La Fe Green Hot Sauce, 5.6 Fl. Oz. - 165 mL, Imported by: G & T Foods, Inc., Moonachie, N.J. 07074, Distributed by: LA FE Foods, Product of Columbia, UPC 023545211052
La Fe Green Hot Sauce contained undeclared FD & C Blue #1 and undeclared FD & C Yellow #5.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product was shipped to the following states: IN, MD, MI, NC, NJ, OH, TN, WA & WI.
Jose' Madrid SALSA BLACK BEAN CORN POBLANO SALSA NET WT 13 OZ (369 G) www.josemadridsalsa.com Jose Madrid Salsa PO Box 1061 Zanesville, OH 43702 740.221.3934***0 93662 45287 4
The firm was notified by the Ohio Department of Agriculture that jars of product appear to be under processed.
AMERICA'S BEST (JEERA) CUMIN POWDER, 1) NET WT. 7 OZ. (200 GMS), 2) 14 OZ. (400 GMS),  and 3) 28 OZ.  Packed by: Patel Grocery 5303 4th Avenue Brooklyn, NY 11220 Tel: 718-748-6369
The product was found to contain undeclared peanut protein on four occasions (11700 PPM, 2500 PPM, 86.9 PPM & 69.85 PPM) based on sampling and analysis by New York State Department of Agriculture & Markets
Gouveia Crushed Red Pepper Imported from the Azores Pimenta Moida, Packed in glass jar, Net Wt 16 oz
Product fails to declare allergens FD& C Yellow #5 and sulfites
Simply Balanced Organic Chopped Spinach NET WT 10 OZ (283g) steam-in-bag Needs to be fully cooked Keep frozen
Carter-Thomason II Port Closure System; Model Number(s) CTI-1015P, for use in endoscopic and laparoscopic surgery.
The pad printing around the suture entry holes on the 15mm Suture Guide included in the kit may not have been appropriately manufactured resulting in the pad printing flaking off around the entry holes.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20
Failed Impurities/Degradation Specifications:  the manufacturer recalled product due to slightly above specification results for a Related Compound during routine stability testing
Inova Health Care Services, Inova Blood Donor Services
Blood products, collected from a donor who gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked, were distributed.
Blood and Blood Products for Reprocessing
Blood product, inappropriately released from quarantine for which malarial travel history was disclosed, was distributed.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Blood product, collected on an instrument undergoing validation, and for which quality control testing was not performed, was distributed.
Aurora Area Blood Bank Dba Heartland Blood Centers
Red Blood Cells, not manufactured according to cGMP regulations, were distributed.
Worldwide Distribution - Nationwide Distribution and the countries of Australia, Austria, Argentina, Canada, China, Chile, Colombia Czech Republic, Great Britain, Germany, Egypt, Finland, France, India, Ireland, Japan, Malaysia, Macedonia, Mexico, Netherlands, New Zealand, Nepal, Peru, Poland, Russia, Saudi Arabia Singapore, Switzerland, Sweden, Spain, United Arab Emirates and United Kingdom.
Philips Healthcare DigitalDiagnost System X-Ray
Digital Diagnost Stationary X-ray System Release 4.0.0, 4.0.1, 4.0.2
The system is designed to emit a beep upon termination of an exposure.  However, if the system has been powered on for over 12 hours, the system will no longer emit this signal.  This is a failure to comply with 21CFR 1020.31(j).
Deer Cumin Powder Packed for Best Foods Inc., Edison, NJ 08817   a) 7 oz. UPC 71476027497  b)  14 oz..UPC 714760027503    Not all packages are marked with a UPC barcode    12 packages to a case
Cumin Powder 7 oz and 14 oz may contain undeclared peanuts.
Blood product, routine testing/testing performed, interpreted, or documented incorrectly, was distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition)   Product Usage:  The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.
Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that the compounder will load the incorrect formula upon scanning the bag label when two or more different formula files have been created with the same order number.
AL, AZ, CA, FL, GA,, MN, MO, MT, ND, NJ, OK, TN, TX, VA, WY
Macadamia Nuts in 8 oz and 16 oz clear plastic bags.
Product may be contaminated with Salmonella
Texas Pecan Company Macadamias Roasted/Salted Net Wt. 16 oz. (454g) UPC: 033;  Manufactured By: Texas Pecan Co., 2850 Satsuma Dr., Dallas TX 75229 972-241-7878;  Texas Pecan Company Macadamias Roasted/Salted Net Wt. 8 oz. (227g) UPC: 034; Manufactured By: Texas Pecan Co., 2850 Satsuma Dr., Dallas TX 75229 972-241-7878;   Macadamias Roasted/Salted Net Wt. 5 LB. (2270g) Manufactured By: Texas Pecan Co., Inc. 2850 Satsuma Dr., Dallas TX 75229 972-241-7878;  Macadamias Roasted/Salted Net Wt. 25 LB. (11350g) Packed By: Texas Pecan Co., 2850 Satsuma Dr., Dallas TX 75229 972-241-7878
The Junior Executive (Nut Assortment) UPC: 320-34 Net Wt. 27 ozs. (766g) Manufactured By: Texas Pecan Co., Inc. 2850 Satsuma Dr. Dallas TX 75229 972-241-7878.  The macadamia nuts are in one section of the 3 pound tin container;  The Executive (Nut Assortment) UPC: 321-54 Net Wt. 53 ozs. (1504g) Manufactured By: Texas Pecan Co., Inc. 2850 Satsuma Dr. Dallas TX 75229. The macadamia nuts are in one section of the 5 pound tin container.
Mini Sweet-N-Salty Nuts UPC 335-26 Net Wt. 27 ozs. (766g) Manufactured By: Texas Pecan Co., 2850 Satsuma Dr., Dallas TX 75229 972-241-7878.  The macadamia nuts are in one section of the 2 pound tin container; Sweet-N-Salty Nuts 337-56 Net Wt. 63 ozs. (1788g) Manufactured By: Texas Pecan Co., Inc. 2850 Satsuma Dr., Dallas TX 75229 972-241-7878.  The macadamia nuts are in one section of the 5 pound tin container.
Blood product, in which labeling/crossmatch tag, or missing information, was distributed.
Red Blood Cells Leukocytes Reduced Irradiated
Blood products, possibly contaminated with air, were distributed.
Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Red Blood Cells For Further Manufacturing
Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
Recovered Plasma for Further Manufacture
Product was distributed in Alaska, Idaho, Oregon, and Washington
BRIDGE CITY Baking gluten free Marionberry Crumble Pie.  This product is frozen ready to bake.  Net Wt 24oz   UPC 0 91037 54454 4
BEST BY 04 15 through 10 15.  This represents April - October, 2015.
Bridge City Baking is recalling three frozen ready to bake pies due to undeclared milk.  Butter is declared without the sub-ingredient milk.
BRIDGE CITY Baking gluten free Cherry Crumble Pie.  This product is frozen ready to bake.  Net Wt 24oz   UPC 0 91037 54455 1
BRIDGE CITY Baking gluten free Apple Crumble Pie.  This product is frozen ready to bake.  Net Wt 24oz   UPC 0 91037 54453 7    Label is orange and maroon with black, white and orange lettering.
Worldwide Distribution: US (nationwide) including PR and countries of: Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain.
Stryker Howmedica Osteonics RESTORATION Acetabular Augment System; hip prosthesis component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. The RESTORATION Acetabular Wedge Augments provide multiple options to address the wide range of bone deficiencies encountered in acetabular revision. The augments provide support for the shell in the acetabulum with superior and/or posterior defects.
Stryker Orthopaedics initiated a voluntary product recall for specific lots of Triathlon Femoral, Scorpio Femoral, Restoration Wedge Augments distributed from their Mahwah Manufacturing Facility.  It was found that the peel strength of the inner blister may have been below internal validated requirements.  The strength of the seal is directly related to long term shelf life of the sterile barrier.
Stryker Orthopaedics Scorpio Howmedica Osteonics Corp.,  A subsidiary of Stryker Corporation Made in USA Sterile.   For use in total reconstructive replacement of the knee joint.
Item number 26-3005L Lot numbers MNH0ND, MNH3V7, MNH8XR, MNHN0E, MNH6Y5; 70-3003L Lot MNE6NM; 70-3003R Lot MNE963; 70-3007L Lots MNE58K, MNE6HL, MNE8MN, MNEKXP; 70-3007R Lots MNEV2Y, MNEVDV, MNEN3D, MNEX43; 70-3013L Lot MMMXTY; 70-4104L Lots MNE0Y8, MNE2J2, MND743, MNDVDT; 71-3009L Lots MNE12D, MNEALW, MNEEE4, MNEXLK, MNEXV0; 71-3009R Lots MNELHM, MNEYNE; 71-3013L Lot MMR24J; 71-4104L Lot MMAKXS; 71-4503R Lots MMT7P8, MMT8J3, MNDKJ7; 71-4504L Lots MNE5D4, MNEHV1; 71-4504R Lots MND272, MNDD9D, MNEL8W; 71-4505L Lots MMT4KY, MMTPHS, MNAJ78, MNAN2L, MNDP2N; 71-4505R Lots MMTEW1, MNA062, MNANVA; 71-4506L Lots MNAJ1W, MNARAR, MNEL1Y, MNEW53;  71-4507L Lots MMT971, MMT9R5X1, MMTJRT, MNALJA, MND1V8; 71-4507R Lots MNA17E, MND4WP, MNEAAD, MNEM55; 71-4509R Lots MMR2HL, MND9AE; 80-4403L Lots MNE0LE, MNEJ70, MNEK3L; 80-4404R Lot MNHTRK, 80-4405L Lot MNERD1; 80-4405R Lots MNEEND, MNEHNO, MNEK42, MNEMNR, MNEMXH, MNEY4A; 80-4406L Lots MNA4HR, MNEH40, MNE37L, MNE769, MNE9RD, MNEATP, MNEX06, MNEXA8; 80-4407R Lots MNELAL, MNEP9K, MNEPVE; 80-4408L Lot MNEX9T; 80-4409L Lots MNE7H9, MNEDWK, MNEDXN; 80-4409R Lots MNE0R2, MNETXP, MNEVTV; 80-4411L Lots MNEN81, MNEWN4; 80-6404R Lot MNDKD0; 80-6405R Lots MMTA8L, MNA175; 80-6407L Lot MMRV9D; 80-6411L Lot MMP7TS; 81-4404R Lots MNE34H, MNE9WN, MNEKY7; 81-4405L Lots MNE3XK, MNE4OR, MNE473, MNE50T, MNE6A5, MNE7NN, MNE9DD, MNEDX6, MNEJ0N, MNELK5, MNERR2; 81-4405R Lots MNE5PE, MNE5W5, MNEA1T, MNEH09, MNEK9M, MNEP17, MNEPET, MNEPX6, MNER3V, MNEWW7, MNEXDP, MNEXLL, MNEY3R; 81-4406L Lots MNE0J3, MNE5D6, MNEA42, MNEHL1, MNEM0H, MNEMD4, MNEMJ8, MNEMPD, MNENAR, MNEPN6, MNEW72; 81-4406R Lots MNE1XK, MNE5D2, MNEA75, MNED3A, MNEVLY, MNEYHH; 81-4407L Lots MNE127, MNE26L, MNE3KJ, MNE63T, MNE6XK, MNE71T, MNE8PT, MNE996, MNEPYY; 81-4407R Lots MMPE33, MNEOJ9, MNE217, MNE2NH, MNE3MH, MNE525, MNE5YP, MNE6WT, MNE7V2, MNE9J1, MNEA62, MNEAR2, MNEAXJ, MNED83, MNENNE, MNELEP, MNENM4, MNENY7, MNEPEP, MNERAV, MNETYX, MNEVN7, MNEW3Y, MNEW56, MNEWN0, MNEX5E, MNEXV1, MNEXVT, MNEY27, MNEYR6, MNHTW5; 81-4408L Lots MNE2VE
Stryker Orthopaedics Triathlon Howmedica Osteonics Corp.,  A subsidiary of Stryker Corporation Made in USA Sterile.   For use in total reconstructive replacement of the knee joint
Item number  Lot number 5512-F-201 Lots JYET, KFVZ, KGLX ; 5512-F-202 Lots IPPOP, JYKX, KHZL, KJDN, KJHI, KJKY;  5512-F-301 Lots JTJA, KKAE, KKNB; 5512-F-302 Lots JXXF, KEYD, KFBY, KFTZ, KFXT, KHAB; 5512-F-401 Lots JWGY, KIED; 5512-F-402 Lots IUAJ, JJHT, JOMB, JWPF, JXXM, KGPE, KJMO, KLUP;  5512-F-501 Lots JXMV, KGKP; 5512-F-502 Lots KHWY, KJBK; 5512-F-601 Lots JIML, JIRX, KFAS, KIIY; 5512-F-602 Lots KEXE, KFOS, KFPI, KJAG, KKJW;  5512-F-701 Lot JKTF; 5512-F-801 Lots JWNL, JWPY; 5515-F-301 Lots IVXZD, JEPOD, JHZRA, JITNA, JITND,JJAFD, JJNYA, JJNYD, JKEND, JSNRD,  JXBXA, JYFTD, JYGID, JYMTD,JYPJD, KFWHA, KFXID, KGAXD, KGJTD, KGXNA, KIBTA, KIEBA, KIGRD, KIYUD, KJABD, KJISD, KJRID; 5515-F-302 Lots IOLSD, IOLTD, IPRVD, IPTFD, IVGVA, IVLVD, JGIXD, JIGSD, JIYVD, JJSYA, JJWNA, JNVTA, JOWJD, JPFDA, JPHRA, JPIWA, JSZGD, JVYDD, JWPRA, JXBKD, JXOBA, JXXZD, JYBRA, JYBRD, JYKFD, JYKTA, JYMXA, JYNIA, JYNID, JYUED, JZDWD, JZEHD, JZFDD, KFNEA, KFOBA, KFOBD, KFOHD, KFVND, KGMFA, KGMFD, KGWGA, KGZFA, KHBGA, KIEXD, KJBFD, KJDLD, KJFXA, KJFXD, KJNPA, KKJOD; 5515-F-401 Lots JPDRA, JPIXD, JVLND, JVMTD, JXUDD, JYIDD, JYMUD, JZDSA, KABYA, KFDKD, KFMLA, KFPNA, KGAVD, KHEAA, KHKSA, KHZHA, KIATA, KIBVD, KIFMD, KIFOA, KIIFA, KJKBD, KKFYD; 5515-F-402 Lots JIFRD, JIGXD, JIMUD, JIRZD, JKESD, JLVSA, JLWTA, JOUGD, JPFEA, JPGKD, JYEIA, KAJID, KFSND, KGFLD, KGRBA, KGSHD, KGYOD, KJXDD, KKVHA, KLBHD, KLLBD; 5515-F-501 Lots HWHLA, IEXUA, IFDEA, IKEMD, JIAID, JILXA, JJBFD, JJTVD, JKGXD, JOXUA, JPMVD, JZRRA, KFSRA, KGIVD, KGKZA, KGSID, KGVHD, KGVPD, KHGPA, KHKAD, KHWRD, KHXWA, KJGBA, KKHFA, KKHFD, KLOSA; 5515-F-502 Lots IKRKA, JIDLA, JIEZD, JIVTA,JIYYD, JJWSA, JKAAD, JNVJA, JOPDD, JPFBD, JVUAD, JXBYD, JXFLA, JXTRD, JXYSA, JZHAD, JZKTD, KFNGD, KGTLA, KGTMA, KGYFA, KHGVA, KHGVA, KHGVD, KHOFD, KHPLA, KHRTA, KHWMA, KHWVA, KIDPA, KIJDA, KJGLD, KKMDD, KKOOD, KKPKA, KKWAA, KLBZA, KLMBA, KLSFA, KLSFD;  5515-F-601 Lots IPFTA, JIUMD, JJHZA, JMBTA, JWFHD, JWKTA, JXWXA, KABRD, KAGLA, KFISA, KFJXA, KGBVA, KGTDA, KHFSA, KHGNA, KHJAA, KHLIA, KHSWA, KHUAA, KHYED, K
Spinach; Packaging configurations per case:  One 4 pound bag; Four 2.5 bags; Four 1 pound bags;
YTF92A27; YTF92A28; YTF92A24; YTF92A1; YTF92A2; YTF92A11 Recalling firm to provide a more comprehensive list
Taylor Farms California, Inc. is voluntarily recalling select bags of spinach due to an isolated instance in which a random sample yielded positive for Salmonella.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Worldwide Distribution to the countries of : Denmark, Spain, Great Britain, Germany, Bosnia Herzeg, China and Russian Federation.
IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.  In vitro diagnostic.
IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80
Product was shipped to the following states: AZ, ID, MT, NM, NV, UT & WY.
Smith's Bakery brand fresh carrot cake, net weight 5 ounces  7 50903 91714 0, 22 ounce 1.38 pound 1/8 Sheet) 7 70118 22460 4, 82 ounce (5.13 pound 1/4 sheet) 0 41573 07058 8 Smith's Food & Drug Stores
Firm discovered a Carrot Cake scale label that did not print the ingredient statement in its entirety and failed to include the allergen statement ''CONTAINS: WHEAT, MILK & SOY, EGGS, WALNUTS, RAISINS.''
Medtronic DBS Extension Kit for Deep Brain Stimulation,  Models 37085 and 37086.  Sterile
Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances.  This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa PC (Model 37601), Activa RC (Model 37612), and the Activa  SC (Model 37603).
Walnuts Halves & Pieces in black foam trays with a green and gold label. Net Weight 16-oz 454.0 grams UPC: 0078264065165 Hines Nut Company Dallas, Texas 75201
WHOLE FOODS MARKET Raw MACADAMIA NUTS NET WT 11OZ (312g) Distributed by Whole Foods Market Austin, TX 78703
Best By date 2/4/2016 and UPC code 7695862059-1
Product may be contaminated with Salmonella.
The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters.   The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).
Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R)  due to complaints that the audible speaker malfunctions.
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters.   The LCX02 monitor measures and displays oxygen partial pressure (Pt02) and temperature in brain tissue.
Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R)  due to complaints that the audible speaker malfunctions.
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters.   The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue.
The product comes in a 4-ounce clear plastic tear-strip enclosed container. The pine nuts are sold in store Produce Departments with a clear package front and tan-colored label on the back.  The back label list Pine Nuts as the only ingredient.
This voluntary recall has been initiated because pine nuts supplied by Superior Nut & Candy Co., Inc.  may contain Salmonella.
Nationwide Distribution-including PR and the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, ME, MI, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, , SC, TN, TX, VA, WA, and WV.
Homocysteine test system - Homocysteine Reagent. 05385415190; Homocysteine 100 Tests, cobas c, COBAS INTEGRA    Homocysteine Enzymatic Assay is an in vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems.
05385415190, Homocysteine 100Tests, cobas c, COBAS INTEGRA   Lot number 69781101
Customers complained about under-recovery of non-Roche controls and discrepant low patient results with certain Homocysteine reagent lots. This negative bias could, in the worst case, lead to inaccurately low Homocysteine results. An elevated level of Homocysteine is considered an important risk factor in the assessment of peripheral vascular disease. Falsely low values could lead to a delay of diagnosis and treatment. No immediate or vital hazard is expected, due to the long-term effect of homocysteine.
Worldwide Distribution-Algeria, Argentina, Australia, Austria, Brazil Canada, Chile China, Colombia, Czech Republic, France Germany , Greece, Hungary, India, Italy Japan, Korea, Mexico, Netherlands, Poland, Portugal, Russia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, Angola, Armenia, Kocaeli, Bahrain, Bangladesh, Republic of Belarus, Benin, Bolivia, Bosnia, Brunei, Bulgaria, Burkina Faso, Cambodia, Cameroon, Chad, Democratic Republic of Congo, Costa Rica, Germany Dominican Republic, Dutch Antilles, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Gabon, Georgia, Guam, Guatemala, Guinea, Honduras, Indonesia, Iran, Iraq, Israel, Ivory Coast, Kazakhstan, Kenya, Kuwait, Laos, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Mali, Malta, Morocco, Portugal, Myanmar, Managua, Niger, Nigeria, Oman, Palestine, Panama, Paraguay, Peru, Philippines, Qatar, Romania, Kingdom of Saudi Arabia, Senegal, Slovakia, Sri Lanka, Tanzania, Togo, Tunisia, Ukraine, UAE, Uraguay, Venezuela, Vietnam, Yemen and Zimbabwe.
MYLA server HP Proliant: DL380-G8 and ML350-G6 version 3.xx computer application software.   MYLA V3 is a computer application (''Middleware'') based on Web 2.0 technology which: Interfaces between the instruments connected to the application and the LIS(s) (Laboratory Information System(s).
The MYLA server could slow down due to  the volume (weight) of the data to manage and it could also stop processing, impacting the server start-up phase. The problem occurs in high volume settings. The MYLA server slows down and will stop processing completely if any task requires more than 5 minutes to complete. The server then fails to reboot and requires service, provided remotely or on-site, from the manufacturer to restart the computer.     When the MYLA server does not reboot, results are not uploaded to MYLA or transferred to LIS; the results already transferred to MYLA but not yet uploaded into LIS are not accessible. It also means new test requests are not transferred from LIS to MYLA or from MYLA to the systems. In this circumstance the VITEK 2 and BacT/Alert systems can be used as stand-alone systems however the VITEK MS system connected to MYLA would be unusable as MYLA is the user interface for this system.
American National Red Cross (The) - North Central Region
Platelet products, collected on an instrument that failed leukoreduction quality control procedures, and labeled as leukoreduced, were distributed.
Initial: Florida, Maryland, New York, & New Jersey for further distribution to Starbucks Company-operated stores in Florida, New York, New Jersey, Pennsylvania, Washington DC, Maryland, Virginia, Connecticut, Delaware, Georgia, Ohio, South Carolina, and West Virginia.
Black & White Mini Cookies, Net Wt. 2 oz. (56 g), SKU 408785, UPC code 833282000495, Manufactured for: Starbucks Coffee Company, Seattle, WA --- The product comes in a clear film package, each containing two cookies.  Each case contains 12 - 2 oz. packages (units).
all lots sold in Starbucks Company operated stores on or before Thursday, April 23rd, 2015.
18,720 cases (equals 224,640 retail 2- packs)
The Black & White Mini Cookies contain undeclared milk.  The product also contains soy lecithin, but the labeling only lists lecithin in the ingredient statement.
Raw Pine Nuts sold in the following brands and package sizes:   -Good Sense  3 oz. (85g) bag  UPC 30243-86681,    -Good Sense 4 oz. (113g) bag, UPC 30243-86680,    -Good Sense 4 oz. (113g) tub UPC 30243-50799,    -Good Sense 15 oz. (425g) bag UPC 30243-86687,    -Good Sense 5 lbs. box UPC 30243-02860,   -Good Sense 4 oz. bags may have been sold as a floor display, UPC 30243 86683 ,  and    -Weis 4 oz. (113g) tub UPC 30243-72557
Waymouth Farms is recalling Raw Pine Nuts because they have the potential to be contaminated with Salmonella.
Total 1108 units (490 units in US and 618 units outside the US)
When EPIQ 5 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to ''Metric'' and weight and/or height is entered, a unit conversion error may result in the incorrect display of their values and incorrect calculation of the patients Body Surface Area (BSA).
1692 units total (902 units in the US and 790 units outside the US)
When EPIQ 7 Ultrasound System, WITHOUT the Pediatric Cardiology option, is set up to ''Metric'' and weight and/or height is entered, a unit conversion error may result in the incorrect display of their values and incorrect calculation of the patients Body Surface Area (BSA).
Today's Harvest(TM) Field Peas w/Snaps, GRADE A SELECT, NET WT. 2 LBS., (907 g), KEEP FROZEN, packed by Greystone Foods, LLC, Birmingham, Alabama 35209
Today's Harvest(TM) Silver Queen style Corn, GRADE A SELECT, NET WT. 2 LBS., (907 g), KEEP FROZEN, packed by Greystone Foods, LLC, Birmingham, Alabama 35209
Today's Harvest(TM) Broccoli Florets, GRADE A SELECT, NET WT. 2 LBS., (907 g), KEEP FROZEN, packed by Greystone Foods, LLC, Birmingham, Alabama 35209
US Nationwide Distribution in the states of MO, FL, OH
Pinnacle3  Software Version 10.0, Model 459800200841.   Product Usage:  The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualified medical personnel may output the plan in an electronic or printed form for use by other systems in the delivery of treatment to a patient.
A problem (the dose computed in planning mode is calculated incorrectly ) has been detected in the Philips Pinnacle3 software version 10.0 that, if it were to re-occur, could pose a risk for patients or users.     Specifically, the dose engine is being passed the wrong snout position.  The snout position is used to determine the penumbra of the beam which includes the calculation of the source size and the calculation of the compensator scatter. The actual snout position is shown in the planning window as X, but the value passed to the dose engine is Y, where Y=X + (unmilled compensator thickness  physical thickness of compensator).    The unmilled compensator thickness is defined in physics mode and is usually around 20-30 cm.  In rare situations, this translates into an error in the calculation of the penumbra that in some cases, goes beyond the limits of our specification.    The issue only exists in planning mode.  In physics mode we do not have this issue because the mechanism for sending the snout position to the dose engine is different in physics than in planning mode.  Thus the dose computed in planning mode is different than the dose computed in physics mode.  The issue is most pronounced for beams that do not have compensators or where the milled compensator is relatively thin compared to the unmilled compensator.
7 -Layer Bar, 7-ounce(200 gram) flexible plastic wrap with adhesive-backed label.
7-Layer Bar product declared Graham crackers but did not declare wheat.
AL, CA, CT, CO, FL, HI, IL, MA, MD, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA and WA
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
PHALINX (TM) HAMMERTOE HANDLE, SIZE: X-SMALL, STYLE: ANGLED, REF 45304011, CONTENTS 1 EACH, RX ONLY
The term DORSAL was laser etched on the incorrect side on some of the angled handles.
PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY
PHALINX (TM) HAMMERTOE HANDLE, SIZE: MEDIUM, STYLE: ANGLED, REF 45304013, CONTENTS 1 EACH, RX ONLY
PHALINX (TM) HAMMERTOE HANDLE, SIZE: LARGE, STYLE: ANGLED, REF 45304014, CONTENTS 1 EACH, RX ONLY
ImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 Single Use Applicator Tip per carton, Manufactured for OCULUS SURGICAL, Port St. Lucie, FL 34986, NDC 62144-5510-05
Fetting's Jumbo 2.5 oz Cinnamon Roll Dough 140, Approx. 120 count, Keep Frozen, NET WT 18.8 LB., UPC 0 75812 79140 0,  Packaged in plastic liner in cardboard box, Manufactured by Top Taste Inc, Finley, ND 58230..
Firm discovered than an incorrect ingredient label which did not state defatted soy flour as an ingredient was used.
CT LightSpeed 16. Catalogue # 2339985.   Designed to be a head and whole body CT scanner utilizing a new solid state detector.
GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanners. In the  unlikely event that the component becomes loose on the CT gantry during operation, it  could result in serious bodily injury if the component were expelled. There were no  incidents or injuries reported as a result of this over-torqueing.
Worldwide Distribution - US Nationwide in the states of: AR; AZ; CA; CO; FL; GA; I A;  IL; IN; KY; MA; MN; MO; MS; MT; NC; ND; NJ; NV; NY; OH; OK; PA; PR; SD; TN; TX; VA; WA; WI and the countries of: Bangladesh, Canada, China, Costa Rica, Dubai, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Korea, Netherlands, Panama, Poland, Portugal, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, and UK.
Mucolytic Agent 1 pint/473 ml; 1 gallon/3.8 l   Product Usage:  A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx &#38; Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.
Product 76166- 116; Product Code 76167-29
Richard Allan Scientific (RAS) is initiating a recall of Mucolytic agent and Mucolexx following a customer complaint reporting that a lab had found fungal contamination in 2 lots of Mucolexx.
Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL    Product Usage:  A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx &#38; Mucolytic Agent liquefies mucus and allows for optimal cytologic diagnostic results.
506 cases = 20 of Product Code 44041; 37 of Product Code 44042; 185 of Product Code 9990370; 92 of Product Code 9990371; 27 of Product Code 9990375
DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only    Product Usage:  The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.
The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Worldwide Distribution - US Nationwide in the states of: AR, AZ, CA, CO, DE, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA & WI and the country of Hong Kong.
ENDOPATH ECHELON'' Vascular White Reload for Advanced Placement Tip,    Product Usage:  The instruments have application in multiple open or minimally invasive general, gynecologic, urologic, thoracic and pediatric surgical procedures.
M/N: VASECR35; Product Lot L4FF3W, Expiry Date 2017-11; Product Lot L4FF3X, Expiry Date 2017-11; Product Lot L4FF3Y, Expiry Date 2017-11; Product Lot M4H046, Expiry Date 2017-12; Product Lot M4H105, Expiry Date 2017-12; Product Lot M4H27D, Expiry Date 2017-12; Product Lot M4H30H, Expiry Date 2017-12; Product Lot M4H37J, Expiry Date 2017-12; Product Lot M4H399, Expiry Date 2017-12; Product Lot M4H589, Expiry Date 2018-01; Product Lot M4H54M, Expiry Date 2018-01; Product Lot M4H643, Expiry Date 2018-01 & Product Lot M4H691, Expiry Date 2018-01..
During an internal inspection of the production process the firm discovered an issue which may cause the cartridge to deploy an incomplete staple line.