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
Shimadzu Medical Systems
R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06...
Diagnostic Devices·308 affected·Oct 28, 2011
High RiskFDA
Progressive Medical Inc
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamage...
Medical Devices·124 affected·Oct 28, 2011
High RiskFDA
Shimadzu Medical Systems
0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospi...
Medical Devices·5 affected·Oct 28, 2011
High RiskFDA
Tortilleria Provincia
Yellow Corn Tortillas in 5 lb clear flexible plastic bags with green and yellow printing. Tortilleria Provincia 1200 B Clay Street Bowlin...
Food·60 affected·Oct 19, 2011
High RiskFDA
Philips Healthcare Inc.
Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide
Medical Devices·11 affected·Oct 19, 2011
High RiskFDA
Meda Pharmaceuticals Inc.
Prefera OB One Gel Capsules, 30 softgels, Rx Only, Manufactured by: IVC industries, Inc. Irving ton, NJ 07111, For: Alaven Pharmaceutical...
Oral Drugs·478,569 affected·Oct 17, 2011
High RiskFDA
Scc Soft Computer
SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. Product UsageSoftLab is a labora...
Medical Devices·88 affected·Oct 17, 2011
High RiskFDA
Exactech, Inc.
OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC T...
Medical Implants·70 affected·Oct 17, 2011
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to...
Surgical Devices·1,090 affected·Oct 17, 2011
High RiskFDA
Quality Dairy Farms Inc.
Mercer's Ice Cream Old Fashioned Cookie Dough, Half Gallon, (1.89 Liter), UPC 036667 200231
Dairy·454 affected·Oct 13, 2011
High RiskFDA
Quality Dairy Farms Inc.
Mercer's Ice Cream Cream N' Coffee Fudge, Half Gallon, (1.89 Liter), UPC 074513 003513
Dairy·241 affected·Oct 13, 2011
High RiskFDA
Quality Dairy Farms Inc.
Mercer's Ice Cream Cookies 'N Cream, Half Gallon (1.89 Liter), UPC 036667 200392
Dairy·499 affected·Oct 13, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A71460. The DxI Immunoassay System ...
Diagnostic Devices·2,442 affected·Oct 13, 2011
High RiskFDA
Beckman Coulter Inc.
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: A25288; Dxl 800 with spot B: A71456;...
Diagnostic Devices·2,442 affected·Oct 13, 2011
High RiskFDA
Intuitive Surgical, Inc.
Thyroidectomy Indication for the da Vinci Surgical Systems; Product Usage: da Vinci Thyroidectomy offers a minimally invasive surgery...
Surgical Devices·2,423 affected·Oct 13, 2011
RecallFDA
Mothers' Milk Bank At Austin
Mother's Milk Bank at Austin, Batch # 9429-1, 3 oz. (100 mL), Pasteurized, Exp: 3/25/2012, KCal/Oz: 20, Protein: .9 g/dl
Dairy·54 affected·Oct 11, 2011
Medium RiskFDA
Beckman Coulter Inc.
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) level...
Diagnostic Devices·117,385 affected·Oct 11, 2011
High RiskFDA
Integra Lifesciences Corp.
Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tri...
Surgical Devices·22 affected·Oct 11, 2011
High RiskFDA
Integra Lifesciences Corp.
Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and c...
Surgical Devices·42 affected·Oct 11, 2011
High RiskFDA
Raysearch Laboratories Ab
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial na...
Medical Devices·20 affected·Oct 10, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archiving, and communication of data acquired by Em...
Diagnostic Devices·11 affected·Oct 6, 2011
High RiskFDA
Orthosoft, Inc. Dba Zimmer Cas
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of ...
Medical Devices·105 affected·Oct 6, 2011
High RiskFDA
Vistapharm, Inc.
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
Oral Drugs·27,221 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-8450-R1 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in ...
Medical Devices·3 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The...
Medical Devices·538 affected·Sep 30, 2011
High RiskFDA
Ge Healthcare, Llc
GE Healthcare, CARESCAPE Monitor B650. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple ar...
Medical Devices·2,813 affected·Sep 30, 2011
High RiskFDA
Custom Medical Specialties, Inc.
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
Medical Devices·16 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-4316 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in ski...
Medical Devices·6 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-2586 Custom Amnio Tray containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in the kit is used in sk...
Medical Devices·7 affected·Sep 30, 2011
High RiskFDA
Custom Medical Specialties, Inc.
CMS-4219-R2 Custom Laser Pack containing 2 oz bottles PVP Prep Solution The PV contained in the kit is used in skin prep
Medical Devices·4 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz. bottle PVP Prep Product Usage: Usage: The PVP contained in the kit is used...
Medical Devices·3 affected·Sep 30, 2011
High RiskFDA
Custom Medical Specialties, Inc.
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
Medical Devices·3 affected·Sep 30, 2011
High RiskFDA
Custom Medical Specialties, Inc.
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Sol...
Medical Devices·15 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
BR980-9600 Hysteroscopy Sterile Procedure Kit containing 2 oz. bottle PVP Prep Solution Product Usage: Usage: The PVP contained in th...
Medical Devices·75 affected·Sep 30, 2011
CriticalFDA
Custom Medical Specialties, Inc.
CMS-4501-R1 Custom HSG Tray containing 2 oz. PVP Prep Bottle Product Usage: Usage: The PVP contained in the kit is used in skin prep
Medical Devices·5 affected·Sep 30, 2011
CriticalFDA
Shamrock Medical Solutions Group Llc
metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lew...
Oral Drugs·88 affected·Sep 27, 2011
High RiskFDA
Shamrock Medical Solutions Group Llc
Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical So...
Oral Drugs·99 affected·Sep 27, 2011
CriticalFDA
Shamrock Medical Solutions Group Llc
Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged...
Oral Drugs·55 affected·Sep 27, 2011
CriticalFDA
Shamrock Medical Solutions Group Llc
Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Cent...
Oral Drugs·89 affected·Sep 27, 2011
High RiskFDA
Shamrock Medical Solutions Group Llc
Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trime...
Oral Drugs·284 affected·Sep 27, 2011
High RiskFDA
Shamrock Medical Solutions Group Llc
Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solut...
Oral Drugs·99 affected·Sep 27, 2011
High RiskFDA
Exactech, Inc.
Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gain...
Surgical Devices·12 affected·Sep 23, 2011
High RiskFDA
Exactech, Inc.
Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Ex...
Medical Devices·16 affected·Sep 23, 2011
High RiskFDA
Physicians Total Care, Inc.
Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count t...
Injectable Drugs·4 affected·Sep 19, 2011
High RiskFDA
Intuitive Surgical, Inc.
da Vinci Si Surgeon Console. Intended to assist in the accurate Control of Intuitive Surgical Endoscopic Instruments.
Surgical Devices·0 affected·Sep 19, 2011
High RiskFDA
Intuitive Surgical, Inc.
Flush Port (used in almost all da Vinci instruments) Assists in cleaning the instrument.
Medical Devices·0 affected·Sep 19, 2011
High RiskFDA
The Anspach Effort, Inc.
.***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only P...
Medical Devices·5 affected·Sep 19, 2011
CriticalFDA
Engineered Medical Systems,inc
Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory and anesthesia applications as a conduit for var...
Respiratory Devices·1,500 affected·Sep 12, 2011