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High RiskFDA
Bliss Bros Dairy, Inc.
Bliss Moose Tracks Ice Cream 64oz Product Code: 51049
Dairy·36 affected·Mar 17, 2016
High RiskFDA
Bliss Bros Dairy, Inc.
Bliss Mix 5% Yog 5gal FRESH Product Code: 79801
Food·40 affected·Mar 17, 2016
High RiskFDA
Bliss Bros Dairy, Inc.
Emack & Bolios Stoney's Dream Ice Cream, 3gal Product Code: 36276
Dairy·50 affected·Mar 17, 2016
High RiskFDA
Bliss Bros Dairy, Inc.
Emack & Bolios Caramel Moose Prints Ice Cream, 3gal Product Code: 36285
Dairy·150 affected·Mar 17, 2016
High RiskFDA
Bliss Bros Dairy, Inc.
Cresent Ridge Vanilla Ice Cream 48oz Product Code: 35410
Dairy·2 affected·Mar 17, 2016
High RiskFDA
Mondelez Puerto Rico
Label reads in part as: "Clight***Naranja*** Orange***CALORIE FREE ARTIFICIALLY FLAVORED DRINK MIX***TWO PACKAGES IN ONE***MAKES 1 LITER*...
Beverages·9,239 affected·Mar 17, 2016
High RiskFDA
Mondelez Puerto Rico
Label reads in part as: "Clight***Lim¿n*** Lemon ***CALORIE FREE ARTIFICIALLY FLAVORED DRINK MIX***TWO PACKAGES IN ONE***MAKES 1 LITER***...
Beverages·9,239 affected·Mar 17, 2016
High RiskFDA
Bliss Bros Dairy, Inc.
Newport Creamery Coffee Ice Cream, 3Gal Product Code: 35104
Dairy·20 affected·Mar 17, 2016
High RiskFDA
Bliss Bros Dairy, Inc.
Cresent Ridge Vanilla Ice Cream 3gal Product Code: 36100
Dairy·4 affected·Mar 17, 2016
High RiskFDA
Bliss Bros Dairy, Inc.
Emack & Bolios Serious Choc Addiction Ice Cream 3gal Product Code: 36271
Dairy·181 affected·Mar 17, 2016
High RiskFDA
Bliss Bros Dairy, Inc.
Cresent Ridge ChocChp CookiDgh WRAP Ice Cream 48oz Product Code: 35403
Dairy·1 affected·Mar 17, 2016
High RiskFDA
Bliss Bros Dairy, Inc.
Bliss French Vanilla Ice Cream 64oz Product Code: 51051
Dairy·42 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Assays: Triglycerides (TGL)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Assay and ADVIA Chemistry Glucose.
Diabetes Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Assays: ENZYMATIC CREATININE
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 14mm Sterile. For use in total knee arthropl...
Medical Devices·0 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Assays: Direct HDL Cholesterol (AHDL)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Ortho-clinical Diagnostics
enGen (TM) Laboratory Automation System configured with Thermo Scientific Recapper Module (230V or 110V -- COMMON/USUAL NAME: enGen (TM) ...
Diagnostic Devices·19 affected·Mar 17, 2016
High RiskFDA
Zimmer Manufacturing B.v.
Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS) Left Height 18mm Sterile For use in total knee arthropla...
Medical Devices·0 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Assays: Triglycerides (TRIG)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRIG_c) REAGENT
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Medtronic Navigation, Inc.-littleton
Medtronic Navigation O-arm 02 surgical x-ray imaging system
Surgical Devices·63 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista Assays: Uric Acid (URCA)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
Diagnostic Devices·137,422 affected·Mar 17, 2016
High RiskFDA
Bumble Bee Foods Llc
Bumble Bee Chunk Light Tuna in Oil, 48cans/case, 5oz., UPC 8660000021
Seafood·410 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Hot smoked Escolar chunks, vacuum packaged, one chunk per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·40 affected·Mar 16, 2016
High RiskFDA
Heb Retail Support Center
Hill Country Fare Chunk Light Tuna in pure vegetable oil NET WT. 5 OZ (142g) packaged in a metal can.
Seafood·5,376 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Hot smoked Atlantic Ocean Perch, vacuumed package, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·108 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Hot smoked Mackerel, vacuum packaged, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·628 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Cold smoked Mackerel, vacuum packaged, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·1,447 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Sliced cold smoked Escolar, 8 oz and 1 lb, vacuum packaged. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·8 affected·Mar 16, 2016
High RiskFDA
Bumble Bee Foods Llc
Bumble Bee Chunk Light Tuna in Water, 6cans, 4pk, 5oz, UPC 8660000736
Seafood·20,721 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Cold smoked white fish, vacuum packaged, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·167 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Salted Mackerel, vacuum packaged, one fish per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·160 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Cold smoked Saira (Saury), vacuum packaged, 3 pieces per package. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·186 affected·Mar 16, 2016
High RiskFDA
Tarry Medical Products, Inc.
DandleLION Kisses, 24% Sterile Organic Sucrose In Purified Water, 2 ml polyethylene vial. For oral use Part Number D 12442 C384
Beverages·86 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Cold smoked Sliced Fish Assorted (cold smoked Salmon and Escolar), 8 oz and 1 lb, vacuum packaged. Manufactured by North Fish USA, Pembr...
Seafood·8 affected·Mar 16, 2016
High RiskFDA
North Fish Usa
Cold smoked sliced Salmon 8 oz and 1 lb, vacuum packaged. Manufactured by North Fish USA, Pembroke Pines, FL 33009
Seafood·8 affected·Mar 16, 2016
High RiskFDA
Terumo Medical Corporation
PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath PINNACLE¿ TIF TIP" Introducer Sheath PINNACLE¿ R/O II Radiopaque ...
Medical Devices·1,370,995 affected·Mar 16, 2016
High RiskFDA
Optovue, Inc.
iVue and iVue 500 (now called iScan) OCT systems with software version 2016.0.0.127 (USA only) and 2016.1.0.127 (out of US) Opthalmic:...
Medical Devices·40 affected·Mar 16, 2016
High RiskFDA
Intuitive Surgical, Inc.
da Vinci S Surgical System (IS4000) user manual English and OUS. Product Usage: The Intuitive Surgical Endoscope Instrument Control S...
Cardiac Devices·248 affected·Mar 16, 2016
High RiskFDA
Nuwati Herbals Inc
Nuwati Herbals SeeLessO'Me Diet and Weight Management Tea packaged in two different size amber glass jars with Net Wt 3 oz. or Net Wt 6 o...
Beverages·2,600 affected·Mar 15, 2016
High RiskFDA
Merit Medical Systems, Inc.
Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; Used to create the primary puncture in the interatrial septum when pa...
Cardiac Devices·25 affected·Mar 15, 2016
High RiskFDA
Ge Medical Systems, Llc
GE Healthcare, Aisys and Aisys CS2. Intended to provide general inhalation anesthesia and ventilator support to a wide range of patien...
Respiratory Devices·952 affected·Mar 15, 2016
High RiskFDA
Polymer Technology Systems, Inc.
PTS Panels CHOL+HDL+GLU Test Strips, Reference Number 5412, for use on CardioChek PA or CardioChek Plus analyzers
Medical Devices·6,467 affected·Mar 15, 2016
High RiskFDA
Ventlab Llc
STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer Intended for use in various clinical s...
Respiratory Devices·2,430 affected·Mar 15, 2016
High RiskFDA
Philips Electronics North America Corporation
Philips Healthcare System X-ray Tomography Computed :
Medical Devices·1,363 affected·Mar 15, 2016