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High RiskFDA
Geneva Foods, Llc
Lysander's All Natural Bourbon Flavor Rub; for beef, chicken, pork, and fish; 3.8 oz (107.7 g), foil bag, 6 units per case. Manufactured...
Meat & Poultry·5,145 affected·Feb 1, 2016
High RiskFDA
Laserex Systems Inc.
Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery hea...
Medical Devices·72 affected·Feb 1, 2016
High RiskFDA
Merge Healthcare, Inc.
RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·25 affected·Jan 31, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Enterprise Archive. The firm name on the label is Merge Healthcare, Hartland, WI. iConnect Enterprise Archive is intended fo...
Medical Devices·96 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
CADstream software. The firm name on the label is Merge Healthcare, Hartland, WI.
Medical Devices·844 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge FlexConnect software, a component of Merge LIS. Merge FlexConnect is middleware used in conjunction with Merge LIS to facilitate c...
Medical Devices·324 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
Merge PACS software. The firm name on the label is Merge Healthcare, Hartland, WI. Intended to create and display two-dimensional an...
Medical Devices·109 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various...
Diagnostic Devices·146 affected·Jan 30, 2016
High RiskFDA
Merge Healthcare, Inc.
iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various...
Diagnostic Devices·146 affected·Jan 30, 2016
High RiskFDA
Siemens Medical Solutions Usa, Inc
software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, ...
Medical Devices·151 affected·Jan 29, 2016
High RiskFDA
Novadaq Technologies Inc.
PINPOINT Endoscopic Fluorescence Imaging System
Medical Devices·110 affected·Jan 29, 2016
High RiskFDA
Biomet, Inc.
Crosslock DVR ePAK -Sterile, Ref 81180050, are complete surgical sets including plates, screws, and instruments for orthopedic fixation ...
Surgical Devices·21,268 affected·Jan 29, 2016
High RiskFDA
Valeant Pharmacueticals International
Orapharma (Onpharma) Onset Mixing Pen Rx only, Product/Part Number 1054-02. Manufactured for Onpharma Inc. Los Gratos, CA 95030 The ...
Medical Devices·7,716 affected·Jan 29, 2016
High RiskFDA
Corin Usa Limited
Trinity Acetabular System Product Usage - Total Hip Replacement.
Medical Devices·629 affected·Jan 29, 2016
High RiskFDA
Corin Usa Limited
Trinity Acetabular Shell Product Usage Total Hip Replacement.
Medical Devices·629 affected·Jan 29, 2016
High RiskFDA
Gi Supply
Large Volume Paracentesis Kit is packaged in a thermaformed tray which contains slots and snap-in holders for most components. Packed ste...
Medical Devices·390 affected·Jan 28, 2016
High RiskFDA
Conformis, Inc.
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model: TCR-111-1111
Medical Devices·1 affected·Jan 28, 2016
High RiskFDA
Bonita Pharmaceuticals, Llc
Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patche...
Topical Drugs·3,308 affected·Jan 27, 2016
High RiskFDA
Physio-control, Inc.
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software versio...
Cardiac Devices·44,798 affected·Jan 27, 2016
High RiskFDA
Karman Healthcare Inc
Karma Flexx Wheelchair Manual Wheelchair.
Medical Devices·35 affected·Jan 27, 2016
High RiskFDA
Qig Group Llc
Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x 8 channel)
Medical Implants·40 affected·Jan 26, 2016
High RiskFDA
Applied Medical Technology Inc
AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SINGLE USE ONLY Rx ONLY STERILE. For use in patients who canno...
Medical Devices·20 affected·Jan 26, 2016
High RiskFDA
Qig Group Llc
Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400
Medical Devices·31 affected·Jan 26, 2016
High RiskFDA
Scenic Fruit Company
Freeze Dried Black Raspberry Powder, Item no. 30007 or 30041. Nutrifruit brand. Each plastic jar has a net wt. 5 oz. The UPC is 0 79947 0...
Produce·4,813 affected·Jan 25, 2016
High RiskFDA
Scenic Fruit Company
Freeze Dried Mango Powder, Item no. 30042. Nutrifruit brand. Each plastic jar has a net wt. 5 oz. The UPC is 0 79947 00110 4.
Produce·331 affected·Jan 25, 2016
High RiskFDA
Sorin Group Usa, Inc.
Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Produ...
Surgical Devices·60 affected·Jan 25, 2016
High RiskFDA
Mary's Gone Crackers, Inc.
Mary's Gone Crackers Thins, Light and Tasty Snack Crackers; Lightly salted. Organic, gluten free, non gmo, vegan; NET WT. 4.5 oz (127 g...
Bakery & Grains·1,160 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover PREM U/M 14FR TMP SNS CSD Item Code: P4P14TSD P400 Castile soap towelettes are used to clean the genital area for mal...
Medical Devices·3,000 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male an...
Medical Devices·31,200 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover PPREM 18FR UL LTX FOLEY TRY CSD Item Code: P18ULD Castile soap towelettes are used to clean the genital area for ma...
Medical Devices·1,980 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap towelettes are used to clean the genital are...
Medical Devices·600 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes are used to clean the genital area for male...
Medical Devices·4,500 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male ...
Medical Devices·3,600 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 16FR SIL COUDE CATH SECURE Item Code: P4P16CSD Castile soap towelettes are used to clean the genital a...
Medical Devices·4,200 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and f...
Medical Devices·95,700 affected·Jan 22, 2016
High RiskFDA
3m Company - Health Care Business
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
Medical Devices·74 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover PRECISION PRM 18FR SIL COUDE CATH SECURE Item Code: PP18CSD Castile soap towelettes are used to clean the genital are...
Medical Devices·1,950 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male an...
Medical Devices·25,080 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes are used to clean the genital area for mal...
Medical Devices·11,400 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover 7 OZ MIDSTREAM W/CAST SOAP Item Code: 24035 Castile soap towelettes are used to clean the genital area for male and fe...
Medical Devices·0 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover EASY CATCH MIDSTREAM KT W/CAST Item Code: 25015 Castile soap towelettes are used to clean the genital area for male a...
Medical Devices·74,300 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes are used to clean the genital area for male...
Medical Devices·71,430 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes are used to clean the genital area for male ...
Medical Devices·7,200 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile soap towelettes are used to clean the genital area for m...
Medical Devices·1,320 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male a...
Medical Devices·7,200 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover 4.5OZ MIDSTREAM W/CASTILE TOWL Item Code: 24015 Castile soap towelettes are used to clean the genital area for male an...
Medical Devices·16,500 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes are used to clean the genital area for mal...
Medical Devices·600 affected·Jan 22, 2016
High RiskFDA
Covidien Llc
Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and f...
Medical Devices·83,400 affected·Jan 22, 2016