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High RiskFDA
Biomet 3i, Llc
Osseotite 2 Certain Prevail 5mm(D)X 4.1mm (P) X X 11.5mm (L) Dental Implant Product Usage: Surgical placement in the upper or lower j...
Medical Implants·215 affected·Jun 10, 2013
High RiskFDA
Baxter Healthcare Corp.
SIGMA SPECTRUM Infusion Pump with Master Drug Library. Intended to be used for the controlled administration of intravenous fluids.
Medical Devices·273,835 affected·Jun 10, 2013
High RiskFDA
Steritec Products Mfc. Co., Inc.
EZTest Steam Biological Indicator, SteriTec Product Code EZS and EZS-400 EZTest Steam Biological Indicator: Mesa EZTest Steam Biologic...
Medical Devices·14,900 affected·Jun 10, 2013
High RiskFDA
Zimmer, Inc.
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A...
Medical Devices·70,986 affected·Jun 10, 2013
High RiskFDA
Steritec Products Mfc. Co., Inc.
Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Product Code PL 200, Distributor Product Code MDS200500IR S...
Medical Devices·3,535 affected·Jun 10, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
syngo Dynamics Information System (sDIS) versions 9.5 and VA10A. The syngo¿ Dynamics system is intended for the acceptance, transfer, ...
Medical Devices·9 affected·Jun 10, 2013
High RiskFDA
Steritec Products Mfc. Co., Inc.
Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Product Code PL 395, Distributor Product Code 61301606638 The Smart-Read ...
Medical Devices·10,170 affected·Jun 10, 2013
High RiskFDA
Zimmer, Inc.
Persona (TM) The Personalized Knee System CPS Tibial Articular Surface Provisional Top Nonsterile TASP MLC L 3-5 CD TOP TASP MLC L 6...
Medical Devices·70,986 affected·Jun 10, 2013
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical en...
Surgical Devices·30 affected·Jun 8, 2013
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical e...
Surgical Devices·30 affected·Jun 8, 2013
RecallCPSC
The Magnets Were Distributed Nationwide By Adobe As Part Of A Promotional Package For Their Adobe Connect Product During November 2012 At No Cost To Consumers.
Adobe Recalls High-Powered Magnets Distributed with Promotional Materials Package (Recall Alert)
Consumer Products·500 affected·Jun 7, 2013
CriticalFDA
Terrafina
1) terrafina Natural Roasted Unsalted Pistachios, Net wt. 10 oz (283g) UPC 847938103201, 2) terrafina Natural California Unsalted Pistach...
Food·5,250 affected·Jun 7, 2013
CriticalFDA
Sequel Naturals Ltd
vega one, all-in one nutrition bar; chocolate cherry flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antiox...
Dairy·1,292 affected·Jun 7, 2013
CriticalFDA
Sequel Naturals Ltd
vega one, all-in one nutrition bar; Double chocolate flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antio...
Dairy·1,328 affected·Jun 7, 2013
CriticalFDA
Torn & Glasser Inc.
Torn and Glasser Brand Roasted & Salted Natural Pistachios, 8 oz. 24/8oz Case. Labeling reads in part:"TORN & GLASSER***ROASTED & S...
Food·3 affected·Jun 7, 2013
CriticalFDA
Terrafina
1) terrafina Natural Roasted Salted Pistachios, Net wt. 2.25 oz(63g) UPC 847938032112, 2) terrafina Natural Roasted Salted Pistachios, Ne...
Food·3,500 affected·Jun 7, 2013
CriticalFDA
Sequel Naturals Ltd
vega sport, Natural Plant-Based Protein Bar; Chocolate Coconut flavor Gluten Free; 2.1 oz/ 60g Complete protein " 4g of fiber per ser...
Dairy·59 affected·Jun 7, 2013
CriticalFDA
Sequel Naturals Ltd
vega sport, Natural Plant-Based Protein Bar; Chocolate Saviseed flavor Gluten Free; 2.1 oz/ 60g Complete protein " 4g of fiber per se...
Dairy·36,764 affected·Jun 7, 2013
CriticalFDA
Windy Acres Candy & Nut, Outlet Inc.
RAW SUNFLOWER KERNEL, DARK RAISIN 50/50 MIX 24/l0 oz packaged in clear plastic wrap.
Food·7,968 affected·Jun 7, 2013
CriticalFDA
Sequel Naturals Ltd
vega one, all-in one nutrition bar; chocolate almond flavor Added vitamins and minerals; 15 g Protein, 6 g Fiber and 1.5 g Omega Antiox...
Dairy·1,515 affected·Jun 7, 2013
CriticalFDA
Torn & Glasser Inc.
Roasted and Salted Pistachios packed under the following brand names and packaging: Sprouts Brand Roasted & Salted Pistachios, various...
Food·328 affected·Jun 7, 2013
High RiskFDA
Sagent Pharmaceuticals Inc
VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SA...
Injectable Drugs·831,950 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·23 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·22 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compa...
Medical Devices·26 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx,...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX P...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Steril...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·30 affected·Jun 7, 2013
High RiskFDA
Baxter Healthcare Corp.
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.
Medical Devices·3,255,096 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-R Rx Sterile; Used in total knee arthropl...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM,...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·25 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·24 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compa...
Medical Devices·26 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, S...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile; 00597001403 Fem...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Baxter Healthcare Corp.
Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.
Medical Devices·3,255,096 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 005...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Ste...
Medical Devices·192,355 affected·Jun 7, 2013
CriticalFDA
Codman & Shurtleff, Inc.
MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) ...
Medical Implants·2 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·22 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral comp...
Medical Devices·23 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; 00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 1...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx,...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Biomet, Inc.
REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compa...
Medical Devices·28 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx...
Medical Devices·192,355 affected·Jun 7, 2013
High RiskFDA
Zimmer, Inc.
00597201101 Femur CR POROUS FEM COMP SIZE AML Rx, Sterile; 00597201102 Femur CR POROUS FEM COMP SIZE AMR Rx, Sterile; 00597201201 ...
Medical Devices·192,355 affected·Jun 7, 2013