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
Ormco/sybronendo
Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bracket Buccal Tubes are intended to hold in orthodontic wires ...
Medical Devices·8,210 affected·Mar 8, 2013
High RiskFDA
Hospira Inc.
The LifeCare PCA Plus II infusion pump system is designed for safe, effective, analgesic delivery to patients through the intravenous or ...
Surgical Devices·53,151 affected·Mar 8, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the ...
Medical Devices·2 affected·Mar 8, 2013
High RiskFDA
Linde Gas North America Llc
MEDICYCL-E- Lite Portable Oxygen System An integrated portable oxygen delivery system intended to provide supplemental oxygen to adult...
Respiratory Devices·52,264 affected·Mar 8, 2013
High RiskFDA
Hospira Inc.
The PCA 3 system cam be used in a wide range of clinical settings, including but not limited to: general floor, labor/delivery,post-partu...
Surgical Devices·8,216 affected·Mar 8, 2013
High RiskFDA
Synthes Usa Hq, Inc.
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the fo...
Medical Devices·62 affected·Mar 8, 2013
High RiskFDA
Ozone Confection & Bakers Supply Co.
Assorted Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
Food·481 affected·Mar 7, 2013
High RiskFDA
Chu Minh Corp
CHU MINH TOFU Fried Soybean Cake (Tofu), net weight 12 oz. The UPC is 8 18140 00003 9. The product is labeled in parts: "***CHUMINH T...
Bakery & Grains·0 affected·Mar 7, 2013
High RiskFDA
Ozone Confection & Bakers Supply Co.
Harvest Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
Food·481 affected·Mar 7, 2013
CriticalFDA
Riggio Dist Co
Glory Foods Mixed Greens, Verduras Mixtas 16 oz
Food·2,200 affected·Mar 7, 2013
High RiskFDA
Ozone Confection & Bakers Supply Co.
Easter Mix Non-Pareil Seeds; Ozone Confectioners, Elmwood Park, New Jersey 07407. Non-Pareil Seeds, 10 LBS. Net
Food·481 affected·Mar 7, 2013
High RiskFDA
Chu Minh Corp
CHU MINH TOFU Fresh Soybean Cake (Tofu), net weight 16 oz. The UPC is 8 18140 00002 2. The product is labeled in parts: "***CHUMINH T...
Bakery & Grains·0 affected·Mar 7, 2013
Medium RiskFDA
Novartis Consumer Health
4 way Saline Moisturizing Mist with Eucalyptol & Menthol, 1-fl. oz. bottles, OTC. Distributed by Novartis Consumer Health, Inc., Parsippa...
Drugs·227,124 affected·Mar 7, 2013
RecallFDA
Novartis Consumer Health
Nupercainal, Dibucaine, Hemorrhoidal & Topical Analgesic Ointment, a) 1-oz. tubes (NDC 0067-5812-96), b) 2-oz. tubes (NDC 0067-5812-86), ...
Topical Drugs·91,872 affected·Mar 7, 2013
High RiskFDA
Sanofi Us
Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC ...
Oral Drugs·2,462 affected·Mar 7, 2013
RecallFDA
Novartis Consumer Health
4 way Nasal Decongestant Menthol Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2087-05) b) 1-f...
Inhaled / Nasal Drugs·44,604 affected·Mar 7, 2013
Medium RiskFDA
Novartis Consumer Health
4 way Nasal Decongestant Fast Acting Nasal Spray, containing phenylephrine hydrochloride 1%, a) 1/2-fl. oz. bottles (NDC 0067-2086-05), b...
Inhaled / Nasal Drugs·538,092 affected·Mar 7, 2013
Medium RiskFDA
Novartis Consumer Health
Myoflex (trolamine salicylate) 10%, Pain Relieving Cream, a) 2-oz tube, b) 4-oz. tube, OTC. The firm name on the label is Novartis Consum...
Topical Drugs·240,120 affected·Mar 7, 2013
CriticalFDA
Maquet Cardiovascular Us Sales, Llc
Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). Battery for use with the SERVO-i ...
Respiratory Devices·90,000 affected·Mar 7, 2013
High RiskFDA
Maquet Cardiovascular, Llc
MAQUET CARDIOHELP Support System: CARDIOHELP-I Software (up to version 3.3.0.0) Product Usage: The Cardiohelp System is a blood oxyg...
Respiratory Devices·154 affected·Mar 7, 2013
High RiskFDA
Devilbiss Healthcare Llc
DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6...
Respiratory Devices·112,849 affected·Mar 7, 2013
High RiskFDA
Shantea Llc
ShanTea Ride The Dragon Honeybush/Licorice (UPC 794504283808) USDA Organic.
Beverages·97 affected·Mar 6, 2013
High RiskFDA
Shantea Llc
ShanTea Enlightened Mind Mate/Kukicha (UPC 794504284102) USDA Organic.
Beverages·111 affected·Mar 6, 2013
High RiskFDA
Smith & Nephew Inc
TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA orth...
Medical Devices·23 affected·Mar 6, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determine...
Medical Devices·4,467 affected·Mar 6, 2013
High RiskFDA
Advanced Orthogonal Equipment, Incorporated
Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adj...
Medical Devices·54 affected·Mar 6, 2013
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Inform II Blood Glucose Monitoring System bar code scanner. Used with the ACCU-CHEK Inform II System to quantitatively meas...
Diabetes Devices·4,467 affected·Mar 6, 2013
High RiskFDA
Alere San Diego, Inc.
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative determination of alanine aminotransferase (AL...
Medical Devices·38,571 affected·Mar 6, 2013
CriticalFDA
Carefusion Corporation
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and pow...
Medical Devices·9,241 affected·Mar 6, 2013
High RiskFDA
Zydus Pharmaceuticals Usa Inc
Venlafaxine Hydrochloride Tablets, 75 mg*, 100-count tablets per bottle, Rx only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, Ind...
Oral Drugs·13,320 affected·Mar 5, 2013
High RiskFDA
Stryker Endoscopy
1488 HD 3-Chip Camera; Model Number 1488-210-105 - C-Mount. Product Usage: High definition camera to view endoscopic surgical site...
Surgical Devices·1,965 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Stryker Endoscopy
1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera t...
Surgical Devices·1,965 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
High RiskFDA
Biosense Webster, Inc.
20-Pole Eco Cable, Catalog #EM-5050-060 Product Usage: The 20-Pole Eco Cable is intended to be used as an interface cable between the...
Surgical Devices·54 affected·Mar 5, 2013
High RiskFDA
Siemens Medical Solutions Usa, Inc
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for...
Medical Devices·621 affected·Mar 5, 2013
RecallFDA
Juice Bar Solutions
Add a Scoop by Smoothie Essentials; Probiotic; Supports Digestive Health, dietary supplement; Net Weight: 1 lb (464g) 16 oz. Contains ...
Beverages·26 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
SEPP 10% Povidone Iodine Solution USP (1% available Iodine, Surfactant & USP Purified Water), packaged in a) 200-count applicators (Net 0...
Drugs·8,960,000 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
Donor Prep Kit containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit, packaged ...
Drugs·46,500 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
SEPP 70% Isopropanol (isopropyl alcohol) 70% v/v, USP, 200-count applicators (net 0.67 mL each) per carton, Cat. No 260201, NDC 54365-170...
Drugs·698,000 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
FREPP/SEPP Kit containing 1 FREPP (povidone iodine 2% aqueous solution), Net 1.1 mL and 1 SEPP (povidone iodine 10% USP), Net 0.67 mL per...
Drugs·544,500 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
SEPP 2% Iodine Tincture USP (47% v/v Ethyl Alcohol, 2% w/v Iodine, USP, Sodium Iodide USP, & Purified Water USP), packaged in a) 200-coun...
Drugs·3,032,000 affected·Mar 4, 2013
High RiskFDA
Carefusion 213, Llc
Blood Culture Prep Kit II containing 1 FREPP (70% isopropyl alcohol), Net 1.1 mL and 1 SEPP (iodine tincture 2% USP), Net 0.67 mL per kit...
Drugs·929,000 affected·Mar 4, 2013
High RiskFDA
Arrow International Inc
Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berman Angiographic Balloon Catheter. The Arrow Berman(TM) Ang...
Cardiac Devices·99,627 affected·Mar 4, 2013
High RiskFDA
Philips And Neusoft Medical Systems Co., Ltd.
NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system....
Medical Devices·23 affected·Mar 4, 2013