Pressure IQ Evolve Mattress; Non-powered mattress replacement system.   Intended for patients with medium to high risk for developing pressure ulcers while on a mattress.
All Pressure IQ Evolve mattresses equipped with the 60g pods, manufactured January 2012-December 2013.
The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
AL, GA, FL, IL, IN, MA, MD, MI, NJ, NY, NV, OH, PA and VA.
TranSmart Raspberry Filled frozen unbaked cookie dough, 108/1.75 oz. units, CSM Bakery Products, 3301 Montreal Industrial Way Tucker, GA 30084..
Micro Labs Usa, Inc                                    S
Simvastatin Tablets, USP, 20mg a) 90- count bottle (42517-0020-10), b) 1000-count-bottle (NDC 42571-0020-10), Rx only,  Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,Princeton, NJ 08540
240 (1000-count bottle), 26,904 (90-count bottle)
Failed Impurities/Degradation Specifications: Product failed known Impurity specification
Simvastatin Tablets, USP, 40mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,  Princeton, NJ 08540 NDC 42571-0040-90.
Simvastatin Tablets, USP, 80mg, Rx Only, 90 count bottles, Manufactured by: Micro Labs Limited Goa-403 722, India, Manufactured for: Micro Labs USA Inc.,  Princeton, NJ 08540 NDC 42571-080-90.
Weis Veggie Chips  Net Wt. 6 oz.  Packed For Weis Markets, Inc. Sunbury, PA 17801  With code dates: 10 Dec 2014 thru 7 Apr 2015    Natures Place  Veggie chips  Net Wt. 6 oz  Distributed By: DZA Brands, LLC, Salisbury NC 28147/Scarborough, ME 04074  With code dates: 15 Dec 2014 thru 10 Apr 2014      Market Basket  Veggie Chips   Net Wt. 6 oz  Distributed by: DeMoulas Supermarkets, Inc. Tewksbury, MA 01876  With code dates: 22 Jan 2015 thru 21 Mar 2015
Firm's sodium claims of 55 g/serving is incorrect. Product analyzed and found to contain shows approx. 290 mg/serving size
Weis Veggie Sticks  Net Wt. 6 oz.  Packed For Weis Markets, Inc. Sunbury, PA 17801  With code dates: 10 Dec 2014 thru 7 Apr 2015    Natures Place  Veggie Straws  Net Wt. 6 oz  Distributed By: DZA Brands, LLC, Salisbury NC 28147/Scarborough, ME 04074  With code dates: 6 Jan 2015 thru 27 Apr 2015    Market Basket  Veggie Sticks  Net Wt. 6 oz  Distributed by: DeMoulas Supermarkets, Inc. Tewksbury, MA 01876  With code dates: 2 Oct 2014 thru 8 Dec 2014
Firm's sodium claims of 55 g/serving is incorrect. Product analyzed and found to contain shows 260 - 290 mg/serving size
PURE GROUND CUMIN, Net Weight XXX Lbs. -- FIRST SPICE MIXING COMPANY - LONG ISLAND CITY, N. Y.
Firm was notified by immediate supplier that certain lots of  ground cumin may have been contaminated with peanut protein which is not declared on the label.
EHMER COOKED ANDOUILLE SAUSAGE SEASONING (AND-119), Net Weight XXX Lbs. -- INGREDIENTS: SALT, BROWN SUGAR, SPICES, PAPRIKA, DEHYDRATED GARLIC, OLEORESIN PAPRIKA AND SPICE EXTRACTIVES.  FIRST SPICE MIXING COMPANY NEW YORK  --- The % of cumin used in the finished seasoning product is 2.6%. --- The affected lots were shipped on 8/11/14 and 10/24/14.
BLUE TORTILLA ALL-PURPOSE SEASONING R-1 (SEA-188), Net Weight XXX Lbs. -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, NEW YORK -- INGREDIENTS: SALT, HYDROLYZED SOY PROTEIN, SUGAR, SPICES, FLAVORINGS (SPICE EXTRACTIVES). ALLERGEN: CONTAINS SOY. --- The % of cumin used in the finished seasoning mix is 0.75%. The affected lots were shipped on 9/13/14, 10/30/14 and 12/16/14.
BURRITO LOCO ALL-PURPOSE SEASONING (SEA-189) -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, N.Y. --- INGREDIENTS: SALT, HYDROLYZED SOY PROTEIN, SUGAR, SPICES, FLAVORINGS (SPICE EXTRACTIVES). --- The % of cumin used in the finished seasoning mix is 0.75%. --- The affected lots were shipped on 8/6/14 and 11/4/14.
WORTHINGTON HOT SOUTHWESTERN SEASONING II- B, Net Weight 50 Lbs. -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, N. Y. --- INGREDIENTS: SPICES, ONION POWDER, GARLIC POWDER, PAPRIKA, LEMON EXTRACT. --- The % of cumin used in the finished seasoning mix is 4.0%.   --- The affected lots were shipped between 8/12/14 and 12/15/14.
ESPOSITO MILD CHORIZO (CHO-122), Net Weight XXXX Lbs. -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, N.Y. --- INGREDIENTS: SALT, PAPRIKA, SPICES, DEHYDRATED GARLIC, EXTRACT OF PAPRIKA, LESS THAN 2% PROPYLENE GLYCOL AS ANTI-CAKING AGENT.  --- The % of cumin used in the finished seasoning mix is 14.0%. --- The affected lot was shipped on 11/18/14.
GREEN CACTUS SPICY SPECIAL SEASONING (SEA-903), Net Weight XXXX Lbs. -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, N.Y. --- INGREDIENTS: SALT, SUGAR, SPICES, PAPRIKA, ONION POWDER, GARLIC POWDER, CORN STARCH, LESS THAN 2% CALCIUM SILICATE AS AN ANTI-CAKING AGENT.  --- The % of cumin used in the finished seasoning mix is 7.75%.  --- The affected lot was shipped on 9/16/14.
KARL'S HOT CHORIZO SEASONING R-1 (CH0-015), Net Weight XXXX Lbs. -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, N.Y. --- INGREDIENTS: SALT, PAPRIKA, SPICES, GARLIC POWDER, FLAVORING (SPICE EXTRACTIVES). NO MORE THAN 2% PROPYLENE GLYCOL AS ANTI-CAKING AGENT.  --- The % of cumin used in the finished seasoning mix is 13.40%.  --- The affected lots were shipped on 7/30/14 and 10/14/14.
PINATA'S ASADA SEASONING (SEA-164), Net Weight XXXX Lbs. -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, N.Y. ---  INGREDIENTS: SALT, SPICES, SUGAR, CITRIC ACID, DEHYDRATED GARLIC, PAPRIKA, NATURAL SMOKE, OIL OF LIME. --- The % of cumin used in the finished seasoning mix is 3.30%.  --- The affected lot was shipped on 10/21/14.
PINATA'S ASADA SEASONING R-1 (BBQ-140), Net Weight XXXX Lbs. -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, N.Y. --- INGREDIENTS: SALT, TURBINADO SUGAR, BROWN SUGAR, SPICES, DEHYDRATED GARLIC AND ONION, PAPRIKA. --- The % of cumin used in the finished seasoning mix is 1.70%.  --- The affected lot was shipped on 8/14/14.
RIEKER GRILL & BRATEN (SAU-048), Net Weight XXXX Lbs.  -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, N.Y. --- INGREDIENTS: SALT, SPICES, PAPRIKA, MONOSODIUM GLUTAMATE, ONION POWDER, GARLIC POWDER. --- The % of cumin used in the finished seasoning mix is 0.50%. --- The affected lot was shipped on 10/21/14.
SALSA PICA ASADA (SEA-268), Net Weight XXXX Lbs. -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, N.Y.  --- INGREDIENTS: SALT, SPICES, SUGAR, PAPRIKA, CITRIC ACID, GARLIC POWDER, DEHYDRATED ONION. --- The % of cumin used in the finished seasoning mix is 4.50%. --- The affected lots were shipped on 9/5/14 and 11/7/14.
TACO HUT ENCHILADA SAUCE BASE SEASONING (ENC--101), Net Weight XXXX Lbs. -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, N.Y.  --- INGREDIENTS: WHEAT FLOUR, SALT, SUGAR, SPICES, GARLIC POWDER, HYDROLYZED SOY PROTEIN, ONION POWDER, MONOSODIUM GLUTAMATE, CARAMEL POWDER, OLEORESIN PAPRIKA. ALLERGEN: CONTAINS WHEAT & SOY. --- The % of cumin used in the finished seasoning mix is 4.50%.  --- The affected lot was shipped on 11/4/14.
TACO PERFECTOS ALL-PURPOSE SEASONING (SEA-323), Net Weight XXXX Lbs. -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, N.Y. --- INGREDIENTS: SALT, HYDROLYZED SOY PROTEIN, SUGAR, SPICES, FLAVORINGS (SPICE EXTRACTIVES).  ALLERGEN: CONTAINS SOY. --- The % of cumin used in the finished seasoning mix is 0.75%. --- The affected lot was shipped on 11/10/14.
VALLARTA'S ASADA R-1 (SEA-230), Net Weight XXXX Lbs. -- FIRST SPICE MIXING COMPANY LONG ISLAND CITY, N.Y.  ---  INGREDIENTS: SALT, SUGAR, CITRIC ACID, SPICES, DEHYDRATED GARLIC, PAPRIKA, DEHYDRATED TOMATO, NATURAL SMOKE, LIME OIL. --- The % of cumin used in the finished seasoning mix is 3.0%. --- The lot was shipped on 11/19/14.
Worldwide Distribution - US nationwide including Puerto Rico, Canada, Mexico, Albania, Algeria, Argentina, Austria, Bahrain, Belgium, Bosnia Herzegovina, Botswana, Brazil, Bulgaria, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, Iceland, Iraq, Ireland, Israel, Italy, Ivory Coast, Kazakhstan, Kuwait, Latvia, Lebanon, Lesotho, Lithuania, Luxembourg, Macedonia, Netherlands, New Caledonia, Norway, Peru, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, U.A.E., United Kingdom, Vatican City, Venezuela, White Russia/Belarus.
RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number:  10310464, 10322347, 10314817, 10317193, 10318999, 10320055, 10322347, 10328278, 10328302, 10336784.   These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili.
Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is >12 mg/dl and the tHb concentration exceeds the upper reportable range of >25 g/dl.
RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number:  10492730, 10696855, 10696857, 10697306.   The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili.
RAPIDLab 1245 System; Siemens Material Number:  10321844, 10491393, 10337179.   The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb.
RAPIDLab 1265 System; Siemens Material Number:  10491395, 10321852, 10335524.   The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb.
US Distribution to the states of: AZ, AL, CA, CO, CT, DC, FL, IA, IL, IN, MI, MD, MS, MA, MO, NY, OH, PA, UT, TN and TX.
It has been discovered that the system - does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
Worldwide Distribution-US (nationwide) and the countries of  Canada, Australia and England.
VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System.  This product is an accessory for use with VITROS Analyzer Systems.
In combination with the Batch Programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup positions within a sample tray. This issue only occurs when using the Batch Programming option; all other sample programming options function as intended.
Worldwide Distribution.   US Nationwide, Australia, Austria, Belgium, Bosnia, Herzegovina, Canada, Colombia, Croatia, Curacao, Czech Republic, Estonia, Finland, France, Georgia, Germany, Great Britain, Hong Kong, Ireland, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates.
Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood collection Multicap glass and Multicap-S plastic capillaries  SMN: 10311053  Legacy Part number: 478601
Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary
Siemens Healthcare Caps for capillary 140/175  uL,  Package count 100 For use with  blood collection Multicap glass and Multicap-S plastic capillaries  SMN: 10311054  Legacy Part number: 478605
Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with  blood collection Multicap glass and Multicap-S plastic capillaries  SMN: 10328655  Legacy Part number: 478527
Gourmet Sandwich Rolls sold under the Jewel brand and packaged with 8 rolls to a 20 oz. plastic transparent bag.
Sub Buns sold under the Gonnella brand and packaged with 8 buns to a 20 oz. plastic transparent bag.
CA, CT, FL, GA, IL, LA, MD, MS, NC, NH, NJ, NY, TX, VA
GROUND CUMIN STERILE TREATED PROD. OF TURKEY, 50 LBS.
Cumin contains undeclared peanut protein
Dr. Praeger's Sensible Foods Bombay Curry Veggie Burgers  11 oz retail box Manufactured  by Dr. Praeger's Sensible Foods Elmwood Park, NJ 07047 www.drpraegers.com Made in the USA  UPC 80868 00050
Ungar's Food Products Inc. was notified by a supplier that cumin, an ingredient in the Bombay Curry Veggie Burger, tested positive for peanut protein.
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
Similac Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container.
Lot 36499SH05 Expiration Date January 1 2016 Lot 36691SH05 Expiration Date January 1 2016
The firm received three consumer calls of product with Chinese labeling.  After an internal investigation, the firm discovered that product manufactured for export to China was distributed to three states in the US. All labeling is in Chinese.
American National Red Cross, Penn Jersey Region
Blood and Blood Products for Reprocessing
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
La Centro Americana COMINO MOLIDO Ground Cumin, Net Wt. 5 LBS held in clear plastic containers.  Distributed by: La Centro Americana Corp. 2280 Union Blvd. Bay Shore, NY 11706 Tel. (631) 206-3097
Cumin may contain undeclared peanut protein.
Blood product, in which quality control and distribution/distribution of product did not meet specifications, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Walter Reed National Military Medical Center
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Various lots of BIVIGAM (Immune Globulin Intravenous (Human), 10% Liquid), 100 mL vial, with a potential for a very small percentage of the vials to exhibit a vial integrity defect, were distributed.
Worldwide Distribution.   Argentina, Australia, Burkina-Faso, Chile, China, Colombia, Ecuador, France, Germany, Hungary, Indonesia, Iraq (NL), Kuwait, Libya, Macedonia, Malaysia, Mayotte, Poland, Saudi Arabia, Slovenia, Spain, Switzerland, Turkey, United Kingdom, Uzbekistan
Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float
Products were sold online to customers located within the U.S.  The firm does not have any foreign consignees for these two recalled products.
Paleo Protein Bar Chocolate Brownie  NET WT. 2.1OZ (60G)    GMO-Free, Gluten-Free, No Sugar Alcohols    Ingredients: Egg (White Protein, Isomalto-Olgosaccharide (Prebiotic Fiber), Organic Sunflower Seeds, Coconut Oil, Cold Presses Organic Palm Oil, Chocolate, Water, Vanilla, Orange Pulp, Monk Fruit, Sea Salt.  (Isomalto-Oligosaccharide are Prebiotic Fibers derived from plant sources.)  Contains: Egg    Bars are packaged in plastic white, red, and black packaging.  12 bars are packaged into a cardboard box that also contains pre-printed labeling information.
Bars are coded with manufacturing dates.  Bars produced are coded with MFD 12/15/14 to 01/25/15.
The firm is recalling Paleo Protein Bar Chocolate Brownie and Paleo Protein Bar Cookies N' Creme due to undeclared tree nuts (cashews).
Paleo Protein Bar Cookies N' Creme  NET WT. 2.1OZ (60G)  Manufactured by Julian Bakery, Inc. Developed by Paleo, Inc.    GMO-Free, Gluten-Free, No Sugar Alcohols    Ingredients: Egg Whites, Isomalto-Olgosaccharide (Prebiotic Fiber), Organic Sunflower Seeds, Chocolate, Water, Cold Pressed Organic Palm Oil, Orange Pulp, Vanilla, Cocoa Powder, Tumeric, Monk Fruit, Sea Salt, (Isomalto-Oligosaccharide are Prebiotic Fibers derived from plant sources.)  Contains: Egg    8 13926 00274 0
Bars are coded with manufacturing dates.  Bars produced are coded with MFD 12/25/14 to 01/25/15.
District of Columbia; Arizona; California; Maryland
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, with lack of assurance of sterility, were distributed.
Blood product, quality control and distribution/distribution of product did not meet specifications, was distributed.
US Distribution to states of: AZ, AR, CA, GA, IL, IN, IA, KS, MI, MN, MO, NY, OH, OR, PA, UT and WA.
Apollo (cold) Laser Desktop Control Units, Model AP2-DT.   The Apollo IR Heat Lamp System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and / or promoting relaxation of muscle.
Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. These units were manufactured prior to Pivotal Health Solutions acquisition of the Apollo product line.
SOYBEAN SPROUTS Go-Hang Net Wt. 1 LBS.and 2 LBS.(Keep Refrigerated)  TEL: (972)790-4800 1311LUKEST IRVING. TX.75061 Korean Food Co.; SOYBEAN SPROUTS Go-Hang NET. WT 10 LBS. (KEEP REFRIGERATED) Korean Food Grop 1311 LUKEST IRVING. TX.75061
eighty 1 pound bags; eighty 2 pound bags, and eight 10 pound bags
Product may be contaminated with Listeria monocytogenes.
Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands.
EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc.  Knee prosthesis component.
Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.
Alere Determine HIV-1/2 Ag/Ab Combo Controls, For In vitro Diagnostic PN: 7D2628
Alere Determine HIV-1/2 Ag/Ab Combo Controls, with a decrease in the activity of the HIV-1 p24 Antigen Control solution, were distributed.
Blood product, which did not meet acceptable product specifications, was distributed.
Blood products, in which quality control and distribution/distribution of products did not meet specifications, were distributed.
Two distribution centers.  One in Portland, OR and one in Seattle, WA.  These distributors further distributed to local grocery chains in OR and WA.
Product labeling is on the bottom of the container.  Label reads in part ''SMALL HEART STRAWBERRY TRAY WITH DEVONSHIRE DIP***Use By: 02/16/15 Net Weight 1.5# ***KEEP REFRIGERATED***''   Product is packaged in a non flex plastic heart shaped container which is pink on the bottom and clear on the top.  The container of dressing is visible through the clear plastic top.
Real Foods of Seattle, LLC discovered that the wrong dressing was added to the package of strawberries.  The wrong dressing contains egg and soy, which is not declared on the product packaging.
Worldwide Distribution-US (nationwide) including the states of  AK, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI,and  WV, and the countries of ARGENTINA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, IRELAND, ITALY, JAPAN, NEW ZEALAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SLOVAKIA, SPAIN, and UNITED KINGDOM.
GE Healthcare Proteus XR/a with wall stand model number 2260354.   Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
Potential breakage of the steel cable which supports the bucky device in certain wall stands of Proteus XR/a X-ray imaging systems. A fall of a bucky while the system is in use could result in an injury to a patient or operator.
Worldwide Distribution -- US, including the states of AK, AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI; and, the countries of Canada, Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, Luxembourg, Netherlands, South Africa, Sweden, Switzerland, and United Arab Emirates.
Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer   For use in either posterior cruciate retaining or sacrificing surgical procedures.
All lots and sizes; Sizes C-J Left and Right.
An increase in complaints of loosening and radiolucent lines.
MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Length, Catalog No. Z-MAX9-7.   Product Usage:  The MAX Implant is intended to be implanted in the upper and lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX-TL Implant, 9mm diameter, 7mm length.  And vice versa.
- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile)  - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile)  - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile)  - NGF-60 60ml Nutrio GraviFeed Syringe (sterile)    The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger.  At the tip of the barrel is an oral lock connector.  Product is considered sterile.
The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging.
Byglands, Non-GMO soybeans for Sprouting in 25KG bags and 1MT tote bags.
Non-GMO soybeans are being recalled by firm due to the presence of Listeria monocytogenes found in a sample collected by the FDA Dallas District.
US Nationwide Distribution in the states of PA, MA,MN, NY, SC, MD, NY, IL, OH, TX and KY.
SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA50A_SP0;   Product Usage:   The intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo Flash, and Head modes. The update improves system start-up behavior and resuming, ECG handling with visual feedback of correct placement of ECG leads and contact quality, and other safety related issues.
Worldwide Distribution: US (nationwide) and countries of:  AT, AU, BE, CA, CH, DE, DK, ES, FR, GB, IE, IT, JP, NL, NO, PL, and SE.
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
992640 Rev. 02, 992085 Rev.no H, 992625 Rev.no F, 992326 Rev.no C   Each device is labeled with a unique serial number.    Catalog/Model Number:  - AS480  - S3800  - S3400  - AS100
A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the AS480, or slide locations 35 and 36 on the AS100, S3400, and S3800
Carton:  Richard-Allan Scientific CYTO-STAIN; REF 7501R; Quantity: 1x1 Gallon; Size: 1 Gallon/3.8L; LOT 313833; 11/2016; Bottle:  Richard-Allan Scientific CYTO-STAIN G; REF 7501G; 1 Gallon/3.8L; Thermo Scientific.
The case was correctly labeled as REF 7501R, however the gallon bottle was incorrectly labeled as REF 7501G Cyto-Stain G. The bottle label has the correct lot number of 313833 and EXP date 11/2016. The gallon bottle contains the correct intended contents of 7501R: Cyto-Stain R Stain.
Synthes Inserter for Titanium Elastic Nails; The Inserter for Titanium Elastic Nails (TEN) is intended for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount.  This includes: lower extremity fractures in pediatric and small-statured patients and upper extremity fractures in patients.   This system is also intended to treat metaphyseal and episphyseal fractures, such as radial neck fractures, and is intended for fixation of small long bones, such as carpal and tarsal bones.  In pediatric applications, the flexibility of the elastic nail allows it to be inserted at a point which avoids disruption of the bone growth plate.
The Inserter has the potential for mechanical failures such as breakage of the main shaft of the Inserter for the TEN, malfunction of the chuck of the Inserter for the TEN in the form of the chuck getting stuck/jammed, breakage of the cross bar of the Inserter for the TEN.
PROMETHAZINE DM SYRUP (Promethazine Hydrochloride, USP and Dextromethorphan Hydrobromide, USP), EACH 5 ml (ONE TEASPOONFUL) CONTAINS:  Promethazine Hydrochloride 6.25 mg, Dextromethorphan Hydrobromide 15 mg, alcohol 7%,  ONE PINT (574 mL), Rx only, Manufactured for:  QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC:  0603-1586-58.
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix  (IAB),  8 Fr 40 cc  Model: IAB-05840-LWS
Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
DICOPANOL (diphenhydramine hydrochloride in 5 mg/mL oral suspension kit) FusePaq, 150 mL Kits, Rx Only.  Fusion Pharmaceuticals LLC., 768 Calle Plano, Camarillo, CA 93012. NDC: 43093-104-01.
Microbial Contamination of a Non-Sterile Product: Kit component is contaminated with Burkholderia multivorans.