/15
Medical Devices·50 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTVM-DWCB
Medical Devices·30 affected·Mar 22, 2021
High RiskFDA
Normand-info S.a.s.u.
Normand Remisol Advance Data Manager is a software device that interfaces between laboratory information systems (LIS) and laboratory ins...
Medical Devices·8,402 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
10 GAUGE DRILL, CODE INTVM-DRL
Medical Devices·75 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
BPB medica RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP, 187 mm, 10G, RES RESWTR1112C-US
Medical Devices·10 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
8G DIRECT WORKING CANNULA BEVEL TIP, CODE INTV-DWCB
Medical Devices·30 affected·Mar 22, 2021
High RiskFDA
Biopsybell S.r.l.
10 GAUGE SINGLE CEMENT DELIVERY 4 FILLERS 4 SYRINGES, CODE INTVM-SCDK
Medical Devices·305 affected·Mar 22, 2021
High RiskFDA
Ampi
AMPI Buttermilk Powder, formula 219. 25 KG Net (55.12 Lbs Net). Distributed by: Associated Milk Producers, Inc., New Ulm, Minnesota 5...
Dairy·621 affected·Mar 19, 2021
High RiskFDA
X-gen Pharmaceuticals Inc.
Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14...
Oral Drugs·720 affected·Mar 19, 2021
High RiskFDA
Carefusion 213, Llc
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10...
Drugs·7,990,100 affected·Mar 19, 2021
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.10 fl. oz. (3 ...
Drugs·14,275,400 affected·Mar 19, 2021
High RiskFDA
Golden State Medical Supply Inc.
Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA...
Oral Drugs·0 affected·Mar 19, 2021
High RiskFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each,...
Drugs·24,969,700 affected·Mar 19, 2021
High RiskFDA
Carefusion 213, Llc
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3...
Drugs·40,720,900 affected·Mar 19, 2021
High RiskFDA
Aesculap Implant Systems Llc
Univation X System knee implant devices as follows: Catalog/Product: NL470 UNIVATION F MENISCAL COMP.T1 RM/LM 7MM; NL471 UNIVATION F ...
Medical Implants·0 affected·Mar 19, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a...
Diagnostic Devices·133 affected·Mar 19, 2021
High RiskFDA
Cardiac Assist, Inc
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 ...
Surgical Devices·13 affected·Mar 19, 2021
High RiskFDA
Cytocell Ltd.
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481
Diagnostic Devices·89 affected·Mar 19, 2021
High RiskFDA
Aesculap Implant Systems Llc
Univation X System knee implant devices as follows: Catalog/Product: NO156Z AS UNIVATION XF TIBIA CEMENTED T1 RM; NO157Z AS UNIVATI...
Medical Implants·0 affected·Mar 19, 2021
High RiskFDA
Aesculap Implant Systems Llc
Univation X System knee implant devices as follows: Catalog/Product: NL494 UNIVATION F MENISCAL COMP.T1 RM/LM 11MM; NL495 UNIVATION ...
Medical Implants·0 affected·Mar 19, 2021
High RiskFDA
Aesculap Implant Systems Llc
Univation X System knee implant devices as follows: Catalog/Product: NO180Z AS UNIVATION XF FEMUR CEMENTED F1 RM; NO181Z AS UNIVATI...
Medical Implants·0 affected·Mar 19, 2021
High RiskFDA
Ge Healthcare, Llc
Revolution CT
Medical Devices·197 affected·Mar 19, 2021
High RiskFDA
Aesculap Implant Systems Llc
Univation X System knee implant devices as follows: Catalog/Product: NL476 UNIVATION F MENISCAL COMP.T1 RM/LM 8MM; NL477 UNIVATION F ...
Medical Implants·0 affected·Mar 19, 2021
High RiskFDA
Babco Foods International, Llc
Anand Far Far (Garlic Sandige) Net Weight 7 oz./200 g package ingredients: rice, wheat flour, garlic, red chilli, refined palm oil and ...
Beverages·10 affected·Mar 18, 2021
High RiskFDA
Waldemar Link Gmbh & Co. Kg (mfg Site)
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
Medical Implants·22 affected·Mar 18, 2021
High RiskFDA
Gentueri Inc
Gentueri Viral Transport Medium (VTM), Sterile, IVD
Medical Devices·4,150 affected·Mar 18, 2021
High RiskFDA
Power Selles Imports Dba Culinary Collective
Blanxart Milk Chocolate with Hazelnuts Cacao 33% Min. Net wt.7 oz. Product is packaged with paper and internal foil wrapper. UPC 6 66785 ...
Dairy·12 affected·Mar 17, 2021
High RiskFDA
Change Healthcare Canada Company
Change Healthcare Enterprise Viewer
Medical Devices·28 affected·Mar 17, 2021
High RiskFDA
Medtronic Sofamor Danek Usa, Inc
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usag...
Medical Devices·11 affected·Mar 17, 2021
High RiskFDA
Medtronic Sofamor Danek Usa, Inc
Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Small, 8 mm, Product Number 5146-1208-N - Product Usag...
Medical Devices·11 affected·Mar 17, 2021
High RiskFDA
Becton Dickinson & Co.
BD BBL Martin-Lewis Agar, 100 Ea - Product Usage: used for the isolation of pathogenic Neisseria from specimens containing mixed flora o...
Medical Devices·15,550 affected·Mar 17, 2021
High RiskFDA
Becton Dickinson & Co.
BD BBL Martin-Lewis Agar 20 Ea - Product Usage: use for the isolation of pathogenic Neisseria from specimens containing mixed flora of ba...
Medical Devices·33,660 affected·Mar 17, 2021
High RiskFDA
Bonduelle Usa Inc.
El Sembrador Peas and Carrots, poly bags, 12/16 oz
Food·104 affected·Mar 16, 2021
High RiskFDA
Bonduelle Usa Inc.
EL Sembrador MIxed vegetables, Poly bags, 12/ 32 oz.
Produce·123 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CL3946 Oncology Kit w/5" (13 cm) Add-On Set w/ChemoLock Additive Port, Vented Cap; ChemoLock , Spinning Spiros w/Red Cap - Product U...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CH2060 60mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to ...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Cardinal Health Inc.
OPTICHAMBER DIAMOND SPACER WITH LARGE MASK Item Number: 4742326
Medical Devices·375 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CH3011 30" (76 cm) Appx 3.3 mL, 20 Drop Admin Set w/Integrated ChemoClave Drip Chamber, Spiros w/Red Cap, Bag Hanger - Product Usag...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Cardinal Health Inc.
ACCU-CHEK SMARTVIEW 100 TEST STRIPS Item Number: 4742862
Medical Devices·537 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CL3960 Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/w/ChemoLock Port, Clamp, Anti-Siphon Valve, Spiros ; w/ChemoLock;...
Surgical Devices·0 affected·Mar 16, 2021
High RiskFDA
Cardinal Health Inc.
FREESTYLE LIBRE 2 GLUCOSE MONITORING SYSTEM: Item number: 5658877
Diabetes Devices·2,115 affected·Mar 16, 2021
High RiskFDA
Biomerieux Inc
VIDAS¿ CMV IgM 30 Tests
Medical Devices·18,705 affected·Mar 16, 2021
High RiskFDA
Icu Medical, Inc.
REF CH3397 Oncology Kit w/Spiros¿, Red Cap, Bag Spike w/Clave Additive Port LOT 5118610 - Product Usage: for use in the preparation and p...
Medical Devices·0 affected·Mar 16, 2021
High RiskFDA
Cardinal Health Inc.
FREESTYLE LIBRE 14 DAY GLUCOSE MONITORING SYSTEM. Item Number: 5479084
Diabetes Devices·8,959 affected·Mar 16, 2021
High RiskFDA
Cardinal Health Inc.
DEXCOM G6 SENSOR 3 PACK Item Number: 5447552
Medical Devices·2,357 affected·Mar 16, 2021
High RiskFDA
Cardinal Health Inc.
ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT Item Number: 2990174
Medical Devices·5,356 affected·Mar 16, 2021
High RiskFDA
K2m, Inc
Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Ca...
Medical Devices·1 affected·Mar 16, 2021