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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
High RiskFDA
Beijing Syntech Laser Co., Ltd
Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers
Surgical Devices·11 affected·Jul 3, 2017
RecallUSDA
Willow Tree Poultry Farm, Inc.
Willow Tree Poultry Farm Recalls Chicken Salad Products Due To Misbranding And Undeclared Allergens
Poultry·0 affected·Jul 1, 2017
RecallUSDA
Willow Tree Poultry Farm, Inc.
Willow Tree Poultry Farm Retira Productos De Ensalada De Pollo Debido A Error De Rotulación Y Alergenos No Declarados
Poultry·0 affected·Jul 1, 2017
High RiskFDA
Publix Supermarkets, Inc. (deli Kitchen)
Publix Greenwise Cashew Butter, NET WT 16 oz (1 lb) 454g, Distributed by Publix Super Markets, Inc, Lakeland, FL 33802
Dairy·414 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 120V/60 Hz
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Alcon Research, Ltd.
ORA System with VerifEye+ Cart, Catalog Number 8065998307 For use during intraocular lens surgery
Medical Devices·429 affected·Jun 30, 2017
High RiskFDA
R82 A/s
Heron toilet and bath chair Model 880505-01 & 880505-11
Medical Devices·687 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 230 V
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Zoll Medical Corporation
731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are indicated for use in the management o...
Medical Implants·46 affected·Jun 30, 2017
High RiskFDA
Alcon Research, Ltd.
ORA System with VerifEye, Catalog Number 8065998300 For use during intraocular lens surgery
Medical Devices·367 affected·Jun 30, 2017
High RiskFDA
Carefusion 303, Inc.
VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock ...
Surgical Devices·1,546,800 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 208V/60 Hz
Medical Devices·7,546 affected·Jun 30, 2017
High RiskFDA
Sorin Group Usa, Inc.
STOCKERT Heater-Cooler System 3T, 240V/60 Hz
Medical Devices·7,546 affected·Jun 30, 2017
RecallCPSC
Babies R Us, Buybuy Baby, And Online At Babiesrus.com, Buybuybaby.com, Amazon.com, Kohls.com, Target.com, Zulily.com, Diapers.com, Hautelook.com, And Burtsbeesbaby.com From December 2016 Through May 2017 For About $18.
Burt's Bees Baby Recalls Infant Coveralls Due to Choking Hazard
Children's Products·8,500 affected·Jun 29, 2017
CriticalCPSC
Home Depot Stores Nationwide And Online At Www.homedepot.com From December 2014 Through March 2017 For Between $95 And $110.
Design Solutions International with Home Depot Recalls Light Fixtures Due to Laceration and Burn Hazards
Kitchenware·64,200 affected·Jun 29, 2017
RecallFDA
Teva Pharmaceuticals Usa
Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc....
Oral Drugs·25,264 affected·Jun 29, 2017
Medium RiskFDA
Teva Pharmaceuticals Usa
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., N...
Oral Drugs·196,275 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART 1/4" PEDS PACK, REF 627262502, STERILE EO, Rx Only, 1 EA
Medical Devices·4 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
SORIN GROUP, SMART PERFUSION PACK, SMART CIRCULATORY ASSIST PACK, REF 627255003, STERILE EO, Rx Only, 1 EA
Medical Devices·98 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit includes 9733908 (which includes 9733452 containing 9733449, Str...
Surgical Devices·6 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70...
Surgical Devices·13 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity of the enzyme alanine amino transfera...
Diagnostic Devices·33,233 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Set, Contains Spinous Process Clamps, Short and Tall When used with a Medtronic StealthStation Naviga...
Medical Devices·2,051 affected·Jun 29, 2017
High RiskFDA
Sorin Group Usa, Inc.
NON-STERILE SAMPLE, SORIN GROUP, SMART PERFUSION PACK, REF 627376401, 1 EA, NOT FOR CLINICAL USE
Medical Devices·1 affected·Jun 29, 2017
High RiskFDA
Boston Scientific Corporation
SQ-RX 1010 Pulse Generator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of l...
Cardiac Devices·12,450 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc., Louisville, CO. The ...
Surgical Devices·60 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·19,991 affected·Jun 29, 2017
High RiskFDA
Medtronic Navigation, Inc.
Spine Referencing Instrumentation, Double Spinous Process Clamp, Short When used with a Medtronic StealthStation Navigation System, the ...
Medical Devices·2,051 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·10,056 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measure Ammonia levels in human plasma (hep...
Diagnostic Devices·7,014 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)
Diagnostic Devices·181,072 affected·Jun 29, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium h...
Diagnostic Devices·1,667 affected·Jun 29, 2017