Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Blood product, which did not meet the acceptable product specifications, was distributed.
Blood products, collected from a donor who received a MMR vaccine prior to donation, were distributed.
Blood product, collected from a donor who traveled to potential malaria endemic areas, was distributed
Blood products, collected using a scale for which the quality control results were not documented, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
University of Miami Miller School of Medicine Tissue Bank
Nationwide, including Puerto Rico. Countries: South Korea and Greece.
Human tissue allografts, whose donor eligibilities  were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.
Human tissue allografts, whose donor eligibilities were not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.
Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed.
Volcano Male Enhancement Liquid, 2 FL OZ (60 ml) bottle, www.volcanoenhancement.com, DISTRIBUTED BY VOLCANO Long Beach, CA 90813, UPC 6 09613 85996 0.
Marketed Without An Approved NDA/ANDA: All lots of Volcano Liquid and Volcano Capsules, marketed as dietary supplements, are being recalled because they were found to contain undeclared active pharmaceutical ingredients, making them unapproved new drugs.
Volcano Male Enhancement (Proprietary Formula, Pueraria lobata, Cinnamon Bark, Cuscuta, Gui, Licorice, Altractylodes, Dang Condonopsis, Dismutase, Cornus, Rubus, Deng Sen Extract, Panax Ginseng, Cordyceps Sinensis, Go Ji Extract, Superoxide Dismutase) Capsules,1500 mg, 1-count capsule packaged in a black round plastic pop top container
Diovan (valsartan) 160 mg per tablet, 7 Tablets per bottle,  Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9359-07
Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Diovan (valsartan) 320 mg per tablet, 7 Tablets per bottle,  Rx only Physician Sample Not For Sale, Manufactured by: Novartis Pharmaceuticals Corporation Suffern, NY 10901 for Novartis Pharmaceuticals Corporation East Hanover, NJ 07936, NDC # 0078-9360-07
Product code: 704414; Lot Number: F1027; Exp 2/28/2014
Exforge (amlodipine and valsartan Tablets) 5/160 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale.  Manufactured by: Novartis Pharma Stein AG Stein, Switzerland.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9488-07
Exforge (amlodipine and valsartan Tablets) 5/320 mg, Rx only 7 tablets per bottle, Physician Sample - Not For Sale.  Manufactured by: Novartis Pharma Stein AG Stein, Switzerland.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 - NDC # 0078-9490-07
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 10/320/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9563-89
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/12.5 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9559-89
Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9560-89
Exforge (amlodipine and valsartan Tablets) 10/160 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9489-07
Exforge (amlodipine and valsartan, Tablets) 10/320 mg, Rx only, 7 tablets per bottle, Physician Sample - Not For Sale. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9491-07
Lescol XL (fluvastatin sodium) Extended-Release Tablets, 80 mg per tablet, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only. Manufactured by: Novartis Pharma Stein AG Stein, Switzerland.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9354-07
Product code: 707136; Lot Number: F0017, Exp 01/31/2015
Stalevo (carbidopa, levodopa, and entacapone) 12.5/50/200 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only,  Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9407-01
Product code: 707156; Lot Number: F0012, Exp 02/28/2014
Tekturna (aliskiren) Tablets 150 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only.  Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9485-07
Tekturna (aliskiren) Tablets 300 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only.  Manufactured by: Novartis Pharma Produktions GmbH Wehr, Germany.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9486-07
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 150/12.5 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only, Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936 , NDC # 0078-9521-89
Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photo curing agent used in inks on shrink-wrap sleeves.
Tekturna HCT (aliskiren and hydrochlorothiazide) Tablets 300/25 mg, 7 tablets per bottle, Physician Sample-Not For Sale, Rx only,  Manufactured by: Novartis Pharma Productions GmbH Wehr, Germany.  Distributed by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC # 0078-9524-89
Ethambutol Hydrochloride Tablets USP, 400 mg, 100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-281-01, UPC 3 68180 28101 6.
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
American Red Cross Blood Services Tennessee Valley Region
Blood component, prepared from Whole Blood that was centrifuged at room temperature, was distributed.
Blood product, manufactured from a unit of Whole Blood designated as a low volume collection, was distributed.
Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Sugar free cake: Carrot flavor, Package size: 4 oz, 12 oz.
Lack of phenylketonuric warning in products containing aspartame.
Sliced Sugar free cake: almond flavor with cinnamon. Package size: 16 oz each.
Lack of phenylketonuric warning. The main ingredient ''Sugar Free RichCreme Base' contains aspartame.
Sugar free cake: Vanilla flavor. Package size: 4 oz, 12 oz; Sliced Sugar-free cake: Vanilla flavor 16 oz.
Sugar free cake: Pistachio flavor. Package size: 4 oz, 12 oz
Sugar free cake: Corn. Package size: 4 oz, 12 oz
Sugar free cake: Almond flavor. Package size:12 oz
Blood product, with unacceptably high platelet count, was distributed.
Blood product, collected from a donor who received a body piercing within 12 months of donating, was distributed.
Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.
Synthes Trochanteric Fixation Nail    As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.
Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.
Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NY, PA, SD, TX, UT, VA, and WA and  countries of: Canada and EMEA.
Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA.   Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.
3,560 units distributed from June 2004 - December 2012
Hospira has recieved reports that the vacuum needed to create suction with the 1L Receptal System cannot be achieved due to the canister and liner not properly seating.
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
American National Red Cross (The) - North Central Region
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only.  Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1.  Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532.  NDC 51672-1351-8.
Vitacost Mega Spectrum Enzyme, packaged with 180 Vegetarian Capsules, UPC Code: 84419701519. Manufactured for Vitacost Lexington, NC 27295
796,800 total capsules for all varieties
Nature's Value Inc. has recalled two Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent.
Digestive Enzyme Complex/Enzyme Formula Caps, Quantity:13M, Product #: IB286, product is packaged in bulk form.  Manufactured For: Indiana Botanic.  Manufactured by Nature's Value Inc. 468 Mill Road, Coram, NY 11727, Telephone: 631-846-2500.
Vitacost Super Daily Enzymes 500 mg caps, product is packaged in a plastic bottle with 240 capsules per bottle, UPC Code: 844197017164.  Manufactured for Vitacost Lexington, NC 27295.
Nature's Value Inc. has recalled three Dietary Supplements due to the presence of Chloramphenicol, an antimicrobial agent.
Worldwide Distribution - USA Nationwide and countries of: Austria, Germany, Japan, and Taiwan.
Aesculap GNI161 Bipolar Foot Control   Product Usage:  The Aesculap Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery.
all GN161's distributed between 4/28/2009 and 5/22/2013.
Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Price Chopper stores located in CT, VT and NY
1) 8'' Coconut Custard Pie, Net Wt 22 oz (1 lb 6oz), UPC numbers 4173523721 and 4173522453, 2) 10'' Coconut Custard Pie, Net Wt 42 oz (2 lb 10oz), UPC number 4173523713
36 pies sold to customers (2 pies were quarantined in store)
Products lack an ingredient statement - undeclared eggs, tree nuts, milk, wheat and soy.
Worldwide Distribution - USA (nationwide) Canada and Mexico
Synthes TomoFix Plates   The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.
A labeling correction was initiated related to the Surgical Technique Guide J5606-C ''TomoFix Osteotomy System'' due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present.
Human tissue allograft, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, was distributed.
Human allograft, recovered from a donor who may have participated in high risk behavior, was distributed.
Worldwide Distribution - USA (Nationwide) and Internationally to Australia, Brazil, Canada, China, Ireland, New Zealand, Singapore, and Thailand.
Arrow Transradial Artery Access products   Arrow Transradial Artery Access products are used for percutaneous introduction of devices into the radial artery for diagnostic and therapeutic purposes.
There is a risk that the introducer needles packaged within the kits can be partially or fully occluded, which can cause delayed treatment or an adverse event when used on a patient.
International Distribution to Canada and Switzerland only.
Digital Pathology System (DPS) Software version 1.1   The Omnyx'' Integrated Digital Pathology system, which consists of a whole slide scanner and associated software applications, is a scanning, receiving, storing, managing, annotating and computer monitor viewing system for digital whole slide images. Omnyx'' products are for in vitro diagnostic use for specific clinical applications, and are intended for research use only on other applications. Specific clinical use applications are indicated in separate clinical specific user guides supplied by Omnyx.
There is an issue associated with Digital Pathology System (DPS) Software, in which the annotation tools within the DPS version 1.1 Image Viewer will display incorrect measurements and area calculations for a region of interest on a scanned slide, under certain conditions.
Garden-Fresh German Potato Salad, UPC 0 11596 14017 9, 16 oz, product code 4017 Code Date 9/25/2013 - 9/30/2013
Garden-Fresh Foods is recalling various ready-to-eat salads, slaw, and dip products sold under various brands and codes because they may be contaminated with Listeria monocytogenes.
Market Pantry Macaroni Salad, UPC 0 85239 24105 9, 16 oz, Product Code 24105. Weis Original Macaroni Salad, UPC 0 41497 05839 6, 16 oz, Product Code 5839. Spartan Macaroni Salad, UPC 0 11213 90321 7, 16 oz, Product Code 4073. Grandpa's Macaroni Salad, UPC 0 11596 14066 7, 16 oz, Product Code 4066. Finest Traditions Macaroni Salad, UPC 7 33147 00018 2, 16 oz, Product Code 38856. 9 Market Pantry Macaroni Salad, UPC 0 85239 24101 1, 3 lb. , Product Code 24101. Weis Original Macaroni Salad, UPC 0 41497 05904 1, 3 lb. Product Code 05904. Weis Original Macaroni Salad, UPC 0 11596 52106 0, 2/5 lb., Product Code 2106. Dairy Fresh Macaroni Salad, UPC 0 70163 56415 2, 2/5 lb. , Product Code 407364. Family Style Macaroni Salad, UPC 0 11596 52060 5, 2/5 lb., Product code 2060. Garden-Fresh Macaroni Salad, UPC 0 11596 34305 1, 3 lb., Product Code 4305. Garden-Fresh Macaroni Salad, UPC 0 11596 52005 6, 2/5 lb., Product Code 2005. Spoon River Signature Macaroni Salad, UPC 0 11596 55690 1, 2/5 lb., Product Code 5690.
Market Pantry Mustard Potato Salad , UPC 0 85329 24104 2, 16 oz, Product Code 24104. Garden-Fresh Mustard Potato Salad, UPC 0 11596 14010 0, 16 oz, Product Code 4010. Spartan Mustard Potato Salad, UPC 0 11213 90319 4, 16 oz, Product Code 4071. Garden-Fresh Mustard Potato Salad, UPC 0 11596 24215 6, 2 lb., Product Code 4215. Garden-Fresh Mustard Potato Salad , UPC 0 11596 34313 6, 3 lb., Product Code 4313. Garden-Fresh Mustard Potato Salad, UPC 0 11596 51013 2, 2/5 lb., Product Code 1013. Market Pantry Mustard Potato Salad, UPC 0 85239 24100 4, 3 lb., Product Code 24100. Dairy Fresh Mustard Potato Salad , UPC 0 70163 89090 9, 2/5 lb., Product Code
Market Pantry Reduced Fat Mustard Potato Salad, UPC 0 85329 20016 2, 16 oz, Product Code 200162
Market Pantry American Style Potato Salad, UPC 0 85239 24107 3, 16 oz, Product Code 24107. Garden-Fresh American Potato Salad, UPC 0 11596 14015 5, 16 oz, Product Code 4015. Spartan American Potato Salad, UPC 0 11213 90320 0, 16 oz, Product Code 4070. Market Pantry American Potato Salad, UPC 0 85239 24102 8, 3 lb. Product Code 24102. Garden-Fresh American Potato Salad, UPC 0 11596 24200 2, 2 lb., Product Code 4200. Garden-Fresh American Potato Salad, UPC 0 11596 34310 5, 3 lb, .Product Code 4310. Garden-Fresh American Potato Salad, UPC 0 11596 51010 1, 2/5 lb., Product Code 1010. Garden-Fresh Large Diced American Potato Salad, UPC 0 11596 91018 5, 2/5 lb., Product Code 1018
Market Pantry Reduced Fat American Potato Salad, UPC 0 85239 20115 2, 16 oz, Product Code 201152.
Archer Farms Steakhouse Potato, UPC 0 85239 40219 1, 16 oz, Product Code 402191. Archer Farms Steakhouse Potato, UPC 0 85239 40218 4, 8 oz, Product Code 402184. Grandpa's Steakhouse Potato Salad, UPC 0 11596 14068 1, 16 oz, Product Code 4068,
Grandpa's Deviled Egg Potato Salad , UPC 0 11596 14012 4, 16 oz, Product Code 4012. Grandpa's Deviled Egg Potato Salad, UPC 0 11596 51065 1, 2/5 lb., Product Code 1065. Grandpa's Deviled Egg Potato Salad, 0 00 11596 51065 1, 4/5 lb., Product Code 1068.
Grandpa's Potato Salad, UPC 0 11596 14027 8, 16 oz, Product Code 4027. Marsh Signature Potato Salad, UPC 0 11596 51085 9, 2/5 lb. , Product Code 1085. Family Style Potato Salad, UPC 0 11596 51061 3, 2/5 lb., Product Code 1061. Grandpa's Potato Salad, UPC 0 11596 24227 9, 2 lb., Product Code 4227. Grandpa's Potato Salad, UPC 0 11596 34326 6, 3 lb., Product Code 4326. Grandpa's Potato Salad, UPC 0 11596 91026 0. , 2/5 lb., Product Code 1026. Spoon River Potato Salad, UPC 0 11596 51032 3, 2/5 lb., Product Code 1032.
Grandpa's Red Skin Potato Salad, UPC 0 11596 14061 2, 16 oz, Product Code 4061. Weis Red Potato Salad, UPC 0 41497 05848 8, 16 oz, Product Code 05848. Portillo's Gourmet Red Skin Potato Salad, UPC 0 11596 14060 5, 16 oz, Product code4060. Weis Red Potato Salad, UPC 0 11596 51105 4, 2/5 lb., Product Code 1105. Grandpa's Red Skin Potato Salad, UPC 0 11596 51080 4, 2/5 lb., Product Code 1080
Finest Traditions Deluxe Potato Salad, UPC 7 33147 00007 6, 16 oz, Product Code 38768. Chef's Kitchen Deluxe Egg Salad, UPC 0 11596 52044 5, 1/5 lb., Product Code 2044. Finest Traditions Deluxe Potato Salad, UPC 7 33147 00030 4, 3 lb., Product Code 38768. Garden-Fresh Deluxe Egg Salad, UPC 0 11596 52043 8, 1/5 lb., Product Code 2043.
Finest Traditions Homestyle Potato Salad, UPC 7 33147 00019 9, 16 oz, Product Code 38860. Acme Homestyle Potato Salad, UPC 0 11596 91029 1, 2/5 lb. , Product Code 1029. Dairy Fresh Homemade Potato Salad, UPC XXXX, 2/5 lb., Product Code 410055. Finest Traditions Homestyle Potato Salad, UPC 7 33147 00031 1, 3 lb., Product Code 38980. Our Own Homestyle Potato Salad, UPC 0 11596 51042 2, 4/5 lb. , Product Code 1042
Weis Potato with Egg Salad, UPC 0 41497 05841 9, 16 oz, Product Code 05841. Weis Potato Salad with Egg, UPC 0 41497 05902 7, 3 lb., Product Code 05902. Weis Potato Salad with Egg, UPC 0 11596 51101 6, 2/5 lb., Product Code 1101
Weis Amish Potato Salad, UPC 0 41497 05845 7, 16 oz, Product Code 05845. Weis Amish Potato Salad, UPC 0 41497 05901 0, 3 lb., Product Code 05901. Weis Amish Potato Salad, UPC 0 11596 51105 4, 2/5 lb., Product Code 1103. Garden-Fresh Amish Country Potato Salad, UPC 0 11596 51005 7, 2/5 lb., Product Code 1005. 9/28/2013
Weis Original Potato Salad, UPC 0 41497 05838 9, 16 oz, Product Code 05383. Weis Original Potato Salad, UPC 0 41497 05900 3, 3 lb., Product Code 05900. 10/1/2013 - 10/10/2013 Weis Original Potato Salad, UPC 0 11596 51102 3, 2/5 lb., Product Code 1102. 10/1/2013 - 10/10/2013
Market Pantry Coleslaw, UPC 0 85239 24106 6, 15 oz, Product Code 24106. Spartan Cole Slaw, UPC 0 11213 90322 4, 16 oz, Product Code 4072. Market Pantry Coleslaw, UPC 0 85239 24114 1, 44 oz., Product Code 24114. Family Style Cole Slaw, UPC 0 11596 53060 4, 2/5 lb., Product Code 3060. Grandpa's Cole Slaw, UPC 0 11596 08006 2, 3.5 oz, Product Code 8006. Grandpa's Cole Slaw, UPC 0 11596 24237 8, 2 lb., Product Code 4325. Grandpa's Cole Slaw, UPC 0 11596 34325 9, 3 lb., Product Code 4237. Grandpa's Cole Slaw, UPC 0 11596 93021 3, 2/5 lb., Product Code 3021.
Market Pantry Reduced Fat Coleslaw, UPC 0 85239 20117 6 15 oz, Product Code 201176.
Finest Traditions Homemade-Style Cole Slaw, UPC 7 33147 00025 0, 16 oz, Product Code 38858.
Garden-Fresh Creamy Cole Slaw, UPC 0 11596 14022 3, 16 oz, Product Code 4022. Weis Creamy Coleslaw, UPC 0 41497 05906 5, 3 lb., Product Code 05906. Weis Creamy Coleslaw, UPC 0 11596 53101 4, 2/5 lb., Product Code 3101. Copperwood Kitchens Creamy Chopped Cole Slaw, UPC 8 11839 01020 3, 2/5 lb., Product Code 01020. Garden-Fresh Creamy Shredded Cole Slaw, UPC 0 11596 24203 3, 2 lb., Product Code 4203. Garden-Fresh Creamy Shredded Cole Slaw, UPC 0 11596 34309 9, 3 lb.,Product Code 4309. Garden-Fresh Creamy Shredded Cole Slaw, UPC 0 11596 93014 5, 2/5 lb., Product Code 3014.
Weis Old Fashion Cole Slaw, UPC 0 41497 05849 5, 16 oz, Product Code 05849.  Weis Old Fashion Coleslaw, UPC 0 11596 53100 7, 2/5 lb., Product Code 3100.
Market Pantry Italian Style Pasta Salad, UPC 0 85239 20119 0, 14 oz, Product Code 201190.
Market Pantry Baked Beans, UPC 0 85239 24110 3, 16 oz, Product Code 24110
Market Pantry Egg Salad, UPC 0 85239 24109 7, 12 oz., Product Code 24109, Weis Egg Salad, UPC 0 11596 55221 7, 1/5 lb., Product Code 5221. Garden-Fresh Egg Salad, UPC 0 11596 52022 3, 1/5 lb. , Product Code 2022. .
Archer Farms Artichoke Spinach Dip, UC 0 85239 99015 5, 11 oz, Product Code 99015. Archer Farms Artichoke Spinach Dip, UPC 0 85239 69053 6, 18 oz, Product Code 69053. Roundy's Artichoke Spinach Dip , UPC 0 11596 06170 2, 12 oz. Product Code 6170.
Archer Farms Smoked Salmon Dip , UPC 0 85239 99019 3, 11 oz, Product Code 99019
Archer Farms Bacon Parmesan Dip, UPC 0 85239 99017 9, 11 oz, Product Code 99017.
Archer Farms Spinach Dip, UPC 0 85239 69052 9, 11 oz, Product Code 99010. Archer Farms Spinach Dip, UPC 0 85239 69053 6, 18 oz, Product Code 69052. Finest Traditions Spinach Dip, UPC 7 33147 10538 2, 8 oz. Product Code 38992.  Our Own Spinach Dip, UPC 0 11596 55149 4, 1/5 lb., Product Code 5149
Archer Farms Feta & Roasted Red Pepper Dip, UPC 0 85239 69048 2, 11 oz, Product Code 69048
Archer Farms Vanilla Crme Dip, UPC 0 85239 99014 8, 12 oz, Product Code 99014.
Roundy's Taco Dip, UPC 0 11150 52604 3, 12 oz , Product Code 52604. Maggie's Taco Dip, UPC 0 11596 06201 3, 12 oz , Product Code 6201. Finest Traditions Taco Dip, UPC 7 33147 10556 6. 8 oz, Product Code 38984.
Roundy's Dill Dip, UPC 0 11150 52603 6, 12 oz, Product Code 52603. Finest Traditions Dill Dip, UPC 7 33147 10554 2, 8 oz, Product Code 38988
Maggie's White Fruit Dip, UPC 0 11596 06200 6, 12 oz, Product Code 6200.
Fresh Salsa Serrano Spicy, UPC 0 11596 06143 6, 15 oz, Product Code 6143
Finest Traditions Southwest Dip, UPC 7 33147 10540 5, 8 oz , Product Code 38996
Finest Traditions Smoky Baked Beans,UPC 7 33147 00161 5, 16 oz, Product Code 38854
Chef's Kitchen Cucumber Dill Dip, UPC 0 11596 06180 1, 12 oz, Product Code 6180
Dairy Fresh Deluxe BLT Pasta Salad, UPC 0 70163 50074 7, 1/5 lb, Product Code .410074. Garden-Fresh Deluxe BLT Pasta Salad, UPC 0 11596 52039 1, 1/5 lb., Product Code 2039.
Dairy Fresh Homemade Dixie Cole Slaw, UPC 0 70163 55890 8, 2/5 lb., Product Code 405890. 9/30/2013 - 10/6/2013
Dairy Fresh Homemade Mustard Potato Salad, UPC 0 70163 56700 9, 2/5 lb., Product Code 410059.  Our Own Homestyle Mustard Potato Salad, UPC 0 11596 51047 7, 4/5 lb., Product Code 1047.
Dairy Fresh Sour Cream Mac & Cheddar, UPC 0 70163 50043 3, 2/5 lb., Product Code 410043. Garden-Fresh Sour Cream Mac & Cheddar, UPC 0 11596 92031 3, 2/5 lb. , Product Code 2031.
Archer Farms Broccoli Bacon Toss Kit, UPC 0 85239 24105 9, 2/2.35 lb., Product Code 040409
Garden-Fresh Amish Country Cole Slaw, UPC 0 11596 53010 9, 2/5 lb., Product Code 3010.
Rogge's White Potato Salad, UPC 0 11596 51052 1, 2/5 lb. , Product Code 1052.
Old Tyme Sweet Bow Tie Pasta with Bacon, UPC 0 94776 03409 3, 1/5 lb., Product Code 03409. Garden-Fresh Sweet Bow Tie Pasta with Bacon, UPC 0 11 11596 52047 2, 1/5 lb., Product Code 2047. 9/30/2013 - 10/9/2013
Market Pantry Tuna Salad, UPC 0 85239 24108 0, 12 oz., Product Code 24108. Weis Tuna Salad, UPC 0 41497 05345 2, 6 x 8 oz, Product Code 05345
Finest Traditions Tuna Salad Spread, UPC 7 33147 10487 3 6 x 12 oz. Product code 38622.
Market Pantry Reduced Fat Macaroni Salad, UPC 0 85239 20118 3, 16 oz, product code 201183.
Archer Farms Garlic Herb Cheese Dip, no UPC, 7 oz, Product code 6186
Weis Amish Macaroni Salad, UPC 0 41497 05844 0, 16 oz, Product Code 05844. Weis Amish Macaroni Salad, UPC 0 41497 05905 8, 3 lb. Product Code 05905. Weis Amish Macaroni Salad, UPC 0 11596 52105 3, 2/5 lb., Product Code 2105.  Garden-Fresh Amish Country Macaroni Salad, UPC 0 11596 52010 0, 2/5 lb., Product Code 2010
Grandpa's German Potato Salad, 16 oz, UPC 0 11596 14016 2, product code 4016.
Garden-Fresh Country Style Potato Salad, UPC 0 11596 51075 0, 2/5 lb., Product Code 1075. 10/10/2013
Garden-Fresh Broccoli Cheese Salad Base, UPC 0 11596 55136 4, 1/5.25 lb., Product Code 5136. 9/30/2013 - 10/4/2013
Garden-Fresh Foods Broccoli Cheese Salad Kit, UPC 0 11596 93038 1, 1/11.25 lb., Product Code 3038. 9/30/2013
Garden-Fresh Chopped Broccoli Cauliflower Salad Base, UPC 0 11596 55188 3, 1/5.25 lb., Product Code 5188. 10/1/2013 - 10/14/2013
Garden-Fresh Foods Chopped Broccoli Cauliflower Salad Kit , UPC 0 11596 93046 6, 1/11.25 lb., Product Code 3046. 10/2/2013
Garden-Fresh Creamy Cole Slaw Dressing, UPC 0 11596 43200 7, 4/2 lb., Product Code 3200. 10/26/2013 - 11/2/2013
Garden-Fresh Dixie Style Cole Slaw, UPC 0 11596 93007 7, 2/5 lb., Product Code 3007. 9/30/2013 - 10/10/2013
Garden-Fresh Gourmet Dill Potato Salad, UPC 0 11596 55137 1, 2/5 lb., Product Code 5137. 10/4/2013
Garden-Fresh Greek Style Pasta Salad, UPC 0 11596 52035 3, 1/5 lb., Product Code 2035. 9/30/2013 - 10/8/2013
Garden-Fresh Seven Layer Salad Kit, UPC 0 11596 85161 7, 2/3.25 lb., Product Code 5161. 10/11/2013
Garden-Fresh Sour Cream Mac & Cheddar, UPC 0 11596 92031 3, 2/5 lb, Product Code 2031. 10/1/2013 - 10/10/2013
Garden-Fresh Taco Pasta Salad, UPC 0 11596 52076 6, 1/5 lb., Product Code 2076. 10/1/2013
Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969.   Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
K113004 D183642  All product codes beginning with SXPP1A.
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products collected from a donor for whom donor suitibility was not adequately determined were distributed.
Domestic distribution of the product is nationwide with direct accounts in 27 states in all geographical regions. Foreign distribution consists of direct accounts in the following countries: Canada, China, Malaysia, Norway, Slovakia, South Korea, Sweden, Taiwan, and the United Kingdom.
Houston Enzymes TriEnza with DPP IV Activity, Broad-Spectrum Enzyme Product for general Digestive Support, packaged in 90-(SKU 53379) and 180-(SKU 53380) capsule bottles. The firm name on the label is Houston Nutraceuticals, Inc. (HNI), Siloam Springs, AR (2) 9212 TRIENZA Bulk Capsules (SKU 91980) packaged in varying quantities in poly bags within corrugated containers.
54,887 bottles, and 327,139 bulk capsules
Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol
Dietary Supplement packaged in the following configuration:  (1)Nutri-Essence Digestion Super Potency Enzymes & Herbs with patent-pending CereCalase Plus, packaged in 180-(SKU 51832) capsule bottles. The firm name on the label is Enzymes, Inc., Parkville, MO  (2) Positive Changes Hypnosis Centers Enzymes Digestion Dietary Supplement packaged in 60-(SKU 53793) and 180-(SKU 53794) capsule bottles. The firm name on the bottle is Positive Changes Hypnosis Center Dublin, OH 43017
ProSol Professional Solutions Fiber Digestion Enzyme Supplement, packaged in 90-(SKU 51855) capsule bottles. The firm name on the label is Enzymes, Inc., Kansas City, MO
Advanced Formula, CarbohydrEnz, packaged in 60-(SKU 52083) capsule bottles. The firm name on the label is Enzymes, Inc., Parkville, MO
3989 Bulk TPP TEC DIGEST powder, Transformation Enzyme Corporat, packaged in varying quantities in poly bags within corrugated containers. SKU 81814
Dietary Supplements packaged in the following configurations:  (1)Transformation Professional Protocol Digest Enzyme Supplement, Packaged in 45-(SKU 54646), 60-(SKU 52413), 90-(SKU 52520), 120-(SKU 53098) capsule bottles. The firm name on the label is Transformation Enzyme Corp. Houston, TX;  (2) 3989V TEC-TPP DIGEST UNL 60' unlabeled 60-(SKU 53571) capsule bottles;  (3) Transformation Digest. Packaged in 60-(SKU 54599) capsule bottles. Russian label;  (4) Anti-aging Nutrition Health Graph Professional Strength Digest Enzyme Supplement. Packaged in 120-(SKU 54752) bottles. The firm name on the label is Health Graph, Glenview, IL;  (5) The Lohad Center for Anti-Aging Digest Enzyme Supplement. Packaged in 90-(SKU 54914) capsules bottles. The firm name on the label is The Lohad Center, Jacksonville, FL.  (6) Bulk 3989V TPP-TEC Digest Conv Pa capsules (SKU 92494) packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
enzyme essentials, OxiCellZyme, Enzyme Supplement with Herbs, packaged in 90-(SKU 54929) and 180-(SKU 52270) capsule bottles.
WELLZYMES, Digestive Health, Enzyme Supplement  packaged in 60-(SKU 52235) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO
WELLZYMES, Gastric Ease, Enzyme Supplement  packaged in 60-(SKU 52238) capsule bottles. Manufactured exclusively for enzymes, inc. Kansas City, MO
4764 Higher Nature Supergest, Bulk Capsules, packaged in varying quantities in poly bags placed inside fiber drums for foreign export.
Applied Health, Solutions for Life, Foundation Blue-Green Algae, Detoxify and Regenerate Energy and Immune Booster, Daily Essential Nutrients packaged in 90-capsule bottles (SKU 53623). Firm name on the label is Applied Health Solutions, Scottsdale, AZ.
Dietary Supplements packaged in the following configurations:  (1) Houston Enzymes, No-Fenol, Multi-Enzyme Product for Digestion of Phenolic Foods and Fiber packaged in 90-capsule bottles (SKU 52437). Firm name on the label is Houston Nutraceuticals, Inc. (HNI), Siloam, AR;  (2) 5327 Houston NO-FENOL blk 1v, Bulk Capsules (SKU 91456)
Dietary Supplement packaged in the following configurations:  (1) 5357 NWC UltraEnzSup 90' packaged in 90 count capsule unlabeled bottles (SKU 50027);  (2) 5357 NWC UltraEnzSup UNL 200 packaged in 200 count capsule unlabeled bottles (SKU 50028);  (3) NWC Naturals Ultra Enzyme Support packaged in 200-(SKU 52466) and 90-(SKU 52467) count capsule bottles. Manufactured exclusively for Natural Wellness Centers of America, Laguna Hills, CA.
Dietary Supplement packaged in the following configurations:  (1) KIRKMAN, Enzym-Complete / DPP-IV, Broad Spectrum Digestion Formula with Dipeptidyl Peptidase IV Analog, packaged in 60-capsule bottles (SKU 52587), 120-capsule bottles (SKU 52588), and 200-capsule bottles (SKU 53853). Manufactured exclusively for KIRKMAN, Lake Oswego, OR;  (2) KIRKMAN, EnZym-Complete / DPP-IV, GF/CF Enzyme Dietary Supplement, packaged in 200-capsule bottles (SKU 54956). Manufactured exclusively for KIRKMAN, Lake Oswego, OR;
NWC Naturals, Daily Cal, packaged in 200-capsule bottles (SKU 53343). Manufactured exclusively for Natural Wellness Centers of American, Inc. Laguna Hills, CA.;
WELLZYMES, Protein/Fat Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52643). Manufactured exclusively for enzymes, inc., Kansas City, MO.
Dietary Supplement packaged in the following configurations:  (1) WELLZYMES, Carbohydrate Digestion, Enzyme Supplement packaged in 90-capsule bottles (SKU 52644). Manufactured exclusively for enzymes, inc., Parkville, MO.;  (2) 6306 WellZymes CarboDigest U, packaged in 90-capsule, unlabeled bottles (SKU 54799);
Dietary Supplement packaged in the following configurations:  (1) KIRKMAN Phenol Assist, packaged in 90-capsule bottles (SKU 52640). Manufactured exclusively for Kirkman, Lake Oswego, OR.;  (2) 6379 Kirk Phenol Assist UNL, packaged in 90-capsule unlabeled bottles (SKU 53855)
Dietary Supplements packaged in the following configurations:  (1) Healthy Reflections, Amylase Amylolytic Enzymes Dietary Supplement, packaged in 90-capsule bottles (SKU 52896). Firm name on the label is Healthy Reflections a division of Healthy Alternatives, Garfield, MN;  (2) 6895 Hlthy Alternatives Amyl, packaged in 90-capsule unlabeled bottles (SKU 54328)
Dietary Supplements packaged in the following configurations:  (1) Bulk 6916 Shanghai DigestiveBlend powder, packaged in varying quantities in poly bags within fiber drums (SKU 83274);  (2) Bulk 6916 WEDAR DIGESTIVEBLEND powder, packaged in varying quantities in poly bags within fiber drums (SKU 82426);
Dietary Supplements packaged in the following configurations:  (1) 7 Lights, FULL SPECTRUM ENZYMES, packaged in 90 capsule bottles (SKU 52785). Firm name on the label is 7 Lights, Black Mountain, NC;  (2) 6926 Crusador TempleBuilders, packaged in unlabeled 90 capsule bottles (SKU 54335);
Dietary Supplements packaged in the following configurations:  (1) 7263 Kirk Enz-Comp-W-TG UNL, packaged in unlabeled, 90-capsule bottles (SKU 52939);  (2) 7263 Kirk Enz-Comp-W-TG UNL2, packaged in unlabeled 180-capsule bottles (SKU 53852);
Bulk 7775 GreenPlanet Enzymeblend Powder packaged in poly bags within fiber drums (SKU 82566)
8532 Kirkman MaxEnzComp w/DP packaged in unlabeled 120-capsule bottles (SKU 53854)
Bulk 877 HOLISTIC DIGESTIVE MULTI packaged in poly bags within fiber drums (SKU 90461)
Dietary Supplements packaged in the following configurations:  (1) Natural Health Industries, Opti-Zyme HP, packaged in 90-capsule bottles (SKU 54654). Firm name on the label is Natural Health Industries, Clarmonte, CA;  (2) 8974 Enzymes Inc Natural Hea, packaged in unlabeled, 90-capsule bottles (SKU 54756);
Northern Nutrition, Pro-3-Zyme, packaged in 180-capsule bottles (SKU 53373). Firm name on the label is Northern Nutrition, LLC, Shipshewana, IN;
Bulk 9245 YOGIHOUSE DIGESTIVE BUL powder, packaged in poly bags within corrugated containers (SKU 82993);
9326 Kirkman Bacterial Bio 6, packaged in unlabeled 60-capsule bottles (SKU 53666);
Bulk 9399 OceanwideUSA DIGESTENZY capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92033);
Bulk 9414 PROTHERA CANDIDACHLOREL powder, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83056);
Bulk 9665 BioSan Labs Hi Potency capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92093);
DigestEasy, Hypoallergenic Enzyme Supplement, packaged in 60-capsule bottles (SKU 53557). Firm name on the label is Master The Body, Joliet, IL
Bulk 9730 BIOSANLABS GLUTENEZYME capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).
Bulk 9809 ENZYMEDICA CARBGESTKOSH capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92103).
Bulk 9835 ENZYMEDICA DIGESTBASICK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92085).
Bulk 9843 NOW Digest Platinum BLK capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92101).
Bulk 9896 BIOMEDICALRESEARCH DIGE capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92115).
Bulk A036 Threshold Ess Enz Ultra capsules, packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92131).
NWC Naturals, Total-Nutrition Program, Dietary Supplement with L.E.A.D.S., packaged 270-capsule bottles (SKU 92131). Firm name on the label is Natural Wellness Centers of America, Inc., Laguna Hills, CA;
Bulk A123 ORTHOMOLECULAR DIGESTIV powder (SKU 83202), packaged in poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Bulk A164 NUTRACHOICE DIGESTIVEBL powder (SKU 83196), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Dietary Supplement Formula ID A200;  Packaged in the following configuration: Bulk A200 Nutr Provider Comp Dige capsules (SKU 92132), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Bulk A213 Phion Complete Digestiv capsules (SKU 92123), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Bulk A216 MRM DPPIV DIGEST BULK powder (SKU 83217), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Bulk A322 Houston Chewable Enzyme powder (SKU 83226), packaged in varying quantities within poly bags in corrugated boxes (for domestic distribution) or fiber drums (for international distribution)
Mountain States Health Products, Inc., Gluten & Dairy Digest, Enzyme Supplement packaged in 90-capsule bottles (SKU 53830). Firm name on the label is Mountain States Health Products, Inc., Lyons, CO;
Bulk A776 Healthline Nutri Pet Di powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83287);
Bulk A957 Nutra Med Digestive Bul powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83318);
Bulk A977 Wedar Digestive Blend 2 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83314);
Dietary Supplements packaged in the following configuration:  (1) Competitive Nutrition, Healthy Digest, packaged in 90-capsule bottles (SKU 83314). Firm name on the label is Competitive Nutrition, Monaca, PA;  (2) New Earthlings Nutritionals, Healthy Digest, Complete Digestive Enzyme Formula packaged in 90-capsule bottles (SKU 54626). Firm name on the label is Guest Chiropractic Clinic, Inman, SC;  (3) Doctor Faz, Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54555). Firm name on the bottle is National Enzyme Company, Forsyth, MO;  (4) Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54784). Firm name on the bottle is Natural Solutions 101, Walnut Shade, MO;  (5) NEC, Healthy Digest, Full Spectrum Digestion, packaged in 90-capsule bottles (SKU 54169). Firm name on the label is National Enzyme Company, Forsyth, MO;  (6) Solutions Rx, DIGESTIVE WELLNESS, COMPLETE DIGESTIVE ENZYME FORMULA, packaged in 90-capsule bottles (SKU 54608). Firm name on the bottle is Pharmacy & Healthcare Solutions, Saltillo, MS;  (7) The Essentials, Ultra Professional, Digestive Essentials, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54512). Firm name on the label is Ask The Pharmacist, Oakmont, PA;  (8) FeelIt Healthy Digest, Complete Digestive Enzyme Formula, packaged in 90-capsule bottles (SKU 54872). Firm name on the label is Victory International Group, Irvine, CA;
Dietary Supplements packaged in the following configuration:  (1) NEC Healthy Pre Menopausal, Feminine Support for Active Women, packaged in 60-capsule bottles (SKU 54389). Firm name on the label is National Enzyme Company, Forsyth, MO;  (2) Root 86, Healthy Pre Menopausal, Healthy Vitality In Active Women  packaged in 60-capsule bottles (SKU 54632). Firm name on the label is Root 86, Ridgedale, MO;
Bulk B199 Reviva Digestion Bulk powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83342).
Dietary Supplements packaged in the following configurations:  (1) Bulk B341 Shanghai Actizyme Tab6 tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92275);  (2) ActiFIT, Actizyme, Digest Miracle, packaged in 60-tablet bottles (SKU 54955). Firm name on the label is ActiFit Biotechnology Co, Bellevue, WA.
TriEnza Powder with DPP IV Activity, packaged 105 gram bottles (SKU 54045). Firm name on the label is Houston Nutraceuticals, Inc., (HNI), Siloam Springs, AR;
Bulk B807 True Botanica Digestive, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83377);
Dietary Supplement Formula ID B859;  Packaged in the following configuration:   B859 Kirkman Enz Comp DPP-IV, packaged in unlabeled, 90-count bottles (SKU 54112);
Bulk B910 Houston Nutr TriEnz Bu powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83381);
B911 Kirkman Max Spectrum E, packaged unlabeled, 90-capsule bottles (SKU 54255);
Bulk B983 Vitamin Shoppe Advnaced powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83408);
IMTWellnes, Legume Digest 2.0, packaged 120-capsule bottles (SKU 54179). Firm name on the label is ANAT, LLC, Bloomfield, CT;
IMTWellnes, Tribulus Supreme 2.0, GI & Immune Support, packaged 60-capsule bottles (SKU 54217). Firm name on the label is ANAT, LLC, Bloomfield, CT;
Bulk C012 BioSan Enzyme Blend 3 O capsules,packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92438);
Bulk C184 Ace Health Enzyme Blend powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83403);
Multi Plant Enzyme Tablets, packaged 60 tablet bottles(SKU 54451). Firm name on the label is Wedar Nutrasource Inc., Hacienda Height, CA;
Dietary Supplements packaged in the following configurations:  (1) Heryben, Eumin Integrated Plant Enzymes, packaged 60 capsule bottles(SKU 54440). Firm name on the label is ActiFit Biotechnology, Bellevue, WA;  (2) Bulk C269 Shanghai Digestive Blen capsules, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92473);
Bulk C434 Shanghai Enzyme Blend B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83419);
Enzyme - Travnie Extra, Formula C500, packaged in 30-capsule bottles (SKU 54513). Firm name on the label is National Enzyme Company;
Bulk C542 Vitakost Low Carb Diet, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92544);
Dietary Supplements packaged in the following configurations:  (1) Carbo Converter-I powder, packaged 25 gram bottles (SKU 54663). Firm name on the label is National Enzyme Company, Forsyth, MO;  (2) C560 NEC Carb Converter Blen packaged in unlabeled, 25 gram bottles.
Cellulase Cellulolytic Enzymes, packaged 100-capsule bottles (SKU 54553). Firm name on the label is Healthy Reflections, Garfield, MN;
Healthy Reflections, Colon Health Support, packaged 120-capsule bottles (SKU 54554). Firm name on the label is Healthy Reflections, Garfield, MN;
Dietary Supplements packaged in the following configurations:  (1) No-Fenol Chewable, Multi-Enzyme Product for Digestion of Phenolic Foods and Fibers, packaged 180-chewable tablets bottles (SKU 54651). Firm name on the label is Houston Nutraceutical Inc. (HNI), Siloam, AR;  (2) Bulk C613 Houston No-Fenol Bulk powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83451);  (3) Bulk C613 Houston No-Fenol Chew T chewable tablets, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 92566);
594 bottles, 0.23 kg of powder, and 20,580 bulk capsules
Bulk C665 powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 7256000)
Bulk C676 BnG Global Digestive Blend powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83430)
Bulk C812 ZoiVi Digestive Formula powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83438)
PerformanceZyme, packaged 250-capsule bottles (SKU 54825) and 120-capsule bottles (SKU 54826). Norwegian label;
Healthy Alternatives, Digestion & Stomach Upset Support, packaged 90-capsule bottles (SKU 54897). Firm name on the label is Health Enhancement, Inc. Grass Valley, CA;
Bulk D008 Glykon Tech Digestive B powder, packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83453)
Bulk D103 Life Tree Digestive Ble powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 83466).
Dietary Supplements packaged in the following configurations:  (1) Bulk Isolase-I powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 71453);  (2) Bulk Bision Isolase powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72073);  (3) Bulk Isolase (Shanghai) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72077);  (4) Bulk Isolase (Wedar) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72080);  (5) Bulk Isolase (Nutri Sport) powder packaged in varying quantities within poly bags within corrugated boxes (for domestic distribution) or fiber drums (for international distribution) (SKU 72106);
Distribution was made to NE.  There was not foreign or military distribution.
Hubbard Grolean 16% B91Aureo 140+Vit A, medicated, contains Lasalocid, 91g/ton and Chlortetracycline 140 g/ton, vitamin A, vitamin D, and vitamin E, packaged in 50 lb/bags. Hubbard Feeds Inc., Mankato, MN.
The product is being recalled because a routine sample analyzed by the Nebraska Department of Agriculture was found to contain Oxytetracycline.
Worldwide Distribution - USA (nationwide) and Internationally to Canada
Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA   The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin.
Worldwide Distribution - USA (nationwide) including the states of CA, IN, OH, GA, WI, IA, NE, NJ, PA, NY, MD, NC, AZ, NM, TX, CO, IL, AL, MI, WA, FL and KS, and the countries of  China, Japan and Taiwan.
NexGen Complete Knee Solutions Stemmed Tibial Component Precoat   NexGen Tibial Baseplates are part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis. The device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis; Collagen disorders, and/or avascular necrosis of the femoral condyle; Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; Moderate valgus, varus, or flexion deformities.
Two complaints were received in which it was reported that the stem would not lock into the tibia.  Evaluation of the returned device found that the stemmed portion of the tibial plate would not hold the stem as the connection was too loose. The taper diameter was found to be oversized by .010.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, Finland, Germany, and Italy.
Zimmer Trabecular Metal Total Ankle Talar Component Left Sizes 1-6   Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: '' Rheumatoid arthritis. '' Post-traumatic arthritis. '' Degenerative arthritis. This device is intended for cemented use only.
As part of routine manufacturing process monitoring by Zimmer, it was discovered that the Tibial Base and Talar Components from the Total Ankle system have the potential of containing elevated levels of manufacturing materials residue on the implants.  The specific material was found to be mass media utilized during the manufacturing process to provide the uniform surface finish.  This mass media is comprised of aluminum oxide and a polyester resin binder.
Zimmer Trabecular Metal Total Ankle Talar Component Right Sizes 1-6   Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: '' Rheumatoid arthritis. '' Post-traumatic arthritis. '' Degenerative arthritis. This device is intended for cemented use only.
Zimmer Trabecular Metal Total Ankle Tibial Base Component  Sizes 1-6   Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer Trabecular Metal Total Ankle is indicated as a total ankle replacement in primary or revision surgery for patients with: '' Rheumatoid arthritis. '' Post-traumatic arthritis. '' Degenerative arthritis. This device is intended for cemented use only.
390 units (US) 129 units (outside of US)
Misbranded red blood cell was distributed.
Nationwide Distribution including states: AL, GA, IL, and WA.
1) Accolade II 127 Neck Angle Hip Stem, Size # 3 2) Accolade II 127 Neck Angle Hip Stem, Size #5    Howmedica Osteonics Corp.  325 Corporate Drive  Mahwah, NJ 07430 USA    Telephone # +1 201-831-5000    Stryker France  ZAC Satolas Green Pusignan  Av de Satolas Green  69881 MEYZIEU Cedex France    Intended for cementless application in total or hemiarthroplasty procedures.
510K K120578   Accolade II I27 Neck Angle Hip Stem, Size # 3  Catalog No.# 6721-0330 Lot Code #44416307    Accolade II 127 Neck Angle Hip Stem, Size #5  Catalog No. # 6721-0535 Lot Code 44564405
Stryker received a report from the field indicating that an Accolade II Hip Stem Size #3 was identified in packaging with an Accolade II Hip Stem Size #5.
US Distribution including the states of AR, CA, CO, KS, MA, MI, MO, NJ, NY, NC, OH, OK, PA, SD, TX and WA.
Helion S Exam Light or H300   The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice.
Possible fatigue failure of the plastic joint may occur after an average use of seven years.
Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05
11,496 bottles (100 count) and 62 bottles (500 count)
Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.
IVD with weakened reactivity was distributed.
Red Blood Cells, with discrepant labeled volumes, were distributed.
Worldwide Distribution - US Distribution including the states of CT, MA, OH, CA, SC, NY and OK, and the countries of International distribution (from Germany)  Poland, Germany, GB, The Netherlands, Spain, Turkey, Canada, Mexico, China, Hong Kong and Singapore.
iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator)   radiological
SW Version 3.0. Catalong Number CS10-100
The development partner of IBA informed that there is problem in a SW component used in COMPASS when converting Region of Interest (ROI) geometries to dose grid representation. Under certain conditions this problem generates too large ROI voxel volumes causing erroneous dose statistics and DVHs.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Canada, Denmark, Ecuador, Germany, India, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Peru, Singapore, South Africa, Spain, Switzerland, UAE, and UK.
NexGen Complete Knee Solution Porous Patella Drill Guide-26mm dia./10mm thickness  Non sterile, Rx Only    Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.
This is an expansion of the June 2013 recall related to NexGen Micro components due to a component compatibility issue.  Since the initiation of this recall, five (5) additional instruments have been identified that are associated only with the NexGen Micro components.  Given this, all lots of these additional instruments are now being recalled as well.   There is the potential for these devices to be inadvertently utilized during surgery and the associated implanted would not be available due to the previous recall.
NexGen Complete Knee Solution Porous Patella Drill Guide-29mm dia./10mm thickness  Non sterile, Rx Only    Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.
NexGen Complete Knee Solution CR Articular Surface Provisional-Purple 9mm Height  Nonsterile    Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.
NexGen Complete Knee Solution CR Articular Surface Provisional-Yellow 9mm Height Nonsterile    Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.
NexGen Complete Knee Solution CR Articular Surface Provisional-Striped Green 9mm Height Nonsterile    Devices are used in total knee arthroplasty and indicated for patients with severe pain and disability due to conditions such as arthritis, collagen disorders, post-traumatic loss of joint configuration, flexion deformities, and in revision of previous surgical attempts.
Distribution was made to a distribution center in Iowa.
HyVee Chocolate Caramel Clusters, packaged in 9-oz. clear plastic clamshell containers (UPC 077232125153), 16 containers/case (UPC 10077232125150).  The firm name on the label is HyVee, West Des Moines, IA.
Chocolate caramel clusters containing peanuts were  mislabeled as chocolate covered caramels, which do not contain peanuts.
HyVee Chocolate Covered Caramels, packaged in 12-oz. clear plastic clamshell containers (UPC 077232125207), 16 containers/case (UPC 10077232125204).  The firm name on the label is HyVee, West Des Moines, IA.
Unlicensed blood products were distributed in interstate commerce.
Nationwide Distribution including states of: TX, PA, and NY.
Axillent Debakey Grasping Forceps, Part No. 33821DYD   In general the surgeons use 33821DYD Debakey forceps to grasp tissue.
KARL STORZ is recalling the Axillent Debakey Grasping Forceps because the 33821WTD Wavy grasper was mislabeled as 33821DYD Axillent Debakey Grasping Forceps.
Worldwide Distribtion - USA Nationwide including the countries of Algeria, Andorra, Angola, Australia, Austria, Bahrain, Bangladesh, Belgium, Bermuda, Bosnia and Herzegovina, Bulgaria, China, Colombia, Croatia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Republic of, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Pakistan, Panama, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Virgin Islands, U.S., and Zimbabwe.
Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570    Product Usage:  The Coulter LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids
Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degradation may potentially cause a delay in reporting results for nucleated red blood cells (nRBC), white blood cell differential and/or reticulocytes.
Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728    Product Usage:  Coulter LH 780 Hematology Analyzer is a is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The Coulter LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.
Micro SSP'' DNA Typing Trays, Micro SSP High Resolution HLA Class II Tray, Catalog Identification: SSP2H.    510(K) Number: BK960062
Micro SSP High Resolution HLA Class II Tray; Catalog Identification: SSP2H  Article Number: SSP_DNAT_PI Rev 18  Lot number: 005, batches 003-034
HLA typing assay, in certain instances associated with incorrect typing results, was distributed.
US Distribution including the states of GA, LA and NY.
Centurion Sterile # 84 Rubber Bands Reorder EB84,  Caution: This product contains natural rubber latex  which may cause allergic reactions.  LATEX FREE ,   CAUTION: FEDERAL lAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN  Single Use Only    bands items together and podiatry office uses bands as tourniquet on toe during in grown toenail procedure
Package labeling indicates both ''latex free''  and ''contains natural rubber latex'' . The rubber bands do contain natural rubber latex.   This could cause a significant risk to users with latex allergies.
Dawn's Vidalia Onion Dip, Net Wt. 5 lbs. (2.27 kg)
Dawn's Foods is recalling Vandellia Onion Dip due to undeclared egg.
Nationwide Distribution including  NY, PA, DC, CT, IN, NJ, AR, TX, AZ,and NM.
VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310,   10 tests/box; 690 total tests.    The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow lIb/IlIa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow lIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide.
Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information for the amount of time in which to perform the test following collection of the patient sample.  The correct instruction is to perform the test within 15 minutes of collecting the patient sample.
Misbranded venomil maintenance kits were distributed.
Worldwide Distribution - USA Nationwide in the states of: AL, AZ, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, MI, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, WY and the District of Columbia including the countries of: Brazil, Canada, Chile, Guam, Mexico, Saudi Arabia, United Arab Emirates & Venezuela.
AMSCO Evolution steam sterilizer Transfer Carriage.    Product Usage:  Mobile, wheeled transportation unit utilized to carry, load, &#38; unload the Loading Car into and out of steam sterilizer units.
The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or maneuvered incorrectly or with excessive force.
20 retail locations in the San Francisco Bay area.
Chocolate La Boulange Soft Caramel, Net WT. 8.4 oz. (238 g);  Cooked in small batches in copper pots; all natural    La Boulange   South San Francisco, CA
Firm discovered that 8.4 oz. jars of Hazelnut Jam were produced on 8/15/13 and were mislabeled as La Boulange Soft Caramel. the Hazelnut jam contains hazelnuts which were undeclared on the label.
Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp.  325 Corporate Drive  Mahwah, NJ 07430 USA    Stryker France  ZAC Satolas Green Pusignan  Av de Satolas Green 69881 Meyzieu Cedex France    Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting Stryker's Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arthroplasty (TKA) when implanting Stryker's Series 7000 Standard Tibial Tray systems. The use of bone screws, during both THA and TKA are intended as supplemental fixation.
510K # K894124 1) 6.5 mm Cancellous Bone Screw 25mm  Catalog No: 2030-6525-1  Lot code MMLNLA    2) 5.5 Cancellous Bone Screw 40 mm  Catalog No: 2029-5540-1  Lot Code MMLMJ1
Catalog Number 2030-6525-1- 4 units; Catalog No: 2029-5540-1-7 units
Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.
Trader Joe's Authentically Korean Seaweed Salad with Spicy Dressing, Net Wt. 3.5oz (99g), SKU 97677.
Jayone Foods is recalling Trader Joe's Dried Seaweed Salad with Spicy Dressing because it may contain traces of undeclared peanuts.
Phenytoin Oral Suspension USP 125mg/5mL,  50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Worldwide Distribution - USA (nationwide) and the countries of Brazil, Czech Republic, Denmark, France, Hong Kong, Italy, Middle East, Netherlands, Singapore, Switzerland, and the United Kingdom.
Vasoview Hemopro Endoscopic Vessel Harvesting System Maquet Cardiovascular LLC 45 Barbour Pond Drive Wayne, NJ 07470    Indicated for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass. It is indicated for cutting tissue and controlling bleeding through coagulation, and for patients requiring blunt dissection of tissue including dissection of blood vessels, dissection of blood vessels oft he extremities, dissection of ducts and other structures int he extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/vessel harvesting along the saphenous vein for use in coronary artery bypass grafting and peripheral artery bypass or the radial artery for use in coronary artery bypass grafting. Thorascopic procedures include exposure and dissection of structures external to the parietal pleura including nerves blood vessels and other tissues of the chest wall.
Maquet has received an increase in the number of complaints for ''self-activated/remains activated/overheats'' for the Hemopro VH-30000, ''Hemopro 1''
Worldwide Distribution - USA (nationwide)  to CA, CT, FL, GA, MO, NC, NJ, PA, TX, WI and Internationally to:   FRANCE, PORTUGAL, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BARBADOS, BELGIUM, BOLIVIA, BOSNIA 7 HERZEGOVINA, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, NEW ZEALAND, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, COTE DLVOIRE, CROATIA, CYPRUS,. CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, FINLAND, GABON, GERMANY, GREECE, GUATEMALA, HONDURAS, HUNGARIA, INDIA, INDONESIA, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LITHUANIA, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, MYAMMARA, NAMBIA, NAPAL, NETHERLANDS, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PHILIPPINES, POLAND, PORTUGAL ROMANIA, RUSSIA, SENEGAL SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SIR LANKA, SWEDEN, SWITZERLAND, THAILAND, THE NETHERLANDS, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES , UNITED KINGDOM, URUGUAY, UZEBEKISTAN, VENEZUELA, and VIETNAM.
HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B20): The PROCARE Monitor B20 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor B20 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor B20 is not intended for use during MRI. The PROCARE Monitor B20 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, EGG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for continual monitoring. Esosophageal/Nasopharyngeal/Tymnpanic/Rectal/Bladder/Axillary/Skin/Airway/Room/Myo cardial/Core/Surface temperature, and functional oxygen saturation (Sp0 2) and pulse rate via continuous monitoring , including monitoring during conditions of clinical patient motion or low perfusion. K120598 (Procare Monitor B40): The PROCARE Monitor 840 is a portable multiparameter unit to be used for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adult, pediatric, and neonatal patients in a hospital environment and during intra-hospital transport. The PROCARE Monitor 840 is intended for use under the direct supervision of a licensed health care practitioner. The PROCARE Monitor 840 is not intended for use during MRI. The PROCARE Monitor B40 monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), invasive blood pressure, end-tidal carbon dioxide, heart/pulse rate, respiration rate, ECG (including arrhythmia and ST segment analysis), temperature with a reusable or disposable electronic thermometer for cont
GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient Monitors.   The B20, B30 and B40 Patient Monitors set the ECG filter setting incorrectly if the monitor starts with impedance respiration set in the ON position. Instead of the user selected filter, an additional 0.5 Hz high pass filter is used. The additional 0.5 Hz high pass filter causes changes to the ECG waveform morphology and incorrect display of ST values. The ST-elevation measurement can be under estimated in this situation and therefore the treatment of the patient can be delayed.
SoftBank II versions: 23.1, 23.2, 25.0, 25.1, 25.2, and 25.3. When used with SoftScape GUI 1.2.0.x and 1.3.0.x
SoftBank II version 23.1; 23.2; 25.0; 25.1; 25.2 and 25.3. When used with SoftScape GUI 1.2.0.x and 1.3.0.x
Blood Bank software with a defect or glitch, was distributed.
Nationwide Distribution including UT, CA, WA, VA, OH, and TN.
Opal Orthodontics by Ultradent. Avex CX2 Ceramic Orthodontic Brackets   Avex CX2 ceramic brackets are intended for use in orthodontic treatment.
Ultradent Products Inc. is recalling various lots of Avex CX2 Orthodontic Brackets because the design control process was not complete prior to distribution.