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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
High RiskFDA
Ergoactives, Llc
HeaterBaum Foot & Ankle Heating Pad, Heating Soft Compression Therapeutic Boot with Precise Temperature Control Thermostat, 110 V with AC...
Medical Devices·278 affected·Jan 19, 2016
High RiskFDA
Amerisource Health Services
Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 6808...
Oral Drugs·3,888 affected·Jan 18, 2016
High RiskFDA
Perrigo Company Plc
Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.
Drugs·948 affected·Jan 18, 2016
High RiskFDA
Perrigo Company Plc
Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157
Drugs·918 affected·Jan 18, 2016
High RiskFDA
Vital Scientific N.v.
V-Twin, Model # 6002-800, UDI: 03661540600180 Product Usage: An in-vitro diagnostic device, which is an automated chemistry analyzer,...
Diagnostic Devices·2 affected·Jan 18, 2016
High RiskFDA
Philips Respironics
Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy 100, Trilogy 200, Garbin, Garbin plus prov...
Respiratory Devices·104,508 affected·Jan 18, 2016
High RiskFDA
Hain Celestial Group
Celestial Seasonings Roastaroma Herbal Tea Lot code: Best Before 20DEC17 Pack size: 6 retail units (20 count)/ per case
Beverages·4,180 affected·Jan 15, 2016
High RiskFDA
Abbott's Compounding Pharmacy, Inc.
progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded, Abbott's Compounding Pharmacy...
Drugs·10 affected·Jan 15, 2016