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
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68,659 recalls
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Computed Tomography X-ray systems intended to produce cross-secti...
Medical Devices·33 affected·Jul 20, 2016
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectio...
Medical Devices·24 affected·Jul 20, 2016
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Automated Pretreatment (A1c_3) r...
Medical Devices·32 affected·Jul 20, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal ...
Medical Devices·495 affected·Jul 20, 2016
High RiskFDA
Zimmer Biomet, Inc.
ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be...
Surgical Devices·18 affected·Jul 20, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue ...
Medical Devices·111 affected·Jul 20, 2016
High RiskFDA
Nobel Biocare Usa Llc
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical C...
Medical Implants·231 affected·Jul 20, 2016
RecallFDA
Sterling Diagnostics, Inc.
Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES ...
Diagnostic Devices·97 affected·Jul 20, 2016
RecallFDA
Sterling Diagnostics, Inc.
Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analyt...
Diagnostic Devices·173 affected·Jul 20, 2016
CriticalFDA
Cardinal Health
BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Sterile, Single Use ...
Surgical Devices·4,062,511 affected·Jul 20, 2016
High RiskFDA
Misono Food Ltd
Smoked Herring Slow Food (Quality: Polar Golden Presidia), Net weight 0.378 (others may vary slightly), Produced by: Njardar AS 6094 Lein...
Produce·5 affected·Jul 19, 2016
High RiskFDA
Gourmet Foods, Inc.
Artichoke Bottom Ratatouille Pack Size: 240 ea. per case UPC: 18010-03 Keep Frozen: Gourmet Foods, Hayward, CA
Frozen Food·8 affected·Jul 19, 2016
High RiskFDA
Gourmet Foods, Inc.
Strudel Wild Mushroom Pack Size: 240 ea. per case UPC: 17338-03 Keep Frozen: Gourmet Foods, Hayward, CA
Frozen Food·16 affected·Jul 19, 2016
CriticalFDA
Agave Dream
Agave Dream Cappuccino Ice Cream Pint UPC code: 899349002048
Dairy·396 affected·Jul 19, 2016
High RiskFDA
Misono Food Ltd
Smoked Herring Roe, Salted and smoked herring roe, Net weight 0.152 (others may vary slightly), Produced by: Njardar AS 6094 Leinoy, Pro...
Produce·8 affected·Jul 19, 2016
High RiskFDA
Gourmet Foods, Inc.
Breaded Cheese Ravioli Pack Size: 1 oz. ea. 15 lb. per case UPC: 18890-03 Keep Frozen: Gourmet Foods, Hayward, CA
Dairy·6 affected·Jul 19, 2016
CriticalFDA
Trophy Nut Co Inc
Honey Peanuts Net Wt. 25 lbs (11.360g) Ing:peanuts, seasoning***honey, wheat starch***Allergen Statement: Contains peanuts and wheat. Man...
Food·420 affected·Jul 19, 2016
CriticalFDA
Krispak Inc
GFS Honey Roasted Peanuts, 38 oz PET (Polyethylene terephthalate) plastic jar marked with lot number 176-16 stamped above the UPC code 09...
Food·756 affected·Jul 19, 2016
High RiskFDA
Gourmet Foods, Inc.
Stretched Coconut Shrimp Pack Size: 180 ea. per case UPC: 22102-03 Keep Frozen: Gourmet Foods, Hayward, CA
Seafood·58 affected·Jul 19, 2016
High RiskFDA
Gourmet Foods, Inc.
Artichoke Heart Breaded with Goat and Cheddar Cheese : Pack Size: 240 ea. per case; UPC: 13014-03 Keep Frozen: Gourme...
Dairy·25 affected·Jul 19, 2016
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Venlafaxine HCL ER Capsule USP, 150mg, packaged in a) 30-count bottles (NDC 68382-036-06), b) 90-count bottles (NDC 68382-036-16), and c)...
Oral Drugs·223,776 affected·Jul 19, 2016
High RiskFDA
Talon Compounding Pharmacy
Human Chorionic Gonadotropin Injection (a) 2500 iu, (b) 2500 iu with B12, (c) 3500 iu, (d) 5000 iu, (e) 5000 iu with B12, (f) 6000 iu, (g...
Injectable Drugs·6,500 affected·Jul 19, 2016
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Venlafaxine HCL ER Capsule USP, 75mg, packaged in a) 30-count bottles (NDC 68382-035-06), b) 90-count bottles (NDC 68382-035-16), and c) ...
Oral Drugs·0 affected·Jul 19, 2016
High RiskFDA
Talon Compounding Pharmacy
Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection, 12 mg, 10 ml depyrogenated vials, Rx Only, Compounded by Talon Compounding Pharmacy...
Injectable Drugs·500 affected·Jul 19, 2016
High RiskFDA
Philips Electronics North America Corporation
MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
Diagnostic Devices·993 affected·Jul 19, 2016
High RiskFDA
Bake N Joy Foods, Inc.
Bake'n Joy Sanding Sugar Net Wt. 16 lbs. pail Product Number: 0209416
Food·1,497 affected·Jul 18, 2016
CriticalFDA
Theo Chocolate Inc
Theo Chocolate Salted Almond 70% Dark Chocolate bars are wrapped in a white paper envelope, weighs 3 oz., UPC is 8 74492 00170 4, and sto...
Snacks & Candy·70 affected·Jul 18, 2016
CriticalFDA
J&d's Down Home Enterprises, Inc.
Original Bacon Flavored Seasoning Salt, Big Pig brand, 16oz plastic jars, 3 jars per case. UPC 98300 00110
Food·231 affected·Jul 18, 2016
High RiskFDA
Glaxosmithkline, Llc
Bactroban Cream, (Mupirocin Calcium Cream 2%), 15 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England...
Topical Drugs·28,131 affected·Jul 18, 2016
High RiskFDA
Glaxosmithkline, Llc
Bactroban Ointment, (Mupirocin Ointment 2%), 22 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, ...
Topical Drugs·18,000 affected·Jul 18, 2016
High RiskFDA
Glaxosmithkline, Llc
Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, ND...
Topical Drugs·153,119 affected·Jul 18, 2016
High RiskFDA
Glaxosmithkline, Llc
Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England,...
Topical Drugs·7,480 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Medical Devices·1 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
Medical Devices·3 affected·Jul 18, 2016
High RiskFDA
Aribex Inc
NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number 08500011; NOMAD Pro Packaged X-Ra...
Medical Devices·16,871 affected·Jul 18, 2016
High RiskFDA
Medtronic Navigation, Inc.
S7 MACH FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. ...
Medical Devices·27 affected·Jul 18, 2016
High RiskFDA
Bovie Medical Corporation
BVX-450NR Bovie Precise 360 Handpiece 45cm, needle Product is used for the delivery of helium gas plasma for cutting, coagulation, a...
Surgical Devices·95 affected·Jul 18, 2016
High RiskFDA
Aribex Inc
NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number 08500022; NOMAD Pro2 Vet Pack...
Medical Devices·16,871 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,
Medical Devices·0 affected·Jul 18, 2016
High RiskFDA
Medtronic Navigation, Inc.
FrameLink. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. Product...
Medical Devices·27 affected·Jul 18, 2016
High RiskFDA
Cepheid
Xpert MRSA Catalog GXMRSA-120, Rev. AJ Microbiology: The Cepheid Xpert MRSA assay performed in the GeneXpert Dx System (Xpert MRS...
Diagnostic Devices·68 affected·Jul 18, 2016
High RiskFDA
Medtronic Navigation, Inc.
Synergy Cranial S7. The software application is sent in CD format with an IFU, wrapped in plastic with a label for shipping purposes. ...
Medical Devices·27 affected·Jul 18, 2016
High RiskFDA
Bovie Medical Corporation
BVX-330BR Bovie Precise 360 Handpiece 33cm, blade Product is used for the delivery of helium gas plasma for cutting, coagulation, an...
Surgical Devices·95 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,
Medical Devices·3 affected·Jul 18, 2016
RecallFDA
Becton, Dickinson And Company, Bd Biosciences
BD Tritest CD3 FITC/CD4 PE/CD45 PerCP (IVD); Catalog number 340383. Label states: Contains CD3 FITC/CD4 PE/CD45 per CP with Gelatin and...
Diagnostic Devices·14,089 affected·Jul 18, 2016
High RiskFDA
Medtronic Sofamor Danek Usa Inc
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
Medical Devices·2 affected·Jul 18, 2016
High RiskFDA
Conagra Frozen Foods, Inc
PF Chang's Home Menu Brand Shrimp Lo Mein, UPC 3100067005, 22 oz bag, 4 bags per case, ConAgra Foods, Omaha, NE 68102
Seafood·2,969 affected·Jul 16, 2016
CriticalFDA
Greenberg Fruit Co
potato/whole peeled, Label states "Joe's Pride" and bears the address 9705 I Street, Omaha, NE 68127. Product is packaged in poly bags i...
Food·58 affected·Jul 15, 2016