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
Stryker Communications
SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and ...
Medical Devices·953 affected·Mar 17, 2014
High RiskFDA
Stryker Communications
BAM (SHAPE) ARM, RIGHT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting a...
Medical Devices·953 affected·Mar 17, 2014
High RiskFDA
Stryker Communications
BAM (SHAPE) ARM, LEFT, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting an...
Medical Devices·953 affected·Mar 17, 2014
High RiskFDA
Smiths Medical Asd, Inc.
Smiths Medical HOTLINE¿ Fluid Warming Set L-70. Product Usage: intended for the delivery of warmed blood and intravenous fluids at no...
Medical Devices·393,210 affected·Mar 17, 2014
High RiskFDA
Remel Inc
Oxoid Legionella Pneumo Groups 2-14, DR0802M, containing 50 tests per box. The box contains a variety of components, one of which is Oxo...
Diagnostic Devices·2 affected·Mar 17, 2014
High RiskFDA
Arjo Hospital Equipment Ab
ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic ...
Medical Devices·1,695 affected·Mar 17, 2014
High RiskFDA
Whole Foods Market South Seafood Distribution
Fresh Wild Gulf Amberjack (Whole, Fillet and Portion)
Food·314 affected·Mar 15, 2014
High RiskFDA
Claymount Assembli
The Claymount Harmony is a grid cabinet designed to accept a digital x-ray imaging receptor and stationary grid. It contains signaling el...
Medical Devices·125 affected·Mar 15, 2014
High RiskFDA
Smiley National Inc
All Natural, XL Kratom, Herbal Dietary Supplement, capsule, UPC code 5410600307, 4 capsules per package.
Supplements·2,880 affected·Mar 14, 2014
High RiskFDA
Smiley National Inc
Enhanced Maeng Da Leaf Powder, Maeng Da Kratom, capsule, UPC code 5410600330, 10 Pack, 2 Servings Per Pack, 10 grams.
Food·864 affected·Mar 14, 2014
High RiskFDA
Smiley National Inc
Enhanced Bali Leaf Powder, Max Kratom, Capsule, UPC Code 5410600332, 20 count pack, 5 servings per pack, Herbal Dietary Supplement.
Supplements·2,592 affected·Mar 14, 2014
CriticalFDA
Fannie May Confection Brands Inc
Fannie May Assorted Chocolates Rich dark & milk chocolate & pastels with an assortment of decadent fillings NET WT 14 OZ (396 g) Assorte...
Dairy·89 affected·Mar 14, 2014
High RiskFDA
Smiley National Inc
Natural Bali Kratom 40, capsule, UPC code 5410600335, 20 capsules per bottle.
Food·900 affected·Mar 14, 2014
CriticalFDA
Shire Human Genetic Therapies, Inc.
VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Wa...
Injectable Drugs·8,359 affected·Mar 14, 2014
High RiskFDA
Breg Inc
Economy Elastic Knee Sleeve Open, Model No. 121414 and 121415. Product Usage: The product is intended to provide flexible knee support.
Medical Devices·20 affected·Mar 14, 2014
High RiskFDA
Intervalve Inc
InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular proce...
Surgical Devices·2 affected·Mar 14, 2014
High RiskFDA
Alcon Lensx, Inc.
Alcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisions, anterior capsulotomy and laser pha...
Medical Devices·75 affected·Mar 14, 2014
CriticalFDA
Dole Fresh Vegetables Inc
Italian blend Salad (Romaine Lettuce and Radicchio) packaged under the following brand names: Dole Italian Blend, (UPC 7143000819); Fr...
Produce·3,807 affected·Mar 13, 2014
High RiskFDA
Blu Pharmaceuticals Inc
Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmace...
Oral Drugs·101,500 affected·Mar 13, 2014
CriticalFDA
Pain Free By Nature
REUMOFAN PLUS Tablets, 30 Tablet Bottles, OTC. Previene el cancer en los huesos, Nueva presentacion el original.
Oral Drugs·7,123 affected·Mar 13, 2014
High RiskFDA
Blu Pharmaceuticals Inc
Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceu...
Oral Drugs·14,000 affected·Mar 13, 2014
High RiskFDA
Intuitive Surgical, Inc.
5X300 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sun...
Surgical Devices·5,217 affected·Mar 13, 2014
High RiskFDA
Intuitive Surgical, Inc.
5X250 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sun...
Surgical Devices·5,217 affected·Mar 13, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantit...
Medical Devices·76 affected·Mar 13, 2014
High RiskFDA
Merit Medical Systems, Inc.
Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Medical Devices·15 affected·Mar 13, 2014
High RiskFDA
Intuitive Surgical, Inc.
5X250 MM Curved Cannula, Arm 2 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sun...
Surgical Devices·5,217 affected·Mar 13, 2014
High RiskFDA
Intuitive Surgical, Inc.
5X300 MM Curved Cannula, Arm 1 for use with daVinci SI Surgical System, model number IS3000. Intuitive Surgical 1266 Kifer Road Sun...
Surgical Devices·5,217 affected·Mar 13, 2014
High RiskFDA
Command Nutritionals, Llc
Juggernaut a) Crimson Punch UPC 811020906803 b) Orange UPC 811020906841 c) Raspberry Lemonade UPC 811020906858 Net Wt. 1.76 lbs...
Produce·1,990 affected·Mar 11, 2014
High RiskFDA
Flying Food Group Llc
Sausage & Egg English Muffin, Good and Fresh brand, 4.1 oz, packaged in clear plastic wrap. UPC 855173005204.
Food·450 affected·Mar 11, 2014
High RiskFDA
Command Nutritionals, Llc
Hard Blast Pink Lemonade Net Wt. 19 oz. Developed and exclusively distributed by: TBI Labs LLC, Miami, FL 33137 www.tbilabs.com 888-253...
Food·989 affected·Mar 11, 2014
High RiskFDA
Paddock Laboratories, Llc
Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01
Oral Drugs·156,012 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is ...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used...
Medical Implants·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
5/10/12 mm Weck¿ Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used t...
Medical Devices·55,521 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
CAPIO, Monodeck, Violet Monofilament Polydioxanone Suture, 1 x 48 inches (122cm) Absorbable Surgical Suture, Rx Only, Teleflex Medical. ...
Surgical Devices·7,380 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
5/10 mm Weck¿, Vista" Optical Bladeless Laparoscopic Access Port, Product Usage: An endoscope and accessories is a device used to ...
Medical Devices·55,521 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorbable polypropylene surgical suture is ...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Tele...
Surgical Devices·7,380 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Weck¿ Vista", Universal Laparoscopic Port, Size 5/10mmx100mm, Product Usage: An endoscope and accessories is a device used to prov...
Medical Devices·55,521 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approx...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
5/10 mm Weck Vista Optical Bladeless Laparoscopic Access Port, Catalog No. 405910R; 5/10/12 mm Weck Vista Optical Bladeless Laparoscopic ...
Medical Devices·55,521 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
5/10 Weck¿ Vista" Universal Balloon Open Access Port - Long Length (100mm), Product Usage: An endoscope and accessories is a devic...
Medical Devices·55,521 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green...
Surgical Devices·32,271 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
10mm Weck¿ Vista" Cannula-only, Teleflex Medical, Product Usage: An endoscope and accessories is a device used to provide access, ...
Medical Devices·55,521 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
5/10 Weck¿ Vista" Universal Balloon Open Access Port  Short Length (53mm), Product Usage: An endoscope and accessories is a devic...
Medical Devices·55,521 affected·Mar 11, 2014
High RiskFDA
Philips Medical Systems (cleveland) Inc
IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model number 881030; ISP LX SPECT, Model number 881035), Philips M...
Diagnostic Devices·157 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
5/10/12 Weck¿ Vista" Universal Balloon Open Access Port  Long Length (100mm), Product Usage: An endoscope and accessories is a dev...
Medical Devices·55,521 affected·Mar 11, 2014
High RiskFDA
Teleflex Medical
10mm Weck Vista Cannula-only, Catalog No. 405910C, 12mm Weck Vista Cannula-only, Catalog No. 405912C. An endoscope and accessories is ...
Medical Devices·55,521 affected·Mar 11, 2014