Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phenolphthalein
Forever Beautiful BEE POLLEN, capsules, 250mg in 60-count bottles, 900 Commonwealth Place, Ste 104, Virginia Beach, VA
M1-ALPHA LABS MEGA MASS BUILDER (M1A, Methyl-1-Etiocholenolol- 20mg, Epietiocholanolone) Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
Marketed without an approved NDA/ANDA  - These products are being recalled due to the presence of synthetic hormone/prohormone (methylated anabolic steroid) ingredient making them unapproved new drugs.
M14-MENT ADVANCED MASS BUILDER (7a-Methyl-estra-4-en-3,17-dione MENT 5mg, M14D 20 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
HALO-70 MEGA MASS BUILDER (4-chloro-17a-methyl-androst-1,4-diene-3b,17b-diol 35mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
7-MENT ALPHA ADVANCED MASS BUILDER (7a-methyl-estra-4-en-3,17-dione 10 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
ESTRASTAIN PRO-ANABOLIC MASS AND HARDENING COMPLEX (Estra-4,9,11-triene-3,17-dione 15mg, 2a-3a-epithio-17a-methyl-5a-androstan-17b-ol 10 mg), Capsules, 60 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
SWOLL-250 SUPER MASS BUILDER QUAD STACK (18-Methylestr-4-en-3-one-17b-ol 15mg, 6-a-Chloro-androst-4-en-17b-ol-3-one 15mg, 13-ethyl-3-methoxy-gona-2,5(10)-diene-17-one 15mg, 2,17a-dimethyl-5a-androsta-1-en-17b-ol-3-one 3 mg), Capsules, 90 count bottle, Manufactured for: Wyked Labs LLC, Winter Park, FL 32789
PROFESSIONAL FORMEXX BLACK (AromaMaXX 250mg: 13-dimethyl-1,2,7,8,9,11,12,14,15,16-decahydro-cyclopenta[a]phenanthrene-3,6,17-trione,4-Androsten 4,17-beta-diol-3one), Capsules, 60 count bottle, Manufactured for: ANABOLIC SCIENCE LABS WINTER PARK, FL 32789
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Pride of Szeged Hungarian Exquisite 100 % Sweet Delicacy Paprika, Net Wt. 5 oz., 142g, UPC 0 78006 00010 2
Lot # 091617PAHU05PS Lot # 091717PAHU05PS
Spiceco is recalling Pride of Szeged Sweet Hungarian Paprika  because it may contain undeclared peanut protein. Spiceco expanded their recall to include additional products that contain the implicated paprika.
Emeril's Cajun Seasoning Blend, 3.45 oz. (98g) Distributed by: B&G Foods, Inc., Parsippany, NJ 07054 USA, UPC 07468309979
Emeril's Blackened Seasoning Blend, 3.1 oz. (88g) Distributed by: B&G Foods, Inc., Parsippany, NJ 07054 USA, UPC 074683097633
Sylvia's Rib Rub N More Seasoning, Net Wt. 5.5 oz. (155g), Distributed by: Sylvia Woods Food Company, P.O. Box 240, Harlem, NY 10027, UPC 608623000683
Sylvia's Sizzlin' Hot Spice, Net Wt. 5.5 oz. (156g), Distributed by: Sylvia Woods Food Company, P.O. Box 240, Harlem, NY 10027, UPC 608623000515
Shoppers Value Chicken Seasoning  5 oz. - UPC 041130310676 Distributed By: Supervalu Inc., Eden Prairie, MN 55344 USA,
Fiesta Seasoned Salt Net Wt 16 oz (1 LB) 454 g Distributed By Fiesta Mart Houston TX 77246-7481
Spice Eagle Brand Seasoning Salt BLN101200 Net Wt: 50 Lbs  Packed by : Spiceco Avenel, New Jersey 07001
Hytop Seasoned Salt  Packed for Federated Group, Inc Arlington Heights, IL 60005 a) 5.25 oz. (149 g) UPC 050700083964  b) 16 oz(454 g) UPC 050700482576
Spiceco - unlabeled containers of seasoned salt.     a) 1 lb.  b) 25 lb
Lot #011217SESABXNL Lot #100617SESA16NL  Lot #100617SESA16NL  Lot #100617SESA16NL  Lot #100617SESA16NL
Redner's Warehouse Markets Spice Rack Chicken Rub 2.75 oz (77 g) Manufactured for Redner's Warehouse Markets #3 Quarry Road, Reading PA 19605 UPC 015984695937
Spice Deluxe Chicken Seasoning Net Wt. 3.5 oz (99 g) Manufactured by Spiceco Terminal Way Avenel, NJ 07001 USA www.spice-co.com UPC 078006000048
Pride of Szeged Fish Rub Seasoning Net Wt. 5 oz (142 g) Spiceco, Avenel NJ 07001 UPC 078006020018   2.75 oz  50 lb boxes
Twin Tree Gardens Premium Spice Blends Seasoning Salt Net 5.5 oz (155 g) Distributed to Flavor Delite, Inc. Reinburg South Carolina   PC4016
Better Valu Chicken Seasoning Net. Wt. 5.25 oz (149 g) Distributed by: Federated Group, Inc. 3025 W. Salt Creek Lane Arlington Heights, IL 6005 www.better-valu.com  UPC 079807003794
EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC  27529, UPC 8 52175 00417 4.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making EDGE an unapproved drug.
iNDiGO capsules, 220 mg, 60-count bottle,  Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00404 4.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making iNDiGO an unapproved drug.
AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00418 1.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making AMPD GOLD an unapproved drug.
BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00406 8.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, making BtRiM Max an unapproved drug.
iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, 1027 Highway 70 W, Suite 227, Garner, NC 27529, UPC 8 52175 00408 2.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein and fluoxetine, making iNSANE an unapproved drug.
Ground Cumin, Bulk Package Size:  a) 50 lb. paper carton  b) 16 oz. jar/ 8 plastic jars per case
Ground cumin may contain peanut protein.
UPC# 061500005582, Net weight 1L All codes
May contain a trace amount of Tree Nuts (walnut) which is not listed in the ingredient list
UPC 7-17544-11799-5, Net Weight 1 L (12 singles p/c)
Kroger Shots Tropical Mango Flavor 2 pack
MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MACHINERY WORK
Worldwide Distribution - US including FL, NY, OH, & TX, **Internationally - Belgium, Italy, Korea, France & Germany.
MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
The operator console allows users to deliver therapeutic radiation to patients even though a specific communication error relevant to imaging conditions has occurred. In addition, the treatment record (the delivered radiation record) cannot be saved.
Nationwide and Puerto Rico Foreign: Spain and Ecuador
ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068.
Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein
US Distribution to the state of CA., and Internationally to Italy and Japan.
The alignment lasers are missing the labels required by radiation safety regulations.
Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administration Only, Not for Resale or Dispensing to an Individual Patient, Rx Only, Preferred Physician Medical LLC, 405-551-8216
Non-Sterility: The recalled lot failed sterility testing.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood product, which tested positive for red cell antibodies was not labeled for the red cell antibodies, was distributed.
Blood products, collected from a donor with high risk behavior(s), were distributed.
US Distribution to the states of: CA, DE, PA, MN, FL, MO, OH, IN and IL.
EOS, Digital radiography system used in general radiographic examinations.
When performing calibration, an alert message on the spectral filtration of the X-ray beam may be suppressed.  Improper filtration of the X-ray Beam can then occur in exams set up with copper filtration.
Captopril Tablets, USP 12.5 mg, Rx Only, a) 100 count bottles NDC 64679-902-01, b) 1000 count bottles NDC 64679-902-02, Manufactured by Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt USA LLC., 20 Waterview Boulevard, Parsippany, NJ 07054 USA
Failed Tablet/Capsule Specifications: out of specification for thickness.
Cumin used was contaminated with peanut protein.
Sazon with Saffron, Package Weights: 18 / 20 env 3.52 oz and 36 / 8 env 1.41 oz
Cumin contains undeclared peanut protein.
Cumin used has undeclared peanut protein.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who had been incarcerated, were distributed.
La Terra Fina Organic Thick & Creamy Spinach Dip and Spread; Made with Greek Yogurt. 24 oz. plastic tub (1 lb. 8 oz,) 680 g:  Keep refrigerated  UPC 640410513730.    Manufactured by'' La Terra Fina, Union City, CA 94587
All units with Best-By Dates of: 3/24/2015   4/01/2015   4/14/2015  4/20/2015.  4/29/2015 - this expiry date was not distributed and is still at the facility.
Firm was notified by their supplier of IQF chopped spinach that the product that tested positive for Listeria Monocytogenes had been erroneously shipped.
La Terra Fina Spinach Artichoke & Parmesan Dip made with Greek Yogurt 31-ounce tub  Keep refrigerated  UPC 6-40410-51338-9  Manufactured by'' La Terra Fina, Union City, CA 94587
All units with Best-By Dates of: 4/14/2015  4/20/2015
La Terra Fina Chunky Spinach Artichoke & Parmesan Dip 31-ounce tub  Keep refrigerated  31-ounce tub; UPC: 6-40410-51193-4   Item number 407600 - Costco  Item number 4300193 - Smart and Final    10 oz. Retail size - UPC 6-40410-51327-3    Manufactured by La Terra Fina, Union City, CA 94587
All units with Best-By Dates of: Costco:  3/31/2015  4/4/2015  5/9/2015;    Smart and Final:  3/28/2015  5/9/2015    10 oz. retail size - Best by 4/4/15.
4077 cases ( 12 x 31 oz. tub per case) 483 cases (6 x 10 oz. per case
Blood product in which routine testing/testing performed, interpreted, or documented incorrectly, was distributed.
0.9% Sodium Chloride Injection, USP, 250 mL,  Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
Giant Eagle Store cut Fontal Cheese wrapped in plastic wrap Belgium Imported Fontal - CD;  Sell By: (up to and including) 04/23/2015  PLU: 16124  Giant Eagle  Distributed by: Giant Eagle, Inc., Pittsburgh, PA 15238
Sell By: (up to and including) 04/23/2015
Retail store cut cheese packages did not declare the presence of Lysozyme, an egg allergen.
Stryker Instruments Div. of Stryker Corporation
Worldwide Distribution - US nationwide, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and  Japan.
3/16 in. Trocar with Single Drain   Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a potential sterility breach in the packaging
3/16 in. Double Trocar with Wound Drain   Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
1/8 in. Trocar with Single Drain   Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
1/8 in. Double Trocar with Wound Drain   Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
1/4 in. Trocar with Single Drain   Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
1/4 in. Double Trocar with Wound Drain   Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
Part Number: 0215-019-200 and lot numbers: 14122012
3/16 in. Round Drain with Trocar   Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
1/4 in. Round Drain with Trocar   Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
3/16 in. Curved Trocar with Wound Drain   Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
1/8 in. Curved Trocar with Wound Drain   Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
1/4 in. Curved Trocar with Wound Drain   Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from the sharp end of the trocar during handling. The double trocar wound drain has metal trocars on either side of the flexible wound drain tube. These are also equipped with trocar guards.
Ambulating Bulb   Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in order to collect wound drainage.
Domestic: AK, AL, AR, CA, CO, DE, FL, GA, IA, IL, KY, LA, MA, MD, MI, MS, NC, NE, NH, OH, OK, PA, SD, TX, UT, VA, WI, WV,    Foreign: None
Pregestimil ready to use 20 calorie, 2 oz bottle; 6 bottles per carton; 8 cartons per case
Some Pregestimil 20 Calorie Nursette Bottles from batch EV5A6F were inadvertently packaged in Pregestimil 24 Calorie Nursette cartons. The individual Nursette bottles are correctly labeled as 20 Calorie. The carton is the cardboard sleeve wrapped around 6 bottles, the bottle labels and the outer corrugated case all correctly state 20 calorie.
Aspire HD, Full Field Digital, System, x-Ray, Mammographic; Model: FOR MS-1000.    A mammography system used for screening and diagnosis of breast cancer.
User Manual lacks a description for handling some errors even though the system can be recovered from such errors
Clean & Clear Morning Burst Hydrating Gel Moisturizer Net Wt. 3 oz. (85 g( Distributed by Johnson & Johnson Consumer Products Company Division of Johnson & Johnson Consumer Companies, Inc. Skillman, NJ 08558-9418
Clean & Clear Morning Burst Hydrating Gel Moisturizer and Neutrogena Hydro Boost Water Gel was manufactured with a combination of the raw materials 1,3 Butylene Glycol and Dimethicone, rather than only Dimethicone as intended and as listed on the product labeling.
Neutrogena Hydro Boost Water Gel Net Wt. 1.7 oz (48 g) Dist. by Neutrogena Corp., L.A., CA 90045
Deer  Raisin Golden 7 oz., marked and unmarked packages Packed for Best Foods Inc. Edison, NJ 08817   Some have UPC 714760029255.    packaged in clear plastic packages.
unmarked and marked packages no lot code listed
Deer Brand Golden Raisin contain undeclared sulfites discovered through NYSDAM laboratory sampling.
CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural  Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural  Anesthesia Tray, ESPOCAN Combined Spinal and Epidural Anesthesia Tray,   PERIFIX Continuous Epidural Anesthesia Tray, PERIFIX FX Continuous  Epidural Tray, PERIFIX One Continuous Epidural Pediatric Tray; Utilization of Product: Injection of local anesthetics to provide regional anesthesia for pain management. Route of administration is injection into subarachnoid space or epidural space or tissue surrounding peripheral nerve bundle(s).                                          Custom Epidural and  Anesthesia Tray
There is a potential for a hole to be present in the outer tray of a limited number of pain control trays.  This issue has a low rate of occurrence, but may cause the integrity of the sterile barrier to be compromised. A compromised sterile barrier poses a risk of inflammatory response and/or possible contamination of the spinal fluid or epidural space. At this time, there have been no field reports or patient harm/adverse impact noted as a result of this issue.
Lifesouth Community Blood Centers - Montgomery Region
Blood products, in which Quality Control and Distribution of product did not meet specifications, were distributed.
Blood products, in which Donor Screening/Deferral screening was not done or incorrectly performed, including incorrect ID used during search,prior deferral due to history, were distributed.
Blood products, in which donor screening/donor record incomplete or incorrect, were distributed.
Wawa brand Kale and Quinoa Salad, 7.5-oz. plastic container, UPC Code: 726191066402
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood product, in which Quality Control and Distribution of product did not meet specifications, was distributed.
Northeastern Pennsylvania Region of American Red Cross
Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607
Failed Stability Specifications: Product failed to meet 12 months long term stability specification  for viscosity
C-Topical 4% CII (cocaine hydrochloride), topical solution, 4 ml bottle, (NDC 0527-1728-74), Rx Only, Manufactured for Lannett Company, Inc. Philadelphia, PA 19136 by Cody Laboratories, Inc. Cody, WY 82414
Labeling: Label mix-up; bottles were incorrectly labeled as 10 mL instead of correctly labeled as 4 mL
Whole Foods Market Health Starts Here Rye Bread (formerly 100% Rye) 16 oz. PLU# 41844
US Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MD, MI, MO, MS, MT, NC, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and the foreign country of: Canada
Universal Charger   Product Usage:  The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger has the optional functionality to track device usage data. Usage data is accumulated by Stryker and reports are able to be provided to the customer.
The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed.  The firm is initiating a software correction to address the issue.
Krystyna Bakery Polish Style Cheese Cake, Weight 18 oz., UPC 789438000096
Polish Style Cheese Cake contains undeclared ingredients, whole blueberries, FD&C Blue #1, Red #3, Red #40, Yellow #5 and Yellow #6.
The American National Red Cross - Southern Region
Platelets Pheresis Leukocytes Reduced Washed
Blood product, labeled with an incorrect expiration date, was distributed.
*** US: Nationwide; *** FOREIGN: Austria, China, Denmark, France, Germany, Hong Kong, Japan, Netherlands, Qatar, Russian Federation, South Korea, Switzerland
ExacTrac 6.x. is software used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures.
Software Versions: ExacTrac v. 6.x (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5; and v. 6.1.0);    Model/Catalog Numbers: 49971, CBCT IMPORT & ALIGNMENT SOFTWARE; 20836, EXACTRAC 6.0 VARIAN CBCT LICENSE;   48320, ET UPGRADE SOFTWARE 6.0 TO 6.1;   48320-99, ET UPGRADE SOFTWARE 6.0 TO 6.1 SLA;   49973B, ET DATA PREP / REVIEW SYSTEM;   49973A, ET DATA PREP / REVIEW SYSTEM;   49973, ET DATA PREP / REVIEW SYSTEM;   49998B, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;   49998A, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;   49998, ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT;   48304, ET 6.1 DATA PREP/REVIEW SYSTEM UPG. KIT;   48302, ET DATA PREP / REVIEW SYSTEM
25 systems (US only); 53 systems (Foreign)
ExacTrac 6.x Patient Positioning System: Potentially incorrect patient positioning when using the ExacTrac Cone Beam CT (CBCT) with a CBCT acquired at a couch angle other than 0.0 degrees.
Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WI, WV and the countries of: France, Mexico, Netherlands, Panama, United Kingdom, Switzerland, Spain, Poland, Norway, Iceland, Italy, Greece, Finland, Belgium, Germany, Austria, China, Taiwan, Singapore, Korea, Australia, and Japan.
BARD MAX-CORE Disposable Core Biopsy Instrument   Gauge x Length  18g x 20cm    The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device.  It is available in several needle gauge sizes and lengths.  The side and rear actuator buttons are color-coded according to the various gauge sizes e.g., yellow=20 gauge, pink=18 gauge, purple=16 gauge, and green=14 gauge.
Product Code: MC1820 Gauge x Lengh: 18g x 20cm  Lot Numbers: REYA2017, REYC2853
The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.
Blood products, in which donor screening/deferral screening were not done or incorrectly performed, were distributed.
All products were distributed within CA and CO.
Earth Coco Raw Coconut Water  100% Pure  -320ml UPC 799632-585022  -500ml UPC 799632-585015    Distributed by:  Earthcoco, Inc.  2651 Main Street  Santa Monica  CA 90405  www.earthcoco.com    Product of Philippines  **store frozen for maximum freshness**
The firm is recalling EarthCoco Pure Coconut Water 320ml and 500ml because they lack a 5-log reduction process.
Distributed in the states of IN, MN, FL, and IL, and the countries of Argentina and Germany.
NexGen Augment; 5mm Distal Femoral Augment;Part number 00-5990-036-10.   Intended to be used in total knee arthroplasty when there is insufficient bone in the distal femur.
The affected lot is being recalled because it was packaged without the locking screw.  The locking screw packaged with the augment is used to fix the augment to the femoral component.  This has the potential to delay surgery
TRADER JOES  A Dozen Sweet Bites Chocolate and Coffee Opera Cake, Raspberry Macaroon Cake, Caramel & Chocolate Cake, 9.16 oz UPC 00967679 or SKU 096767.
Prolainat is recalling all lots of 9.16 oz packages of Trader Joes A Dozen Sweet Bites (Chocolate & Coffee Opra Cake, Raspberry Macaron Aux Framboises Cake, Caramel & Chocolate Cake) due to undeclared coconut.
Nationwide in US: SC, NC, MN, CT, KY, MD, FL, VA, TN
119'' (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037   Product Usage:  IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
ICU Medical is recalling MicroClave T-Connectors because they have potential connection separation issues that could lead to leakage.
107'' (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041   Product Usage:  IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
104'' (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065   Product Usage:  IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
113'' (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Smallbore Quadfuse Ext Set w/MicroClave, 4 Clamps (Blue, 2 Red, White), Rotating Luer, Non-DEHP Tubing, Item No. B33303 Product Usage:  IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
108'' (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33326
127'' (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351   Product Usage:  IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
98'' (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon Valve, Trifuse Ext Set w/2 MicroClave, Rotating Luer, Non-DEHP Tubing, Item No. B3338 Product Usage:  IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
98'' (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372   Product Usage:  IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
AXIOM ARISTOS FX; Multipurpose Radiography System (MPRS) is a dedicated x-ray system with a flat panel detector which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, and excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.
If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators.
Blintzes with Cherry, Net Wt. 18oz (510g), 10 pieces.   18-oz. plastic trays containing ten pieces of Royal Frozen Food, BLINTZES Blintzes with Cherry with bar code 6 0723830021 8; 12 packs per case.
Royal Frozen Food is recalling Royal Frozen Food Blintzes because they contain undeclared milk.
Blintzes with Potato, Net Wt. 18oz (510g), 10 pieces.   18-oz. plastic trays containing ten pieces of Royal Frozen Food, BLINTZES Blintzes with Potato with bar code 6 0723830020 1; 12 packs per case.
Blintzes with Potato & Mushroom, Net. Wt. 18oz (510g), 10 pieces.   18-oz. plastic trays containing ten pieces of Royal Frozen Food, BLINTZES Blintzes with Potato Mushroom with bar code  6 0723830020 1.  12 packs per case.
Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed.
Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.
ViewRay System, Radiation Therapy System
The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error.
OSSIE'S HERRING IN SOURCREAM, NET WT. 8 OZ,  UPC  739885114174 --- The product is packaged in clear, plastic containers/tubs.
date code 06/08/15 (represents expiration date and located on the bottom of the tub)
The product contains undeclared milk, a sub-ingredient of the sour cream used in the product.
OSSIE'S PICKLED LOX DAIRY, NET WT. 8 OZ,  UPC  739885114136 --- The product is packaged in clear, plastic containers/tubs.
OSSIE'S PICKLED LOX & CREAM, NET WT. 8 OZ,  UPC  739885114136 --- The product is packaged in clear, plastic containers/tubs.
date code 06/04/15 (represents expiration date and located on the bottom of the tub)
The product contains undeclared eggs, a sub-ingredient of the mayonnaise used in the product.
Worldwide Distribution - US (nationwide and DC) and Internationally to Norway, India, New Zealand, Bahrain, Sweden, Italy, Australia, France, Netherlands, Switzerland, Germany, Austria, and Turkey.
751 units total (246 units in the US and 505 units outside the US)
When Epiq 5 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patients Body Surface Area (BSA).
2472 units total (1154 units in the US and 1315 outside the US)
When Epiq 7 Ultrasound System, WITH the Pediatric Cardiology option, is set up to Metric and weight and/or height is entered, a unit conversion error may result in the incorrect calculation of the patients Body Surface Area (BSA).
KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRepack, Indiana, PA, mfg by Hospira, Inc. Lake Forest, IL NDC 61786-0055-01
Worldwide Distribution -  US Nationwide and the countries of:Angola, Armenia, Australia, Austria, Belgium, Bosnia Herzeg., Brazil, Brunei, Bulgaria, Colombia, Czech Republic, Finland, France, Germany, India, Japan, Kazakhstan, Kenya, Kuwait, Mauritius, Mexico, Norway, Oman, P.R. China, Poland, Rep. of Yemen, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom.
ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816.   Product Usage:  The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications;
In some cases, the system is unable to capture a clip or image during a routine scan.
Worldwide Distribution:US (nationwide) including states of:  AL, AR, AZ, CA, FL, GA, IA, ID, IL, LA, ME, MI, MN, MO, NE, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA, WY, and Puerto Rico and countries of: Argentina, Australia, Bangladesh, Canada, Chile, France, Great Britain, India, Kuwait, Panama, Poland, Qatar, Saudi Arabia, and Turkey.   .
Ultraview SL Command Modules, Model 91496,  with the Masimo SpO2 PCBA, PN: 010-1636-02.   The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
1944  ( total 1920 modules (1316 in the US and 604 outside the US) and ( total 24 PCBAs (3 in US and 21 outside the US)
Modules resetting. This failure mode happens when the Spacelabs Command Module is configured with the Masimo SpO2 option (-M), the Spacelabs Respiration option (-R) and the Masimo SpO2 PCBA, PN: 010-1136-02. With these two options and the Masimo SpO2 PCBA present, the module may experience random resets.
US and Albania, Australia, Austria, Bangladesh, Bulgaria, Canada, Colombia, Denmark, Ecuador, Egypt, France, Germany, Hungary, Iceland, India, Israel, Italy, Japan, Kenya, Kuwait, Malaysia, Mauritius, Mexico, Netherlands, P.R. China, Philippines, Portugal, Rep. of Yemen, Republic Korea, Russian Fed., San Marino, Saudi Arabia, Singapore, Spain, Suriname, Sweden, Switzerland, Taiwan, Thailand, Turkey, U.A.E., United Kingdom, Venezuela
ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B.  Model number 10433816.   The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.
In certain situations, loss of post exercise images can occur in Stress Echo.