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
CriticalFDA
Central Admixture Pharmacy Services, Inc.
PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Drugs·1 affected·May 28, 2014
CriticalFDA
Central Admixture Pharmacy Services, Inc.
LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Drugs·4 affected·May 28, 2014
CriticalFDA
Nitinol Devices And Components, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Straight Tip, 150 CM...
Surgical Devices·8,485 affected·May 28, 2014
High RiskFDA
Shape Medical Systems, Inc
Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-40...
Medical Devices·800 affected·May 28, 2014
CriticalFDA
Nitinol Devices And Components, Inc.
HydroFinity Hydrophilic guidewire; 0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length; Manufactured for Covidien, Plymouth, MN; Man...
Surgical Devices·8,485 affected·May 28, 2014
High RiskFDA
Vascular Technology, Inc.
07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous eval...
Medical Devices·164 affected·May 28, 2014
CriticalFDA
Nitinol Devices And Components, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Steril...
Surgical Devices·8,485 affected·May 28, 2014
High RiskFDA
Vascular Technology, Inc.
07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4, REF 138660 The Doppler probe is intended for the intraoperative and transcutaneous evalua...
Medical Devices·147 affected·May 28, 2014
CriticalFDA
Nitinol Devices And Components, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Standard Shaft, Angled Tip, 180 CM L...
Surgical Devices·8,485 affected·May 28, 2014
CriticalFDA
Nitinol Devices And Components, Inc.
HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile. 0.035 OD, Stiff Shaft, Angled Tip, 150 CM Leng...
Surgical Devices·8,485 affected·May 28, 2014
High RiskFDA
Vascular Technology, Inc.
07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous ev...
Medical Devices·34 affected·May 28, 2014
High RiskFDA
Dot Foods Inc.
Large Pitted Kalamata Olives, packaged in 4.4lb black plastic barrels. Labeling reads in part: Savor Greek Large Pitted Kalamata Olives, ...
Food·720 affected·May 27, 2014
CriticalFDA
Vascular Solutions, Inc.
Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as...
Surgical Devices·8,580 affected·May 27, 2014
CriticalFDA
Biofire Diagnostics, Inc.
FirmArray Blood Culture Identification (BCID) Panel, Model 2.0 The FilmArray Blood Culture Identification (BCID) Panel is a qualitativ...
Diagnostic Devices·1,084 affected·May 27, 2014
High RiskFDA
Interbake Foods Llc
Mrs. Fields Milk Chocolate Chip Cookies, Net Wt. 8 oz (227 g) cardboard carton with 8 individually wrapped 1 oz cookies. 12 cartons in a ...
Dairy·16 affected·May 24, 2014
High RiskFDA
Brunkow Cheese Of Wisconsin, Inc.
Fayette Creamery Jalapeno Pepper Raw Milk Cheddar Cold Pack Cheese, Net Wt. 8 oz (226g), UPC 09513-00008
Dairy·4,160 affected·May 23, 2014
CriticalFDA
Suntree Llc
California Grown Shelled Walnuts, Net Weight 12 oz (340g), UPC 69887507806 46 cases, 24 count, 12 oz packages.
Food·1,104 affected·May 23, 2014
CriticalFDA
Farmers Market
Shelled walnuts, 8 oz., packed in a clear plastic container and sold under the Farmer's Market brand.
Food·32 affected·May 23, 2014
CriticalFDA
Oceans Cuisine, Ltd.
Oceans Cuisine brand CRAB STUFFING WITH REAL CRABMEAT, NET WEIGHT 3 LBS. (48 oz.) UPC 7 30692 00031 5, PRODUCT OF USA --- PACKED BY: OCEA...
Meat & Poultry·96 affected·May 23, 2014
High RiskFDA
Dr. Reddy's Laboratories, Inc.
Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratori...
Oral Drugs·13,560 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarn...
Medical Devices·7,460 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: ...
Medical Devices·7,190 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula ...
Medical Devices·6,720 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Ven...
Medical Devices·34,470 affected·May 23, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module,...
Respiratory Devices·4,961 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusio...
Medical Devices·120 affected·May 23, 2014
High RiskFDA
Elekta, Inc.
MOSAIQ, an oncology information system used to manage workflows for treatment planning and delivery. It supports information flow among h...
Medical Devices·723 affected·May 23, 2014
High RiskFDA
Zimmer, Inc.
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femora...
Medical Implants·315 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion o...
Medical Devices·3,040 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: ...
Medical Devices·2,290 affected·May 23, 2014
High RiskFDA
Siemens Healthcare Diagnostics Inc
RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; R...
Medical Devices·20,507 affected·May 23, 2014
High RiskFDA
Terumo Cardiovascular Systems Corporation
Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicate...
Medical Devices·135,340 affected·May 23, 2014
CriticalFDA
Rome Packing Co., Inc.
Ocean's Catch RTE All Natural Jonah Crab Combo Meat Fresh Hand Picked Crabmeat , Net WT. 8 oz. and 16 oz. plastic container Ingredient...
Meat & Poultry·802 affected·May 22, 2014
CriticalFDA
Whole Foods Market Group Inc.
Whole Foods Thai Soba Noodle Salad , 9 oz. refrigerated plastic container UPC Code: 36406304107
Produce·140 affected·May 22, 2014
CriticalFDA
Rome Packing Co., Inc.
Ocean's Catch Jonah Crab Minced Meat Crabmeat , Net WT. 10 lb. plastic bag
Meat & Poultry·300 affected·May 22, 2014
CriticalFDA
Rome Packing Co., Inc.
Ocean's Catch RTE Fresh Hand Picked Crabmeat , Net WT. 6 oz. plastic container Ingredients; Contains Jonah Crab Meat
Meat & Poultry·262 affected·May 22, 2014
CriticalFDA
Gsf Nut Company Llc
GSF LLC Shelled Walnuts, Kernel Combo Halves & Pieces, 15% New Wt. 25 lbs. GSF LLC, Visalia, CA 93290
Food·440 affected·May 22, 2014
High RiskFDA
Aidarex Pharmaceuticals Llc
Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories...
Oral Drugs·531 affected·May 22, 2014
High RiskFDA
Sandoz, Inc
Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, ...
Oral Drugs·22,818 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 5.0mm Acorn Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neuros...
Medical Implants·71 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 2.0mm Tapered Round Elite Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue...
Medical Implants·6 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 3.0mm x 3.8mm Precision Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related ...
Medical Implants·6,481 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 5.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related ti...
Medical Implants·1,537 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 1.5mm Wire Pass Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during ...
Medical Implants·246 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 3.0mm x 3.8mm Neuro Drill Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue dur...
Medical Implants·497 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 3.0mm Round Fluted Bur Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related ti...
Medical Implants·285 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 4.0mm Round Fluted Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during ...
Medical Implants·281 affected·May 22, 2014
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker 6.0mm Egg Bur Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosur...
Medical Implants·65 affected·May 22, 2014