IL; AR. Product was not shipped to foreign consignees.
Product is packaged in a white plastic bottle with green lettering.  The label reads in part LIFE RISING, Chinese Herbal Supplement, BRAIN-ECM, Brain E-Calm, 54 Capsules, Life Rising to Higher Well Being.  Manufactured for:  Life Rising Corp., Willowbrook, IL 60527
The dietary supplement Brain ECM contains lead.
Distributed within the state of Florida and in the following countries: France, Jamaica, Columbia, Dominican Republic, Barbados, Honduras, St John Antigua
Tasty Sawa Ground Turmeric, 50 lb bag.  Manufactured by Spices USA.
Product contains elevated levels of lead.
The Int'l. Company For Agricultural Production & Processing
Strawberries Whole IQF, Fresas IQF 1024439, Net Wt. 30 LB (13.6g), 20lbs, 10lbs
Processing (ICAPP) is recalling certain lots of its frozen strawberries because they may be contaminated with Hepatitis A virus.
IQF Recipe Ready Diced Strawberries Fresa Picada, Net Wt. 80oz (5lb) 2.27kg, 6.5 lbs, 10lbs, 30lbs, UPC 7 60695 01018 9
Worldwide distribution.  US nationwide, Europe, Australia, New Zealand, South Africa, Greater Asia, Middle East, and Canada.
Alaris System PC unit, model no. 8000 and 8015.  The central programming, monitoring and power supply component for the Alaris infusion pump System.
613,800 total units (575,221 units in US)
Reports where the Low Battery alarm and/or the Very Low Battery alarm are not being triggered before the battery is discharged and all infusion channels are stopped.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Life Rising TT Side Head Regulator, Chinese Herbal Supplement, 60 Tablets; Manufactured for: Ton Shen Health (USA), Chicago, IL, 60616; Made in China
High levels of lead discovered in product.
Boulder Ice Cream Strawberry. 2.5 gallon tub with white top. Keep frozen at -20F.
Altamira Specialty Food Service announces a voluntary field action for Strawberry Ice Cream after receiving notice from its supplier that the strawberries used in the product may be contaminated with Hepatitis A virus.
Strawberry Nutella gelato, 5 Liter & 4 Liter pans
Leo Leo Gelato is recalling gelato and sorbetto because they contain frozen strawberries that may be contaminated with hepatitis A virus.
Strawberry Cream gelato, 5 Liter & 4 Liter pans
Strawberry Sorbet, 5 Liter & 4 Liter pans
Strawberry Basil gelato, 5 Liter & 4 Liter pans
Raspberry Chip gelato, 5 Liter & 4 Liter pans
Mixed Berries gelato, 5 Liter & 4 Liter pans
Blackberry Sorbet, 5 Liter & 4 Liter pans
Strawberry White Chocolate gelato, 5 Liter & 4 Liter pans
Blackberry Cabernet gelato, 5 Liter & 4 Liter pans
Raspberry Sorbet, 5 Liter & 4 Liter pans
Colorado. No Canadian, other foreign, VA/govt/military consignees.
Ciao Bovina Italian Strawberry. 1 Pint (473 ml). Non-Dairy Gelato. No GMO's. Coconut Free. Soy Free.
Ciao Bovina, LLC announces a voluntary field action for Italian Strawberry Gelato due to potential contamination with Hepatitis A Virus.
Nationwide in US: OK, CA, NV, MD, CA, FL, MA, NY, CO, AZ, SC, MN, ND, UT, MT, IL
Villa Dolce Gelato is recalling Strawberry Gelato and Strawberry Sorbetto because they have the potential to be contaminated with hepatitis A virus.
Exp. Date Feb 5, 2018  Exp. Date March 19, 2018
Distributed to customers within the state of Kansas.
PLT 22 STARTER AMP, Manufactured by Fourth & Pomeroy Associates, Inc. Clay Center, Kansas 67432, packaged in 50 lb bags.
Medicated feed was manufactured with expired Type A medicated article
KEY POULTRY GROWER 17% AMP MEDICATED Fourth & Pomeroy Associates, Inc. Clay Center, KS 67432, packaged in 50 lb bags.
Nationwide Distribution to AR, AZ, CA, FL, GA, IA, ID, IN, KS, MD, MN, MO, NC, NE, NJ, NY, OH, OR, PA, SD, UT, VA, and WI.
Arial Wireless Water-Resistant Call Pendant   The Arial Pendant tag is part of the Arial wireless emergency call management system. It enables residents in assisted living, skilled nursing or independent living to call staff with the press of a button.
Devices were incorrectly programmed during manufacturing therefore depressing the pendant button may result in an alarm not sounding as intended.
Serial numbers WP149149 through WP149398 and WP149649 through WP149898.
This voluntary recall is limited only to the Sour Cream & Chive Flavor, distributed to retail, grocery, and food service in the USA, Hong Kong, Jakarta, and Singapore.
2 oz Sour Cream & Chive cases:  6,207 , 6 oz Sour Cream & Chive cases:  2,402
On December 19th, Small Fry Inc. was advised by their seasoning supplier that an ingredient in the Sour Cream & Chive seasoning was subject to a RECALL.  The ingredient is nonfat dry milk powder, and was produced by their supplier.  An FDA inspection identified Salmonella at the supplier's facility.
Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay,  Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia
Product Stability issues:  The current shelf-life claims of the ETEST products are not supported by internal testing.
Worldwide Distribution - US Nationwide in the state of  AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and the countries of Canada and Mexico.
Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132    Product Usage:  To provide a patent airway for a patient with a blockage or potential blockage of the nasal cavity or nasopharynx.
Worldwide Distribution - US (nationwide and Puerto Rico) Bahamas and Internationally to UK, Trinidad & Tobago, Taiwan, Spain, Panama, Netherlands Antilles, Mexico, Lebanon, Japan, Ireland, Honduras, El Salvador, Ecuador, Costa Rica, Colombia, Canada, Brazil, and Venezuela,
Giraffe OmniBed  Ohmeda Medical Omnibed- The OmniBed is a combination of an infant incubator ( incubator ) and an infant radiant warmer ( warmer ). Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperature controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment
CarePlus Incubator  Ohmeda-Ohio CarePlus Incubator- Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. Most Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. Most incubators can be used in two operating modes: 1. Air Control: The clinician sets the appropriate air temperature for maintaining the desired patient temperature. The air temperature is initially selected based on the clinician s training and experience and then is adjusted based on the patient s needs and clinical status. 2. Patient control: The clinician sets the desired patient temperature. A skin temperature probe sense the patient temperature and feeds this information to the controller of the incubator. Thecontroller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient s temperature while minimizing overshooting and patient stress. Incubators have alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient s temperature from the set value. Incubators may incorporate other features, such as humidification of the infant environment, tilting of the bed, oxygen supply, and data output to remote monitors or nurse call systems
Giraffe Spot PT  Ohmeda Medical Spot PT Lite Phototherapy System- The Spot PT Lite Phototherapy System provides light therapy for the treatment of hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in the hospital
Giraffe Incubator  Ohmeda Medical Giraffe Incubator-The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. They achieve this by providing an enclosed temperature controlled environment for the infant. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Giraffe OmniBed  Ohmeda Medical Giraffe OmniBed- The OmniBed is a combination of an infant incubator and an infant warmer. The device can be operated as an incubator or as a warmer and can transition from one mode to the other on user s demand. It cannot be operated in both modes at the same time. Incubators and warmers provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed, temperatures controlled environment and warmers provide infrared heat in an open environment. They may also be used for short periods of time to facilitate the neonate s transition from the uterus to the external environment. This device may incorporate a Servo Controlled Oxygen Delivery System. This is indicated to provide a stable oxygen concentration within the infant compartment at the value set by the operator (21-65%).
Giraffe Bedded Warmer, Panda Warmer  Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermoregulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.
Giraffe Incubator  The Giraffe Incubator is an infant incubator. Incubators provide heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Incubators provide an enclosed temperature controlled environment
Giraffe Bedded Warmer, Panda Warmer  Modifiction to Giraffe and Panda Warmer- Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant
IWS  Infant Warmer System-Infant radiant warmers provide infrared heat, in a controlled manner, to neonates who are unable to thermoregulate based on their own physiology or necessitate external heat to smoothen the transition from the uterus to the external environment. They fulfill the same purpose of neonatal incubators but they may be preferred over incubators when total access to the patient is needed or desirable (e.g., surgical procedures, extracorporeal membrane oxygenation, frequent resuscitation, etc.). Most infant radiant warmers can be used in two operating modes: 1. Manual: The clinician sets the appropriate heater output for maintaining the desired patient temperature. The heater output is initially selected based on the clinician s training and experience and then is adjusted based on the patients  needs and clinical status. 2. Servo: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the controller of the infant radiant warmer. The controller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient s temperature while minimizing overshooting and patient stress. Infant radiant warmers have alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient s temperature from the set value. Infant radiant warmers may incorporate other features, such as phototherapy, observation light, tilting of the bed, and data output to remote monitors or nurse call systems
Giraffe Exam Light  The Exam Light illuminates body surfaces and facilitates patient observation during a medical examination. It increases ambient light to facilitate performance of procedures on the mattress field. It is designed to mount on the accessory railings of the Giraffe OmniBed, incubators and warmers except for Panda and Giraffe Warmers. It is not intended for use to support surgical field lighting.
Giraffe Bedded Warmer, Panda Warmer  Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply) - Infant radiant warmers provide infrared heat in a controlled manner to neonates who are unable to thermo-regulate based on their own physiology. Infant radiant warmers may be used to facilitate the neonate's transition to the external environment or to provide a controlled open environment. An optional integrated SpO2 monitoring feature may be used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SP02 sensor). An optional integrated resuscitation system may be used to provide the basic equipment required for pulmonary resuscitation of infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the infant.
Hot Barbecue Sauce;  Net wt. 16 ounces;  Manufactured by Carriage House Creations, 544 Gordon Alley, Reynoldsville, PA 15851;
Carriage House Creations is recalling 3 varieties of Bourbon Basting Sauce and Hot BBQ Sauce due to undeclared peanuts and soy. The recall was initiated after receiving notification that the Worcestershire sauce ingredient was recalled for the undeclared allergens.
Batch #3131601; Best If Used By: 5082018
Carriage House Creations;   Bold N' Spicy Bourbon Basting Sauce;   Net wt. 12 Ounces;   Carriage House Creations, 544 Gordon Alley; Reynoldsville, PA  15851;
Carriage House Creations;   Bourbon Basting Sauce Hot;   Net wt. 12 Ounces;   Carriage House Creations, 544 Gordon Alley; Reynoldsville, PA  15851;
Carriage House Creations;   Bourbon Basting Sauce Mild;   Net wt. 12 Ounces;   Carriage House Creations, 544 Gordon Alley; Reynoldsville, PA  15851;
Distribution was made USA (nationwide) to medical facilities. Government distribution was made.  Foreign distribution was made to Canada.  There was no military distribution.
Merge Eye Station Import Utility (ESIU).  The firm name on the labeling is Merge Healthcare.
78 sites potentially have the affected accessory
System locks up which may result in potential patient injury or delay in diagnosis or treatment.
LipiFlow Thermal Pulsation System/LipiFlow, System Activator (Disposable), Rx Only, Sterile
Labeling: The labeled storage temperature is not consistent with the temperature conditions tested for the entire four year shelf life duration.
Model number LFD-1000 and LFD-1100, All lots
, Morelia, MX 58300; Hospital General de Occidente, Zoquipan 1050 Avenue, Zapopan Jalisco, MX 45170    The product was distributed to the following countries: Brazil.
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
Nationwide Distribution to MN, NV, OH, NC, CA, CO, CA, GA, VA, MI, AZ, PA, TN, WA, TX, NY.
Final Fit Software Version 1.11 and  1.12;  PC Based software installed outside Nidek EC-5000 Excimer Laser System.      Ophthalmic laser system use for correction of corneal refraction and ablation of the corneal surface. The system is composed of a laser generator which produces an excimer laser radiation of wavelength 193nm, a beam delivery unit, an optical system for observation, a gas system and a computer for system control.
During treatment planning, the procedure was programmed with an unintended (wrong) correction.
The product from the Franklin Park facility is distributed throughout the United States, Canada, and to the U.S. Military.
Skoal Brand Products     Bandit Mint   Bandit Wintergreen   Long Cut Apple Tobacco Blend   Long Cut Berry Tobacco Blend   Long Cut Cherry   Long Cut Citrus Tobacco Blend   Long Cut Classic   Long Cut Peach Tobacco Blend   Long Cut Spearmint   Pouch Apple Tobacco Blend   Pouch Berry Tobacco Blend   Pouch Citrus Tobacco Blend   Snus Mint   Snus Smooth Mint   Xtra Long Cut Mint   Xtra Long Cut Rich Tobacco Blend   Xtra Long Cut Wintergreen   Xtra Pouch Crisp Tobacco Blend   Xtra Pouch Mint Blend   Xtra Pouch Rich Tobacco Blend   Fine Cut Wintergreen (overseas military only)   Long Cut Mint (overseas military only)   Long Cut Straight (overseas military only)   Long Cut Wintergreen (overseas military only)   Pouch Mint (overseas military only)   Pouches Wintergreen (overseas military only)
The firm is working on providing exact numbers
The discovery of a potential product incident associated with US Smokeless Tobacco Company LLC (USSTC) products involving a non-product related material.
This recall applies to all Franklin Park products regardless of manufacturing date or trace code.
Copenhagen Brand Products :    Extra Long Cut Natural   Long Cut Mint   Long Cut Southern Blend   Pouch Mint   Pouch Wintergreen   Long Cut (overseas military only)   Fine Cut (overseas military only)   Long Cut Straight (overseas military only)   Long Cut Wintergreen (overseas military only)   Pouch (overseas military only)   Fine Cut Plastic Can (only available in Alaska and Hawaii)   Long Cut Plastic Can (only available in Alaska and Hawaii)   Pouch Plastic Can (only available in Alaska and Hawaii)
Husky Brand Products :    Fine Cut Natural   Long Cut Straight   Long Cut Wintergreen
EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).
There is a possibility for data to be stored under the wrong patient on the DICOM Server following a non-standard workflow.
US: AL, AZ, CA, FL, GA, HI, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, SD, TN, TX,  UT, WA
Raindrop Near Vision Inlay, Model# RD1-1
ReVision Optics has updated the instructions for use (IFU) for the Raindrop Near Vision Inlay to emphasize that only Balanced Salt Solution (BSS) may be used to irrigate under the flap and that topical medications or lubricants should not be administered until centration of the inlay and proper flap positioning has been confirmed at the slit lamp.
Distribution was nationwide to medical facilities.  There was also military distribution.  There was no foreign/government distribution.
217 sites potentially have the affected versions
Cardio study list does not show STAT studies without refreshing.
FL, GA, IL, IN, KS, KY, MA, MI, MO, MC, OH, PA, SC, TN, TX, UT
Colby Jack Cheese packaged as follows:  (a) m markets of Meijer(R), NET WT 6 LBS (2.72 kg), Item 18755, UPC 71091718755  (b) Amish classics Colby Jack RW Halfmoon, Item 18244, 8 oz, no UPC  (c) Meijer Colby Jack EW Halfmoon Chunk, Item 18758, 8 oz, UPC 713733340588  (d) Amish Classics Colby Jack RW Fullmoon, Item 18241, 8 oz, no UPC  (e) Amish Classics Colby Jack EW Fullmoon, Item 18245, 	8 oz, 828653182450  (f) Deli Readi Colby Jack 1/2 Moon Slices, Item 18830, 1 lb, UPC 6 34660 62875 7  (g)  Amish Classics Colby Jack Mini Horn, Item 18209, 6 lbs, no UPC  (h) LIPARI OLD TYME Colby Jack EW Halfmoon, Item 18703, 8 oz, UPC 094776102211  (I) Deli Readi Colby Jack St Pk 1oz Mn Hrn Slice, Item 18831, 2 lbs, UPC 634660628603  (j) Dietz & Watson Colby Jack Mini Horn, Item 18740, 6 lbs, no UPC  (k) Winder Farms Colby Jack St Pk .75oz Slice, Item 18790, 1 lb, UPC 828653187905
Sample of product collected by the State Department of Agriculture tested positive for Listeria Monocytogenes
Jalapeno Cheese  packaged as:    (a) Deli Readi Jalapeno St Pk 1oz Slice, Item 10831, 2 lbs, UPC 634660628788
Potential cross contamination from a of product collected by the State Department of Agriculture which tested positive for Listeria Monocytogenes
Hot Pepper Cheese packaged as:    (a) AMISH CLASSICS Hot Pepper RW Square, Item 26244, 12 lbs, UPC 858653262442	  (b) Deli Made EZ Hot Pepper St Pk .5oz, Item 26555, 1.5 lbs, UPC 828653265559   (c) Deli Readi Hot Pepper St Pk 1oz Slice, Item 26831, 2 lbs, UPC 634660628788	  (d) LIPARI Old Tyme Hot Pepper Cheese Food EW Square, Item 26703, 8 oz, UPC 94776102280
Potential cross contamination from a sample of product collected by the State Department of Agriculture which tested positive for Listeria Monocytogenes
Muenster Cheese packaged as:  (a) AMISH CLASSICS Muenster RW End Chunks, Item 61243, 12 lbs, no UPC      (b) AMISH CLASSICS Muenster RW square, Item 61244, 8 oz, no UPC     (c) Deli Made EZ Muenster St Pk .75 oz Slice, Item 61552, 1.5 lbs, UPC 828653615521	  (d) Meijer Muenster EW Square, Item 61758, 8 oz, UPC 886926375735     (e) Old Tyme Muenster EW Square, Item 61703, 8 oz, UPC 94776102242
Provolone Cheese Salame packaged as:  (a) Sutters Quality Foods Provolone Salame, Item 58814, 6 lbs, no UPC
Lot Numbers:  (a) Best if Used by:  5/6/2017
Marble Cheese packaged as:  (a) Troyer Marble EW Halfmoon, Item 18840, 8 oz, UPC  49646936113	  (b) Troyer Marble EW Full Moon, Item 18841, 8 oz, UPC 49646936052	  (c) Troyer Marble RW Halfmoon, Item 18842, 8 oz, no UPC
Lot Numbers:  (a)  Best if used by: 02/28/2017 through 08/14/2017  (b)  Best if used by: 02/28/2017 through 08/14/2017  (c)  Best if used by: 02/28/2017 through 08/14/2017
Mozzarella Cheese packaged as:  (a) Deli Made EZ Mozzarella St Pk .75oz Slice, Item 11553, 1.5 lbs, UPC 828653105558
Lot Numbers:   (a) Best if Used by:  322-16, 333-16
Jalapeno Jack cheese packaged as follows:  (a) AMISH CLASSICS Jalapeno Jack Mini Horn, Item 10209, 6 lbs, No UPC   (b) AMISH CLASSICS Jalapeno Jack RW Fullmoon, Item 10241, 12 lbs, no UPC  (c) AMISH CLASSICS Jalapeno Jack RW Halfmoon, Item 10244, 12 lbs, no UPC  (d) AMISH CLASSICS Jalapeno Jack EW Fullmoon, Item 10245, 8 oz, UPC 828653102458	  (e) AMISH CLASSICS Jalapeno Jack Cheese, Item 10311, 10 lbs, no UPC 10 lbs, no UPC	  (f) Deli Made EZ Jalapeno Jack St Pk .75 oz Slice, Item 10553, 1.5 lbs, no UPC     (g) Deli Made EZ Jalapeno Jack St Pk .75 oz Slice, Item 10554, 1.5 lbs, UPC 828653105541	  (h) Deli Made EZ Jalapeno Jack St Pk .5 oz Slice, Item 10555, 1.5 lbs, UPC 828653105558	  (i) LIPARI Old Tyme Jalapeno Jack EW Halfmoon, Item 10703, 8 oz, UPC 94776102303	  (k) Sutters Quality Foods Jalapeno Jack St Pk .75oz Slice, Item 10812, 1.5 lbs, UPC 828653108122    (l) Sutters Quality Foods Jalapeno Jack Loaf, Item 10815, 5 lbs, no UPC  	  (n) Winder Farms Jalapeno Jack St Pk .75oz Slice, Item 10790, 1 lb, UPC 828653107903
Provolone Cheese packaged as:  (a) Santino Deli Made EZ Provolone St Pck .75oz Slice, Item 58554, 1.5 lbs, UPC 828828653585541 	  (b) Deli Made EZ Provolone St Pck .5oz Slice, Item 58555, 1.5 lbs, UPC 828653585558	  (c) Duck Deli Provolone Stk Pck .75oz Slice, Item 58747, 1.5 lbs, UPC 828653587476	  (d) La Rosa's Pizzaria Provolone St Pk .667oz, Item 58774, 2.25 lbs, UPC 828653587743
Lot Numbers:  (a) Best if Used by:  3/28/2017  (b) Best if Used by:  3/28/2017  (c) Best if Used by:  004-17  (d) Best if Used by:  004-17
Colby Cheese packaged as follows:  (a) AMISH CLASSICS, DELI HORN, Item 55209, NET WT 6 LBS, UPC 0 08 28653 55209 3  (b) AMISH CLASSICS, FULLMOON(R), Item 55241, approximately 8 oz, UPC 828653552413  (c) AMISH CLASSICS EW FULL MOON, ITEM 55245, 8 oz, UPC 828653552451  (d) 8/2# RW Deli Readi Colby Mini Cheese Slices, ITEM 55831,  2 lbs., UPC 634660 628597  (e) Deli Made EZ(R) Slices, NET WT1.5 LB (681g), Item 55553, UPC 8 28653 55554 4  (f) Meijer Colby Cheese DELI HORN, Item 55755, 6 lbs., no UPC   (g) Amish Classics Colby RW Halfmoon, Item 55244, 8 oz, no UPC  (h) Meijer Colby EW Halfmoon, Item 55758, 8 oz, UPC 7 13733 34047 2  (i) RW Deli Readi Colby 1/2 Moon Slices, Item 55830, 1 lb, UPC 6 34660 62872 6  (j) Old  Tyme Colby EW Halfmoon, Item 55703, 8 oz, UPC 8 28653 10555 8  (k) AMISH CLASSICS Colby Longhorn, Item 55523, 15 lbs, no UPC  (l) Dietz & Watson Colby Mini Horn, Item 55740, 6 lbs, no UPC  (m) Troyer Colby EW Halfmoon, Item 55840, 8 oz, UPC 04964693609   (n) Troyer Colby EW Full Moon, Item 55841, 8 oz, UPC 049646936045  (o) Troyer Colby RW Halfmoon, Item 55842, 8 oz, no UPC
(a) Lot Numbers: Sell By: 02/28/2017 through 08/14/2017  (b) Lot Numbers:  Best if Used By: 02/28/2017 through 08/14/2017  (c) Lot Numbers:  Best if Used By: 02/28/2017 through 08/14/2017  (d) Lot Numbers:  Best if used by: 02/28/2017 through 08/14/2017  (e) Lot number 335-16, Best if used by:  02/28/2017 through 08/14/2017  (f) Lot Numbers: Sell by Date: 05/02/2017, 02/28/2017 through 08/14/2017  (g) Lot Numbers: Best if used by: 02/28/2017 through 08/14/2017  (h) Lot Numbers: Best if used by: 02/28/2017 through 08/14/2017  (i) Lot Numbers: USE BY: 02/28/2017 through 08/14/2017  (j) Lot Numbers:  Best if used by: 02/28/2017 through 08/14/2017  (k) Lot Numbers:  Best if used by: 02/28/2017 through 08/14/2017  (l) Lot Numbers:  Best if used by: 02/28/2017 through 08/14/2017  (m) Lot Numbers:  Best if used by: 02/28/2017 through 08/14/2017  (n) Lot Numbers:  Best if used by: 02/28/2017 through 08/14/2017  (o) Lot Numbers:  Best if used by: 02/28/2017 through 08/14/2017
Monterey Jack Cheese packaged as:  (a) AMISH CLASSICS Deli Made EZ Monterey Jack St Pk .75 oz Slice, Item 03554, 1.5 lbs, UPC 828653035541
Lot Numbers:  (a) Best if Used by:  3/28/2017, 5/3/2017
Grand Butterkase Cheese packaged as:    (a) AMISH CLASSICS Grand Butterkase, Item 65209, 6 lbs, UPC 828654652090  (b) AMISH CLASSICS Grand Butterkase RW Fullmoon, Item 65241, 12 lbs, no UPC  (c) AMISH CLASSICS Grand Butterkase EW Fullmoon, Item 65245, 8 oz, UPC 828653652458
Lot Numbers:  (a) Best if used by: 02/28/2017 through 08/14/2017  (b) Best if used by: 02/28/2017 through 08/14/2017  (c) Best if used by: 02/28/2017 through 08/14/2017
Cheddar Cheese packaged as:  (a) AMISH CLASSICS Cheddar Mild Color, Item 28311, 10 lbs, No UPC	  (b) Deli Made EZ Cheddar Mild Stick, Item 28532, 4.5 lbs, no UPC 	  (c) Deli Made EZ Cheddar Mild C St Pk .75oz Slice, Item 28545, 2 lbs, UPC 828653285458	  (d) AMISH CLASSICS Deli Made EZ Cheddar St Pk .75oz Slice, Item 28553, 1.5 Lbs, no UPC 	  (e) AMISH CLASSICS Deli Made EZ Cheddar Mild Stk Pk .5oz Slice, Item 28555, 1.54 lbs, UPC 828653285557	  (f) Deli Readi Cheddar St Pk 1oz Slice, Item 28831, 2 lbs, UPC 634660628771	  (g) Duck Deli Cheddar Mild Color Loaf, Item 28745, 5 lbs, no UPC 	  (h) Duck Deli Cheddar st pk .75oz Slice, Item 28747, 1.5 lbs, UPC 828653287476	  (i) Madison Valley Farms Cheddar St Pk .75oz Slice, Item 28769, 1.5 lbs, UPC 828653287698	  (j) Sutters Quality Foods Cheddar St Pk .75oz Slice, Item 28812, 1.5 lbs, UPC 828653288126	  (k) Sutters Quality Foods Cheddar Mild Color Loaf, Item 28815, 5 lbs, no UPC			  (l) Troyer Cheddar EW Full Moon, Item 28841, 8 oz, UPC 49646936076
Farmers Cheese packaged as:    (a) AMISH CLASSICS Farmers Cheese Mini Horn, Item 69209, 6 lbs, no UPC  (b) Troyer Farmers EW Halfmoon, Item 69840, 8 oz, UPC 49646936137	  (c) Troyer Farmers EW Full Moon, Item 69841, 8 oz, UPC 49646936083	  (d) Troyer Farmers RW Halfmoon, Item 59842, 8 oz, no UPC
Havarti Cheese Packaged as:   (a) AMISH CLASSICS Deli Made EZ Havarti .75oz St Pk Slice, Item 	71554, 1.5 lbs, UPC  82853715542
Lot Numbers:  (a) Best if Used by:  5/3/2017
Jalapeno Colby Jack Cheese packaged as:    (a) AMISH CLASSICS Jalapeno Colby Jack EW Fullmoon, Item 17245, 8 oz., UPC 828653102458(b) AMISH CLASSICS Jalapeno Colby Jack Mini Horn, Item 17209, 6 lbs., No UPC
Lot Numbers:  (a)  Best if used by: 02/28/2017 through 08/14/2017  (b)  Best if used by: 02/28/2017 through 08/14/2017
Pepper Jack Cheese  packaged as:    (a) Troyer Pepper Jack EW Halfmoon, Item 10840, 8 oz, UPC 49646936106  (b) Troyer Pepper Jack EW Full Moon, Item 10841, 8 oz,  UPC 49646936069
Lot Numbers:   (a) Best if used by: 02/28/2017 through 08/14/2017  (b) Best if used by: 02/28/2017 through 08/14/2017
Worldwide distribution.  US Nationwide including Puerto Rico, Canada, Argentina, Australia, Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Lithuania, Malaysia, Mexico,  Netherlands, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Orthosize Templating Version 1.2.6  Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.
Digital templates were created with the incorrect files.
USA:   AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC,  PR, TN, TX, UT, VA, VT, WA, WI.    OUS: GUATEMALA, MEXICO, PANAMA, NASSAU
Sargento Chef Blends Shredded Nacho & Taco Cheese, 8 oz., UPC 4610040041.,Sell By dates of H14JUN17,  H12JUL17, H04MAY17, S15MAY17, H01JUN17.
116,554 cases  / 2,467,145 units for all products
Sargento Foods Inc. was notified by their supplier that the cheese that was supplied may have been contaminated with Listeria monocytogenes.
Sell By dates of H14JUN17,  H12JUL17, H04MAY17, S15MAY17, H01JUN17.
Sargento Ultra Thin Sliced Longhorn Colby, 6.84 oz., UPC 4610000228, with Sell By dates of 12APR17B, 02FEB17F, 01MAR17B, 16MAR17F  and 10MAY17B.
Sell By dates of 12APR17B, 02FEB17F, 01MAR17B, 16MAR17F  and 10MAY17B.
Sargento Deep V SHRED Monterey Jack Cheese withy Fiesta Peppers, 5 lbs , UPC 4610033648.
Sargento Sliced Colby, 8oz., UPC 4610000105, Sell By date: 15MAY17F
Sargento Shredded Chef Blends 4 Cheese Pizzeria, 8oz., UPC 4610041105, Sell By date: H10APR17
Sargento Shredded Reduced Fat Colby-Jack, 8oz., UPC 4610041018, Sell By date: H07APR17
Sargento Sliced Colby-Jack Cheese, 12 oz., UPC 4610000109 with Sell By date of 11JUN17B & 01MAY17B.
Sargento Sliced Tomato & Basil Jack, 6.67oz., UPC 4610000279, Sell By date: 03MAR17B
Sargento Sliced Muenster, 8oz., UPC 4610000107, Sell By dates: 05MAR17F, 06MAR17F,16APR17F, 17APR17Fand 15APR17F
Sell By date of 05MAR17F, 06MAR17F,16APR17F, 17APR17Fand 15APR17F .
Sargento Off The Block Shredded Fine Cut Colby-Jack Cheese, 8 oz., UPC 4610040014 with Sell By date of F05JUL17, H06MAY17
Sargento Sliced Pepper Jack Cheese, 12 oz., UPC 4610000108 with Sell By dates of  12JUN17B, 09JUL17B, 02MAY17B, 03MAY17B, 11JUN17B,  and 10JUL17B.    Sargento Sliced Pepper Jack, 7.5 oz., UPC 4610000122, Sell By date: 03MAY17B
Sell By dates of  12JUN17B, 09JUL17B,02MAY17B, 03MAY17B, 11JUN17B    and 10JUL17B.
Sargento Sliced Red Rind Munster Cheese, 0.75 oz, UPC 4610031554.
Code Date 28116F Best by Date 1/5/17  Code Date 32116F Best by Date 2/14/17
Sargento Mont Jack Cheese w/hot peppers, 5 lbs, UPC 4610033926.
Sargento Chef Blends Shredded Taco Cheese, 8 oz., UPC 4610040002 with Sell By dates of H14JUN17, F28JUN17, H11MAY17, H01JUN17
Sell By dates of H14JUN17, F28JUN17, H11MAY17, H01JUN17.
Sargento Artisan Blends Double Cheddar Shredded Cheese, 8oz., UPC 4610040094, Sell By date: H09JUN17 and H08JUN17
Sargento Off The Block Shredded Fine Cut Cheddar Jack Cheese, 8 oz., UPC 4610040076 with Sell By date of F05JUL17,  H07MAY17, H08MAY17, H09MAY17
Sell By date of F05JUL17 ,  H07MAY17, H08MAY17, H09MAY17
Sargento Sliced Pasteurized Process Cheddar Cheese , 0.4 oz, UPC 4610034527.
Alabama, Florida, Georgia, Kentucky, Louisiana, Mississippi, North Carolina, South Carolina, Tennessee, Texas
Country Fresh Creations Stuffed Mushrooms Net Wt. 7 oz. (198g) Packed Regionally by Country Fresh LLC Headquarters, Conroe, TX 77384 www.countryfreshinc.com UPC: 074641072078
Possible contamination with Listeria monocytogenes.
Southwestern Stuffed Mushrooms Net Wt. 7 oz. (199g) UPC: 072036884718 Proudly Distributed By: Harris Teeter, LLC. Matthews, NC 28105 Facility #865
HEB Ready Fresh Go Fresh Fruit and Hatch Pepper Cheese Net Wt. 5.5 oz. (156g) Made With Pride and Care For H-E-B San Antonio, TX 78204 UPC: 041220036806
Country Fresh Creations Tuscan Style Portabella Mushrooms Net Wt. 8oz (227g) Distributed by Country Fresh, LLC., Houston, TX 77090 UPC: 074641072115
Marketside Garlic & Four Cheese Stuffed Baby Bellas Net Wt. 7 oz. (198g) Distributed By: Wal-Mart Stores, Inc., Bentonville, AR 72716 UPC: 681131148214
Worldwide distribution - US Distribution to the states of : NH, MD, MS, MN, IL, TX, CA and  WA,  and to the countries of :  Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hungary, India, Indonesia, Iran, Ireland, Italy, Japan, Jordan, Latvia, Malaysia, Myanmar, Netherlands, New Zealand, Norway, P.R. China, Peru, Philippines, Poland, Portugal, Qatar, Republic of Korea, Saudi Arabia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Uruguay, Vatican City, and Vietnam.
Siemens Healthcare Diagnostics has identified multiple software issues for all the ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. These issues may affect the operation and workflow of the system. The potential exists for an apparent delay to testing when these issues occur. The software issues affecting the analyzer may potentially impact all analytes available on the ADVIA Centaur XPT System test menu.
COUSINS PRODUCTS(R)  Creole Tomato SALAD DRESSING, NET WT. 16 OZ (473 ML),
One lot of Creole Tomato Salad dressing may contain Blue cheese salad dressing; undeclared milk.
Veggie Noodle Co. Butternut Spirals in 10.7 ounce clear plastic containers, UPC: 852287006059 Manufactured By Veggie Noodle Co., LLC. Austin TX 78744
Pan Molido Sazonado Seasoned Bread Crumbs, Net Wt. 6oz and 12oz
Chapis Spice & Tea is recalling bread crumbs because of undeclared allergens (wheat, milk, eggs, tree nuts, soybean).
Pan Molido Natural Bread Crumbs, Net Wt. 6oz and 12oz
Harris Teeter,  Sweet Green Peas, 12 oz (340g), UPC 007203671652
Lakeside Foods is voluntarily recalling frozen green beans, peas and  peas/carrots  due to the potential  to be contaminated with Listeria monocytogenes.
Package code: DC*7013 (* Most packages will have a 2 in that space.)   Production code: BNAC7206  Best By: BEST BY 01/2019
Kroger Peas & Carrots, Net Wt. 12 oz (340g), UPC 11110-89741;    Harris Teeter Peas and Diced Carrots 12 oz, UPC 007203671661
Kroger Peas & Carrots-Package code: DC*7013 (*Most packages will have a 2 in that space.)   Production code: DCMA1127, DCMA1137 BEST BY 01/2019;  Harris Teeter Peas and Diced Carrots - Package code: DC*7013 (* Most packages will have a 2 in that space.)   Production code: DCMA1127, DCMA1137, Best By: BEST BY 01/2019
Kroger French Style Green Beans, Net Wt. 12 oz (340g), UPC 11110-89731
Production Code:   MTAA7276, MTAB7276, MTAC7276, MTAE7276, MTAA7286.    Best  By 11/2018.    Packaging Code:  DC*6333 (* Most packages will have a 2 in that space.)    ***Package code: DC*7013 (* Most packages will have a 2 in that space.)   Production code: BNAC7206  Best By: BEST BY 01/2019
Product distributed to foodservice customers nationwide. There was no foreign/military/government distribution reported.
Natural Cocoa Powder 22-24% cocoa butter, Net Wt. 5 lbs. (2.27 kg) packaged under the following brand name: Chef's Companion:  1 bag /case, UPC 10719098582240; Diamond Crystal Brands, Inc. Savannah, GA 31405
During sanitation, the firm discovered metal pieces missing from a sifter screen.
Baking Powder Net Wt. 5 lbs. (2.27 kg) packaged 6 bags per case, under the following brand names:    Chef's Companion UPC 50719098580015, Diamond Crystal Brands, Inc. Savannah, GA 31405; and   Sysco UPC 10074865238813, distributed by Sysco Corporation, Houston, TX 77077-2099.
Natural Cocoa Powder 10-12% cocoa butter, Net Wt. 5 lbs. (2.27 kg) packaged under the following brand names: Monarch distributed by U.S. Foodservice UPC 50758108102533;   Chef's Companion:  1 bag /case, UPC 10719098582233; and 6 bags/case, UPC 50719098582293 Diamond Crystal Brands, Inc. Savannah, GA 31405
Food City random weight cut Monterey Jack Cheese. (Bashas' brand).    Also sold as Longhorn Monterey Jack RW EW case 36# for Bashas'    Also sold to Bashas' in RW EW case 36# - no label and 12 oz. packages.
355,477.90 pounds of cheese (all varieties)
Firm was notified by supplier that cheese supplied to Lakeview from September 1, 2016 through January 27, 2017 is being recalled due to the potential of   Listeria monocytogenes. contamination.
Food City Colby Monterey Cheese, 12 oz. package.   (Bashas' brand)    Also sold as Banquet Baby Monterey WE Wheel 18/2#;  Banquet Wheel Mont LH 12/3;  Banquet Wheel Mont LH 12/3 Exact Weight
All product received by Lakeview between September 1, 2016 and January 27,  2017.    Lakeview codes:  1204 Banquet BabyMonterey RW Wheel 18/2#;  1234 BanquetWheelMont LH 12/3;  1236 BanquetWheelMont LH 12/3 ExactWeight;  622213 LH Mont Jk. 4/13 # R/W - Bashas'
Food City random weight cut Pepper Jack Cheese.,   Also sold as Banquet Baby Jalap Jk RW Wheel 18/2#; Banquet Wheel Jalapeno Jk LH 3# wheel exact weight.; LH Pepper Jack 4/13# Lakeview brand.    Longhorn identifies the shape of the cheese.  Banquet is a Lakeview brand name.
All product received by Lakeview between September 1, 2016 and January 27,  2017.    Lakeview Codes:  1205 Banquet Baby Jalap Jk RW Wheel 18/2#;  1235 Banquet Wheel Jalapeno Jk LH 3# wheel ExactWeight;;  4361 Longhorn Pepper Jack RW EW case 36# No Label;  622315 LH Pepper Jk.4/13# - Bashas'.
Food City Colby Longhorn Cheese, 12 oz. package; also sold in random weight sizes. (Bashas' brand) sold at retail stores)    Also sold in 4/13# in Bashas' and Lakeview labels; and RW  EW case 36#, no label for Bashas' ;20/1# CW Banquet label and Colby Longhorn Cheese 16 oz. Yokes Fresh Market brand.    Banquet is a Lakeview brand name.
All product received by Lakeview between September 1, 2016 and January 27,  2017.    Lakeview Codes:  1115 Colby LH 4/13#;  1203 Banquet Baby Colby Jk RW Wheel 18/2#;  4355 Colby LH 48/12 oz.;  4358 Longhorn Colby RW EW case 36# No Label;  5536 Colby LH 20/1# CWBanquet Label;  622414 LH Colby 4/13 # R/W - Bahsas'
Cheddar Longhorn, 4/13# under Lakeview brand and LH Cheddar 4/13# RW Lakeview.
All product received by Lakeview between September 1, 2016 and January 27,  2017.    Lakeview codes:  1114 Ched LH 4/13#;  622413 LH Cheddar 4/13#R/W
Food City Colby Jack Cheese, 12 oz. package; also sold in random weight sizes (Bashas' brand name)    Also sold in 4/13# with Lakeview name;  Banquet Baby Colby Jack RW Wheel 18/2# : Colby Jack LH 20/1# CW Banquet;  Colby Jk Longhorn Cheese 16 oz. Yoke's Fresh Market 20# case and Longhorn Colby Jack RQ EW case 36# no label for Bashas'    Longhorn is just a different shape, same recipe.  Banquet is a Lakeview brand name.
All product received by Lakeview between September 1, 2016 and January 27,  2017.    Lakeview Codes:  1119 Co-Jack LH 4/13#;  4356 Colby/Jack LH 48/12 oz.;  4359 Longhorn Colby/Jack RW EW case 36# No Label;  5537 Co Jack LH 20/1# CW Banquet Label;  622415 LH Colby/Jack 4/13 # - Bashas'.
Benniseed, Natural sesame seeds, Vita and fish, Net Weight:  8 oz.  Packed by:  Dukarani Food Processing, Inc., 1729 Lyndale Ave. North, Mpls, MN  55411.  Storage:  Keep in cool dry place.
Minnesota Department of Agriculture is issuing a consumer advisory for products produced by Dukarani Food Processing, Minneapolis, Minnesota because they have the potential to be contaminated with Clostridium botulinum.
Pepper Sauce, Fish and Vita, Net Weight:  8 oz.  Packed by:  Dukarani Food Processing, Inc., 1729 Lyndale Ave. north, Mpls, MN  55411.  Storage:  Keep in cool dry place.
Ketele Sauce, Fish and Vita, Net Weight:  8 oz.  Packed by:  Dukarani Food Processing, Inc., 1729 Lyndale Ave. North, Mpls, MN  55411.  Storage:  Keep in cool dry place.
PureWick External Catheter for Women-Wick    Product  Usage:  A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the body through a PVC tube via a continuous, low pressure vacuum pump (PureWick DryDoc) or to a hospital wall vacuum. There is never a reversal of flow direction or static state of fluid between the device and the patient. Also, the dry natural rubber component is double wrapped with 75D polyester and it is not stretched in its application to expose bare rubber to a user. The Wick does not enter the vagina (Figure 1).
The white gauze component of the PureWick contains dry natural rubber.
A+D Diaper Rash Cream with Dimethicone 1% and Zinc Oxide 10%, Packaged in a) 1.5 oz (42.5g) ( UPC 041100811288), b) 3 oz 85g (UPC 041100811301), c) 4 oz (113g) (UPC 041100811325), Distributed by: Bayer Healthcare LLC, Whippany, NJ 07981
Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.
Massachusetts, Connecticut, New Hampshire, Maine and Rhode Island
Whole Foods Spinach Orzo Salad Our Chef's OWN, sold by weight  PLU:beginning with 61159
Trader Joe's Organic Unsweetened Apple Sauce;  24 oz. glass jar.  Best Before date stamped on top of lid.    UPC: 00194877    Distributed by Trader Joe's, Monrovia, CA
Manzana Products Co. is initiating a recall of three varieties of apple sauce after receiving customer complaints or finding small pieces of glass in the product.
Trader Joe's First Crush Unsweetened Gravenstein Apple Sauce;   24 oz. glass jar.  Best Before date stamped on top of lid.    UPC:00015905     Distributed by Trader Joe's, Monrovia, CA
Trader Joe's All Natural Unsweetened Apple Sauce;  24 oz. glass jar.  Best Before date stamped on top of lid.    UPC: 00014359    Distributed by Trader Joe's, Monrovia, CA
Worldwide Distribution - US Distribution including Puerto Rico and to the countries of :  Argentina  Armenia  Australia  Austria  Belgium  Brazil  Bulgaria  Canada  China  Colombia  Costa Rica  Croatia  Cyprus  Czech Republic  Denmark  Dominican Republic  Ecuador  Egypt  El Salvador  Finland  France  French Polynesia  Germany  Greece  Hong Kong  Hungary  Iceland  India  Indonesia  Iran  Ireland  Israel  Italy  Japan  Jordan  Kazakhstan  Korea  Kuwait  Latvia  Lebanon  Lithuania  Luxembourg  Malaysia  Mexico  Montenegro  Netherlands  New Zealand  Norway  Oman  Panama  Paraguay  Peru  Philippines  Poland  Portugal  Reunion  Romania  Russian Federation  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sri Lanka  Sweden  Switzerland  Taiwan  Thailand  Turkey  United Arab Emirates  United Kingdom  Uruguay  Venezuela  Viet Nam
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems  Model Numbers:   ETBF2516C145E  ETBF2516C166E  ETBF2316C145E  ETBF2313C145E  ETBF2513C166E  ETBF2313C166E  ETBF2316C166E  ETBF2313C124E  ETBF2513C145E  ETBF2516C124E  ETBF2316C124E  ETBF2513C124E.    Cardiology: The Endurant family of stent graft systems is Intended to treat infra-renal abdominal aortic or aortoiliac aneurysms using an endovascular approach. When placed within the aneurysm, the stent graft provides an alternative conduit for blood flow within the patient's vasculature.
Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II  Bifurcated Stent Graft Systems of specific models and serial numbers as this specific subset of stent grafts has greater susceptibility to fabric permeability variations that may be associated with endoleaks observed during the initial implant procedure.
Whole Foods Market King Cake, sold in purple cardboard containers and labeled as Lonestar Bakeries Cream Cheese King Cakes  PLU 44498
Sold between February 4 and February 26, 2017
Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV.  Internationally to Chile and Brazil
Mammotome Revolve Dual Vacuum Assist Biopsy   System  The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV
Microbore extension set.    Product Usage:  Accessory devices used to administer medical fluids.
Incorrect priming volume printed on the device package.
Desonide Ointment, 0.05%, NET WT 60 grams tubes, Rx only, E. FOUGERA & CO.  A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0309-60
Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream
Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for:  AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
Failed impurities/ degradation specifications: Product was above specification for unknown impurities.
9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter  The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media
The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion procedure.
Nationwide Distribution to MO,TX, FL, MA, WI, PA, IN, and CA
Syngo.plaza, Picture Archiving and Communications System (PACS)  Syngo.plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo.plaza also supports storage and archiving of DICOM Structured reports. In a comprehensive imaging syngo.plaza integrates Hospital/Radiology Information Systems (HIS/RIS) to enable customer specific workflows. Syngo.plaza optionally uses a variety of advanced postprocessing applications
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 750 mg/150 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017  Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-205-25).
Failed Dissolution Specifications: Dissolution at 8 hour was out of specification at 12 month at 25 degree Celsius.
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 300 mg/60 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017  Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-10).
Quillivant XR (methylphenidate HCl) for extended-release oral suspension, 900 mg/180 mL (25mg/5mL), Rx Only, Distributed by: NextWave Pharmaceuticals, Inc. A subsidiary of Pfizer Inc, New York, NY 10017  Manufactured by: Tris Pharma, Inc., Monmouth Junction, NJ 08852 (NDC 24478-190-30).
Product was shipped to distribution centers in TN, IN, and AZ then further shipped the product to retail pharmacies nationwide in the USA.
ATENOLOL Tablets, USP, 50 mg, 30-count bottle, Rx only, Distributed by: The Kroger Co., 1014 Vine Street, Cincinnati, OH  45202; Manufactured for: Zydus Pharmaceuticals USA Inc., Pennington, NJ  08534; Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045; NDC 68645-493-54.
Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet.
ATENOLOL Tablets, USP, 50 mg, packaged in a) 100-count bottles (NDC 68382-023-01) and b) 1000-count bottles (NDC 68382-023-10), Rx only, Manufactured by: Cadila Healthcare Ltd., India; Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ  08534.
Worldwide Distribution - US to AR, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OH, TX & WI; Internationally to the following countries: Australia, Austria, Canada, China, Czech Republic, Germany, India, Israel, Jordan, Korea, Mexico, New Cldonia, Romania, Russian Federation, Turkey, & United Kingdom.
Brilliance BigBore Oncology CT - 728243  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
Brilliance BigBore Radiology CT - 728244  Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with 4.2.0 software version through customer complaints. When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary gating device, the CT images might be reconstructed at a single phase, while the annotations on the images incorrectly indicate that the reconstruction is from the requested specific phases (0% to 90%).
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.
Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended.
Panta Nails -   Reference/Model #500050ND - Lot #'s: F33A, F33B, F3BN, F3Y5, F3Y6, F4S4, F56Y, F5LZ, F64W, F7C8, F7C9, F8SZ, F9PC, FCUG, FCUH, FEDW, FEVR, FGAX, FGLN and FHLP;    Reference/Model #500080ND - Lot #'s: F0F1, F64X, F81Y, F81Z, FEVS, FGLP and FGSK;    Reference/Model #500150ND - Lot #'s: F15L, F15L/1, F1ZQ, F27U, F27V, F3Y7, F5M0,F60W, F64Y, F64Z, F6L3, F7CA, F7CB, F7CC, F7CD, F821, F822, F8T1, F8T2, F9D6, F9D7, FEDX, FFB9, FG4T, FGSL and FHLR;    Reference/Model #500180ND - Lot #'s: F1ZS, F33C, F3M9, F4H4, F4ZZ, F68B, F823, F824, F8T3, FDEC, FEDY, FFBA and FFQL;    Reference/Model #500250ND - Lot #'s: EP14, F0WQ, F15M, F4H5, F500, F5M1, F650, F825, F826, F827, F828, F8T4, FGLQ and FGSM;    Reference/Model #500280ND - Lot #'s: F27T, F33D, F3BP, F3MA, F4H6, F5M2, F6L4, F829, F82A, F82B, F82C, F8T5 and FFBB;    Reference/Model #500350ND - Lot #'s: E2W1/1, F3BQ, F3MB, F3MD, F3Y8, F4H7, F5M3, F651, F6TT and FF3B;    Reference/Model #500380ND - Lot #'s: F3BR, F3MC, F4S5, F5M4, F60X, F652, F82D, F82E, F8T6 and FAF2    Panta XL Nails -    Reference/Model #510111ND - Lot #'s: F3H8, F4XA, F507, F5M5, F68C, F82F, F82G, F8T7, F9DC and F9DD;    Reference/Model #51014ND - Lot #'s: ELSS, EPFZ, F3H9, F82H, F82J, F8LG, FEVT and FFBC;    Reference/Model #510211ND - Lot #'s: F6JA, F82K, F82L, F8C8, F8T8, FFQN and FG4V;    Reference/Model #510241ND - Lot #'s: F5M6, F82M, F82N, F8C9 and F8T9;    Reference/Model #510311ND - Lot #'s: EPG0/1, EPG0/2, EPG0/3, EPG0/4, EPG0/5, F82P, F82Q and F8TA;    Reference/Model #510341ND - Lot #'s: F4H8, F508, F657 and F8TB
Poly Component Trial, CR, packaged in the following sizes and configurations:    a) Poly Component Trial - CR 3x10, REF 90-SRK-160310  b) Poly Component Trial - CR 3x12, REF 90-SRK-160312  c) Poly Component Trial - CR 3x14, REF 90-SRK-160314  d) Poly Component Trial - CR 4x10, REF 90-SRK-160410  e) Poly Component Trial - CR 4x12, REF 90-SRK-160412  f) Poly Component Trial - CR 4x14, REF 90-SRK-160414  g) Poly Component Trial - CR 5x10,REF 90-SRK-160510  h) Poly Component Trial - CR 5x12, REF 90-SRK-160512  i) Poly Component Trial - CR 5x14, REF 90-SRK-160514  j) Poly Component Trial - CR 6x10, REF 90-SRK-160610  k) Poly Component Trial - CR 6x12, REF 90-SRK-160612  l) Poly Component Trial - CR 6x14, REF 90-SRK-160614  The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint
The dovetails of poly trials, Beta 2.0,  were observed as either cracked or broken.
Poly Component Trial, PS, packaged in the following sizes and configurations:    a) Poly Component Trial - PS 3x10, REF 90-SRK-180310  b) Poly Component Trial - PS 3x12, REF 90-SRK-180312  c) Poly Component Trial - PS 3x14, REF 90-SRK-180314  d) Poly Component Trial - PS 4x10, REF 90-SRK-180410  e) Poly Component Trial - PS 4x12, REF 90-SRK-180412  f) Poly Component Trial - PS 4x14, REF 90-SRK-180414  g) Poly Component Trial - PS 5x10, REF 90-SRK-180510  h) Poly Component Trial - PS 5x12, REF 90-SRK-180512   i) Poly Component Trial - PS 5x14, REF 90-SRK-180514  j) Poly Component Trial - PS 6x10, REF 90-SRK-180610  k) Poly Component Trial - PS 6x12, REF 90-SRK-180612  l) Poly Component Trial - PS 6x14, REF 90-SRK-180614  The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint
Poly Component Trial, UCCS, packaged in the following sizes and configurations:    a) Poly Comp Trial - UCCS 3x10, REF 90-SRK-170310  b) Poly Comp Trial - UCCS 3x12, REF 90-SRK-170312  c) Poly Comp Trial - UCCS 3x14, REF 90-SRK-170314  d) Poly Comp Trial - UCCS 4x10, REF 90-SRK-170410  e) Poly Comp Trial - UCCS 4x12, REF 90-SRK-170412  f) Poly Comp Trial - UCCS 4x14, REF 90-SRK-170414  g) Poly Comp Trial - UCCS 5x10, REF 90-SRK-170510  h) Poly Comp Trial - UCCS 5x12, REF 90-SRK-170512  i) Poly Comp Trial - UCCS 5x14, REF 90-SRK-170514  j) Poly Comp Trial - UCCS 6x10, REF 90-SRK-170610  k) Poly Comp Trial - UCCS 6x12, REF 90-SRK-170612  l) Poly Comp Trial - UCCS 6x14, REF 90-SRK-170614  The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint
Poly Component Trial, MPCS, packaged in the following sizes and configurations:    a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310  b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310  c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312  d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312  e) Poly Component Trial - MPCS 3x14L, REF 90-SRK-192314  f) Poly Component Trial - MPCS 3x14R, REF 90-SRK-191314  g) Poly Component Trial - MPCS 4x10L, REF 90-SRK-192410  h) Poly Component Trial - MPCS 4x10R, REF 90-SRK-191410  i) Poly Component Trial - MPCS 4x12L, REF 90-SRK-192412  j) Poly Component Trial - MPCS 4x12R, REF 90-SRK-191412  k) Poly Component Trial - MPCS 4x14L, REF 90-SRK-192414  l) Poly Component Trial - MPCS 4x14R, REF 90-SRK-191414  m) Poly Component Trial - MPCS 5x10L, REF 90-SRK-192510  n) Poly Component Trial - MPCS 5x10R, REF 90-SRK-191510  o) Poly Component Trial - MPCS 5x12L, REF 90-SRK-192512  p) Poly Component Trial - MPCS 5x12R, REF 90-SRK-191512  q) Poly Component Trial - MPCS 5x14L, REF 90-SRK-192514  r) Poly Component Trial - MPCS 5x14R, REF 90-SRK-191514  s) Poly Component Trial - MPCS 6x10L, REF 90-SRK-192610  t) Poly Component Trial - MPCS 6x10R, REF 90-SRK-191610  u) Poly Component Trial - MPCS 6x12L, REF 90-SRK-192612  v) Poly Component Trial - MPCS 6x12R, REF 90-SRK-191612  w) Poly Component Trial - MPCS 6x14L, REF 90-SRK-192614  x) Poly Component Trial - MPCS 6x14R, REF 90-SRK-191614  The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint.
Distributed throughout the United States
Mevatron M2/Primus Mid-Energy  PRIMUS HI
Distributed throughout the United States.
ARTIS Q, Interventional Fluroscopic x-ray system
264 distributed worldwide (112 in the U.S.)
In Artis systems with A100G generators, a component can be affected by aging which could result in the potential failure of a module in the high-voltage generator.
US Distribution was made to medical facilities located in GA, IL, MD, MI,  MO, OH, TN, and VT.  There was no foreign/government/military distribution.
Merge Cardio software with Issuer of Patient ID (IPID).  The firm name on the label is Merge Healthcare, Hartland, WI.
11sites were originally identified as potentially having the affected versions
For sites using the Issuer of Patient ID (IPID), the system will display the study list and images from different patients with different IPIDs as though they are for the same patient if they all have the first name, last name, and medical record number in common.
Merge Cardio software.      Product Usage:  Merge Cardio is a system intended to be used to acquire, store, print, transfer, and archive clinical information including images, Hemodynamic studies and reports, measurements (via import from DICOM Structured Reporting, text files or optical character recognition of measurements captured on images) and cardiology signal (waveform) data.
89 sites potentially have the affected software
Users can merge a device import file with an image study that already has a confirmed report, which may result in including information not present at the time of physician interpretation.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood products, in which routine testing performed, interpreted or documented incorrectly,  were distributed.
Testosterone Cypionate Injection , USP, 200 mg/mL,  1 mL vial , For Intramuscular Use Only, Rx Only,  Distributed by Sun Pharma Ind. Inc., NJ 08512, Manufactured by Sun Pharma Ind. Ltd. India, NDC 62756-015-40