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
Perry Drug Inc.
HCG - 10,000 Unit PF Inject, 1mL Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS NDC 88888-0216-49
Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
HCG 200 IU/mL Injection, 30Ml, 10 mL vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-7745-68
Injectable Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Phenylephrine HCl (100 mcg/mL syr) in 0.9% NaCl 1 mg / 10 mL, 3Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park...
Drugs·8 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
HCG Low Dose 10 IU / 0.1 mL, 5 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-2596-17
Drugs·2 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Testosterone Cyp 200 mg/mL Sesame Inj., 4Ml Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-790...
Drugs·1 affected·Nov 7, 2014
Medium RiskFDA
Hospira Inc.
Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx only, Manufactured...
Injectable Drugs·316,640 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
HCG Low Dose 30 IU/0.1 mL, 5 Ml vial, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0231-54
Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Tri-Mix (PGE-10MCG/PAP-30MG/PT 5Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5123-09
Drugs·17 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Sodium Tetradecyl SO4 0.3% Inj., 30 Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-6427-90
Drugs·20 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
HCG 10,000 U/ 10 mL PF Inj, 8Ml vials, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5012-34
Drugs·3 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Tri Mix PF SYR 0.5 mL Inj., Compounded Rx, 10 each, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5036-49
Drugs·20 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17
Drugs·10 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Testosterone CYP-250/PROP-20 mg, 10 Ml Syringe, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0326-44
Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
2Ml HCG 10,000 U/ MB12 - 12,000 MCG/10 Ml Inj, 0.25ML (250IU), Rx, Perry Drug Compounding Pharmacy, Overland Park, KS ---NDC 88888-7945-17
Drugs·1 affected·Nov 7, 2014
High RiskFDA
Perry Drug Inc.
Cyclosporine 0.045 % Sol PF, 12 mL bottle, Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-5120-67
Drugs·3 affected·Nov 7, 2014
High RiskFDA
Depuy Orthopaedics, Inc.
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head i...
Medical Devices·19 affected·Nov 7, 2014
High RiskFDA
Biomet 3i, Llc
OSSEOTITE Tapered Certain Implant Rx Only; 3.25 x 18.5 - 15.0 mm. Dental Implants.
Medical Implants·620 affected·Nov 7, 2014
High RiskFDA
Ion Beam Applications S.a.
adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C is used with a charged particle or photon radiation therapy system for ...
Medical Devices·1 affected·Nov 7, 2014
High RiskFDA
Biomet 3i, Llc
OSSEOTITE Certain 2 Implant Rx only; 3.25 x 8.5 - 18 mm. Dental Implants.
Medical Implants·620 affected·Nov 7, 2014
High RiskFDA
Unomedical As
Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort ...
Diabetes Devices·22,114 affected·Nov 7, 2014
High RiskFDA
Unomedical As
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17...
Diabetes Devices·653,280 affected·Nov 7, 2014
High RiskFDA
Unomedical As
Contact Detach, 8mm, 23", G29; Contact Detach 8 mm, 43", G29; Contact Detach, 6mm, 23" G29; Infusion Set, Contact Detach, 6mm x 23"; Infu...
Diabetes Devices·664,000 affected·Nov 7, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Licox Brain Tissue Oxygen Monitoring Integra Licox Recon Tissue Oxygen Monitoring 1) LICOX¿ Complete Brain Probe Kit (compris...
Respiratory Devices·2,506 affected·Nov 7, 2014
High RiskFDA
Unomedical As
SureT G29 6mm, 18", Paradigm; SureT G29 6mm 23"; SureT G29 6mm, 23", Paradigm; SureT G29 6mm 32"' SureT G29 6mm, 32", Paradigm; SureT G29...
Diabetes Devices·4,748,000 affected·Nov 7, 2014
High RiskFDA
Becton Dickinson & Co.
BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959...
Diagnostic Devices·7 affected·Nov 7, 2014
High RiskFDA
Unomedical As
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm...
Diabetes Devices·9,782,880 affected·Nov 7, 2014
High RiskFDA
Schwartz Brothers Restaurants Dba Schwartz Brothers Bakery
"Everything Bagels" product is packed in a clear 4-pack plastic bag, with visible image of cheese melted on top of the bagels. This pro...
Dairy·321 affected·Nov 6, 2014
CriticalFDA
Conmed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2516H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CO...
Cardiac Devices·174,610 affected·Nov 6, 2014
High RiskFDA
Zimmer Biomet, Inc.
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Surgical Devices·31 affected·Nov 6, 2014
High RiskFDA
Abbott Medical Optics Inc (amo)
Abbott Healon EndoCoat Ophthalmic Viscosurgical Device 3% sodium hyaluronate 0.85 mL 30 mg/mL Sterile A Solution Sterile EO Packaging...
Surgical Devices·484,881 affected·Nov 6, 2014
CriticalFDA
Conmed Corporation
MINI PEDIATRIC Radiotransparent Electrode, REF/Catalog Number 2602H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG...
Cardiac Devices·174,610 affected·Nov 6, 2014
CriticalFDA
Conmed Corporation
CONMED PEDIATRIC R2 Multifunction Electrodes, REF/Catalog Number 3115-1750, Direct Connect to Philips Heartstart, Rx ONLY --- ASSEMBLED I...
Cardiac Devices·174,610 affected·Nov 6, 2014
High RiskFDA
Fisher & Paykel Healthcare, Ltd.
Fisher and Paykel Healthcare (FPH) IW900-Series Infant Warmer Fisher and Paykel; Healthcare CosyCot and Kit Replacement Head Case Asse...
Medical Devices·661 affected·Nov 6, 2014
CriticalFDA
Conmed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-C, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE ...
Cardiac Devices·174,610 affected·Nov 6, 2014
High RiskFDA
Synthes (usa) Products Llc
Synthes Small Electric Drive (SED), part number: 05.001.175: The Small Electric Drive is designed for use in general traumatology, especi...
Surgical Devices·12 affected·Nov 6, 2014
RecallFDA
Illumina Inc
Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina MiSeqDx Platform.
Diagnostic Devices·19 affected·Nov 6, 2014
CriticalFDA
Conmed Corporation
ADULT Radiotransparent Electrode, REF/Catalog Number 2001H-PC, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE...
Cardiac Devices·174,610 affected·Nov 6, 2014
High RiskFDA
Sushi House Inc.
Frozen Raw Yellowfin Tuna Ground Meat (Thunnus albacares), Grade: AAA, Net Weight: 10 lbs (100%), Wild Caught, Product of Indonesia, Impo...
Meat & Poultry·280 affected·Nov 5, 2014
High RiskFDA
Philips Ultrasound, Inc.
Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10.0 with a2DQ and/or aCMQ plug-ins installed with Philips Xc...
Medical Devices·52 affected·Nov 5, 2014
High RiskFDA
Philips Ultrasound, Inc.
EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.x with QLAB a2DQ and/or aCMQ plug-ins are affected. Model: ...
Diagnostic Devices·701 affected·Nov 5, 2014
High RiskFDA
Gambro Renal Products Inc
Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use dev...
Medical Devices·20 affected·Nov 5, 2014
High RiskFDA
Gambro Renal Products Inc
Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices...
Medical Devices·20 affected·Nov 5, 2014
High RiskFDA
Maquet Cardiovascular Us Sales, Llc
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in comb...
Cardiac Devices·28 affected·Nov 5, 2014
High RiskFDA
Custom Healthcare Systems, Inc.
Safety PICC Insertion Tray with Chloraprep OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only.
Medical Devices·3 affected·Nov 5, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro diagnostic device intended to ...
Diagnostic Devices·1,949 affected·Nov 5, 2014
RecallFDA
Baroody Imports Inc.
Baroody Pickled Labneh with Pepper, Net Wt. 20 oz., (1 lb. 4 oz.), 575-g, in sealed glass jar, UPC 642036010549
Food·20 affected·Nov 4, 2014
High RiskFDA
R And S Gourmet Warehouse
Gourmet Warehouse, Island Jerk Marinade, 16 fl oz. (473 mL), Ingredient: Soy Sauce, Lemon Juice, Thyme, Allspice, Onion, Garlic, Cayenne ...
Beverages·0 affected·Nov 4, 2014
CriticalFDA
International Sprout Holding Inc.
Alfalfa Seed in plastic lined bags labeled in part *** VNS Alfalfa, NET WT. 25 KG Lot SAL2-3BJ Product of AUSTRALIA, International Speci...
Food·22,000 affected·Nov 4, 2014