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High RiskFDA
Ge Medical Systems Information Technologies, Inc.
CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitors B850, B650, and B450 v2.0.7 or earlier software The PDM i...
Cardiac Devices·1,196 affected·Jul 13, 2017
High RiskFDA
Stutzman Farms
STUTZMAN FARMS Savory Sprouted Spelt Crackers Net Wt. .30 LB. (136 g)
Bakery & Grains·8 affected·Jul 12, 2017
High RiskFDA
Stutzman Farms
STUTZMAN FARMS Organic Spelt Berries 25 lb 11.4 kg 6197
Produce·25 affected·Jul 12, 2017
High RiskFDA
Fusion Iv Pharmaceuticals, Inc. Dba Axia Pharmaceutical
Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angel...
Drugs·120 affected·Jul 12, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinical), and 27630 and 17630R (industry) software and reagent cards designed for t...
Diagnostic Devices·9,234 affected·Jul 12, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
CORAIL HIGH OFFSET STEM Collarless SIZE 14
Medical Devices·19 affected·Jul 12, 2017
High RiskFDA
Biomerieux Inc
VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software and reagent cards designed for the identification (ID) and antimicrobial sus...
Diagnostic Devices·1,866 affected·Jul 12, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Medical Devices·559 affected·Jul 11, 2017
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tomography X-ray systems
Medical Devices·559 affected·Jul 11, 2017
High RiskFDA
Reshmi's Group Inc.
Sooji Coarse, Siva's brand, packaged in 2 lbs. and 4 lbs poly bags. UPC for 2 lbs. package is 8 46499 00316 1 UPC for 4 lbs. package...
Food·30 affected·Jul 10, 2017
High RiskFDA
Zimmer Dental Inc
IMPLANT,1-PC,ANG,3.0X10MM, REF ZOP30A10; IMPLANT, 1-PC, ANG, 3.0X11.5MM, REF ZOP30A11; IMPLANT, 1 -PC,ANG,3.0X13MM, REF ZOP30A13; ...
Medical Implants·169 affected·Jul 10, 2017
High RiskFDA
Zimmer Dental Inc
Guide Sleeve 3.25 REF 2220, Guide Sleeve 3.75 REF 2221, Guide Sleeve REF 2222, Guide Sleeve REF 2223
Medical Devices·349 affected·Jul 10, 2017
High RiskFDA
Arrow International Inc
Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to o...
Surgical Devices·0 affected·Jul 10, 2017
High RiskFDA
Zimmer Dental Inc
ABUT GOLD FRICTION-FIT, REF HLA3G; ABUT GOLD FRICTION-FIT, REF HLA4G; COPING GOLD ENG 5.7 MM, REF HLA5G; COPING GOLD NON-ENG. 3.5, RE...
Medical Devices·13,235 affected·Jul 10, 2017
High RiskFDA
Zimmer Dental Inc
WAXING COPING, CONT 3.5 MM,ANG, REF ZOCWAX3A; WAXING COPING, CONT 3.5 MM, REF ZOCWAX3S; WAXING COPING, CONT 4.5MM, ANG, REF ZOCWAX4A; ...
Medical Devices·423 affected·Jul 10, 2017
High RiskFDA
Zimmer Dental Inc
TRY-IN,ABUTMENT, CONT, 3.5X4.5, REF ZOAT34; TRY-IN, ABUTMENT, CONT, 4.5X5.5, REF ZOAT45; TRY-IN, ABUTMENT, CONT, 5.7X6.5, REF ZOAT5...
Medical Devices·76 affected·Jul 10, 2017
High RiskFDA
Zimmer Dental Inc
IMPRESSION CAP CONT 3.5MM, REF ZOCIMP3A; MPRESSION CAP CONT 3.5MM, REF ZOCIMP3S; IMPRESSION CAP CONT 4.5MM ANG, REF ZOCIMP4A; IM...
Medical Devices·86 affected·Jul 10, 2017
High RiskFDA
Zimmer Dental Inc
THREAD RETRIEVAL DRILL REF 2224
Medical Devices·237 affected·Jul 10, 2017
High RiskFDA
Amendia, Inc
Mac Pin Non-Cannulated Screw, 6.5 x 60mm
Medical Devices·41 affected·Jul 7, 2017
High RiskFDA
Qualigen Inc
Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit, catalog number 25000068 Vitamin D immunoassay kit
Diagnostic Devices·493 affected·Jul 7, 2017
High RiskFDA
Ondamed Inc
Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation...
Medical Devices·585 affected·Jul 7, 2017
High RiskFDA
Isabel North America, Inc.
ISABEL, Octopus in vegetable oil, Pulpo en aceite vegetal, Net wt - Peso Neto 4 oz(115g)
Produce·5,037 affected·Jul 6, 2017
High RiskFDA
Isabel North America, Inc.
ISABEL, Octopus in marinera sauce, Pulpo en salsa marinera, Net wt - Peso Neto 4 oz(115g)
Food·689 affected·Jul 6, 2017
High RiskFDA
Isabel North America, Inc.
ISABEL, Octopus in garlic sauce, Pulpo al ajillo, Net wt - Peso Neto 4 oz(115g)
Food·5,397 affected·Jul 6, 2017
High RiskFDA
Coborn's, Inc
Fudge Brownie, Net Wt. 9 oz. (0.6 lb.) (255g), with the following brands: 1. Cashwise Gluten Free Bakery, 2. Coborn's Gluten Free Bakery.
Food·122 affected·Jul 6, 2017
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distribut...
Injectable Drugs·131,904 affected·Jul 6, 2017
High RiskFDA
Baxter Healthcare Corporation
5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Co...
Injectable Drugs·54,528 affected·Jul 6, 2017
High RiskFDA
Baxter Healthcare Corporation
0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product C...
Injectable Drugs·295,200 affected·Jul 6, 2017
High RiskFDA
Edwards Lifesciences, Llc
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to ef...
Surgical Devices·200 affected·Jul 6, 2017
High RiskFDA
Precision Dose Inc.
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-...
Oral Drugs·480 affected·Jul 5, 2017
High RiskFDA
Phadia Us Inc
Phadia 1000 Instrument, Article Number 12-3800-01.
Medical Devices·70 affected·Jul 5, 2017
High RiskFDA
Novo Nordisk Inc
Dial-A-Dose Insulin Delivery Device (Pen-Injector) cartridge holders Product Usage: The NovoPen Echo¿ is a re-usable pen injector for...
Diabetes Devices·16,557 affected·Jul 5, 2017
High RiskFDA
Cosman Medical, Llc
Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15...
Medical Devices·11,250 affected·Jul 5, 2017
High RiskFDA
Roche Diagnostics Corporation
cobas e 411 Immunoassay Analyzer-Model/Catalog/Part number: 04775279001/04775279973 - cobas e 411 analyzer (disk system) and 04775201001/...
Diagnostic Devices·923 affected·Jul 5, 2017
High RiskFDA
Roche Diagnostics Corporation
Roche / Hitachi MODULAR Analyzer Systems-Immunoassay Analyzer-Model/Catalog/Part Number: 11568248001/11568248692 - Elecsys 2010 analyzer ...
Diagnostic Devices·255 affected·Jul 5, 2017
High RiskFDA
Orthofix Srl
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit...
Medical Devices·416 affected·Jul 5, 2017
High RiskFDA
Baxter Healthcare Corporation
HomeChoice Automated PD system Model numbers: 5C4471, 5C4471R Product Usage: The HomeChoice Automated Personal Cycler is intended fo...
Medical Devices·15,144 affected·Jul 5, 2017
High RiskFDA
Baxter Healthcare Corporation
HomeChoice Pro Automated PD system Model numbers: 5C8310, 5C8310R Product Usage: The HomeChoice Automated Personal Cycler is intende...
Medical Devices·23,732 affected·Jul 5, 2017
High RiskFDA
Centurion Medical Products Corporation
SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code ...
Medical Devices·0 affected·Jul 5, 2017
High RiskFDA
Stanmore Implants Worldwide Ltd.
JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is intended for the replacement of diseased or deficient bone in t...
Medical Implants·15 affected·Jul 4, 2017
High RiskFDA
The Kroger Co
Comforts FOR BABY Purified Water with Flouride Added. 1 GAL (3.78 L) DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202
Beverages·107,874 affected·Jul 3, 2017
High RiskFDA
Nisbet Oyster Co Inc
Steamers in 5 Clams in Butter & Garlic Sauce, Goose Point brand. Product is packaged in a plastic tray with heat sealed plastic film and...
Dairy·4,610 affected·Jul 3, 2017
High RiskFDA
Trinidad Benham Corp
HY-TOP Rice MIX CHICKEN FLAVORED RICE & VERMICELLI WITH SEASONINGS NET WT 6.9 OZ (196g)
Meat & Poultry·393 affected·Jul 3, 2017
High RiskFDA
Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers
Surgical Devices·6 affected·Jul 3, 2017
High RiskFDA
Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser UL C02 Laser surgical lasers
Surgical Devices·92 affected·Jul 3, 2017
High RiskFDA
Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser Diode Laser surgical lasers
Surgical Devices·13 affected·Jul 3, 2017
High RiskFDA
Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser UL Station surgical lasers
Surgical Devices·199 affected·Jul 3, 2017
High RiskFDA
Avid Medical, Inc.
AVID Medical QA Pack AV10654-10
Medical Devices·330 affected·Jul 3, 2017