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High RiskFDA
The Anspach Effort, Inc.
OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to c...
Surgical Devices·1 affected·Sep 29, 2017
High RiskFDA
C.r. Bard, Inc.
BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR, MODEL BK10001M The Uros(TM) Automated Urine Output and Temperature Monitor ...
Medical Devices·2 affected·Sep 29, 2017
High RiskFDA
Ricker Hill Farms
(1) Ricker Hill Orchards Apple Cider packaged in plastic Half Gallon UV Treated (64 fl. oz.) Jugs UPC 7461380009 (2) Northland Apple...
Food·230 affected·Sep 28, 2017
High RiskFDA
Leading Pharma, Llc
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
Injectable Drugs·2,952 affected·Sep 28, 2017
High RiskFDA
Cosmedent, Inc.
Cosmedent's Etching Gel, 3g, 37% Phosphoric Acid, Rx only. Packaged in 3g Luer Lock syringes. Used for etching enamel and dentin.
Medical Devices·84 affected·Sep 28, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 478...
Medical Devices·1,557 affected·Sep 28, 2017
High RiskFDA
The Magstim Company Limited
Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User Interface, Air Film Coil and Mai...
Medical Devices·43 affected·Sep 28, 2017
High RiskFDA
Siemens Medical Solutions Usa, Inc
Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
Medical Devices·510 affected·Sep 28, 2017
High RiskFDA
United Pharmacy
Glutamine, Arginine and Carnitine, 10/100/200mg/mL, 30 mL (Multi Dose Vial), Rx Only, For Injection, United Pharmacy Compounded, 13951 N....
Injectable Drugs·268 affected·Sep 27, 2017
High RiskFDA
Pfizer Manufacturing Deutschland Gmbh
FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G EP PR, d) 20 mg ...
Oral Drugs·7,387,263 affected·Sep 27, 2017
High RiskFDA
Walkmed, Llc
Reservoir Bag for WalkMed Infusion Pump Part Number 204820 Catalog Number IPR-86/10 65 mL and Reservoir Bag for WalkMed Infusion Pump Par...
Diabetes Devices·25,920 affected·Sep 27, 2017
High RiskFDA
Pharmedium Services, Llc
Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Davis Ave Cleveland...
Drugs·2,390 affected·Sep 26, 2017
High RiskFDA
The Harvard Drug Group
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Private Limited, Verna,...
Oral Drugs·3,935 affected·Sep 26, 2017
High RiskFDA
Integra Lifesciences Corp.
Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a co...
Surgical Devices·155 affected·Sep 26, 2017
High RiskFDA
Mobius Imaging, Llc
AIRO Mobile CT System, Model Number: MobiCT-32 Product Usage: The AIRO¿ is intended to be used for X-ray computed tomography applicat...
Medical Devices·105 affected·Sep 26, 2017
High RiskFDA
Rxq Compounding Llc
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
Injectable Drugs·945 affected·Sep 25, 2017
High RiskFDA
W L Gore & Associates, Inc.
GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. The GORE TAG Thoracic Endoprosthesis is intended for endovascular repair of all lesi...
Medical Implants·12,197 affected·Sep 25, 2017
High RiskFDA
Resource Optimization & Innovation Llc
Regard Custom Surgical Pack Packs contain surgical instruments and accessories intended for use during a surgical procedure.
Surgical Devices·51 affected·Sep 25, 2017
High RiskFDA
Smiths Medical Asd Inc.
CADD(TM) Medication Cassette Reservoir with clamp and female Luer., Nonvented stopper included., 100 mL, For use with CADD(R) pumps (exc...
Medical Devices·11,170,535 affected·Sep 25, 2017
High RiskFDA
Boston Scientific Corporation
Auriga XL 4007 Laser System, Universal Part Number: M0068FS4007G0. Intended to be used in surgical procedures.
Surgical Devices·9 affected·Sep 22, 2017
High RiskFDA
Angiodynamics, Inc.
Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angi...
Surgical Devices·28 affected·Sep 22, 2017
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products DAT Performance Verifier IV in vitro diagnostic
Diagnostic Devices·196 affected·Sep 22, 2017
High RiskFDA
Boston Scientific Corporation
Auriga 30 Laser System, Universal Part Number: M0068S30G0. Intended to be used in surgical procedures.
Surgical Devices·2 affected·Sep 22, 2017
High RiskFDA
Ortho-clinical Diagnostics
VITROS Chemistry Products DAT Performance Verifier V in vitro diagnostic
Diagnostic Devices·102 affected·Sep 22, 2017
High RiskFDA
Circulatory Technology Inc
**Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary bypass blood reservoir; Models: BBB38 (individual, sterile, ...
Medical Devices·410 affected·Sep 22, 2017
High RiskFDA
Taylor Farms New Jersey, Inc.
Wawa Fruit & Cheese, 6oz. (170g), 1 each, rigid plastic, clamshell container, sold per unit, shelf-life= 5 days.
Dairy·36,177 affected·Sep 21, 2017
High RiskFDA
Uptown Bakeries
2.0-oz. Cinnamon Mini Loaf, shipped in 20-count trays.
Food·1,740 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Drugs·65,563 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Drugs·700 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Vitrectomy CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Drugs·5 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Injectable Drugs·350 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093
Drugs·2 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Drugs·280 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Drugs·1,133 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Drugs·144 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Drugs·3,300 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 6...
Drugs·14,675 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Drugs·0 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Drugs·1,250 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
Drugs·288 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Incision and Drainage Tray Kit, Sterile, Single use only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Drugs·11 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Concordia Trunk Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093
Drugs·21 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT ...
Drugs·11,750 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Pediatric IV Kit. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Injectable Drugs·50 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Drugs·3,800 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060
Drugs·3,089 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060
Drugs·9,000 affected·Sep 21, 2017
High RiskFDA
Medline Industries Inc
Medline RAD NECK ENT TRAY Pack, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093
Drugs·4 affected·Sep 21, 2017