Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement.  Manufactured for & Distributed by Nanowellbeing Health, Inc., 14747 Artesia Blvd, #5V, La Mirada, CA 90638.  UPC: 7 99475 35350 5.
Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.
Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boosts Metabolism, Limits Fat Absorption, Increases Energy, Prevents lipid formation by limiting fat absorption 30 pills /Bottle, Distributed by: Bacai, INC. www.litefitusa.com
Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Lite Fit USA, lot 13165, due to undeclared sibutramine, making it an unapproved new drug.
US Distribution including the states of AZ, CA, FL, MN, MT, NE, NJ, NY, TX and WI
Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN), performed using the sample-to-result Verigene System, is a qualitative multiplexed in vitro diagnostic test for the simultaneous detection and identification of selected gram-negative bacteria and resistance markers. BC-GN is performed directly on blood culture media using blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-negative bacteria as determined by gram stain. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections. Sub-culturing of positive blood cultures is necessary to recover organisms for antimicrobial susceptibility testing (AST), for identification of organisms not detected by BC-GN, to detect mixed infections that may not be detected by BC-GN, for association of antimicrobial resistance marker genes to a specific organisms, or for epidemiological typing. The BC-GN test is performed on the Verigene System platform, which is a fully automated, bench-top, molecular diagnostics workstation consisting of Verigene Reader and a bank of up to 32 Verigene Processor SP units. The System enables the detection of bacterial DNA from blood culture, unformed stool, or nasopharyngal swab, depending on the test, through automated nucleic acid extraction and hybridization.
VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021).    TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 040214021A, Cartridge Numbers: 02148613 - 02148832, Expiration Date: 9/29/14
Nanosphere has determined that a portion of BC-GN Test Cartridge Lot number 040214021A has an elevated risk for No Call results and False Negative results. The BC-GN Test Cartridge (20-006-021) is distributed as part of the Verigene BC-GN Test Kit (20-005-021), which is labeled as ''IVD''. Therefore, Nanosphere has initiated a voluntary recall to retrieve the following BC-GN Test Cartridges: Test Cartridge Lot: 040214021A, Identification Numbers: 02148613 through 02148832.
GYC-1000 Green Laser Photocoagulator system   The Nidek Green Laser Photocoagulator Model GYC -1000 is indicated for use in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in the field as per FDA regulation,
Nationwide and ROW, including Canada and Mexico.
Siemens Linear Accelerators of type ARTISTE, ONCOR, and PRIMUS with Automatic Sequenced Cancer Treatment Delivery Option.
The issue affects certain serial numbers of digital linear accelerators (LINAC) of type ARTISTE, ONCOR, and PRIMUS with automatic sequenced treatment delivery option. The safety risk exists with automatically sequenced treatment technique using the SIMTEC Auto Field Option where automatic movements of the gantry and the tabletop during an auto-sequenced treatment have the potential to lead to a collision with the patient.
Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only,  Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA,  NDC 0093-0293-10
Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
Mrs. Fields Milk Cholate Chip Cookies, Net Wt. 8 oz (227 g) cardboard carton with 8 individually wrapped 1 oz cookies. 12 cartons in a case. UPC 8-86002-50651-7.
Lot BB 1-29-15 (with time stamp 9:46 am - 9:49 am). Item 60332.
Undeclared Walnuts. Some cartons labelled as Chocolate Chip cookies actually contain Oatmeal Raisin with Walnut cookies.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Worldwide Distribution - USA (nationwide including Puerto Rico) and Internationally to Canada.
Enhancement Medical expression.  model # EXP-150.  Injectable Gel 1.5cc Syringe with hyaluronic acid concentration of 20 mg/ml.    Product Usage:  Expression is labelled as an Intranasal Splint, intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. However, Expression is currently being used off-label as a subcutaneously injected dermal filler.
Manufacturer made a change in the production process that resulted in a change in final gel weight.   RECALL EXPANDED 7/8/2014   Firm expanded their recall to include all lots of product.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, possibly contaminated with air, were distributed.
Blood and Blood Products for Reprocessing
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Worldwide Distribution - USA (nationwide) and Internationally to: AUSTRALIA  AUSTRIA  BELGIUM  BENIN  CAMEROON  CHINA  ETHIOPIA  FINLAND  FRANCE  GERMANY  INDIA  INDONESIA  IRELAND  ISRAEL  ITALY  KENYA  MALAYSIA  MALAWI  MALI  NETHERLANDS  NEW ZEALAND  NORWAY  PAKISTAN  PHILIPPINES  POLAND  PORTUGAL  RUSSIA  SENEGAL  SINGAPORE  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  TAIWAN  THAILAND  TURKEY  UKRAINE  UNITED KINGDOM  VIETNAM
5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.   The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.
Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be held securely in the 1 mL Subsystem Carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it.
Blood products, collected from a donor who was previously deferred, were distributed.
Inova Health Care Services, Inova Blood Donor Services
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
New Jersey and Worldwide: Belgium, France, Netherland, and Sweden
Medtronic MiniMed Implantable Insulin Pump, Model No. MMT-2007D
Medtronic MiniMed is recalling the Implantable Insulin Pump because there have been reports of a pump malfunction resulting in the disconnection of the delivery of insulin prior to the end of the 7 year useful life of the device.
Siemens Syngo RT Therapist and Syngo RT Oncologist intended use of the SIEMENS branded Syngo RT Therapist and Syngo RT Oncologist software applications used with SIEMENS family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
Syngo RT Therapist (RTT 4.3.SP1) - model no. 08162815 Syngo RT Oncologist (RTO 4.3.SP1) - model no. 10568604  Syngo RT Therapist (RTT 4.3.SP1) for U.S. affected units only:    10010  10046  10586    No Syngo RT Oncologist (RTO 4.3.SP1) listed for U.S.
Siemens became aware of a potential issue with the syngo RT Therapist 4.3.SP1 and syngo RT Oncologist 4.3SP1 software applications running on Siemens brand LINAC systems that may experience sporadic system crashes that will cause the inability to unload patient data.
Nationwide-Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI & WV. International**Product was also shipped to consignees in Canada
Esaote PA230E Transducer A portable and cart base ultrasound system for general and cardiovascular imaging
Using the PA230E transducer with a user-defined setting with the output power to 100% (Max) in 2D-TEI mode focusing at maximum depth, could cause the transducer surface temperature to exceed the maximum allowable limit.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada.
Double Offset Rasp Handle, Left Hand Nonsterile
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
Item Number 82016757830          Lot Number 97009559
Double Offset Rasp Handle, Right Hand Nonsterile
Item Number 82016757931                          Lot Number 97009560
VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
Double Offset Rasp Handle, Left Hand A/S Rasp Handle (Left)
Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)
23.5 Deg Rasp Handle Assy- LEFT Nonsterile
23.5 Deg Rasp Handle Assy- RIGHT Nonsterile
Blood products, collected using equipment that had not been validated, were distributed.
Blood product, possibly contaminated with air, was distributed.
Frederick Farms 4oz chocolate ice cream cups, net wt. 67grams, 24 per box, 231 boxes per pallet, expiration 6-10-15
Product Code: FFC4, Lot# 18422, Exp. Date : 06/10/2015, Bin - 421BF
Produced 905 cases of 24 cups on 6-10-14. 368 boxes were sent out to customers. 537 boxes never left the production facility.
The firm used the wrong lid on end of production run on Frederick Farms 4oz regular Chocolate Ice Cream. The wrong lid used was Frederick Farm NSA (No Sugar Added) Chocolate Ice Cream.
Integra NewPort MIS System   Model No.  NWPIMP        (NewPort Implant Tray w/ Components)  NWP2INSTP  (NewPort Instrument Tray w/ Components)    The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
The affected Serial No.'s are: NWP-016    (NewPort Implant Tray w/ Components)  NWP2-015  (NewPort Instrument Tray w/ Components)
Integra LifeSciences is recalling the Integra NewPort MIS System because there is a possibility that components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in surgery.
CA   CT   FL   MA   MN   MO   NJ   NY   PA   PR   TX   VT
Ronzoni Roasted Garlic Fettuccine Net Wt. 12 OZ.  Enriched Macaroni Product    shelf-stable packed in blue paperboard box    all codes
The firm initiated this recall as a precaution out of concern that the product contains an undeclared allergen soy. Even though the product may contain a very small amount of soy, it has been further processed so there is no detectable level of soy protein.
Blood products, collected from a donor who was permanently deferred, were distributed.
US Distribution including the states of  CA and WA
Nanosphere Verigene    Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigene CDF Amplification Reagent Kit.     The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative multiplexed in vitro diagnostic test for the rapid detection of toxin A (tcdA), toxin B (tcdB), and tcdC gene sequences of toxigenic Clostridium difficile and for presumptive identification of PCR ribotype 027 strains from unformed (liquid or soft) stool specimens collected from patients suspected of having C. difficile infection (CDI). Presumptive identification of the PCR ribotype 027 strain of C. difficile is by detection of the binary toxin (cdt) gene sequence and the single base pair deletion at nucleotide 117 in the tcdC gene. The tcdC gene encodes for a negative regulator in C. difficile toxin production. The test is performed on the Verigene System and utilizes automated specimen preparation and polymerase chain reaction (PCR) amplification, combined with a nanoparticle-based array hybridization assay to detect the toxin gene sequences associated with toxin-producing C. difficile. The CDF test is indicated for use as an aid in the diagnosis of CDI. Detection of PCR ribotype 027 strains of C. difficile by the CDF test is solely for epidemiological purposes and is not intended to guide or monitor treatment for C. difficile infections. Concomitant culture is necessary only if further typing or organism recovery is required.
Verigene CDF Amplification Trays, Catalog Number: 20-011-022, Lot Numbers: 061913022D and 071813022E
Nanosphere has received report of an increased rate of ''No Call - INT CTL 2'' results for the Internal Control 2 (INT CTL 2) when negative samples are tested with certain lots of CDF Amplification Trays (20-011-022), which are contained in the CDF Amplification Reagent Kit (20-012-022); specifically for lots 061913022D and 071813022E.
Worldwide Distribution - US Nationwide and the countries of  (United Kingdom, United Arab Emirates, Turkey, Taiwan, Switzerland, Sweden, Spain, South Africa, Portugal, Poland, Oman, New Zealand, Netherlands, Kuwait, Italy, Israel, Hong Kong, Germany, France, Finland, Denmark, Dubai, Czech Republic, China, Korea, Belgium, Australia, and Amsterdam.
Kodak DirectView DR 7500 Diagnostic X-Ray System    Product Usage:  The DR 7500 system is a permanently installed diagnostic x-ray system composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DR 7500 System is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions.
The device can be tracked according to service code.  The service code for the DR 7500 system is 8087.
An on-site evaluation of the equipment parts that attach the Beta Assembly (x-ray tube and collimator) to the Over Head Tube Crane (OTC) Telescope was completed by Carestream Health (CSH) Service Engineering.   Inspection of these parts revealed that the tab on the lock washer was not bent into the lock nut recess and because the Beta Assembly detached from the OTC telescope, the lock nut was not sufficiently tightened.
AL, AR, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MA, MI, MN, MO, MT, NE, NH, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VT, VA, WA, WV, WI, WY
VIDAS D-Dimer Exclusion II, an automated quantitative test for use on instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products in human plasma using the Enzyme Linked Fluorescent Assay technique.  Also indicated for use in conjunction with clinical pretest probability assessment model to exclude DVT and PE disease.
Customer complaints about not repeatable results below the detection limit (<45 ng/mL).  Therefore false negatives are being reported for results around the medical decision point of 500 ng/mL that initially tested at <45 ng/mL.
Ocean Garden Wild Co-treated Steak IVP 10LB 10 oz. UPC 076550080922
NYSDAM analysis has revealed the presence of histamines above the allowable level in Yellowfin Tuna Steaks.
Worldwide Distribution - US Natinwide in the state of GA, IN, KS, KY, MA, NJ, SC, VA, DC and the country of Canada
DX-D 600 - DXD Imaging Package   Product Usage:Is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities, check abdomen and other both parts.
Some customers reported that while using the DX-D600 in room or exam preparation, the Overhead Tube Crane (OTC) showed increased velocity and uncontrolled longitudinal movement.
Tattoo Ink (all colors), 5ml bottle, Batch No. 8; Tattoo Ink (10 colors), 10ml, Item No. W00231;  Tattoo Ink (20 colors), 10ml, Item No. W00232;  Tattoo Ink (8 colors), 10ml, Item No. W00233.
White & Blue Lion is recalling all tattoo inks, tattoo needles, and tattoo kits because of microbial contamination.
Ink Cups, Item No. W00099, W00100. Size: Medium, Small.
Product was shipped to the following states: CA, CO, TX, PA, NC, FL, and TN.
Cool Tropics Rips Slush, Sour Apple Flavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL), Contains: Water, Apple Juice Concentrate***Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE'' UPC Code 9 76017 00310 1
Manufacturing Solutions International is recalling Cool Tropics Rips Slush, Sour Apple Flavored  drinks with the listed BEST BY DATES because finished product laboratory results revealed spoilage type of bacteria and yeasts.  The product was released prior to receiving the test results.
Cool Tropics Rips Slush, Blue Raspberry Flavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL), Contains: Water, Apple Juice Concentrate***Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE''
Manufacturing Solutions International is recalling Cool Tropics Rips Slush, Blue Raspberry Flavored drinks with the listed BEST BY DATES because finished product laboratory results revealed spoilage type of bacteria and yeasts.  The product was released prior to receiving the test results.
Cool Tropics Rips Slush, Cherry LimeadeFlavored 100% Juice No artificial colors or flavors, Juice from Concentrate 4 fl oz, (118 mL),Manufactured in USA for Tropical Paradise, Inc., www.cool-tropics.com DO NOT MICROWAVE
Manufacturing Solutions International is recalling Cool Tropics Rips Slush Cherry Limeade drinks with the listed BEST BY DATES because finished product laboratory results revealed spoilage type of bacteria and yeasts.  The product was released prior to receiving the test results.
Prismaflex TPE 2000 set, Product Number 1071441. Each set is packaged in a plastic pouch, 4 pouches per carton box
Product Number 1071441. Batch number 12A1905 to 14C1706. Expiry date 01/2015 to 03/2017.
Gambro initiated a field action on the Prisma and Prismaflex sets due to breakages of connectors resulting in leakage of liquid or blood.
Prisma TPE 2000 set. Product number 109672. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma TPE 2000 set. Product number 109672. Batch number 12B0607. Expiry 02/2015.
Prisma M 60 PRE set (new design). Product number 103658. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma M 60 PRE set (new design). Product number 103658. Batch number 12K1205G to 14B1003. Expiry 11/2014 to 02/2016.
Prisma M60 POSTDILUTION set. Product number 104183. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma M60 POSTDILUTION set. Product number 104183. Batch number 13C2103. Expiry 03/2015.
Prisma M 100 PRE set. Product number 103657. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma M 100 PRE set. Product number 103657. Batch number 12A0302G to 14B2102. Expiry 01/2014 to 02/2016
Prisma M100 set. Product number 104182. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma M100 set. Product number 104182. Batch number 12A3005 to 14A1703. Expiry 01/2014 to 01/2016
Prisma M100 PRE pump infusion set. Product number 107791. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma M100 PRE pump infusion set. Product number 107791. Batch number 12A2305 to 13D0902. Expiry 01/2014 to 04/2015
Prisma HF1000 preset (new design). Product number 107639. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prisma HF1000 preset (new design). Product number 107639. Batch number 12A1303 to 13E3104. Expiry 01/2014 to 05/2015
Prismaflex M60 set. Product number 106696. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prismaflex M60 set. Product number 106696. Batch number 12A0605 to 14A2011. Expiry 01/2014 to 01/2016
Prismaflex M100. Product number 106697. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prismaflex M100. Product number 106697. Batch number 12A0401G to 14C2802G. Expiry 01/2014 to 03/2016
Prismaflex M150. Product number 109990. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prismaflex M150. Product number 109990. Batch number 12A0304G to 14C2706. Expiry 01/2014 to 03/2016
Prismaflex HF 1000. Product number 107140. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prismaflex HF 1000. Product number 107140. Batch number 12A0504 to 14C3105. Expiry 01/2014 to 03/2016
Prismaflex HF 1400. Product number 107142. Each set is packaged in a plastic pouch, 4 pouches per carton box
Prismaflex HF 1400. Product number 107142. Batch number 12A1005 to 14C1106. Expiry 01/2014 to 03/2016
PrisMARS Kit (component of MARS Treatment Kit Type 1115/1 PrisMARS US), 1 MARS Treatment Kit  per carton box, Product Number 800480, Batch
Model Number MARS Treatment Kit Type 1115/1 PrisMARS US, Batch 0000017412 - 0000019827, Expiry Date 06/2014 to 05/2016
X-MARS Set (component of MARS Treatment Kit Type 1116/1  X-MARS US), Product Number 800541
Model Number MARS Treatment Kit Type 1116/1  X-MARS US, Batch Number 0000020229, Expiry Date 02/2017
Agfa Digital Radiography X-Ray System DX-D 100   Product Usage:  Is indicated for use in providing diagnostic quality images to aid the physician with diagnoses.
Unit was mislabeled with a factory label showing 32 KW output power.
Product was distributed to US, Germany, Austria, France, Italy, Spain, Australia.
Luma Wrap Phototherapy Swaddler is designed to provide centered and comfortable boundaries as a benefit for restive babies in the Neonatal Intensive Care Unit.
Recalled units include: LW102 (medium), Lot 66812;  LW103 (large), Lots 66813 and 30660; and   LW105 (extra large), Lot 67879.    LumaWrap models with an adhesive strip (LW102 and LW103) have a 2-year shelf life.
Beevers Manufacturing & Supply Inc. is recalling Luma Wrap neonatal phototherapy blankets because the product was inadvertently misclassified and marketed without a cleared 510(k) submission from the US FDA.
Nutrition Express is recalling Lindberg B-Complex and Fitness Multi 1 vitamins because the amount of folic acid in the products was found to be higher than the label claim.
Fitness Labs Fitness Multi 1, 90 capsules (UPC 654186946555) and 180 capsules (UPC 654186946609).
Fitness Labs Fitness Multi 2, 90 capsules (UPC 654186946203) and 180 capsules (UPC 654186946227).
Product was distributed to the following states: IL, MN, OH, and WI.
Part Skim Ricotta cheese: SYSCO Imperial Ricotta Cheese packaged in 5 pound tubs and Sargento Part-Skim Ricotta Natural Cheese and Miceli's Part-Skim Ricotta Cheese packaged in 15 ounce tubs.
SYSCO Imperial Ricotta Cheese item # SYSCO5A with EXP 27AUG14, Sargento Part-Skim Ricotta Natural Cheese item # SARGS15B  with EXP 14SEP14 and Miceli's Part-Skim Ricotta Cheese item # CS15B with EXP 14SEP14
357 cases of SYSCO5A, 36 cases of CS15B, and 169 cases of SARS15B
These ricotta cheese products were manufactured from loads of whey protein concentrate that tested positive for beta lactam residues.
Sargento Fat Free Ricotta Natural Cheese and Dutch Farms Fat Free Ricotta Cheese packaged in 15 ounce plastic tubs.
Sargento Fat Free Ricotta Natural Cheese item # SARGFF15B with EXP 14SEP14 and  Dutch Farms Fat Free Ricotta Cheese item # DFFREE15B with EXP 4OCT14
169 cases SARS15B and 13 cases DFFREE15B
Sargento Light Ricotta Natural Cheese packaged in 15 ounce plastic tubs.
Sargento Light Ricotta Natural Cheese item # SARGLF15B with EXP 14SEP14
Sargento Whole Milk Ricotta Natural Cheese packaged in 15 ounce plastic tubs.
Sargento Light Ricotta Natural Cheese item # SARG15B with EXP 13SEP14
Farimont Foods Ricotta Cheese packaged in 30 pound bags.
Farimont Foods Ricotta Cheese item # 2013WM with EXP 16914.
Uncle Ben's(R) Ready Rice GARDEN VEGETABLE, with PEAS, CARROTS, AND CORN, NET WT. 8.8 OZ (250g), UPC 5480023334
Code:  Best Before Date 06/15 MADE IN CANADA with either 422GBBFP1[L or R] or 423AABFP1[L or R]
Some pouches were filled with a different product that contains barley, a non-wheat source of gluten, which is not declared on the product packaging.
E-Z-HD (barium sulfate) For Suspension (98% w/w), 340 g bottle, Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc., Lake Success, NY 11042, NDC 32909-764-01.
Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Distribution to  Florida and South Carolina
EndoWrist Stapler System User Manual Addendum and Wall Chart;    The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).
Changes were made to the Stapler EndoWrist Stapler 45 System Instruments and Accessories User Manual Addendum (550986-03) and the EndoWrist Stapler 45 Wall Chart (PN 551524-01) in which the pH range specification for the enzymatic cleaner used throughout the cleaning process was modified from pH-neutral to pH-neutral to mild alkaline (mild alkaline is defined as pHd11). Mild Alkaline enzymatic cleaners in the pH range of 8.0-11.0 had not been validated for compatibility or efficacy with the Stapler Instrument when the changes were made.
Nationwide Distribution including CA, CO, IA, MT, OH, OK, OR, TX, and UT
Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.
VERIGENE BC-GN TEST KIT (Catalog Number: 20-005-021). TEST CARTRIDGES: Part Number: 20-006-021, Lot Number: 042914021B, Expiration Date: 10/26/14
1045 extraction trays (840 affected by recall)
Nanosphere Inc. has recently determined through four customer complaints that a small number of Verigene Gram-Negative Blood Culture Nucleic Acid Test (BC-GN) Extraction Trays in Lot 042914021B have low levels or are missing Magnetic Microparticles (MMPs) required for DNA Extraction.
Shelled walnuts, 8 oz., packed in a clear plastic container and sold under the Farmer's Market brand.
All Pack Dates from March 2014 through May 2014
Belleville Farmer's Market of Belleville, IL is recalling its packages of Shelled Walnuts because they have the potential to be contaminated with Listeria monocytogenes.
Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY;  and Internationally to:  Canada, Australia, Austria, Belgium, Brazil, Czech Republic, Denmark, Egypt, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Slovak Republic, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey.
Codman Certas - In Line Valve Only; Product Code:  82-8800   The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Lot Numbers:  CLNCB1, CMBBP1, CMBCPN, CMCBWG, CMCC2V, CMDCN8, CMDDJN, CMGB8H, CMI<B21, CMJCL8, CMJCPW, CMMCGR, CMNBFB, CMNBZJ,  CMNC8T, CMNCYL, CMPB4V, CNBBCV, CNCB6W, CNCCPF, CNDBCW,   CNDBRH, CNDCJ2, CNFCK7, CNGBG0, CNGBI<2, CNGBRY, CNHB95, CNHCKH,   CNHCZN, CNJBW5, CNJBWZ, CNJC38, CNJC4I<, CNJCD3, CNJCFR, CNJCMN,   CNKBWP, CNKCC8, CNKCL3, CNLBR6, CNLCL3, CNLCW3, CNNCWF, CNNDCK,   CNPB1R, CNPB1T, CNPBML, CNPBRH, CNPCLR, CPBB3G, CPBC96, CPBCCR,   CPBCRV, CPCBG8, CPCBG9, CPCCBH, CPCCM1, CPCCMK, CPCCMZ, CPDBYC, CPDC07, CPDCC7, CPFBKP
To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).
Codman Certas - In Line Valve with Catheter and Accessories; Product Code:  82-8801   The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Lot Numbers:  CMBBP2, CMCBLG, CMDBHG, CMFBB8, CMHDFW, CMJCPY, CMLBLW, CMLCKP, CMMBCY, CMMC3F, CMNBFC, CMNCDW, CMPB96, CNCCLK, CNJBWO, CNJC4B, CNJC4W, CNKBWN, CNKCL1, CNLBR3, CNLBZF, CNMDM1, CNNCPL, CNNDH4, CNPBRM, CPBBGP, CPBC97, CPBCRW, CPBCVD, CPCBHB, CPCCMP, CPDBYD, CPDBYF
Codman Certas - In Line Valve with Unitized Catheter and Accessories; Product Code: 82-8802    The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Lot Numbers:  CMBCB2, CMCBLH, CMDBHF, CMGBL5, CMJCMC, CMLBLY, CMNBZK, CNDCV1, CNHC8N, CNI<B41, CNLBR5, CNMB2Z, CNMDNN, CNNCWG, CNPB1Y, CNPCLT, CPBCRY, CPDBM1, CPFBK1
Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8803    The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Lot Numbers:  CLPCM9, CMBBB2, CMBBB3, CMDBHD, CMDCN7, CMDDJT, CMFBNK, CMFBNL, CMNBZG, CNDCP3, CNGBK5, CNHCZP, CNJB1F, CNJC4R, CNJCMP, CNKBOY, CNLCLO, CNMCYY, CNMDNJ, CNNDHO, CNPBRK, CNPCLW,  CPBBGR, CPCCBC, CPCCML, CPDCC2
Codman Certas - In Line Valve only with SIPHONGUARD Device; Product Code: 82-8804    The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Lot Numbers:  CMBC2W, CMDBHB, CMDDJP, CMDDJR, CMKB22, CMLCKR, CMMB1L, CMMCR5, CMNBFD, CMNCVP, CMNCYM, CMPB95, CMPBMD, CNBB13,  CNBBCZ, CNCB4R, CNCB61, CNCB6L, CNDB8B, CNDBVZ, CNDCM8, CNDCM9,   CNFCVH, CNFCVJ, CNHB96, CNHC8J, CNHC8L, CNHCKG, CNHCZH, CNHCZM, CNHCZT, CNJB98, CNJBWW, CNJBWY, CNJC39, CNJC4H, CNJC4J, CNJCBO, CNJCFP, CNJCG9, CNKB42, CNKBOR, CNKBTR, CNKCLO, CNKCLZ, CNLBR2,   CNLBZD, CNLCW4, CNMBFK, CNMCDP, CNMCDR, CNMCDV, CNMCDW, CNMDM2, CNMDM3, CNMDNG, CNMDNH, CNNCWC, CNNCWH, CNNDH2, CNNDH3, CNPB1V, CNPB1W, CNPBRJ, CNPCLP, CPBB39, CPBB3H, CPBBGN,   CPBC98, CPBCKR, CPBCKT, CPBCRO, CPCBG6, CPCBG7, CPCCBD, CPCCBF,   CPCCBG, CPCCMW, CPDBYG, CPDBYH, CPDC09, CPDCC4, CPDCC6
Codman Certas - In Line Valve with SIPHONGUARD Device, Catheter and Accessories; Product Code: 82-8805   The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Lot Numbers:  CMBC2Y, CMDCN9, CMJC48, CMLC6D, CMNBFF, CMNCDY, CNCB6M, CNCCLB, CNCCZ4, CNDBRG, CNDCNB, CNHC8M, CNJC4P, CNKCL4, CNLCL1, CNMB8Y, CNMDMO, CNNDHY, CNPCLZ, CPBC99, CPBCRZ, CPCC27, CPDBYJ, CPDCKL
Codman Certas - In Line Valve with SIPHONGUARD, Unitized Catheter and Accessories; Product Code: 82-8806   The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Lot Numbers:  CMBC2Z, CMBCPR, CMCC2T, CMDB7C, CMDBHC, CMJC49, CMJCMD, CMLBLZ, CMMB14, CNDBCY, CNDCV2, CNJCFT, CNKBHS, CNLB57, CNMDNL, CNNCWD, CNPB1Z, CPBB3J, CPBDBB, CPCCMO, CPDBYK
Codman Certas - In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8807   The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.
Lot Numbers:  CLPCNB, CMBCPT, CMCC2W, CMDB6L, CMDDJV, CMI<B24, CMLCKN, CMMC3H, CMMCGV, CMNBZH, CNBB11, CNCB6N, CNCCLH, CNCCU, CNCCZ2, CNCCZ3, CNDB69, CNDB8C, CNDBRJ, CNDCVO, CNGBK4, CNHCZR, CNJB1G, CNJC4T, CNJCMR, CNKBZD, CNLBVM, CNLBZC, CNMBFL, CNMBFM, CNMDNK, CNNDH1, CNPBRL, CNPCLV, CPBBGT, CPBCR3, CPBCR4, CPCBHC, CPCBHD, CPCCMN, CPDBYL, CPDCC3
Worldwide Distribution - USA (nationwide) including the states of AL,AR,AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, Ml, MN, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI and WV., and the countries of  Austria, Belgium, Cyprus, Denmark, France, Germany, Iraq, Italy, Lebanon, Netherlands, Panama, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, United Kingdom and Uruguay.
Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intrathecal Catheter Pump Segment Revision Kit, model 8784.     The Ascenda Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space.  The implanted infusion system components consist of a Medtronic pump and an Ascenda Intrathecal Catheter.
Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which are used with the implantable SynchroMed drug infusion pump.  This recall is being conducted due to a single component of the catheter, the retainer ring, not meeting specification criteria.  There is a possibility of unintentional disconnection of the catheter from the pump, or difficulty in disconnecting the catheter from the pump during a revision procedures.
Worldwide Distribution - USA including MA, TX, KY, IL, MS, OH and Puerto Rico; Internationally to: Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela.
VITROS Chemistry Products CDM PROM Calibration Data Module Rev. No. 0168 and 0169 (Product Code 1999077) are used in conjunction with VITROS Chemistry Products NH3 DT Slides (Product Code 1532589) GEN 59 and VITROS Chemistry Products DT Calibrator Kit  lot 44 (Product Code 1957927) and tested on the VITROS DT60/DT60 II Chemistry System: IVD, Made in USA by Ortho-Clinical Diagnostics, Inc. Rochester, NY
Inability to calibrate or use VITROS NH3 DT Slides, GEN 59 with VITROS Chemistry Products DT Calibrator Kit, Lot 44 when CDM PROM 0168 or 0169 is installed on VITROS DT60/DT60 II Chemistry Systems.
Worldwide Distribution and US Nationwide in the states of AL, AZ, CA, FL, IL, LA, MI, MN, MS, NE, NH, NJ, NC and country of Canada
Radiomat M+ NIF 14 x 17; Radiomat SG 14 x 17 NIF; RX-B 8 x 10 in./IBF-004355; Radiomat B+ NIF 14 x 17; Radiomat B+ NIF 8 x 10; Radiomat B+ NIF 9 1/2 x 9 1/2; CX Ultra UV-G Plus NIF 11 x 14; Radiomat G Plus 14 x 17 NIF   Product Usage:  Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides of the film, with a radiotransparent material coated on one or both sides of the film, with a photographic emulsion intended to record images during diagnostic radiologic procedures.
Some sheets of the medical screen film are fogged.
Depo-Medrol (methylprednisolone acetate injectable suspension USP), 40 mg/ mL, 1 mL Single-Dose Vial, Rx only, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017  NDC 0009-3073-03   DEPO-MEDROL methylprednisolone acetate Injectable Suspension USP, 40 mg per mL,  1 mL Single-Dose Vial, Rx ONLY, Distributed by Pharmacia & Upjohn Co Division of Pfizer Inc, New York NY 10017, NOVAPLUS is a registered trademark of Novation, LLC NDC 0009-3073-23
Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0
Worldwide:Distribution - US Nationwide and the countries of  Croatia, Denmark, Finland, Germany, Netherlands, Norway, Sweden, Switzerland.
Medtronic MiniMed Guardian Monitor, Model No. CSS7100, CSS7100K   Product Usage:  The Medtronic MiniMed model CSS7100 and CSS7100K Guardian REAL-Time monitors are used in combination with the Minilink transmitter and Sof-sensor glucose sensor for continuous monitoring of subcutaneous glucose concentration. The information provided by these devices is intended for use in identifying potential episodes of high or low blood glucose. The information provided is not intended to be used directly for making therapy adjustment but rather to assist the user in determining that an additional fingerstick glucose measurement may be appropriate. Per the product labeling, all therapy adjustments should be based on fingerstick glucose measurements obtained using standard home glucose meters and not on the sensor glucose values provided by the Guardian REAL-Time monitor. The CSS7100 and CSS7100K monitors are identical expect for the fact that the CSS7100K monitor is a pediatric version that has a minimum programmable low alert setting of 90 mg/dL. The minimum programmable low glucose alert setting for the adult model (CSS7100) is 40 mg/dL.
Medtronic MiniMed is recalling the Guardian REAL-Time monitors because of a manufacturing issue that has the potential to compromise the water resistance of the affected Guardian monitors.
Worldwide Distribution - USA (nationwide) and Internationally to France and Japan
VITROS Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320   VITROS CA 19-9 Reagent Packs are used on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems and VITROS 5600 Integrated Systems for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma.
Customers may receive positively biased results when using VITROS Immunodiagnostic Products CA 19-9 Total Reagent Packs, Lot 1320 and VITROS CA 19-9 Calibrators, Lot 1320 on the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. There is an unexpected observed change in CA 19-9 Calibrators, Lot 1320 calibrator values.
IN, MA, TX, VA, Ca, KY, MD, PA, GA, and BD locations in Singapore and Belgium
BD Multi Check CD4 Low Control  Catalog No. 340916 is intended as a complete process control for immunophenotyping by flow cytometry.
Catalog number 340916; Lot number BM084L
The outer box label contains the incorrect distribution date:  Box states 2017-09-02 ; should be 2014-09-02
AR, LA, TN, TX, IL, GA, OH, IN, NC, VA, MO, FL
Allegro Original Marinade, 12.7 fl oz (375 mL), UPC 0 74964 00100 7
Elevated yeast level with likelihood of premature spoilage.
Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VT, WA, WI, WV, WY,Washington D.C. and Internationally to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Congo, Costa Rica, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Gabon, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malaysia, Mauritius, Mexico, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Viet Nam, and Yemen.
IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and IntelliSpace Portal (ISP) LX SPECT   IntelliSpace Portal (ISP) is a multimodality (CT, NM, and MR) thin-client applications server that delivers full diagnostic viewing and clinical applications to the enterprise. IntelliSpace Portal (ISP) is a medical software system that allows multiple users to remotely access IntelliSpace Workspace Portal (ISP) from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac Application, the ejection fraction (EF) displayed should be the same as the ejection fraction (EF) originally displayed when the bookmark was first created. In some instances, the ejection fraction (EF) may be different.  Problem 2: When processing using one of the following NM clinical applications: AutoQUANT, Emory Cardiac Toolbox, Corridor4DM, or NeuroQ, the patient study presented to the reviewing physician within the application may be for a different patient than the one selected from the patient directory.  Problem 3: While using the NM Viewer application, an arrow annotation added to a display moves away from its original position if the viewer is subsequently maximized or if the image within the viewer is subsequently zoomed in or out.  Problem 4: While displaying PET images within CT Viewer, the SUV results displayed may be calculated with an SUV method different from the one specified in system preferences. This issue affects the CT Viewer and Multi-Modality Tumor Tracking applications. The expected behavior in such a case is that the application displays a warning that SUV cannot be calculated due to missing information, and the images are displayed with the original acquisition units (BQ/ML). Instead, in affected systems, if the patient height has not been entered and the selected SUV calculation method requires height data (i.e., SUV-BSA), the system may display an SUV calculated using a different method (SUV-BW) without providing any warning that required data had not been entered or informing the user of the change.