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All Product Recalls

49,195 recalls from FDA (high severity)

Source:AllCPSCFDAUSDASeverity:AllCriticalHighMedium
High RiskFDA
Hyphen Biomed
ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and ...
Diagnostic Devices·94 affected·Nov 9, 2011
High RiskFDA
Hyphen Biomed
ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG,...
Diagnostic Devices·30 affected·Nov 9, 2011
High RiskFDA
Carefusion 213, Llc
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 26...
Drugs·67,775 affected·Nov 8, 2011
High RiskFDA
Biomet 3i, Llc
Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. . Product is labeled in part: "***Certain 3.25, 13**...
Medical Implants·219 affected·Nov 4, 2011
High RiskFDA
Shimadzu Medical Systems
0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name...
Medical Devices·288 affected·Oct 28, 2011
High RiskFDA
Shimadzu Medical Systems
0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile ...
Medical Devices·133 affected·Oct 28, 2011
High RiskFDA
Shimadzu Medical Systems
0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the ...
Medical Devices·3 affected·Oct 28, 2011
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
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
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
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
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
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
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
High RiskFDA
The Anspach Effort, Inc.
Anspach Single Use Sterile Bone Cutting Burs and Irrigation Clips. Rx Only
Medical Devices·1,805,022 affected·Sep 9, 2011
High RiskFDA
Abbott Point Of Care Inc.
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, h...
Diabetes Devices·310,003 affected·Sep 8, 2011
High RiskFDA
Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calci...
Diabetes Devices·4 affected·Sep 8, 2011
High RiskFDA
Abbott Point Of Care Inc.
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Medical Devices·6,000 affected·Sep 8, 2011
High RiskFDA
Abbott Point Of Care Inc.
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potass...
Diabetes Devices·4 affected·Sep 8, 2011
High RiskFDA
Animas Corporation
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diab...
Diabetes Devices·1,235 affected·Sep 6, 2011