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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68,659 recalls
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
CriticalFDA
Pentax Medical Company
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an a...
Medical Devices·76 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provid...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Virtual Access Pluse SW, StandAlone The CARESTREAM PACS is an image management system whose intended use is to pr...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provid...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Abbott Medical Optics, Inc.
STAR Excimer Laser System with Variable Spot Scanning, Model: STAR S4, Catalog Number: 0030-4077, Product is manufactured and distributed...
Medical Devices·834 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Medtronic Vascular, Inc.
NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtroni...
Surgical Devices·122 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an image management system whose intended use is to ...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT The CARESTREAM PACS is an image management system whose intended use is to pro...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to prov...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image management system whose intended use is to provide c...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Abbott Medical Optics, Inc.
STAR ActiveTrak Excimer Laser System, Model: STAR S3, Catalog Number: 0030-2450, Product is manufactured and distributed by AMO Manufactu...
Medical Devices·834 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to pro...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provi...
Medical Devices·0 affected·Sep 16, 2013
CriticalFDA
Edwards Lifesciences, Llc
Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGF...
Medical Devices·12,034 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
High RiskFDA
Sekisui Diagnostics Llc
Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualita...
Diagnostic Devices·391 affected·Sep 16, 2013
High RiskFDA
Carestream Health Inc.
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image management system whose intended use is to provide...
Medical Devices·0 affected·Sep 16, 2013
CriticalFDA
Garre Farms
Green Leaf Lettuce is sold in bulk cases under "Garre Farms" or "Rossi Farms" brand. There are 24 heads of green leaf lettuce packed in ...
Produce·498 affected·Sep 13, 2013
High RiskFDA
Kerry Foods
Idahoan, Steakhouse Parmesan topping, Net Weight 35 lbs., Item Code ZID800Bulk.
Food·10,500 affected·Sep 13, 2013
High RiskFDA
Amerisource Bergen
Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed b...
Injectable Drugs·60 affected·Sep 13, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01
Oral Drugs·941,270 affected·Sep 13, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only...
Oral Drugs·28,140 affected·Sep 13, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), R...
Oral Drugs·101,450 affected·Sep 13, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles...
Oral Drugs·30,878 affected·Sep 13, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 2650...
Oral Drugs·23,356 affected·Sep 13, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles...
Oral Drugs·60,506 affected·Sep 13, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 265...
Oral Drugs·4,722 affected·Sep 13, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505...
Oral Drugs·11,701 affected·Sep 13, 2013
High RiskFDA
Watson Laboratories Inc
Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona...
Oral Drugs·10,615 affected·Sep 13, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), R...
Oral Drugs·167,866 affected·Sep 13, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01
Oral Drugs·521 affected·Sep 13, 2013
High RiskFDA
Amerisource Bergen
Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed b...
Injectable Drugs·49 affected·Sep 13, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05),...
Oral Drugs·37,752 affected·Sep 13, 2013
High RiskFDA
Mylan Pharmaceuticals Inc.
Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-689...
Oral Drugs·42,174 affected·Sep 13, 2013
High RiskFDA
Merit Medical Systems, Inc.
Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3.
Surgical Devices·200 affected·Sep 13, 2013
High RiskFDA
Southern Implants, Inc
Tri-Nex Healing Abutment, 0.50 mm x 5 mm height, Catalog No. HA-L-50-5. The NSI Implant System is intended to be implanted in the upp...
Medical Implants·197 affected·Sep 13, 2013