Source
FDA Recalls
The U.S. Food and Drug Administration regulates drugs, medical devices, food, cosmetics, and tobacco products. Recall data here includes pharmaceutical adverse events and drug recalls.
68,659Total Recalls
www.fda.gov →Official Site
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How to report to FDA →68,659 recalls
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 Devices600 affectedJan 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 Devices83,400 affectedJan 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 Devices207,000 affectedJan 22, 2016
High RiskFDA
Accuray Incorporated
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package. Product Usage: The CyberKnife Robotic Radiosurgery ...
Medical Devices226 affectedJan 22, 2016
CriticalFDA
Mahina Mele Farm
Izzie Macs! Macadamia Nuts - Unsalted. Certified Organic Macadamia Nuts, 100% Big Island Grown A raw food. Sold in 6 oz. plastic bag a...
Food5,676 affectedJan 21, 2016
CriticalFDA
Mahina Mele Farm
Izzie Macs! Macadamia Nuts - Salted. Certified Organic Macadamia Nuts, 100% Big Island Grown A raw food. Sold in 6 oz. plastic bag and...
Food5,676 affectedJan 21, 2016
CriticalFDA
Mahina Mele Farm
Baby Bruddah's Chocolate Mac Nut Buttah; Certified Organic by International Certification Services Inc. From the Big Island, A raw foo...
Snacks & Candy5,676 affectedJan 21, 2016
CriticalFDA
Mahina Mele Farm
Baby Bruddah's Mac Nut Buttah; Certified Organic by International Certification Services Inc.. From the Big Island, A raw food. Sold ...
Baby Food & Formula5,676 affectedJan 21, 2016
CriticalFDA
Baxter Healthcare Corp.
Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B34...
Injectable Drugs334,560 affectedJan 21, 2016
CriticalFDA
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 Drugs273,520 affectedJan 21, 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 Drugs282,080 affectedJan 21, 2016
CriticalFDA
Baxter Healthcare Corp.
CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30%...
Injectable Drugs7,436 affectedJan 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 Devices147,838 affectedJan 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 Devices147,838 affectedJan 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 Devices147,838 affectedJan 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 Devices145,116 affectedJan 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 Devices1,010 affectedJan 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 Devices10 affectedJan 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 Devices147,838 affectedJan 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 Devices147,838 affectedJan 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 Devices147,838 affectedJan 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 Devices147,838 affectedJan 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 Devices147,838 affectedJan 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 Devices147,838 affectedJan 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 Devices147,838 affectedJan 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 Devices147,838 affectedJan 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 Devices147,838 affectedJan 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 Devices1,330 affectedJan 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...
Produce8,651 affectedJan 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...
Produce9,159 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope
Medical Devices180 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope
Medical Devices2 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope
Medical Devices9 affectedJan 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 Devices25 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
Medical Devices275 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope
Medical Devices3 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope
Medical Devices43 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope
Medical Devices190 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope
Medical Devices54 affectedJan 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 Devices308 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
Medical Devices185 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope
Medical Devices26 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope
Medical Devices122 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope
Medical Devices5 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope
Medical Devices232 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope
Medical Devices4 affectedJan 20, 2016
High RiskFDA
Integrated Medical Systems Inc
Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope
Medical Devices9 affectedJan 20, 2016
RecallFDA
Sorin Group Usa, Inc.
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: H...
Cardiac Devices6,859 affectedJan 19, 2016