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High RiskFDA
Smith & Nephew, Inc.
SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated...
Medical Devices·185 affected·Jul 6, 2016
High RiskFDA
Productos La Finca, Inc.
Label reads in part as: "Maga***BACALAITOS CODFISH FRITTER MIX***Peso Neto/Net Weight 4.5oz (128gr)***Productos La Finca Inc.***Zona Ind....
Seafood·2,652 affected·Jul 5, 2016
High RiskFDA
Let's Talk Health, Inc.
Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Tal...
Inhaled / Nasal Drugs·417 affected·Jul 5, 2016
High RiskFDA
The Binding Site Group, Ltd.
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
Medical Devices·809 affected·Jul 5, 2016
High RiskFDA
Implant Direct Sybron Manufacturing, Llc
RePlant¿ Angled Abutment Part Number 6050-52-60
Medical Devices·205 affected·Jul 5, 2016
High RiskFDA
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Width Plate, 2 inch. Part # 885120200. Width plate is packaged inside of a padded-foam corrugate box. A product...
Medical Devices·90 affected·Jul 4, 2016
High RiskFDA
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Handpiece w/o Hose, item number 00-8851-001-01. The Zimmer Air Dermatome II handpiece and width plates are pa...
Medical Devices·220 affected·Jul 4, 2016
High RiskFDA
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Width Plate, 1.5 inch. Part #00-8851-215-00. Width plate is packaged inside of a padded-foam corrugate box. ...
Medical Devices·60 affected·Jul 4, 2016
High RiskFDA
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Width Plate, 3 inch. Part #00-8851-203-00. Width plate is packaged inside of a padded-foam corrugate box. A pro...
Medical Devices·90 affected·Jul 4, 2016
High RiskFDA
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Handpiece, item number 00-8851-001-00. The Zimmer Air Dermatome II handpiece and width plates are packaged i...
Medical Devices·630 affected·Jul 4, 2016
High RiskFDA
Zimmer Surgical Inc
Zimmer¿ Air Dermatome II Width Plate, 4 inch. Part #00-8851-204-00. Width plate is packaged inside of a padded-foam corrugate box. A pro...
Medical Devices·110 affected·Jul 4, 2016
High RiskFDA
Coca-cola Company (the)
Huberts Lemonade Blackberry, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.
Beverages·53 affected·Jul 1, 2016
High RiskFDA
Coca-cola Company (the)
Huberts Original Lemonade, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.
Beverages·53 affected·Jul 1, 2016
High RiskFDA
Coca-cola Company (the)
Huberts Lemonade Strawberry, 16 Fl. Oz. (473 ml), Manufactured for: Hamsen Beverage, Tustin, CA 92780.
Beverages·53 affected·Jul 1, 2016
High RiskFDA
Dream Body Weight Loss
Dream Body Extreme Gold 800 mg 30 capsules in a plastic screw on top bottle
Oral Drugs·0 affected·Jul 1, 2016
High RiskFDA
Dream Body Weight Loss
Dream Body Advanced 400 mg 30 capsules in brown foil packets.
Oral Drugs·0 affected·Jul 1, 2016
High RiskFDA
Dream Body Weight Loss
Dream Body 450 mg 30 capsules in a plastic screw on top bottle
Oral Drugs·0 affected·Jul 1, 2016
High RiskFDA
Sunrise Medical (us) Llc
Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to per...
Medical Devices·12,142 affected·Jul 1, 2016
High RiskFDA
Stryker Instruments Div. Of Stryker Corporation
120 V Neptune 3 Rover, Model Number: 0703-001-000
Medical Devices·78 affected·Jul 1, 2016
High RiskFDA
Spacelabs Healthcare Inc
91496 Ultraview SL Command Module, Options A, B, C, and I. Option A: ECG/Respiration, SpO2, Temperature x2 & adult/neonate NIBP. Op...
Cardiac Devices·3,801 affected·Jul 1, 2016
High RiskFDA
Circulatory Technology Inc
The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-72 A device that isolates pressure tranducers from blo...
Medical Devices·20 affected·Jul 1, 2016
High RiskFDA
Integra Lifesciences Corp.
Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by ...
Medical Devices·27 affected·Jul 1, 2016
High RiskFDA
Nidek Inc
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can ...
Medical Devices·17 affected·Jul 1, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip syst...
Surgical Devices·241 affected·Jul 1, 2016
High RiskFDA
Mister Cookie Face Corporation
Sundae Shoppe Novelty Ice Cream Dipped "Variety"cones, 32 oz. box, Manufactured by Mister Cookie Face LLC, Lakeland, NJ and Distributed b...
Dairy·2,880 affected·Jun 30, 2016
High RiskFDA
Ac Culinary Group Llc
Label reads in part as: "EL ISLE¿O***SOFRITO GOURMET CON SAZON Y ACHIOTE***PESO NETO/NET WT. ***Keep Refrigerated***Marlin Distributors P...
Food·2,892 affected·Jun 30, 2016
High RiskFDA
Actavis Inc
Glipizide 2.5 mg Extended-release tablets, 30-count bottle, Rx Only, Manufactured By: Patheon Pharmaceuticals Inc Cincinnati, OH 45237, ...
Oral Drugs·167,152 affected·Jun 30, 2016
High RiskFDA
Allergan Sales, Llc
TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03,...
Topical Drugs·25,247 affected·Jun 30, 2016
High RiskFDA
Allergan Sales, Llc
TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, C...
Topical Drugs·17,112 affected·Jun 30, 2016
High RiskFDA
Vision Rt Ltd
TrueBeam¿ Radiotherapy Delivery System and EDGE" Radiotherapy Delivery System, K140528. The TrueBeam and Edge Systems are intended to pr...
Medical Devices·47 affected·Jun 30, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minim...
Medical Implants·1 affected·Jun 30, 2016
High RiskFDA
Stryker Howmedica Osteonics Corp.
Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for eit...
Medical Devices·1 affected·Jun 30, 2016
High RiskFDA
Vision Rt Ltd
AlignRT¿ Plus [private label-OSMS] K123371: The AlignRT Plus system is indicated for use to position and monitor patients relative to th...
Medical Devices·47 affected·Jun 30, 2016
High RiskFDA
Zimmer Biomet Spine, Inc
Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
Medical Devices·5 affected·Jun 30, 2016
High RiskFDA
Eola Bottling Company Inc.
Label reads in part "***Oregon RAIN Natural VIRGIN WATER***" The product is packaged in a blue colored plastic bottle. 16.9 FL OZ. ...
Beverages·90 affected·Jun 29, 2016
High RiskFDA
Isomeric Pharmacy Solution, Llc
Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmac...
Injectable Drugs·274 affected·Jun 29, 2016
High RiskFDA
Vital Care Compounder, Llc
TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS
Drugs·13 affected·Jun 29, 2016
High RiskFDA
Arjohuntleigh Polska Sp. Z.o.o.
ArjoHuntleigh Sara Combilizer; Intended to facilitate early immobilization, rehabilitation, and care of patients.
Medical Devices·106 affected·Jun 29, 2016
High RiskFDA
Winco Mfg., Llc
TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide the caregiver a single pl...
Medical Devices·264 affected·Jun 29, 2016
High RiskFDA
Winco Mfg., Llc
TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the caregiver a single platform for receivi...
Medical Devices·264 affected·Jun 29, 2016
High RiskFDA
Tyrx Inc.
TRYX Antibacterial Envelope Rx Only Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardi...
Medical Implants·3,460 affected·Jun 29, 2016
High RiskFDA
Carefusion 2200 Inc
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Respiratory Devices·544 affected·Jun 29, 2016
High RiskFDA
Trividia Health
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are ...
Diabetes Devices·5,527,921 affected·Jun 28, 2016
High RiskFDA
Trividia Health
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are ...
Diabetes Devices·5,527,921 affected·Jun 28, 2016
High RiskFDA
Trividia Health
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are ...
Diabetes Devices·5,527,921 affected·Jun 28, 2016
High RiskFDA
Chg Hospital Beds Inc
Spirit Plus Bed, A-C Powered Hospital Bed
Medical Devices·4,308 affected·Jun 28, 2016
High RiskFDA
Medtronic Xomed, Inc.
NIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
Medical Devices·3,752 affected·Jun 28, 2016
High RiskFDA
Synthes (usa) Products Llc
Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with St...
Medical Devices·41 affected·Jun 28, 2016