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
The Anspach Effort, Inc.
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
Medical Devices·1,805,022 affected·Sep 9, 2011
High RiskFDA
Abbott Point Of Care Inc.
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, h...
Diabetes Devices·310,003 affected·Sep 8, 2011
High RiskFDA
Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calci...
Diabetes Devices·4 affected·Sep 8, 2011
High RiskFDA
Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Medical Devices·6,000 affected·Sep 8, 2011
High RiskFDA
Abbott Point Of Care Inc.
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potass...
Diabetes Devices·4 affected·Sep 8, 2011
High RiskFDA
Animas Corporation
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diab...
Diabetes Devices·1,235 affected·Sep 6, 2011
High RiskFDA
Exactech, Inc.
OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components**...
Medical Devices·193 affected·Aug 19, 2011
High RiskFDA
Codan Us Corporation
ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 ...
Medical Devices·7,250 affected·Aug 17, 2011
RecallFDA
Sunquest Information Systems, Inc.
Sunquest Laboratory SMART & Sunquest Laboratory SMART Select Product Usage: for clinical use
Medical Devices·47 affected·Aug 12, 2011
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of t...
Medical Devices·2 affected·Aug 12, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel DxI Immunoassay System is an in vitro d...
Diagnostic Devices·1,756 affected·Aug 1, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel DxI Immunoassay System is an in vitro d...
Diagnostic Devices·432 affected·Aug 1, 2011
High RiskFDA
Beckman Coulter Inc.
Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the A...
Diagnostic Devices·6,634 affected·Jul 27, 2011
High RiskFDA
Ge Healthcare, Llc
GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-se...
Medical Devices·166 affected·Jul 25, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CARESCAPE Monitor B850. Intended for use in multiple areas within a professional healthcare facility.
Medical Devices·636 affected·Jul 20, 2011
High RiskFDA
Cosmo's Food Products, Inc.
Jimmy Peppers Hot Cherry Sliced Peppers, 1 gallon plastic jars
Food·2,568 affected·Jul 7, 2011
High RiskFDA
Bausch & Lomb, Inc.
Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, F...
Drugs·59,777 affected·Jul 6, 2011
CriticalFDA
Baxter Healthcare Corporation
Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library, Part Number 35700 -- Common/Classification Name: Infusion P...
Medical Devices·63,225 affected·Jul 6, 2011
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packa...
Topical Drugs·244,320 affected·Jul 5, 2011
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count pat...
Topical Drugs·357,510 affected·Jul 5, 2011
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packa...
Topical Drugs·335,190 affected·Jul 5, 2011
High RiskFDA
Noven Pharmaceuticals, Inc.
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packa...
Topical Drugs·242,100 affected·Jul 5, 2011
High RiskFDA
Keystone Dental Inc
Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical proce...
Medical Implants·22 affected·Jul 5, 2011
High RiskFDA
Keystone Dental Inc
Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedu...
Medical Implants·35 affected·Jul 5, 2011
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for ...
Surgical Devices·30,064 affected·Jul 1, 2011
CriticalFDA
Indalco Foods Corp.
***Dulce De Leche "Del Campo"***Ice Cream "Base" (Flavor)***FB 23546***Mfg. Date***Keep Refrigerated at 40*f***Lot#***Net Wt 55 LBS***Ind...
Dairy·23 affected·Jun 28, 2011
High RiskFDA
Epocal Inc
epoc Blood Analysis BGEM Test Cards for use with the epoc(R) Blood Analysis System Product Usage: Usage: epoc Blood Analysis BGEM ...
Medical Devices·8,650 affected·Jun 28, 2011
High RiskFDA
The Anspach Effort, Inc.
***REF SC2100***eMax 2 Plus Console***SN G 10307653002*** Product Usage: The RPM of the Motor Handpiece may be less than 80,000 RPM (...
Medical Devices·61 affected·Jun 24, 2011
High RiskFDA
Nephron Pharmaceuticals Corp.
Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per cart...
Drugs·56,028 affected·Jun 22, 2011
Medium RiskFDA
Apotex Corp.
Azelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, C...
Inhaled / Nasal Drugs·963,407 affected·Jun 15, 2011
High RiskFDA
Ocho Rios-miami, Inc.
Label reads in part "***OCHO RIOS***Spicy***Jerk***Curry***Distributed by :***Ocho Rios International***Miami, Florida 33142***Ingredient...
Food·0 affected·Jun 1, 2011
High RiskFDA
Ocho Rios-miami, Inc.
Label reads in part "***OCHO RIOS***Mild***Jerk***Curry***Seasoning***Extra delicious!***Distributed by :***Ocho Rios International***Mia...
Produce·0 affected·Jun 1, 2011
High RiskFDA
Ocho Rios-miami, Inc.
Label reads in part "***OCHO RIOS***Jamaican***Curry***Seasoning***Net Wt. 4 & 8 oz (227 g)***Gold Series***Low Sodium***Extra delicious!...
Food·1,100 affected·Jun 1, 2011
High RiskFDA
Ocho Rios-miami, Inc.
Label reads in part "***OCHO RIOS***Hot***Jamaican***Curry***Gold Series***Extra delicious!***Distributed by :***Ocho Rios International*...
Food·0 affected·Jun 1, 2011
High RiskFDA
Wynlife Healthcare, Inc.
Vegi-Fiber Plus; O Trans Fat; only 15.4 Calories; Dietary Supplement; 60 Packets; Scientific formula for Natural Vitality; 15 Vegetable a...
Beverages·210 affected·May 31, 2011
High RiskFDA
Wynlife Healthcare, Inc.
All-In-One Probiotics, K12-BB12-LB3; Dietary Supplement; 30 Packets;Serving size 2 Tablets (1 Packet)l L141/1. Adults take 2 to 4 tablets...
Supplements·456 affected·May 31, 2011
High RiskFDA
Bioderm, Inc.
BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with integral collection chamber (Component: SKIN-PREP Protective...
Surgical Devices·26,040 affected·May 31, 2011
High RiskFDA
Varian Medical Systems, Inc. Oncology Systems
Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System, Model Numbers: H14, H27, H29, HCX. Product Usage: ...
Medical Devices·3,943 affected·May 31, 2011
High RiskFDA
Bioderm, Inc.
BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The recalled wipes are used on intact skin for applying skin protec...
Medical Devices·26,040 affected·May 31, 2011
High RiskFDA
Raysearch Laboratories Ab
The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using i...
Medical Devices·15 affected·May 30, 2011
High RiskFDA
A B Nutrition, Inc.
PIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090
Oral Drugs·2,980 affected·May 27, 2011
High RiskFDA
A B Nutrition, Inc.
PIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090
Supplements·509 affected·May 27, 2011
High RiskFDA
A B Nutrition, Inc.
ANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090
Oral Drugs·912 affected·May 27, 2011
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
Neptune¿ 2 Rover - ULTRA ~120V ~ 60 Hz 12A REF 0702-001-000, Rx, Caution, consult accompanying documents Consult instructions for use, ...
Surgical Devices·5,865 affected·May 24, 2011
RecallFDA
Physicians Total Care, Inc.
Percocet 10/325 mg tablets, 100-count tablets per bottle, Rx only, Dist. By: Physicians Total Care, Tulsa, OK 74146; Mfg. By: Novartis C...
Oral Drugs·1 affected·May 23, 2011
High RiskFDA
Linvatec Corp. Dba Conmed Linvatec
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
Medical Devices·1 affected·May 20, 2011
High RiskFDA
Mindray Ds Usa, Inc. D.b.a. Mindray North America
DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network trans...
Medical Devices·0 affected·May 12, 2011
High RiskFDA
The Anspach Effort, Inc.
Product Catalog (part number 20-0020) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Moto...
Medical Devices·2,020 affected·May 6, 2011