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
Siemens Healthcare Diagnostics
ADVIA Centaur Immunoassay System, Catalog Numbers/Siemens Material Numbers (SMN) 10284980, 10286140, 10309524, 10309525, 10310210, 103132...
Diagnostic Devices·10,515 affected·Aug 13, 2014
High RiskFDA
Gendex Corp
eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW...
Medical Devices·651 affected·Aug 12, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
The Siemens Symbia S series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagn...
Medical Devices·877 affected·Aug 12, 2014
CriticalFDA
Ethicon Endo-surgery Inc
PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Model PXR35), Bu...
Medical Devices·42,798 affected·Aug 12, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
AXIOM Luminos dRF system with SW VD10 or on Luminos dRF Max The Axiom Luminos dRF is intended to be used as a universal diagnostic im...
Diagnostic Devices·33 affected·Aug 12, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc.
The Siemens Symbia T series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagn...
Medical Devices·1,330 affected·Aug 12, 2014
RecallFDA
Elitech Clinical Systems Sas
ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for ...
Cardiac Devices·878 affected·Aug 11, 2014
High RiskFDA
Instradent Usa, Inc.
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for ...
Medical Implants·13 affected·Aug 11, 2014
CriticalFDA
Brooks Tropicals, Llc
Avocados approximately 14-30 oz each in packed 20 units in cardboard boxes with black lettering labeled in part: in part: "USDA/FL 2/1...
Food·401 affected·Aug 8, 2014
CriticalFDA
Cubist Pharmaceuticals, Inc.
CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only, Single use Vial, Manufactured for: Cubist Pharmaceuticals ...
Injectable Drugs·371,879 affected·Aug 8, 2014
High RiskFDA
Ge Healthcare, Llc
CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCAiO, E-sCAiOV, E-sCAiOE, E-sCAiOVE; the Airway Gas Option N-CAiO and respective service ...
Respiratory Devices·748 affected·Aug 8, 2014
CriticalFDA
Carefusion 203, Inc.
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients who require respiratory support or m...
Respiratory Devices·1,729 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Bard Access Systems
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microi...
Surgical Devices·134,554 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Philips Medical Systems, Inc.
Philips Healthcare Integris Allura 15 -12 Fluoroscopy x ray system
Medical Devices·0 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Bard Access Systems
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Acc...
Surgical Devices·135,284 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
Bard Access Systems
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access ...
Surgical Devices·16,410 affected·Aug 8, 2014
High RiskFDA
Beckman Coulter, Inc.
MicroScan Microbiology Systems: Dried Gram Negative MIC/Combo Panels Containing Lower Imipenem Dilutions for Reporting CLSI M100-S20 Br...
Medical Devices·216,240 affected·Aug 8, 2014
High RiskFDA
New Gpc Inc.
MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana.
Drugs·1,320 affected·Aug 7, 2014
High RiskFDA
New Gpc Inc.
alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged within a glass container individually placed in smal...
Drugs·900 affected·Aug 7, 2014
High RiskFDA
New Gpc Inc.
alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a plastic container individually placed in small carton. Count...
Topical Drugs·690 affected·Aug 7, 2014
CriticalFDA
Baxter Healthcare Corp.
Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose, 5000 mL Ambu-Flex II container bags, Rx only, Baxter Hea...
Drugs·50,530 affected·Aug 7, 2014
High RiskFDA
New Gpc Inc.
Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
Topical Drugs·4,320 affected·Aug 7, 2014
High RiskFDA
New Gpc Inc.
Rector's Remedy OINTMENT, Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
Topical Drugs·2,304 affected·Aug 7, 2014
High RiskFDA
New Gpc Inc.
WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
Drugs·360 affected·Aug 7, 2014
High RiskFDA
New Gpc Inc.
Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactur...
Drugs·36 affected·Aug 7, 2014
High RiskFDA
Zimmer, Inc.
PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12...
Medical Devices·77,737 affected·Aug 7, 2014
High RiskFDA
Zimmer, Inc.
PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top;...
Medical Devices·77,737 affected·Aug 7, 2014
High RiskFDA
Hli Dba Humphreyline Inc
Alcohol-Free Hand Sanitizer, 1. fl. oz. (30 ml) bottles capped with white sprayer, OTC, contains Benzalkonium chloride. Mfg. for HLI, Por...
Inhaled / Nasal Drugs·975 affected·Aug 6, 2014
High RiskFDA
Qualitest Pharmaceuticals
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL O...
Oral Drugs·170,113 affected·Aug 6, 2014
High RiskFDA
Qualitest Pharmaceuticals
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4...
Oral Drugs·181,908 affected·Aug 6, 2014
High RiskFDA
Qualitest Pharmaceuticals
CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL ...
Oral Drugs·101,208 affected·Aug 6, 2014
High RiskFDA
Angiodynamics, Inc.
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STER...
Medical Devices·70 affected·Aug 6, 2014
High RiskFDA
Sedecal S.a.
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
Diagnostic Devices·283 affected·Aug 6, 2014
High RiskFDA
Siemens Healthcare Diagnostics
ADVIA Chemistry A1c_3 CAL (Calibrator) for use on the ADVIA Chemistry Systems, REF/Catalog Number/Siemens Material Number (SMN) 10491408,...
Diagnostic Devices·1,122 affected·Aug 6, 2014
High RiskFDA
Ortho-clinical Diagnostics
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C vir...
Diagnostic Devices·463 affected·Aug 6, 2014
High RiskFDA
Angiodynamics, Inc.
Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog No./REF 12401809, Product No. H787124018095, STER...
Medical Devices·36 affected·Aug 6, 2014
High RiskFDA
Arrow International Inc
Arrow Select Kits (ASK) and Maximal Barrier Precautions Kits (CDC) with BD Medical Posiflush 10mL Saline Flush Syringe.
Medical Devices·71,255 affected·Aug 6, 2014
High RiskFDA
Ikko International Trading Llc
Wheat Cake (Maruto "C" Cake), 6.3 ounces (180g), individually packaged in gold foil pouches and sold under the Maruto Brand. Sold at reta...
Bakery & Grains·10 affected·Aug 5, 2014
RecallFDA
Akorn, Inc.
Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mf...
Injectable Drugs·5,539 affected·Aug 5, 2014
High RiskFDA
Zydus Pharmaceuticals Usa Inc
ZyGenerics ATENOLOL Tablets, USP 25 mg 1000 count bottle, Rx Only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by...
Oral Drugs·5,400 affected·Aug 5, 2014
High RiskFDA
Catheter Connections, Inc.
DualCap IV Pole Strips Disinfectant Caps for Luer Access Valves, REF 500-LB, Sterile. When left in place for five (5) minutes DualCap ...
Medical Devices·24,910 affected·Aug 5, 2014
High RiskFDA
Icu Medical, Inc.
Cap Change Kit with MicroClave Clear Connector, Item No. B79103 BD prefilled syringes are co-packaged into a kit with ICU devices and ...
Medical Devices·300 affected·Aug 5, 2014
High RiskFDA
Icu Medical, Inc.
Port Access Kit with MicroClave Clear Connector, Item No. B79104 BD prefilled syringes are co-packaged into a kit with ICU devices and...
Medical Devices·400 affected·Aug 5, 2014
High RiskFDA
Regeneca, Inc
RegeneSlim Appetite Control, 2 capsules/ packet, Dietary Supplement
Supplements·154,748 affected·Aug 4, 2014