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High RiskFDA
Beckman Coulter Inc.
SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) reagent, when used in conjunction with Synchron LX¿ System(s...
Diagnostic Devices·3,353 affected·May 28, 2013
High RiskFDA
Medtronic Sofamor Danek Usa Inc
INFUSE(R) Bone Graft, LARGE II KIT, REF 7510800AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 o...
Medical Devices·2,090 affected·May 28, 2013
High RiskFDA
Medtronic Sofamor Danek Usa Inc
INFUSE(R) Bone Graft, SMALL KIT, REF 7510200AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orth...
Medical Devices·1,319 affected·May 28, 2013
High RiskFDA
Medtronic Sofamor Danek Usa Inc
INFUSE(R) Bone Graft, LARGE KIT, REF 7510600, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 orthopa...
Medical Devices·4,885 affected·May 28, 2013
High RiskFDA
Elekta, Inc.
All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads Product Usage: Deliver of...
Medical Devices·472 affected·May 28, 2013
High RiskFDA
Abbott Medical Optics, Inc.
STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95...
Medical Devices·1,882 affected·May 28, 2013
High RiskFDA
Medtronic Sofamor Danek Usa Inc
INFUSE(R) Bone Graft, MEDIUM KIT, REF 7510400AUS, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132 ort...
Medical Devices·400 affected·May 28, 2013
High RiskFDA
Dental Ez Stardental Division
StarDental Classique(TM) Diamond Dental Bur. Used for specific applications in dental procedures.
Medical Devices·3,560 affected·May 28, 2013
High RiskFDA
Abbott Medical Optics, Inc.
STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 The STAR Excimer...
Medical Devices·1,882 affected·May 28, 2013
RecallFDA
Boston Scientific Corporation
RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation ...
Medical Devices·91 affected·May 28, 2013
High RiskFDA
Earthlabs, Inc. Dba Wise Woman Herbals
Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR
Topical Drugs·581 affected·May 27, 2013
High RiskFDA
Salmolux (a Pacific Seafood Group Company)
ATLANTIC SALMON: 1) "***Raley's***NOVA LOX***NET WT 4 OZ (113 g)***INGREDIENTS: ATLANTIC SALMON (FARM RAISED-COLOR ADDED), SALT, SUGAR...
Seafood·0 affected·May 25, 2013
High RiskFDA
Salmolux (a Pacific Seafood Group Company)
"***NORWEGIAN SMOKED SALMON (NOVA LOX)***Net Wt. 8 oz (227g)***INGREDIENTS: Atlantic Salmon (Farm Raised-Color Added), Salt, Sugar, Sodiu...
Seafood·0 affected·May 25, 2013
High RiskFDA
Salmolux (a Pacific Seafood Group Company)
KETA SALMON: 1) "***ALASKAN SMOKED SALMON (NOVA LOX)***Net WT. 16 oz (454g)***INGREDIENTS: Wild Keta Salmon, Salt, Sugar, Sodium Nitrit...
Seafood·0 affected·May 25, 2013
High RiskFDA
Salmolux (a Pacific Seafood Group Company)
"***WILD ALASKAN NOVA LOX SMOKED SALMON***Sea Passion***INGREDIENTS: Wild Alaskan Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6, FD...
Seafood·0 affected·May 25, 2013
High RiskFDA
Salmolux (a Pacific Seafood Group Company)
SOCKEYE SALMON: 1) "***SMOKED WILD SOCKEYE SALMON (NOVA LOX)***INGREDIENTS: Wild Sockeye Salmon, Salt, Sugar, Natural Wood Smoke. CONT...
Seafood·0 affected·May 25, 2013
CriticalFDA
Salmolux (a Pacific Seafood Group Company)
"***JENSEN'S SEATTLE STYLE SMOKED WILD PACIFIC SALMON ***JENSEN'S SMOKEHOUSE, INC.***10520 GREENWOOD AVE N***SEATTLE, WA 98133*** (206) 3...
Seafood·4,930 affected·May 25, 2013
High RiskFDA
Hospira Inc.
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60...
Injectable Drugs·94,110 affected·May 25, 2013
CriticalFDA
Fresenius Kabi Usa, Llc
Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharma...
Injectable Drugs·15,625 affected·May 25, 2013
CriticalFDA
Blessing Seafood, Inc.
Blessing Brand Wild White EZ Peel Shrimp, 16/20 CT. 4 x 5 lbs cartons. The product is bagged in 5 lbs clear plastic bags, the only lab...
Seafood·36,920 affected·May 24, 2013
High RiskFDA
Abco Laboratories, Inc.
Soy Protein Isolate; 79 bulk raw material lots and 52 finished product lots. Soy Protein Isolate was sold in bulk to two customers, b...
Food·52 affected·May 24, 2013
High RiskFDA
Gyrus Acmi, Incorporated
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD,...
Respiratory Devices·100 affected·May 24, 2013
High RiskFDA
Fresenius Medical Care Holdings, Inc.
Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodi...
Medical Devices·725 affected·May 24, 2013
CriticalCPSC
The Home Depot Stores In The Following Regions: Washington D.c.; San Diego, Calif.; San Francisco, Calif.; Las Vegas, Nev. And Houston, Texas In September 2012 For Between $179 And $389.
Nourison Recalls Rugs Due to Fire Hazard; Sold Exclusively at Home Depot
Kitchenware·1,400 affected·May 23, 2013
High RiskFDA
Mother Earth International Llc
Mother Earth Products, Veggie Burger, Textured Vegetable Protein, packaged in 2-cup mylar bags, 1-quart mylar bags, 1-quart plastic jar, ...
Produce·210 affected·May 23, 2013
High RiskFDA
Good Source Incorporated
Vegetarian Burger Mix, Item #VB 100, Pack size: 25lbs.
Food·159 affected·May 23, 2013
High RiskFDA
Indelicare Llc
INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Top...
Topical Drugs·2,849 affected·May 23, 2013
High RiskFDA
Indelicare Llc
INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC ...
Topical Drugs·683 affected·May 23, 2013
High RiskFDA
Sotera Wireless, Inc.
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinic...
Medical Devices·75 affected·May 23, 2013
High RiskFDA
Zimmer, Inc.
Bigliani/Flatow¿ The Complete Solution Fukuda Retractors Large Nonsterile 4305-19-40. Used in retracting the humeral shaft posteriorl...
Medical Devices·722 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-820-000 T4 Zipper Toga (L/XL) Sterile, O; single use; Product Usage: Protection System and are intended to...
Medical Devices·334,520 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-760-000 T4 Toga, Pullover, Large Sterile, EO; single use; Product Usage: Protection System and are intende...
Medical Devices·34,640 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to...
Medical Devices·7,960 affected·May 23, 2013
High RiskFDA
Prism Medical Services Usa
BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for ex...
Medical Devices·5 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-770-000 T4 Toga, Pullover, Ex-Large Sterile, EO; single use; Product Usage: Protection System and are inte...
Medical Devices·21,660 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments0400-720-000 T4 Pullover Toga (L/XL) Sterile, EO; single use; Product Usage: Protection System and are intended...
Medical Devices·48,040 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use; Product Usage: Protection System and are intended...
Medical Devices·9,930 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are ...
Medical Devices·1,980 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-820-000S7 T4 XXL Toga w/T3 Cut, Sterile, O; single use; Product Usage: Protection System and are intended ...
Medical Devices·3,980 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-850-000 T4 Toga, Zipper, (XL-Tall) Sterile, EO; single use; Product Usage: Protection System and are inten...
Medical Devices·88,040 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-820-100 T5 Zipper Toga with Peel Away, Sterile, O; single use; Product Usage: Protection System and are in...
Medical Devices·25,770 affected·May 23, 2013
High RiskFDA
Prism Medical Services Usa
BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for exa...
Medical Devices·5 affected·May 23, 2013
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are i...
Medical Devices·6,990 affected·May 23, 2013
High RiskFDA
Prism Medical Services Usa
BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patien...
Medical Devices·10 affected·May 23, 2013
High RiskFDA
Prism Medical Services Usa
BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for e...
Medical Devices·1 affected·May 23, 2013
High RiskFDA
Pinook-usa
Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles.
Medical Devices·28,994 affected·May 23, 2013
High RiskFDA
Sotera Wireless, Inc.
ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified ...
Medical Devices·90 affected·May 23, 2013
CriticalCPSC
Insolroll Independent Window Covering Installer Retailers Nationwide From June 2012 Through March 2013 For Between $400 And $700 Per Window Shade.
Insolroll Recalls Roller Shades with Solar and Rechargeable Motors Due to Fire Hazard
Vehicles / Atvs·1,500 affected·May 22, 2013