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High RiskFDA
Cascade Kelly Holdings Llc
Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Ma...
Topical Drugs·0 affected·Jun 30, 2021
High RiskFDA
Cascade Kelly Holdings Llc
Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Ma...
Topical Drugs·0 affected·Jun 30, 2021
High RiskFDA
Ge Healthcare, Llc
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at diffe...
Cardiac Devices·0 affected·Jun 30, 2021
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q flo...
Diagnostic Devices·70 affected·Jun 30, 2021
High RiskFDA
Ge Healthcare, Llc
Revolution Apex, Revolution CT with Apex Edition
Medical Devices·273 affected·Jun 30, 2021
High RiskFDA
Baxter Healthcare Corporation
Sharesource Connectivity Platform for Use with the Amia Automated PD System
Medical Devices·1 affected·Jun 30, 2021
High RiskFDA
Merit Medical Systems, Inc.
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 008844504...
Cardiac Devices·760 affected·Jun 30, 2021
High RiskFDA
Aesculap Implant Systems Llc
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Medical Devices·2 affected·Jun 30, 2021
High RiskFDA
San Diego Coffee, Tea And Spice
Pow Pow Powders: A standard of Quality Spice Chai; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Dairy Creamer (coconut oil, Corn S...
Dairy·75 affected·Jun 29, 2021
High RiskFDA
San Diego Coffee, Tea And Spice
Pow Pow Powders: A standard of Quality Hot Cocoa Mix; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Dairy Creamer (coconut oil, Co...
Dairy·75 affected·Jun 29, 2021
High RiskFDA
San Diego Coffee, Tea And Spice
Pow Pow Powders: A standard of Quality Vanilla Chai; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Fat Dry Milk, Non-Dairy Creamer ...
Dairy·0 affected·Jun 29, 2021
High RiskFDA
San Diego Coffee, Tea And Spice
Pow Pow Powders: A standard of Quality Mocha Latte; NET Wt. 3.50 lb. (1.59kg) Ingredients: Sugar, Non-Dairy Creamer (coconut oil, Corn ...
Dairy·75 affected·Jun 29, 2021
High RiskFDA
Eli Lilly & Company
Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285,...
Injectable Drugs·36,540 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutr...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lippe...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Li...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Lin...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech BIOLOX delta Femoral Head, 36m O.D. + 3.5mm, REF 170-36-03. Hip prosthesis component.
Medical Implants·30 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Medical Implants·29 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 De...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Line...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Lin...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Lin...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Exactech, Inc.
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, ...
Medical Implants·89,050 affected·Jun 29, 2021
High RiskFDA
Encore Medical, Lp
AltiVate Anatomic Shoulder System for the following Part Numbers: 1. Part # 520-08-00, Rev. C., 2. Part # 520-10-000, 3. Part # 520-1...
Medical Devices·0 affected·Jun 28, 2021
High RiskFDA
Yakult U.s.a. Inc.
Yakult Nonfat Probiotic Drink; Live and active Lactobacillus casei Shitota; 2.7 FL. OZ. (80 mL), 5 individual bottles per pack, 10 packs ...
Dairy·16,073 affected·Jun 26, 2021
High RiskFDA
Dole Fresh Fruit Company
Dole Fresh Picked-Emballes frais Blueberries/Bleuets: Packed in clear plastic container in the following sizes; 18 oz. - UPC: 0 71430 0...
Produce·7 affected·Jun 25, 2021
High RiskFDA
Fresenius Kabi Usa Llc
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose...
Injectable Drugs·234,800 affected·Jun 25, 2021
High RiskFDA
B. Braun Medical, Inc.
Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Medical Devices·36,144 affected·Jun 25, 2021
High RiskFDA
Opti Medical Systems, Inc
OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004
Medical Devices·3,552 affected·Jun 25, 2021
High RiskFDA
Tornier S.a.s.
The Aequalis Pyrocarbon Humeral Heads. Shoulder implant component. Sold OUS only: a) Catalog # DWH039 - Diameter 39 mm Height 14 mm E...
Medical Implants·6,631 affected·Jun 25, 2021
High RiskFDA
Avanti Frozen Foods
Cooked, Peeled and Deveined, Tail-on, Shrimp. CENSEA, Frozen Cooked, peeled and deveined, Tail Off Shrimps IQF 2 LB Printed Polythene P...
Meat & Poultry·799 affected·Jun 24, 2021
High RiskFDA
Greenwood Ice Cream
JERSEY COOKIE MONSTER ICE CREAM 3 GALLONS (11.34 LITERS) MFG: GREENWOOD ICE CREAM CO LTD 4829 PEACHTREE ROAD, ATLANTA, GA 30341 UPC 0 ...
Dairy·2,454 affected·Jun 24, 2021
High RiskFDA
Cardioquip, Llc
CardioQuip, Modular Cooler-Heater 1000(i), Refrigeration Module, Model: MCH-10RMS, UDI: (01)00860000846127 used with heat exchange devices.
Medical Devices·1,380 affected·Jun 24, 2021
High RiskFDA
Roche Diagnostics Operations, Inc.
cobas infinity central lab running software version 3.01.03 through 3.02.08, Catalog#: 07154003001
Medical Devices·2,058 affected·Jun 24, 2021
High RiskFDA
Biomerieux Inc
ETEST IMIPENEM RELEBACTAM. in vitro diagnostic
Diagnostic Devices·1,431 affected·Jun 24, 2021
High RiskFDA
Bard Peripheral Vascular Inc
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow B...
Medical Devices·3,961 affected·Jun 23, 2021
High RiskFDA
Bard Peripheral Vascular Inc
EJM4011 Jamshidi Evolve" Bone Marrow Biopsy/Aspiration Needle with Specimen Cradle. 11G x 10cm
Medical Devices·560 affected·Jun 23, 2021
High RiskFDA
Beckman Coulter, Inc.
Kaluza C Flow Cytometry Software Versions: 1.0*, 1.1.1 and 1.1.2 Kits: C10574 - Kaluza C Single Perpetual License C10575 - Kaluza C S...
Medical Devices·1,085 affected·Jun 23, 2021
High RiskFDA
Hoyu(us) Logistics Inc
QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun...
Drugs·30,880 affected·Jun 22, 2021