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
FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·10 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic...
Diagnostic Devices·31 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·277 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·156 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·36 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, NEUTRAL, Right, REF CCP-LPX0R. Orthopedic use.
Medical Devices·102 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic I...
Diagnostic Devices·1 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging ...
Diagnostic Devices·7 affected·Mar 6, 2015
High RiskFDA
Nidek Inc
YC-1800 OPHTHALMIC YAG LASER SYSTEM; The YC-1800 allows the safe and bloodless treatment of intraocular diseases for outpatients by m...
Medical Devices·799 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging ...
Diagnostic Devices·376 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·1 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic ...
Diagnostic Devices·126 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·337 affected·Mar 6, 2015
High RiskFDA
Philips Medical Systems (cleveland) Inc
GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Diagnostic Devices·3 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, LAPIDUS CX Plate, 2mm Step, Left, REF CCP-LPX2L. Orthopedic use.
Medical Devices·148 affected·Mar 6, 2015
High RiskFDA
Cyberonics, Inc
VNS Therapy DemiPulse Generator Model 103 and VNS Therapy DemiPulse Duo Generator Model 104; CYBERONICS, INC.
Medical Devices·13 affected·Mar 6, 2015
High RiskFDA
Wright Medical Technology, Inc.
CROSSCHECK(R) Plating system, MTP CX Plate, Left, REF CCP-MPX1L. Orthopedic use.
Medical Devices·270 affected·Mar 6, 2015
CriticalFDA
Hospira Inc.
0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
Injectable Drugs·9,912 affected·Mar 5, 2015
High RiskFDA
Hospira Inc.
5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (...
Injectable Drugs·94,440 affected·Mar 5, 2015
High RiskFDA
Siemens Medical Solutions Diagnostics
Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform ...
Diagnostic Devices·962 affected·Mar 5, 2015
High RiskFDA
Del Mar Reynolds Medical, Ltd.
Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacelabs Healthcare Blease 700/900 Series Ventilators. Designe...
Respiratory Devices·1,040 affected·Mar 5, 2015
High RiskFDA
Spinefrontier, Inc.
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023. The Rod Caliper is a manual surgi...
Surgical Devices·5 affected·Mar 5, 2015
High RiskFDA
Codman & Shurtleff, Inc.
CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO...
Medical Implants·5,463 affected·Mar 5, 2015
High RiskFDA
Siemens Medical Solutions Diagnostics
Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemilumin...
Diagnostic Devices·8 affected·Mar 5, 2015
High RiskFDA
Siemens Medical Solutions Diagnostics
Direct Water feed Kit, Catalog#10373222
Medical Devices·15 affected·Mar 5, 2015
High RiskFDA
Sony Latin America
Sony Medical Monitor LMD-1951MD 19 inch
Medical Devices·4,764 affected·Mar 5, 2015
High RiskFDA
Siemens Medical Solutions Diagnostics
Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perfo...
Diagnostic Devices·186 affected·Mar 5, 2015
High RiskFDA
Merge Healthcare, Inc.
Merge LIS software.
Medical Devices·413 affected·Mar 5, 2015
High RiskFDA
Siemens Medical Solutions Diagnostics
Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perfor...
Diagnostic Devices·15 affected·Mar 5, 2015
High RiskFDA
Ge Healthcare
GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine systems, all configurations. Product Usage: The intended use o...
Diagnostic Devices·472 affected·Mar 5, 2015
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use ...
Cardiac Devices·10,199 affected·Mar 5, 2015
CriticalFDA
Cardiovascular Systems, Inc.
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in p...
Medical Implants·30 affected·Mar 4, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
Medical Implants·28,732 affected·Mar 4, 2015
High RiskFDA
Raysearch Laboratories Ab
RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RaySta...
Medical Devices·245 affected·Mar 4, 2015
High RiskFDA
Hardy Diagnostics
Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella) Cat no: G327 Container type: 15x100mm monoplate...
Diagnostic Devices·840 affected·Mar 4, 2015
High RiskFDA
Depuy Orthopaedics, Inc.
LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
Medical Implants·19,059 affected·Mar 4, 2015
High RiskFDA
Stonewall Kitchen, Llc
Stonewall Kitchen Buffalo Wing Sauce Net Wt. 17.5 oz. glass jar UPC 711381-31395 4 Item # 251805,
Food·327 affected·Mar 3, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material number: 380663-20 and 380663-21. The Intuitive Surgical...
Surgical Devices·167 affected·Mar 3, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Material number: 380662-20 and 380662-21. The Intuitive Surgic...
Surgical Devices·167 affected·Mar 3, 2015
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 380647-20 and 380647-22 The Intuitive Surgical Endoscope Inst...
Surgical Devices·167 affected·Mar 3, 2015
High RiskFDA
Midlon Foods Inc.
***Nice! (Trade Mark)***MARIA BISCUITS {0g TRANS FAT}***NET WT 7 OZ (200g)***Distributed by: Walgreen Co, 200 Wilmot Rd,, Deerfield, IL 6...
Food·5,472 affected·Mar 2, 2015
High RiskFDA
Safecor Health, Llc
Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL amber bottle, Rx Only, Manufactured by Silarx Pharmaceuticals Inc. Carmel, N...
Oral Drugs·3,532 affected·Mar 2, 2015
High RiskFDA
American Health Packaging
Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging,...
Oral Drugs·925 affected·Mar 2, 2015
High RiskFDA
Hill-rom, Inc.
Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
Medical Devices·66,691 affected·Mar 2, 2015
High RiskFDA
Baxter Healthcare Corp
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Prod...
Medical Devices·58 affected·Mar 2, 2015
High RiskFDA
Sunshine Burger & Specialty Food Company, Llc
Frozen vegetable-based burgers RETAIL - DOMESTIC: Organic Sunshine Burgers Gluten Free Soy Free Vegan Barbecue 3 Organic Veggie Bu...
Produce·4,113 affected·Feb 27, 2015
CriticalFDA
Nicomex Inc.
Nicomex Candy Mex, Productos Mexicanos, Distributed by Nicomex, Inc., 88 First Street, Passaic, NJ 07055
Snacks & Candy·24 affected·Feb 27, 2015
High RiskFDA
Sunshine Burger & Specialty Food Company, Llc
Frozen vegetable-based burgers RETAIL - DOMESTIC: Organic Sunshine Burgers Gluten Free Soy Free Vegan South West 3 Organic Veggie ...
Produce·6,630 affected·Feb 27, 2015