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
Icu Medical, Inc.
121" (307 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, T-Connector w/Pre-Slit Port, Rotating Luer,...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
147" (373 cm) Bifuse Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿ w/Remv 3 Gang 1o2¿ Manifold (Blue, Yellow, Red), Check Valve Rota...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
140" (356 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
Lopez Valve¿, Sterile The blood tubing accessory with CLAVE Connector is a single use, sterile, non-pyrogenic device intended for use ...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
117" (297 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 3 Gang 4-Way Stopcocks, Rotating Luer, 1 Ext, Sterile Th...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
126" (320 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 2 Gang 4-Way Stopcock, Clave¿, Rotating Luer, 1 Ext, Sterile The b...
Medical Devices·160,016 affected·Jul 31, 2017
High RiskFDA
Icu Medical, Inc.
135" (343 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 2 Clave¿, Remv 4-Way Stopcock, Rotating Luer, 2 Ext, Sterile The blood ...
Medical Devices·160,016 affected·Jul 31, 2017
CriticalFDA
Silver Hills Bakery
Aldi liveGfree Gluten Free Classic Soft White Hamburger Buns, 11.3 Ounces, in plastic bag
Food·9,639 affected·Jul 28, 2017
High RiskFDA
Pd-rx Pharmaceuticals, Inc.
Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30
Oral Drugs·100 affected·Jul 28, 2017
High RiskFDA
Brainlab Ag
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO is intended to be used for X-ray computed tomography applicati...
Medical Devices·102 affected·Jul 28, 2017
High RiskFDA
Siemens Healthcare Diagnostics, Inc
ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum us...
Diagnostic Devices·33,298 affected·Jul 28, 2017
High RiskFDA
Roche Diagnostics Corporation
Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001
Medical Devices·399 affected·Jul 28, 2017
High RiskFDA
Nxthera
Rezum System, Vapor BPH Ablation System, Model Number D2201-003. NxThera Inc. 7351 Kirkwood Lane Suite 138 Maple Grove, MN 55369 USA. ...
Medical Devices·113 affected·Jul 28, 2017
High RiskFDA
C.r. Bard, Inc.
Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in pat...
Surgical Devices·45,270 affected·Jul 28, 2017
High RiskFDA
Newark Nut Stores, Inc.
Bourbon Street Mix, 157 25 lbs cases and 2,509 one (1) lb bags.
Food·2,666 affected·Jul 27, 2017
High RiskFDA
Optovue, Inc.
iFusion, Device Listing Number D203271. Product Usage: The iCam is a non-contact, high resolution digital imaging device which is sui...
Diagnostic Devices·326 affected·Jul 27, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmona...
Respiratory Devices·10 affected·Jul 27, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiop...
Respiratory Devices·27 affected·Jul 27, 2017
High RiskFDA
Datascope Corporation
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulm...
Respiratory Devices·8 affected·Jul 27, 2017
High RiskFDA
Baxter Healthcare Corporation
Empty IntraVia Container with Non-DEHP Fluid Path, 500mL Containers are intended for use in the preparation and administration of drug...
Medical Devices·29,088 affected·Jul 27, 2017
High RiskFDA
Optovue, Inc.
iVue with Normative Database, Device Listing Number D185549. Product Usage: The iVue (K121739) is a non-contact, high resolution tomo...
Medical Devices·326 affected·Jul 27, 2017
CriticalFDA
Natureall-stf Holding, Llc
Acidophilus-Plus, No. 102, 90 Capsules, Dietary Supplement,
Supplements·367 affected·Jul 26, 2017
High RiskFDA
Natureall-stf Holding, Llc
Leci-thin-Plus, No. 88, 90 Capsules, Dietary Supplement
Supplements·80 affected·Jul 26, 2017
High RiskFDA
Natureall-stf Holding, Llc
Heart-Plus, No. 83, 120 Capsules, Dietary Supplement
Supplements·598 affected·Jul 26, 2017
High RiskFDA
Natureall-stf Holding, Llc
Pancreas-Plus, No. 112, 90 Capsules, Dietary Supplement
Supplements·566 affected·Jul 26, 2017
CriticalFDA
Natureall-stf Holding, Llc
Thymus Plus, No. 114, 90 Capsules, Dietary Supplement
Supplements·107 affected·Jul 26, 2017
High RiskFDA
Natureall-stf Holding, Llc
Liver-Plus, No. 111 & 115, 120 Capsules, Dietary Supplement
Supplements·400 affected·Jul 26, 2017
CriticalFDA
Natureall-stf Holding, Llc
Metabo-Plus, Garlic/Papaya Plus, No. 103, 90 Capsules, Dietary Supplement
Supplements·254 affected·Jul 26, 2017
High RiskFDA
Natureall-stf Holding, Llc
Prostate-Plus, No. 117, 90 Capsules, Dietary Supplement
Supplements·186 affected·Jul 26, 2017
High RiskFDA
Hospira Inc, Lake Forest
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial. Mfd For: Teva Parenteral Medicines, Inc., I...
Injectable Drugs·14,300 affected·Jul 26, 2017
High RiskFDA
Icu Medical Inc
0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira, Inc., Lake Forest, IL 60045 USA --- NDC# 0409-798...
Injectable Drugs·436,716 affected·Jul 26, 2017
High RiskFDA
Hospira Inc, Lake Forest
Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Single Dose Vial per Carton, 100 vials per case. Hospira, Inc....
Injectable Drugs·9,009 affected·Jul 26, 2017
High RiskFDA
Hospira Inc, Lake Forest
Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Single Dose Vial.(10 vials per carton NDC 0703-0113-01) and 180 v...
Injectable Drugs·56,340 affected·Jul 26, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
Concorde Lift Torque Limiting Handle. Must be used with supplemental internal spinal fixation systems that have been cleared for use...
Medical Devices·130 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthoped...
Medical Devices·6,257 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
Light Clip for Oracle Retractor, sterile, Part Number: 03.809.925S Reaming Rods are intended for guiding of reamers during orthopedic ...
Medical Devices·6 affected·Jul 26, 2017
High RiskFDA
Depuy Orthopaedics, Inc.
Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar sp...
Medical Devices·130 affected·Jul 26, 2017
High RiskFDA
Synthes (usa) Products Llc
2.5 mm Reaming Rod, Ball tip, 1150 mm, sterile, Part Number: 351.708S Reaming Rods are intended for guiding of reamers during orthoped...
Medical Devices·1,144 affected·Jul 26, 2017
High RiskFDA
Gold Medal Products Co
CORN TREATS CONCENTRATED CARAMEL CORN MIX NET WT 1 LB-6 OZ (22 OZ or 623 g) Manufactured by GOLD MEDAL PRODUCTS CO.
Food·806 affected·Jul 25, 2017
Medium RiskFDA
Teva Pharmaceuticals Usa
Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per ...
Drugs·401,750 affected·Jul 25, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc.
Syngo Imaging version V31 (model # 10014063) is a Picture Archiving and Communication System (PACS) intended to display, process, read, r...
Medical Devices·36 affected·Jul 25, 2017
High RiskFDA
Arrow International Inc
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
Surgical Devices·2,691 affected·Jul 25, 2017
CriticalFDA
Ezweightlosstx Llc
LaBri's Body Health Atomic 60 Capsules Exclusively distributed worldwide by LaBri's Body Health.
Oral Drugs·4,958 affected·Jul 24, 2017
CriticalFDA
Ezweightlosstx Llc
LaBri's Body Health XPLODE 30 capsules Exclusively distribute worldwide by LaBri's Body Health.
Oral Drugs·1,424 affected·Jul 24, 2017
High RiskFDA
Teva Pharmaceuticals Usa
Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-572...
Oral Drugs·28,188 affected·Jul 24, 2017
High RiskFDA
Epimed International
RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)TW, 10 units, Calibrated, Plastic Hub, Detachable Wing, Blunt Stylet, Sterile, Rx only, Fo...
Surgical Devices·500 affected·Jul 24, 2017
High RiskFDA
Epimed International
TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 10 units, Calibrated, Plastic Hub, Fixed Wing, Sterile, Rx only
Medical Devices·263 affected·Jul 24, 2017
High RiskFDA
Vygon Mfg, Inc., Dba/ Churchill Medical Systems, Inc.
3-Way Standardbore Stopcock. Product Code: AMS-100.
Medical Devices·200 affected·Jul 24, 2017