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All CPSC FDA USDAAll Critical High Medium

Philips Medical Systems, Inc.

Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, an...

Medical Devices·188,520 affected·Apr 4, 2014

Bd Biosciences, Systems & Reagents

Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against human epithelial adhesion molecule that has been identified a...

Diagnostic Devices·12 affected·Apr 4, 2014

The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare...

Diagnostic Devices·297 affected·Apr 3, 2014

Siemens Medical Solutions Usa, Inc

Syngo Dynamics v9.5 system. A Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, arc...

Medical Devices·50 affected·Apr 3, 2014

B. Braun Medical, Inc.

Sprotte Spinal Tray / Sprotte Spinal Needle 24 gauge with Introducer Spinal injection of anesthetics to provide regional anesthesia

Medical Devices·7,400 affected·Apr 3, 2014

Shimadzu Medical Systems

Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital w...

Medical Devices·685 affected·Apr 3, 2014

Boston Scientific Corporation

iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ultrasound examinations of intravascular pathology.

Medical Devices·9 affected·Apr 3, 2014

Koru Pacific Packaging, Inc.

Ah! Laska Organic Cocoa Non Dairy Chocolate Mix; Low Fat, Vegan, USDA Organic; Net Wt. 12 oz. (340 g); UPC 7-60519-10028-7; Ingred...

Dairy·2,708 affected·Apr 2, 2014

Fong Kee Tofu Co., Inc.

Soy Bean Cake Net Wt. 9. oz. Ingredient: Soybeans, water, salt, Soy sauce, Spice, Calcium Sulfate. Perishable, keep refrigerated. Fon...

Bakery & Grains·45 affected·Apr 2, 2014

Panda¿ iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based ...

Respiratory Devices·723 affected·Apr 2, 2014

Philips Medical Systems, Inc.

Philips HeartStart XL+ Defibrillator/Monitor with system software version B.00.00 or B.00.01 installed Model: 861290, automatic extern...

Cardiac Devices·9,872 affected·Apr 2, 2014

Philips Medical Systems, Inc.

Philips MDC PACS R2.X / IntelliSpace PACS DCX R3.1 software, software application that is used for receiving, managing, archiving, dist...

Medical Devices·373 affected·Apr 2, 2014

Genesys Orthopedics Systems, Llc

Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. The TiLock P...

Medical Devices·642 affected·Apr 2, 2014

Betty Lou's, Inc.

Just Great Stuff Chocolate Dream Greens, 42 g bar, The bars are individually wrapped and packed in a display containing 12 bars. The...

Snacks & Candy·70,397 affected·Apr 1, 2014

Nutri-force Nutrition, Inc.

Fish Oil Softgel Capsules in white High Density Poly-Ethylene bottles labeled in part: "Major [brand] Fish Oil Cholesterol Free 1000 MG *...

Seafood·9,456 affected·Apr 1, 2014

Wockhardt Usa Inc.

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; D...

Oral Drugs·109,744 affected·Apr 1, 2014

Teva Pharmaceuticals Usa

triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack...

Oral Drugs·89,215 affected·Apr 1, 2014

Hi-tech Pharmacal Co., Inc.

HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg / 5mL, Net Wt 16 fl oz (473 mL), NDC 50383-796-16, Rx Only, Manufactured by: Hi-Tech ...

Oral Drugs·451,916 affected·Apr 1, 2014

Siemens Medical Solutions Usa, Inc

Siemens Linear Accelerator (LINAC) models. Product Usage: deliver X-ray radiation for therapeutic treatment of cancer

Medical Devices·9 affected·Apr 1, 2014

TRABECULAR METAL MODULAR ACETABULAR SYSTEM, Shell with Cluster Holes, Porous 60mm. Catalog number 00-6202-060-22; Hip implant component.

Medical Implants·17 affected·Apr 1, 2014

Vidacare Corporation

EZ-IO 45mm (40kg & up) Needle Set, part number 9079-VC-005; lot code 3606455

Medical Devices·172 affected·Mar 31, 2014

Neo Metrics, Inc.

Boston Scientific, NovaGold High Performance Guidewire, Rx only, Sterilized using ethylene oxide, UPN M00552010 and M00552000, Manufactur...

Diagnostic Devices·1,256 affected·Mar 31, 2014

i heart keenwah Chocolate Sea Salt All Natural Quinoa Clusters. UPC 736211802446 for the 4 oz UPC 713757598101 for the 1 oz

Snacks & Candy·8,032 affected·Mar 28, 2014

i heart keenwah Peanut Butter Cacao All Natural Quinoa Clusters. UPC 736211884442 - 4 oz 12 units/cs

Dairy·1,405 affected·Mar 28, 2014

Emparedados Boricua

"Emparedados Boricua, Tripleta (Turkey Pastrami, Turkey, Ham and Cheese Sandwich), Net Wt. 8 oz. (230g), Elaborated and Distributed by Em...

Dairy·910 affected·Mar 28, 2014

Emparedados Boricua

"Emparedados Boricua, Cubano (Pork, Ham and Cheese Sandwich), net Wt. 7.6 oz (220 g), Elaborated and Distributed by Emparedados Boricua, ...

Dairy·780 affected·Mar 28, 2014

i heart keenwah Cranberry Cashew All Natural Quinoa Clusters. UPC 736211802545 for the 4 oz UPC 713757598309 for the 1 oz

Produce·4,979 affected·Mar 28, 2014

Emparedados Boricua

"Emparedados Boricua, Media Noche (Pork, Ham and Cheese Sandwich), Net Wt. 7.6 oz (220g), Elaborated and Distributed by Emparedados Bori...

Dairy·780 affected·Mar 28, 2014

i heart keenwah Ginger Peanut All Natural Quinoa Clusters. UPC 736211802644 for the 4 oz UPC 713757598408 for the 1 oz

Food·3,143 affected·Mar 28, 2014

i heart keenwah Almond All Natural Quinoa Clusters. UPC 736211802347 for the 4 oz UPC 713757598200 for the 1 oz

Food·4,899 affected·Mar 28, 2014

United Therapeutics Corp.

Tyvaso (treprostinil) Inhalation Solution, Treprostinil 1.74 mg/2.9 mL, Four 2.9 mL Ampules, For Oral Inhalation Use Only, Manufactured f...

Oral Drugs·188 affected·Mar 28, 2014

Integra Lifesciences Corporation

Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws ...

Medical Devices·417 affected·Mar 28, 2014

Rgi Medical Manufacturing, Inc.

Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.

Surgical Devices·19,200 affected·Mar 28, 2014

Depuy Orthopaedics, Inc.

GLOBAL¿ Anchor Peg Glenoid Plus (APG+) 2.5MM Breakaway Guide Pin Part # 2230-00-019, Non-Sterile, DePuy, Johnson & Johnson Product U...

Medical Devices·21,675 affected·Mar 28, 2014

Nw Nutritional Foods Llc

There are three different labels for this product. Label #1 individual bar 100% Natural Zing Nutrition Bar, DARK CHOCOLATE SUNFLOWE...

Snacks & Candy·50,904 affected·Mar 27, 2014

Nw Nutritional Foods Llc

There are two different labels for this product same UPC codes. Version #1 individual bars: 100% natural Zing Complete Nutrition, C...

Dairy·475,308 affected·Mar 27, 2014

Nw Nutritional Foods Llc

Individual Bars: 100% Natural Zing Nutrition Bar, CASHEW CRANBERRY ORANGE, Gluten, Dairy & GMO Free, NET WT. 1.76 OZ (50g), Manufactured...

Dairy·1,812 affected·Mar 27, 2014

Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lak...

Injectable Drugs·255,900 affected·Mar 27, 2014

Boehringer Ingelheim Roxane Inc

Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiot...

Oral Drugs·1,276,710 affected·Mar 27, 2014

Ion Beam Applications S.a.

Proteus 235 Proton Therapy System for cancer treatment.

Medical Devices·8 affected·Mar 27, 2014

Central Purchasing Llc Dba Harbor Freight Tools

Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those with difficulty walking and weighing 225 lbs. or less.

Medical Devices·43,621 affected·Mar 27, 2014

Ge Healthcare, Llc

GE Vivid E9 Ultrasound System, a general-purpose ultrasound system, specialized for use in cardiac imaging.

Cardiac Devices·447 affected·Mar 27, 2014

H:20 Innovations Llc

Meijer Baby Pediatric Electrolyte Fruit Flavor 8oz x 4 with Best by: 10/01/15; 24 bottles per case, 6-4packs

Produce·720 affected·Mar 26, 2014

H:20 Innovations Llc

Meijer Baby Pediatric Electrolyte Strawberry Flavor 8oz x 4 with Best by: 10/02/15; 24 bottles per case, 6-4packs

Produce·900 affected·Mar 26, 2014

Branan Medical Corporation

ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, PT23A, a screening device for the detection of drugs and dru...

Diagnostic Devices·9,800 affected·Mar 26, 2014

The Osteo-Clage System consists of stainless steel cable/sleeves and compression plates. . 2.0 mm x 850mm SS Cable/Sleeve; Part Numbe...

Medical Implants·141 affected·Mar 26, 2014

Stryker Instruments Div. Of Stryker Corporation

Stryker PenAdapt"; Rx Only, Sterile. This device is an accessory to an electrosurgical unit (ESU). The PenAdapt is used to remove smok...

Surgical Devices·35,310 affected·Mar 26, 2014

Ortho-clinical Diagnostics

VITROS Chemistry Products Specialty Diluent, REF 855 9825, 6 x 3 mL, IVD --- Ortho-Clinical Diagnostics, Inc. Rochester, NY

Diagnostic Devices·1,656 affected·Mar 26, 2014

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