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High RiskFDA
Masimo Corporation
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of ...
Respiratory Devices·21,754 affected·Sep 30, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridge on the Dimension clinical chemistry...
Diabetes Devices·53 affected·Sep 30, 2014
High RiskFDA
Boston Scientific Corporation
StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455
Medical Devices·7 affected·Sep 30, 2014
High RiskFDA
Oro Candy Distributors
***Oro Candy*** Vanilla Cookies (Mantecaditos) Nt. Wt. 3 oz. (85 g)
Bakery & Grains·11 affected·Sep 29, 2014
High RiskFDA
Baxter Healthcare Corp.
DOPamine Hydrochloride and 5% Dextrose INJ, USP, 200 mg per 250 mL, Rx Only, Baxter USA, NDC 0338-1005-02.
Drugs·11,808 affected·Sep 29, 2014
High RiskFDA
4-web Inc.
ASTS-LG1212: Anterior Lumbar Interbody Fusion Spine Truss System (orthopedic implant) Large, 12 degrees lordosis, 12 mm height and ASTS-L...
Medical Implants·35 affected·Sep 29, 2014
High RiskFDA
Coloplast Manufacturing Us, Llc
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Medical Devices·217,540 affected·Sep 29, 2014
High RiskFDA
Integra Lifesciences Corp.
Integra Selector Kit Sterile single use device A bi-lumen, sterile single use accessory used for the Selector Integra Ultrasonic Surgica...
Surgical Devices·6,358 affected·Sep 29, 2014
High RiskFDA
Smiths Medical Asd, Inc.
CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-2194-0301-01. Product Usage: The CADD-Solis Medication ...
Medical Devices·24 affected·Sep 29, 2014
High RiskFDA
Dharma Research, Inc.
Dharma Cavity Varnish 15mL
Medical Devices·916 affected·Sep 29, 2014
High RiskFDA
General Mills, Inc.
Cases of refrigerated Pillsbury Biscuits Buttermilk 4pk. (6 - 4pk / case)
Dairy·720 affected·Sep 26, 2014
High RiskFDA
General Mills, Inc.
Pillsbury refrigerated Biscuit Flaky Layers retail 4pk package.
Food·720 affected·Sep 26, 2014
High RiskFDA
Tropical Valley Foods, Inc.
next by Nature brand DARK CHOCOLATE CHERRIES, NET WT. 3 Oz (85 g), UPC 817582252006 --- Produced by Tropical Valley Foods PO Box 2994 Pla...
Snacks & Candy·615 affected·Sep 26, 2014
High RiskFDA
Actavis Laboratories, Fl, Inc.
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only. Manufactured by: Watson Laboratories, ...
Oral Drugs·5,451 affected·Sep 26, 2014
High RiskFDA
Sun Pharma Global Inc.
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, 30-count bottles and 90-count bottles, RX only, Manufactured for Sun Pharma ...
Oral Drugs·68,194 affected·Sep 26, 2014
High RiskFDA
Forest Pharmaceuticals Inc
Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Fore...
Oral Drugs·94,584 affected·Sep 26, 2014
High RiskFDA
Amerx Health Care Corp.
Amerigel Saturated Gauze Dressing Wound management
Medical Devices·21,108 affected·Sep 26, 2014
High RiskFDA
Amerx Health Care Corp.
Amerigel Post-op Surgical Kits Wound management
Surgical Devices·79,677 affected·Sep 26, 2014
High RiskFDA
Teleflex Medical
Pilling Knife Handles: a) REF 352950 b) REF 352953 c) REF 352951 d) REF 352957 e) REF 352952 : Reusable surgical knife handl...
Surgical Devices·6,197 affected·Sep 26, 2014
High RiskFDA
Biomet, Inc.
Green Mamba Suture Passer. The Biomet Sports Medicine Mamba instruments are utilized to aid in passing suture through soft tissue. The...
Medical Devices·12 affected·Sep 26, 2014
High RiskFDA
Tecan Us, Inc.
Freedom EVO-2 100 Base Unit, with Air LiHa Arms The Freedom EVO is an open automation platform product for general laboratory use. It ...
Medical Devices·2 affected·Sep 26, 2014
High RiskFDA
Iba Dosimetry Gmbh
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Medical Devices·124 affected·Sep 25, 2014
High RiskFDA
Roche Diagnostics Operations, Inc.
ACCU-CHEK Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System Product Usage: The ACCU-CHEK Combo System is mean...
Diabetes Devices·8,116 affected·Sep 25, 2014
High RiskFDA
Original Soup Man
THE ORIGINAL SOUPMAN Lobster Bisque, Net Wt 17 oz (482 g). Product is packed as a tetra pak and ships as a pack of 12 or 6 containers pe...
Seafood·3,083 affected·Sep 24, 2014
High RiskFDA
Formulations For Life
FORMULATIONS FOR LIFE Resevera Action High Potency Longevity Complex DIETARY SUPPLEMENT, 60 VEGETARIAN CAPSULES. Distributed by: Formula...
Baby Food & Formula·24 affected·Sep 24, 2014
High RiskFDA
Formulations For Life
FORMULATIONS FOR LIFE Vision Assure Extra Strength Vision Formula DIETARY SUPPLEMENT, 1) 60 VEGETARIAN CAPSULES, 2) 120 VEGETARIAN CAPSUL...
Baby Food & Formula·64 affected·Sep 24, 2014
High RiskFDA
Formulations For Life
Anti-Aging Naturals GENE STRENGTH Purple Longevity Dietary Supplement, 60 Vegetarian Capsules. Manufactured for Anti-Aging Naturals Vene...
Supplements·220 affected·Sep 24, 2014
High RiskFDA
Philips Medical Systems, Inc.
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva i...
Respiratory Devices·168 affected·Sep 24, 2014
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
siemens Dimension¿ Phenytoin Flex¿ Reagent Cartridge The PTN method used on the Dimension¿ clinical chemistry system is an in vitro di...
Diagnostic Devices·1,733 affected·Sep 24, 2014
High RiskFDA
Sterilmed, Inc.
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Surgical Devices·22 affected·Sep 24, 2014
High RiskFDA
Ameditech Inc
ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for th...
Diagnostic Devices·80 affected·Sep 23, 2014
High RiskFDA
Ameditech Inc
ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO. The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for t...
Diagnostic Devices·320 affected·Sep 23, 2014
High RiskFDA
Micro Labs Usa, Inc S
LOSARTAN POTASSIUM TABLETS USP, 25 mg, 1000 Tablet Bottles, Rx Only. Manufactured by: Micro Labs Limited, Goa-403 722, INDIA. Manufacture...
Oral Drugs·144 affected·Sep 22, 2014
High RiskFDA
Physicians Total Care, Inc.
CEPHALEXIN MONOHYDRATE CAPSULES,USP, 500 mg, 20-count bottle, Rx only, Manufactured for Caraco Pharmaceuticals, Detroit, MI 48202 by Sun ...
Oral Drugs·340 affected·Sep 22, 2014
High RiskFDA
C P Medical, Inc.
Monoswift PGCL [poly(glycolide-co-caprolactone)] Absorbable Surgical Suture; USP size 3/0. Product is labeled sterile. The product is s...
Surgical Devices·74 affected·Sep 22, 2014
High RiskFDA
Venus Wafers Inc.
President's Choice- PC Organics brand Original Stoned Wheat Crackers, 200 g UPC: 0 60383 70928 0
Bakery & Grains·784 affected·Sep 19, 2014
High RiskFDA
Mars Chocolate North America
Mars Chocolate North America Milk Chocolate M & M's Net Wt. 3.40 oz packed in a brown, 3 inch x 6.5 inch cardboard box 12 Theater boxe...
Dairy·65,496 affected·Sep 19, 2014
High RiskFDA
United Natural Trading
1) Nature's Place Organic Campfire Trail Mix; Net. Wt. 12 oz. (340 g); Distributed by DZA Brands LLC 2110 Executive Drive Salisbury, NC 2...
Food·820 affected·Sep 19, 2014
High RiskFDA
Ge Healthcare, Llc
GE Healthcare Carescape Patient Data Module
Medical Devices·68,452 affected·Sep 19, 2014
High RiskFDA
Orthohelix Surgical Designs Inc
MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during p...
Medical Implants·38 affected·Sep 19, 2014
High RiskFDA
Kci Usa, Inc.
V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technol...
Medical Devices·1,090 affected·Sep 18, 2014
High RiskFDA
Arrow International Inc
Multi-Lumen Central Venous Catheterization Kit
Surgical Devices·65 affected·Sep 18, 2014
High RiskFDA
Siemens Medical Solutions Usa, Inc
Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagn...
Medical Devices·3 affected·Sep 18, 2014
High RiskFDA
Biomerica
Calcitonin ELISA Kit, Code No. 7024, 7024BU. Intended use of this product is the quantitative determination of Calcitonin in human serum.
Medical Devices·1,062 affected·Sep 18, 2014
High RiskFDA
Intuitive Surgical, Inc.
EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si Syste...
Cardiac Devices·1,034 affected·Sep 18, 2014
High RiskFDA
Naturebox, Inc.
naturebox cranberry macaroon granola net wt. 3.75 oz (106g) naturebox.com Back label incorrectly has nutrition and ingredients for c...
Dairy·1,262 affected·Sep 17, 2014
High RiskFDA
Janssen Ortho L.l.c.
Xarelto (rivaroxaban) Tablets 15 mg per tablet, 5 count bottle, Rx Only, Manufactured by: JOLLC, Gurabo, PR 00778 NDC 50458-578-99
Oral Drugs·13,500 affected·Sep 17, 2014
High RiskFDA
Intuitive Surgical, Inc.
EndoWrist One Vessel Sealer used in conjunction with the da Vinci Si Surgical System IS3000. The Endo Wrist One Vessel Sealer is a bip...
Surgical Devices·1,483 affected·Sep 17, 2014