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High RiskFDA
Covidien Llc
Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are used to clean the genital area for male a...
Medical Devices·74,300 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes are used to clean the genital area for male...
Medical Devices·71,430 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes are used to clean the genital area for male ...
Medical Devices·7,200 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile soap towelettes are used to clean the genital area for m...
Medical Devices·1,320 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male a...
Medical Devices·7,200 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap towelettes are used to clean the genital area for male an...
Medical Devices·16,500 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes are used to clean the genital area for mal...
Medical Devices·600 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and f...
Medical Devices·83,400 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover MIDSTREAM KIT RING CASTILE Item Code: 4090SA Castile soap towelettes are used to clean the genital area for male and f...
Medical Devices·207,000 affected·Jan 22, 2016
High RiskFDA
Accuray Incorporated
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery ...
Medical Devices·226 affected·Jan 22, 2016
High RiskFDA
Baxter Healthcare Corp.
0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corpor...
Injectable Drugs·282,080 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Biomet France Sarl
Endobon-Xenograft Granules, Zimmer Biomet, Synthetic Bone Grafting Material, used in dental and/or surgical procedures. Endobon Xenograf...
Surgical Devices·145,116 affected·Jan 21, 2016
High RiskFDA
Covidien Llc
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog ...
Medical Devices·1,010 affected·Jan 21, 2016
High RiskFDA
Ekos Corporation
EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Devic...
Surgical Devices·10 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Medical Devices·147,838 affected·Jan 21, 2016
High RiskFDA
Covidien Llc
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461...
Medical Devices·1,330 affected·Jan 21, 2016
High RiskFDA
Ouhlala Gourmet Llc
Fruit Tartlets, Raspberry flavor, 9 - 0.56oz (16 g) tartlets - Net Wt. 5.1oz (145 g). Manufactured in France. Distributed by Ouhlala Go...
Produce·8,651 affected·Jan 20, 2016
High RiskFDA
Ouhlala Gourmet Llc
Fruit Tartlets, lemon flavor, 9 - 0.53oz (15 g) tartlets - Net Wt. 4.8 oz (135 g). Manufactured in France. Distributed by Ouhlala Gourm...
Produce·9,159 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
Medical Devices·180 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope
Medical Devices·2 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope
Medical Devices·9 affected·Jan 20, 2016
High RiskFDA
Cook Inc.
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, clos...
Surgical Devices·25 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
Medical Devices·275 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope
Medical Devices·3 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope
Medical Devices·43 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope
Medical Devices·190 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
Medical Devices·54 affected·Jan 20, 2016
High RiskFDA
Agfa Healthcare Corp.
AGFA Digital Radiography X-Ray System DX-D100 DX-D100 is indicated for use in providing diagnostic quality images to aid the physician w...
Diagnostic Devices·308 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
Medical Devices·185 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope
Medical Devices·26 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
Medical Devices·122 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
Medical Devices·5 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope
Medical Devices·232 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
Medical Devices·4 affected·Jan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope
Medical Devices·9 affected·Jan 20, 2016
High RiskFDA
Trumpf Medical Systems, Inc.
Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table system...
Medical Devices·1,284 affected·Jan 19, 2016
High RiskFDA
Centurion Medical Products Corporation
Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus¿ Needless ...
Medical Devices·1,130 affected·Jan 19, 2016