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
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Norwegian SRK General and Plastic...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Intuitive Surgical, Inc.
STAPLER,IS4000; da Vinci Xi EndoWrist Stapler Release Kit (SRK); model number 470298. da Vinci Xi Japanese SRK General and Plastic ...
Surgical Devices·2,059 affected·Mar 15, 2017
High RiskFDA
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX TRUNAV Retrograde Drill is intended for use in c...
Medical Devices·0 affected·Mar 15, 2017
High RiskFDA
J & J Distributing Company
Mix General Tso Chik, 2 lbs Food service plastic bag for Food Service (Supervalu & Franchise). Chinese Chicken Salad, 2.65 lbs for Fo...
Meat & Poultry·10 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Kowalski's Markets, Protein Powerhouse, UPC 6-10014-14692-4, 8 oz in plastic container.
Food·1 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Detox Salad, 8 oz. Plastic deli container with various brand names: Cub Foods (Fresh) UPC 610014-155698 , Cuttin' Time UPC 610014-160876,...
Produce·7 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Shred Carrots, 3 lb Food Service plastic bag.
Food·6 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Kowalski's Markets, Carrot, Apple, Hummus Wrap UPC 6-10014-09915-2 & Vegetable Wrap UPC 6-10014-08723-4 , 11 oz in plastic container.
Produce·11 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Kowalski's Markets, Salad Super Kale, UPC 6-10014-14316-9, 9 oz in plastic container.
Produce·10 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Cub Foods (Fresh), Cranberry Walnut Salad, UPC 0-41144-37302-5, 20 0z. Plastic deli container. Kowalski's Markets, Salad Greens, Cranbe...
Produce·8 affected·Mar 14, 2017
High RiskFDA
J & J Distributing Company
Rainbow Coleslaw, 5 lbs for Food Service (Franchise) in Food service plastic bag.
Food·3 affected·Mar 14, 2017
High RiskFDA
Nexstim Plc
Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for no...
Surgical Devices·11 affected·Mar 14, 2017
High RiskFDA
Hans Pausch Rontgengeratebau Gmbh
Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagn...
Diagnostic Devices·10 affected·Mar 14, 2017
High RiskFDA
Nexstim Plc
NBS System 4 (sw version 4.0 or higher), Software update to 4.3.3 and NBS System 5 (sw version 5.0 or higher), Software update to 5.1.1. ...
Surgical Devices·21 affected·Mar 14, 2017
High RiskFDA
Roche Diabetes Care, Inc.
Accu-Chek Connect Diabetes Management App versions 2.0.0, 2.0.1 and 2.1.0 for iOS and Android Product Usage: This is a digital produc...
Diabetes Devices·64,324 affected·Mar 14, 2017
CriticalFDA
Advanced Fresh Concepts Corp
AFC Edamame Soybeans in Pods, 8 oz , refrigerated, in cardboard container. UPC 0-23012-00261-9
Food·0 affected·Mar 13, 2017
High RiskFDA
Genentech Inc.
Cotellic (cobimetinib) Tablets, 20 mg, 63 count bottle, Rx Only, Made in Switzerland. Distributed by Genentech USA, Inc., South Francisco...
Oral Drugs·748 affected·Mar 13, 2017
High RiskFDA
Akorn Inc
Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARM...
Oral Drugs·55,968 affected·Mar 13, 2017
High RiskFDA
Measurement Specialties Inc
Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and S...
Medical Devices·6,076 affected·Mar 13, 2017
High RiskFDA
Instradent Usa, Inc.
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Medical Devices·170 affected·Mar 13, 2017
High RiskFDA
Nihon Kohden America Inc
Bedside monitor CSM-1901(Life Scope G9) with main unit CU-192RA. The Problem only affects CSM-1901(Life Scope G9) communicating with CN...
Medical Devices·654 affected·Mar 13, 2017
High RiskFDA
Valeant Pharmacueticals International
Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for th...
Respiratory Devices·418 affected·Mar 13, 2017
CriticalFDA
Meridian Medical Technologies A Pfizer Company
EpiPen 2-Pak (Epinephrine) Auto-Injectors 0.3 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Medical...
Drugs·373,960 affected·Mar 12, 2017
CriticalFDA
Meridian Medical Technologies A Pfizer Company
EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 0.15 mg, Rx only, Manufactured for Mylan Specialty L.P., Morgantown WV 26505 by Meridian Me...
Drugs·92,544 affected·Mar 12, 2017
RecallFDA
Mcshare's Inc
Premark HS Vitamin RDA Premix, Net Wt. 50 lbs., Item No. 136375.
Supplements·700 affected·Mar 11, 2017
High RiskFDA
Nestle Usa
Haagen-Dazs Chocolate Dark Chocolate Ice Cream Bars; 3 - 3 FL oz.. bars (9 FL ox (266 ml)
Dairy·82 affected·Mar 10, 2017
High RiskFDA
Claris Lifesciences Inc
Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris I...
Injectable Drugs·18,096 affected·Mar 10, 2017
High RiskFDA
Claris Lifesciences Inc
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick...
Injectable Drugs·24,456 affected·Mar 10, 2017
High RiskFDA
Claris Lifesciences Inc
Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Br...
Injectable Drugs·18,360 affected·Mar 10, 2017
High RiskFDA
Claris Lifesciences Inc
Metronidazole Injection, USP, 500 mg/100 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris In...
Injectable Drugs·72,072 affected·Mar 10, 2017
High RiskFDA
Beckman Coulter Inc.
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Medical Devices·889 affected·Mar 10, 2017
CriticalFDA
Heartware
HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once a...
Cardiac Devices·9 affected·Mar 10, 2017
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Stryker PROFESS Registration Kit. The Stryker PROFESS Registration Kit is a member of the Navigation portfolio and is used as an intraop...
Medical Devices·65 affected·Mar 10, 2017
High RiskFDA
Ge Healthcare, Llc
Vivid S60/S70/S60N/S70N, H45041SU, H45041SW, H45581MS, H45581PD.
Medical Devices·396 affected·Mar 10, 2017
High RiskFDA
Ge Healthcare, Llc
Vivid E95/E90/E80, H45581DC, H45581LB and H45581DA.
Medical Devices·971 affected·Mar 10, 2017
CriticalFDA
Greater Miami Caterers, Inc.
Pan Pita with soynut butter spread on top, 4" pita. Manufactured by Greater Miami Caterers 4001 NW 31 Ave.,
Dairy·43,776 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegeneSlim
Food·4,000 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegeneBlend
Food·3,000 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegeneArouse
Food·0 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegeneBlast
Food·0 affected·Mar 9, 2017
CriticalFDA
Greater Miami Caterers, Inc.
Half Wheat sandwich with soynut butter spread and jelly, served on tray. Manufactured by Greater Miami Caterers 4001 NW 31 Ave.,
Dairy·43,776 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegeneFit
Food·300 affected·Mar 9, 2017
CriticalFDA
Greater Miami Caterers, Inc.
Portion cup of soynut butter served with other food items such as milk, yogurt, raisins, and gold fish crackers, labeled and served on tr...
Dairy·43,776 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegeneBoost
Food·1,800 affected·Mar 9, 2017
CriticalFDA
Greater Miami Caterers, Inc.
Whole Wheat sandwich with soynut butter spread and jelly, served on tray. Manufactured by Greater Miami Caterers 4001 NW 31 Ave.,
Dairy·43,776 affected·Mar 9, 2017
High RiskFDA
Vivaceuticals, Inc. Dba Regeneca Worldwide
RegenErect
Food·0 affected·Mar 9, 2017
CriticalFDA
Nonna Foods
LIDIA'S MARINARA, NET WT 25 oz (708g), UPC 897712001018 --- Manufactured for Nonna Foods LLC Woodbury, NY 11797
Food·750 affected·Mar 9, 2017
High RiskFDA
Smith & Nephew, Inc.
D-RAD, S.T. LOCKING SCREWS, T7, QTY: (1), STERILE R, in the following sizes: (a) 2.4MM X 10MM, RES 74692410 (b) 2.4MM X 12MM, RES 74692...
Medical Devices·197 affected·Mar 9, 2017