Red Blood Cells (Apheresis) Leukocytes Reduced
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Community Blood Center of Greater Kansas City
Blood products, which were mislabeled according to testing results, were distributed.
Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Internationally to Belgium, Canada, Philippines, Singapore, and Taiwan.
TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar   Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of hemolytic reactions. MacConkey II Agar is a selective and differential medium for the detection of coliform organisms and enteric pathogens.
A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the packaging. The contamination is typically observed as 1-3 CFUs per plate when present.
CDC Anaerobe 5% Sheep Blood Agar   CDC Anaerobe 5% Sheep Blood Agar is an enriched, nonselective culture medium particularly useful or the isolation and cultivation of obligate anaerobes from clinical specimens. It supports the growth of a wide variety of obligately anaerobic, faculatively anaerobic, microaerophilic and aerobic bacteria.
Columbia Agar with 5% Sheep Blood   Columbia Agar with 5% Sheep Blood is a general purpose culture medium used for the growth and recovery of fastidious microbial species.
Blood products, labeled leukoreduced which did not meet the QC requirements for leukoreduced products, were distributed.
Platelets Pooled Leukocytes Reduced Irradiated
Blood products, labeled  leukoreduced  which did not meet the QC requirements for leukoreduced products, were distributed.
Worldwide Distribution - USA including CA, FL, GA, IL, MI, NC, NJ, NY, OH, OK, OR, and TX and Internationally to Australia, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, China, Colombia, Costa Rica, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Indonesia, Ireland, Israel, Italy, Kazakhstan, Kenya, Malawi, Mali, Mexico, Morocco, Mozambique, New Zealand, Nigeria, Norway, Pakistan, Poland, Russia, Saudi Arabia, Senegal, South Africa, South Korea, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom.
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
The x-drive assembly may fail prematurely.  This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet.
Worlldwide Distribution - USA including Texas, California, Florida, and St. Lucia, Barbados and St. Marten.
Labeled in part: I Color Complete / Color Lens, blister packing, 14.5mm. (Additional colors include: 1) Illusion style, Chestnut Brown, Violet and others and 2) 2 Tone style: like Misty Blue among others)Eye contact lens    Product Usage - Eye contact lens
A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses.  I Color Color Complete brand color contact lenses are unapproved medical devices.
Labeled in part: I Color Complete / Crazy Lens, blister packing, 14.5mm,    (Additional colors include: #003 White out, #005 Yellow out, #020 Red out, #014 Black out, #070 Manson, #136 Lava, #009 Yellow cat, #073 Red cat, #050 White cat, #032 Soccer ball, #077 Spiral, #071 Target, #057 Wild fire, #056 Spider web, #174 Black moon, #179 Green moon, #180 Zombie, #181 Green hole, and #184 Black hole among others styles)     Product Usage - Eye contact lens
A surveillance sample collected by FDA confirmed the presence of Bacillus Cereus and Bacillus Lentus in the contact lenses, product is not sterile.  I Color Color Complete brand color contact lenses are unapproved medical devices.
USA Distribution to the states of  MO, MI, NY, OK, CA, LA, CT, IN, VA, MD, WA, HI, ME, TX, NY, OH, PA and CO.
Artis zee/ zeego systems,  model numbers: 10094135, 10094137, 10094139, 10094141, 10280959: dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.  Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
The Small Focus of a 3 focal spot x-ray tube may fail and further release of radiation will not be possible.  The Large Focus and Micro Focus focal spots will still be operational without any restriction. Manual switchover is needed, resulting in a short interruption of the procedure.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
CA, FL, IN, KY, MN, NC, NJ, NY, OK, SD and TX  Netherlands, Poland and United Kingdom.
Philips Expression MR200 MRI Patient Monitoring System.
The MR 200 devices failed the initial power up test due to capacitor short and hi-pot testing; possible loss of Patient Monitoring or User/Service Electrical Shock.
GE OEC Brivo 715 Prime Mobile C-Arm X-Ray Product   Used for general surgical applications and musculoskeletal procedures to visualize.
mA Accuracy may exceed the design and labeling specification of+ 10%. Per 1020.32(f): Deviation of x-ray tube potential and current from the indicated values shall not exceed the maximum deviation as stated by the manufacturer in accordance with 1020.30(h)(3).
GE OEC Brivo 865 Plus Mobile C-Arm X-Ray Product   Used for general surgical applications and musculoskeletal procedures to visualize.
Blood products, in which Viral Testing/Testing performed, interpreted, or documented incorrectly were distributed.
Whole Foods Organic Raw Almonds Imported from Spain  USDA Organic;  Net WT. 13.5 oz. (383 g) plastic tub;  Ingredients: Organic Almonds - Unpasteurized    Distributed by Whole Foods Market IP, LP,  Emeryville, CA 94608
Sell by 4/18/15 to 6/6/15; UPC 9-99482-00071-7  Firmis also recalling almonds with a sell by date of 6/7/15, even though they were sourced from a different lot.
226 cases (12 x 13.5 oz. containers) or 228.25 lbs.
Customer reported high levels of hydrogen cyanide in Raw Organic almonds after testing due to a consumer complaint.
Worldwide Distribution - USA including MD and Internationally to Hong Kong, South Korea and the UK.
Infinite 200 The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
Incorrect lumi firmware version installed (E.027 instead of V2.00)
Infinite 200PRO The Tecan Infinite 200 is a multifunctional microplate reader with injector option. The Infinite 200 provides high performance for the vast majority of todays microplate applications and research and is robotic compatible. The infinite 200 has been designed as a general purpose laboratory instrument for professional use, supporting common 6 to 384-well microplates conforming to the ANSI/SBS standards.
HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6   Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.  The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation.  It must be used by or on the order of a physician.
Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadvertently.
Distributed in the states of CA, CO, and OH.
IC PROFILER-MR - Model 1123.   A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.
Has a Potential Pinch Hazard to user performing Machine QA in an MRI environment.
Nationwide in the following states:  AZ, CA, CO,CT, FL, IA, IL, IN, LA, MA, MD, ME, MN, MO, NC, NJ, NY, OH, OK, OR, PA, RI, TX, VA and WV.  Worldwide in the following countries by Institut Straumann AG distribution network:  Austria, Australia, Canada, Germany, Spain, Finland, France, United Kingdom, Netherlands, Belgium, Switzerland, Ireland, Italy.
Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S.  Endosseous dental implant drill set.
Worldwide Distribution-US (nationwide) including Puerto Rico and the countries of Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain and Venezuela.
VITROS 3600 Immunodiagnostic System, Catalog Number  6802783, IVD --- Ortho Clinical Diagnostics.    For use in the in vitro quantitative, semi-quantitative and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents.
Software Version 3.1 & Below; Serial Numbers J36000101 - J36000834 (the serial numbers are sequential; J Numbers are analogous to serial numbers)
Software Anomaly: the firm has identified an anomaly with VITROS System Software Version 3.1 and below, and determined that the software may not properly identify an expired calibration.
VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), Catalog Number 6802445, IVD --- Ortho Clinical Diagnostics.   The VITROS 4600 Chemistry System is intended for use in the in vitro quantitative measurement of a variety of analytes of clinical interest, using both VITROS Chemistry Products Slides (colorimetric endpoint, rate, ion-selective electrode, and immunorate methods) and VITROS Chemistry Products MicroTip liquid reagents (spectrophotometric and spectrophotometric immunoassay methods).
Software Version 3.1 & Below; Serial Numbers J46000108 - J46000492 (the serial numbers are sequential; J Numbers are analogous to serial numbers)
VITROS 5600 Integrated System, Catalog Number 6802413, IVD --- Ortho Clinical Diagnostics.   For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Chemistry Products Slides, VITROS Chemistry Products MicroTip Reagents and VITROS Immunodiagnostic Products Reagents.
Software Version 3.1 & Below; Serial Numbers J56000110 - J56002044 (the serial numbers are sequential; J Numbers are analogous to serial numbers)
So Ca Permamente Med Group Blood Donor Cntr
Blood product, which did not meet the acceptable product specifications, was distributed.
Nationwide Distribution including AZ, CA, CO, CT, FL, GA, HI IL, IN, KS, MD, MI, MN, NC, NJ, NV, NY,  OH, OK, OR, PA, TN, TX, UT, VA, and WA.
Phadia 1000 Instrument (introduced as UniCAP 1000), Article number: 12-3800-01 (All instrument software versions since launch in 2003); Multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.  Software utilized in multiple ImmunoCAP assays for Allergen Testing, FDA Cleared for use on Phadia 1000 instrument with IU statement-see attachments.
During an investigation of instrument logs it was determined that In specific circumstances involving multiple steps, a rack sequencing error may occur. This will result in a mismatch between the sample ID and the test result reported for all subsequent sample racks in that run.
These items were distributed to retail stores in Virginia and Maryland
Clear 1 lb packages of Natto Soybean Sprouts. These products are labeled as produced by Henrys Farm Inc.
Henrys Farm Inc. of Woodford, VA is recalling all packages of Soybean Sprouts because they may be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections to individuals with weakened immune systems.  Although healthy individuals may suffer only short term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Clear 2 lb packages of Bean Sprouts. These products are labeled as distributed by Rhee Bros. Inc. Columbia, MD.
All bulk (approximately 10 lbs.) black plastic bags of Soy Bean Sprouts. These products are labeled as produced by Henrys''s Farm Inc
Inova Health Care Services, Inova Blood Donor Services
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood and blood products for reprocessing
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Flat Creek Lodge, Aztec Cheddar Cheese, 367 Bishop Chapel Church Rd, Swainsboro, GA 30401.
Product was found to be contaminated with Salmonella.
Flat Creek Lodge, Low Country Gouda, raw milk cheese, Flat Creek Lodge, 367 Bishop Chapel Church Road, Swainsboro, GA 30401.
Blood product, in which expiration time was missing from final label, was distributed.
Distributed only in the countries of Finland, France, Germany, Great Britain, Italy, Norway, Spain, Sweden, and Switzerland.
Lotus TAVR 23mm,  Transcatheter Aortic Valve Prosthesis Premounted on Delivery System;  Sterile  Material number H749LTV230, Catalog Number LTV23;  Product Usage:  The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2  or AVA index of <0.6 em /m2)  who are at extreme or high risk for standard surgical valve replacement.
Reports of the Lotus valve was initially locked but became unlocked during release from the delivery system which may result in percutaneous insertion of another valve.   The Lotus Valve is designed to lock in-situ prior to being released from the delivery  system. In four (4) cases in Europe between April and July 2014, the valve was initially  locked but then became unlocked during release from the delivery system. Therefore, a  second Lotus device was implanted resulting in a Valve in Valve (ViV) implantation  procedure. In three of the four cases, the ViV procedure was successful. In the fourth  case, during the implantation of the second valve, the first valve embolized and it was  necessary to convert the patient to surgery.
Lotus TAVR 25mm,  Transcatheter Aortic Valve Prosthesis Premounted on Delivery System;  Sterile  Material number H749LTV250, Catalog Number LTV25;  Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2  or AVA index of <0.6 em /m2)  who are at extreme or high risk for standard surgical valve replacement.
Lotus TAVR 27mm,  Transcatheter Aortic Valve Prosthesis Premounted on Delivery System;  Sterile  Material number H749LTV270, Catalog Number LTV27;  Product Usage: The Lotus Valve System is intended to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2  or AVA index of <0.6 em /m2)  who are at extreme or high risk for standard surgical valve replacement.
Lifesouth Community Blood Centers - Montgomery Region
Blood products, in which Quality Control and Distribution of product did not meet specifications, were distributed.
Blood product, in which Routine Testing/Testing performed, interpreted, or documented incorrectly for FYA, was distributed.
American National Red Cross Southeastern Michigan Region
Blood and Blood Products for Reprocessing
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Worldwide Distribution - US Nationwide including Canada and Mexico.
Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus, ONCOR Expression, ONCOR Impression, PRIUS HI, Mevatron M2/Primus Mid-Energy, MEVATRON PRIMART, MEVATRON KD-2, MEVATRON KDS-2, MEVATRON K2, MEVATRON 6323-2, MEVATRON M2 6740, MEVATRON M2 6700, MEVATRON 6300, MEVATRON MDX-2, MEVATRON MD-2, MEVATRON KD, MEVATRON KDS, MEVATRON 77, MEVATRON K7467, MEVATRON 7767, MEVATRON K8067, MEVATRON M 6300 (MX), MEVATRON M 6730, MEVATRON M 7140, MEVATRON M 7400, MEVATRON MDX, MEVATRON MD (MD, MDX), MEVATRON M 7445 (MXE), MEVATRON M 7400/7440 (MXE), MEVATRON M 6730/6740 (MXE), MEVATRON M 6700 (MX): the intended use of the MEVATRON , PRIMUS , ONCOR  and ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer.
Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator injury, damage to the LINAC, and can potentially compromise customer warranty.  The dark current dose must be considered in the overall dose calculation, or an overdose and serious injury may occur.
SOMATOM Force; 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.
Artifacts are found in acquired imaging on the SOMATOM Force.
Worldwide Distribution - USA including Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, Wisconsin, Wyoming and Internationally to Algeria, Angola, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Latvia, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, Norway, Oman, Panama, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, and Venezuela.
iPlan RT Dose is a stereotactic radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
Software Versions:    1) 21213 IPLAN RT DOSE 3.0 PLATFORM;   2) 21213A IPLAN RT DOSE 3.0.1 PLATFORM;   3) 21213B IPLAN RT DOSE 3.0.2 PLATFORM;   4) 21213D IPLAN RT DOSE 4.1.0 PLATFORM;   5) 21213E IPLAN RT DOSE 4.1.1 PLATFORM;   6) 21213F IPLAN RT DOSE 4.1.2 PLATFORM;   7) 21213G IPLAN RT DOSE 4.1.3 PLATFORM;   8) 21213H IPLAN RT DOSE 4.1.4 PLATFORM;   9) 21381 IPLAN RT DOSE 4.5.0 PLATFORM;   10) 21381A IPLAN RT DOSE 4.5.1 PLATFORM;   11) 21381B IPLAN RT DOSE 4.5.2 PLATFORM;   12) 21381C IPLAN RT DOSE 4.5.3 PLATFORM;   13) 21385 UPGRADE IPLAN RT DOSE 4.X TO 4.5.0;   14) 21385A UPGRADE IPLAN RT DOSE 4.X TO 4.5.1;   15) 21385B UPGRADE IPLAN RT DOSE 4.X TO 4.5.2;   16) 21385C UPGRADE IPLAN RT DOSE 4.X TO 4.5.3;   17) 21387 iPLAN RT DOSE PLATFORM 4.1 (21213);   18) 21387A iPLAN RT DOSE PLATFORM 4.1.2 (21213);   19) 21387B iPLAN RT DOSE PLATFORM 4.5.1 (21381);   20) 21387C iPLAN RT DOSE PLATFORM 4.5.2 (21381);   21) 21387D IPLAN RT DOSE PLATFORM 4.5.3(21381) V;   22) 70213 UPGRADE BRAINSCAN 5.X TO iPLAN RT DOSE 3;   23) 70213A UPGRADE BRAINSCAN 5.X TO iPLAN RT DOSE 3;   24) 70213B UPG BRAINSCAN 5.X TO iPLAN RT DOSE 3.0;   25) 70213C UPG BRAINSCAN 5.X TO iPLAN RT DOSE4.1.0;   26) 70213D UPG BRAINSCAN 5.X TO iPLAN RT DOSE 4.1.1;   27) 70213E UPG BRAINSCAN 5.X TO iPLAN RT DOSE 4.1.2;   28) 70213F UPG BRAINSCAN 5.X TO iPLAN RT DOSE 4.5.1;   29) 70214 UPGRADE BRAINSCAN 3.X/ 4.X TO IPLAN RT D;   30) 70214A UPGRADE BRAINSCAN 3.X/ 4.X TO IPLAN RT D;   31) 70214B UPG BRAINSC 3.X/4.X TO IPLAN RT DOSE 3.0;   32) 70214C UPG BRAINSC. 3/4.X - iPLAN RT DOSE 4.1.0;   33) 70214D UPG BRAINSC. 3/4.X - iPLAN RT DOSE 4.1.1;   34) 70214E UPG BRAINSC. 3/4.X - iPLAN RT DOSE 4.1.2;   35) 70214F UPG BRAINSC. 3/4.X - iPLAN RT DOSE 4.5.1;   36) 70226 UPGRADE IPLAN RT DOSE 3.0 TO 3.0.1;   37) 70226A UPGRADE IPLAN RT DOSE TO 3.0.2;   38) 70228 UPGRADE IPLAN RT DOSE 3.X TO 4.0;   39) 70228A UPG IPLAN RT DOSE 3.X TO 4.1.0;   40) 70228B UPG IPLAN RT DOSE 3.X TO 4.1.1;   41) 70228C UPG IPLAN RT DOSE 3.X TO 4.1.2;   42) 70228D UPG IPLAN RT DOSE 3.X
iPlan RT Radiation Treatment Planning Software: Potentially incorrect patient positioning when using multiple localized CT image data sets.
iPlan RT is a radiation treatment planning system that is intended for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck, and extracranial lesions.
Blood products, which Donor Screening/Deferral screening not done or incorrectly performed, including incorrect ID used during search,prior deferral due to history, was distributed.
American Red Cross Blood Svs. Indiana-Ohio Region
US Nationwide Distribution - AR, AZ, CA, CO, FL, FL, GA, IL, IN, MD, MI, MN, NC, ND, NJ, NY, OH, OK, OR, PA, PA, SC, TN, TX, VA, and WA.    The affected product was also distributed to one government consignee.     The affected product was also distributed to the following foreign countries:   Canada, Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Cayman Islands, China, Czech Republic, Denmark, Ecuador, Ethiopia, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Libyan Arab Jamahiriya, Malaysia, Mauritius, Mexico, Myanmar, Netherlands, New Zealand, Nicaragua, Norway, Oman, Panama, Poland, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, United Kingdom, and Vietnam.
Various Brilliance and Ingenuity Computed Tomography X-ray systems; one unit per package   Product Usage:  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Improper assembly of the vertical motor/brake system may lead to uncommanded vertical motion.
Harvest Blend, Net Wt. 4 oz. (113g)  Best If Enjoyed By: 12/05/2014, DISTRIBUTED BY 7-ELEVEN, INC., DALLAS, TX 75201 UPC 052548558253
Possible contamination with Listeria monocytogenes.
Veggie and Apples W/ Cheese, Total Wt: 7 oz. (198g) Best If Enjoyed By: 12/08/14, DISTRIBUTED BY SHEETZ DISTRIBUTION SERVICES, LLC. CLAYSBURG, PA 16625 UPC 7594465008860
Red Apple W/ Cheese Net Wt: 5oz. (142g) Best If Enjoyed By: 12/06/14, DISTRIBUTED BY SHEETZ DISTRIBUTION SERVICES, LLC. CLAYSBURG, PA 16625 UPC 759465009829
Del Monte Fresh Produce Pineapple Medley Net Wt. 8 oz. (227g) Best If Enjoyed By: 12/06/14, UPC 717524778178; THE FARMERS MARKET Pineapple Medley Net Wt. 8 oz. (227g) Best If Enjoyed By: 12/06/14, DISTRIBUTED BY GIANT EAGLE, INC., PITTSBURGH, PA 15238-2809 UPC 030034303235; THE FARMERS MARKET Pineapple Medley Net Wt. 16 oz. (454g) Best If Enjoyed By: 12/06/14, DISTRIBUTED BY GIANT EAGLE, INC., PITTSBURGH, PA 15238-2809 UPC 03003303242; THE FARMERS MARKET Pineapple Medley Net Wt. 32 oz. (907g) Best If Enjoyed By: 12/06/14, DISTRIBUTED BY GIANT EAGLE, INC., PITTSBURGH, PA 15238-2809 UPC 030034303259; Del Monte Fresh Produce Pineapple Medley Net Wt. 16 oz. (454g) Best If Enjoyed By: 12/06/14, UPC 717524773968
Del Monte Fresh Produce Red Apple Slices Net Wt. 12 oz. (340g) Best If Enjoyed By: 12/08/14, UPC 717524719119; Plain Transparent Label Red Apple Slices Net Wt. 12 oz. (340g) Best If Enjoyed By: 12/08/14; THE FARMERS MARKET Red Apple Slices Net Wt. 12 oz. (340g) Best If Enjoyed By: 12/08/14, DISTRIBUTED BY GIANT EAGLE, INC., PITTSBURGH, PA 15238-2809 UPC 030034303334
Del Monte Fresh Produce Red & Green Apples W/ Dip Net Wt. 5 oz. (142g) Best If Enjoyed By: 12/07/14, UPC 717524719430; Plain Transparent Label with a green and red border-Apples (Red and Green) Tray with Dip Net Wt. 24 oz (680g) Best If Enjoyed By: 12/08/14; THE FARMERS MARKET Apple (Red and Green) Tray with Dip Net Wt. 24 oz. (680g) Best If Enjoyed By: 12/08/14, DISTRIBUTED BY GIANT EAGLE, INC., PITTSBURGH, PA 15238-2809 UPC 030034303341; THE FARMERS MARKET Red & Green Apples with Caramel Dip Net Wt. 5 oz. (142g) Best If Enjoyed By: 12/08/14, DISTRIBUTED BY GIANT EAGLE, INC., PITTSBURGH, PA 15238-2809 UPC 030034087685
Red Apples W/ Dip Net Wt. 5 oz. (142g) Best If Enjoyed By: 12/08/14, Del Monte Fresh Produce UPC 717524719430
Del Monte Fresh Produce Fruit Gourmet Bowl Net Wt. 40 oz. (1134g) Best If Enjoyed By: 12/06/14, UPC 717524773968; Plain Transparent Label with a green and red border-Gourmet Bowl Net Wt. 64 oz. (1814g) Best If Enjoyed By: 12/06/14; THE FARMERS MARKET Gourmet Bowl Net Wt. 64 oz. (1814g) Best If Enjoyed By: 12/06/14, DISTRIBUTED BY GIANT EAGLE, INC., PITTSBURGH, PA 15238-2809 UPC 030034080259
Gourmet Mix Fruit Delight Net Wt. 64 oz. (1814g) Best If Enjoyed By: 12/03/14, Dist. By: Wegmans Food Markets, Inc., Rochester, NY 14603 UPC 077890241516
Apple Cinnamon Parfait Net Wt. 6.5 oz. (184g) Best If Enjoyed By: 12/06/14, DISTRIBUTED BY GIANT EAGLE, INC., PITTSBURGH, PA 15238-2809 UPC 030034999735
THE FARMERS MARKET Fruit & Cheese Snack Mix with Caramel Dip Net Wt. 7 oz. (198g) Best If Enjoyed By: 12/06/14, DISTRIBUTED BY GIANT EAGLE, INC., PITTSBURGH, PA 15238-2809 UPC 030034087708; Nature Made Snack Pack W/ Cheese Net Wt. 7 oz. (198g) Best If Enjoyed By: 12/06/14 UPC 717524720627; Nature Made Apple, Grapes and Cheese Net Wt. 7 oz. (198g) Best If Enjoyed By: 12/06/14 UPC 717524720627
Apple Slices, Grapes, Cheese Net Wt. 7 oz. (198g) Best If Enjoyed By: 12/07/14, Nature Made UPC 717524773944
Plain Transparent Label Apples & Grapes Tray with Caramel Apple Dip Net Wt. 9 oz. (255g) Best If Enjoyed By: 12/08/14
Worldwide Distribution: US Nationwide including Puerto Rico; Austria, Australia, Bangladesh, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, Egypt, Finland, France, Germany, Great Britain, Hungary, Ireland, India, Iran, Italy, Japan, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, and Tunisia.
Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
There are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. components.
Worldwide Distribution - US Distribution to the states of : AZ, MO, PA and WI., and the countries of : Austria, India and Japan.
Civco, MTSR02 Shoulder Retractor with Sherpa Wrist Loops Kit with Base, Non-sterile re-usable wool wrist strap, REF: 20SR02SUB2, Rx Only,    The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
The product (wool wrist loop) was manufactured 7cm shorter than product specifications.
Civco, MTSR03 Shoulder Retractor with Wrist Loops Kit with Base, plus two pairs of wrist loops (nylon and sherpa), Non-sterile re-usable wool wrist strap, REF: 20SR03, Rx     The devise is intended to pull patients shoulders down for clearance when treating lateral fields to the neck.
Worldwide Distrinution - US Nationwide in the states of TX, WI, MO, WV, SC, MA, WA, TN, AZ, CA, IL, NY, LA and countries of Kuwait, India, Venezuela, New Zealand, Turkey, Uruguay.
MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA;     Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies  :  Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone. MUM-1 [BC5] labels MUM-1protein in centrocytes and their progeny, plasma cells, activated T-cells and a wide spectrum of hematolymphoid neoplasms derived from these cells. MUM-1 has been reported to play an important role in mediating B-cell activation and differentiation.
Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over time has been observed.
Worldwide Distribution-US (nationwide) except AK and RI, including PR and the countries of Chile, Canada, Australia, Austria, Belgium, France, Hong Kong, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impactor, for the purpose of impaction, extraction, and insertion applications at steps within the surgical procedure. Due to the frequency of its use, two impaction handles are supplied in each kit.
CATALOG NO. : 2544-01-017 LOT NUMBER: All Lots  Barcode GTIN: 10603295423324
Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in the patient if not observed during surgery.
Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: The Artis family is dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.  Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
Suboptimal routing of the cable may result in increased wear over time. Without additional measures, damage of a cable may result in limited functionality and in rare cases, failure of a system. An ongoing procedure could be terminated in rare cases.
Worldwide Distribution: US (nationwide) and internationally to Canada.
Malleable C- Retractor, Part Number 397.232, used to provide retraction of the soft tissues during use of trocar instrumentation.  Used in the following systems: the Basic Trocar System, Universal Trocar System, Craniofacial Modular Fixation System, Craniofacial (CMF) Distraction System, MatrixORTHOGNATHIC Plating System, and the Matrix MANDIBLE Plating System.
Potential failure and/or corrosion of the internal spring of the retractor, which may have been manufactured from an incorrect material.  Surgical delay may occur. Spring particles could transfer from the instrument to the patient, and may lead to an adverse tissue reaction and/or infection.
Florida, Texas, Illinois, and New Jersey
Hors D'Oeuvre, Holiday Foods Breaded Macaroni & Cheese Bites (item number 4802280). UPC 70220748022808, Keep Frozen, For Institutional Use Only, Contains: 100 - 0.7 oz PCS.
Schwan's Global Supply Chain, Inc. is recalling three Holiday Foods products. This recall has been initiated because the products contain undeclared anchovy, an element of the Worcestershire sauce used in the finished product. People who have an allergy or severe sensitivity to fish run the risk of serious or life-threatening allergic reaction if they consume these products. There have been no reports of consumer illnesses to date.
Hors D'Oeuvre, Holiday Foods Breaded Macaroni and Cheese Bites with Quattro Formaggi & Truffle Oil (item number 4802539), UPC 70220748025397, Keep Frozen, For Institutional Use Only, Contains: 100 - 0.7 oz PCS.
Hors D'Oeuvre, Holiday Foods Breaded Macaroni and Cheese Bites with Quattro Formaggi Cheese, Lobster & Truffle Oil (item number 4802732), UPC 70220748027322, Keep Frozen, For Institutional Use Only, Contains: 100 - 0.7 oz PCS.
US: Nationwide (AL, CA, FL, GA, IL, MN, MO, NC, ND, NH, NJ, NM, NY, PA, TX, VA, WA)
Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform ophthalmic surgeries.
The devices were not shipped with the Starter Kits.
US Distribution to the states of : CA, KS, KY, NC, TX, WA, MI, OH, IA, PA, OR, MS, FL, NY, GA and AR.
POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic Sofamor Danek, USA, Inc.  Spinal surgical instrumrent.
The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
US Distribution to the states of : MA, WV, NY, FL, ME, NC, TX, IL, KS, TN, NJ, PA, CA, OR, WI, GA, and WA
MENTOR MemoryGel Resterilizable Gel Sizer Moderate Plus Profile STERILE.  Breast prosthesis sizer
The IFU provided in the affected units of the MENTOR MemoryGel Resterilizable Sizer is incorrect.  Those units include the IFU for the MENTOR MemoryShape Resterilizable Sizer.
Distributed in PR and the states of NY, AZ, TN, TX, and CA.
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102.    Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25, 2013 and TU00155: July 31, 2013
The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.
US Distribution to states of: AZ, CA, NY, TN, and TX including PR.
Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204    Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
The inner diameter of the Sleeve shaft is undersized; thereby, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl (the &quot;Awl&quot;) or the Anchored Lateral Straight Retractable Drill (the &quot;Drill&quot;) into the Sleeve shaft.
USA:  All states in continental US including, Guam, DC.   OUS;  ARAB EMIRATES, AUSTRIA, BOSNIA AND HERZEGOVINA, BRAZIL, BULGARIA, CAMBODIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CZECH REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONDURAS, HONG KONG, HUNGARY, INDONESIA, IRELAND, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, KUWAIT, LATVIA, LITHUANIA, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PHILIPPINES, POLAND, POLYNESIA, PORTUGAL, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM.
GE Healthcare has recently become aware of a potential safety issue involving the breakage of the two steel cables which support the bucky device in the wall stand of Proteus XR/a X-ray imaging systems.   No injuries reported.
Nationwide Distribution including TX, OH, VA, and Washington, DC.
lnline Persuader- PedFuse Pedicle Screw System; Part Number:  11-80164
A crack may develop in the handle to the Inline Persuader, which may progress if the user continues to use the affected instrument.
St Jude Medical Cardiac Rhythm Management Division
Worldwide Distribution: US (nationwide) and countries of: EU, Mideast, Canada, Australia/New Zealand, and Asia-Pacific (including Japan).
Merlin@home RF Remote Monitoring Transmitter, Model EX1150, with software versions 6.1M or 7.0.   Usage:RF Remote Transmitter
Transmitter may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Assura, Unify Assura, and Quadra Assura ICDs and Assurity and Allure Pacemakers.
US Distribution to states of: AZ, CA, NY, TN and TX including PR.
Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205.  Timberline Anchored Lateral Fixed Retractable Sleeves are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve.   Spinal surgical device.
LOT Numbers: TU00053A, TU00053B and TU00118 Product Code: 86300205
The inner diameter of the Sleeve shaft is undersized; resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve.
Perfect Bar Peanut Butter, size 2.5 oz, UPC 8-55569-00302-9, 144 units/case
Perfect Bar is recalling Peanut Butter and Cranberry Crunch nutritional bars due to potential contamination with Salmonella.
Perfect Bar Cranberry Crunch, size 1.6 oz, UPC 855569-00305-0, 144 units/case
Perfect Bar Variety Pack (Costco Only), size 1 lb 9.6 oz, UPC 8-55569-00313-5, 10 packs/case
Worldwide Distribution-Distributed in the states of CO, CT, MS, NJ, NY, OH, and WA, and the countries of BELGIUM, CANADA, CHINA, FRANCE, GERMANY, JAPAN, MEXICO, PERU, UNITED ARAB EMIRATES, and UNITED KINGDOM.
GE Healthcare, Discovery IGS 730 & Discovery IGS 740.   Discovery IGS 730 : The angiographic X-ray systems are indicated for use in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular & non vascular diagnostic and interventional procedures.     Discovery IGS 740: The angiographic X-ray systems are indicated for use for patients from newborn to geriatric in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and nonvascular, diagnostic and interventional procedures.
GE Healthcare has recently become aware of a potential safety issue with respect to a potential unintentional system motion or rotation due to a positioning user interface issue with your Discovery IGS 730 &amp; 740 products.   There have been no injuries reported due to this issue.
US: FL, WA, IL, UT, NY, CA.       OUS: Canada, France, Hong Kong, Japan, Switzerland, United Arab Emirates.
GE Healthcare Revolution CT., multi-slice (256 detector row) CT scanner.
GE Healthcare has recently become aware of a potential safety issue due to a required torque check on three bolted joints of your Revolution CT scanner.   No injuries or illnesses reported.
ADVIA Chemistry XPT  interfaced to the CentraLink'' Data Management System V14x in specific configurations: The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from all connected instruments so that an operator can review and edit patient and quality control results from a single location.
CentraLink'' Data Management System V14x Catalog Numbers: 10817209, 10818262
Enabling sending of preliminary/initial results on the ADVIA Chemistry XPT creates a risk that a critical result could be overwritten by the same result rather than showing the repeated result on CentraLink. A result could be erroneous and critical and appear to be verified upon repeat.
EXp Tibial Insert ; Intended Use of Device(s):  The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult.
Stryker Instruments Div. of Stryker Corporation
US Nationwide Distribution in the states of  AK, AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
The SurgiCounter Charging Cradle      Product Usage:  SurgiCounter Charging Cradles are designed to be used with the SurgiCounter and are part of the SurgiCount Safety-Sponge System. The SurgiCount Safety-Sponge System is indicated for use in counting and recording the number of Safety-Sponge surgical sponges, laparotomy sponges, and towels used during surgical procedures.
Part number: SC-0014 All lots at time of notice 6/16/2013
Faulty SurgiCounter Charging Cradle can prevent the scanner from charging or downloading information after a procedure.
Sweet Blueberry Almonds - Blueberry Flavored Almonds. Ingredients: Almonds, Sugar, Natural Flavor, Vegetable Color (Red Cabbage Juice Extract), Beet Juice Concentrate.    May also contain other tree nuts, peanuts, milk, wheat, egg.    Packaged in the following configuration:  4 oz (113 gr) stand up pouch;  5 lbs. (80 oz) Corporate Bags;  1 oz. (28 gr) sample size bags.    Distributed by NatureBox,  San Carlos, CA 94070.
Inspector at manufacturing facility noticed that product label did not contain soy lethicin as listed on the product recipe.
Tofu Pad Thai Bowl.  PERISHABLE, KEEP REFRIGERATED.  Net Wt. 13.5 oz   UPC 0 30223 00914 6
Tofu Pad Tai Bowl and Thai Noodle Salad are being recalled due to misbranding and undeclared allergens (shrimp).
Haggen NORTHWEST FRESH Thai Noodle Salad with Thai Peanut Dressing.   KEEP REFRIGERATED.  Net Wt. 8.5 oz   UPC 0 45009 10116 7
Tofu Pad Tai Bowl and Thai Noodle Salad are being recalled  due to misbranding and undeclared allergens (shrimp).
Glycopyrrolate injection, 0.2 mg per mL (1 mg/5 mL), 5 mL Fill in 10 mL Syringe, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR  72205, 877-550-5059
Labeling: Incorrect or missing Lot and/or Exp Date: Printing error caused an overlap in the ''y'' and ''3'' making the actual ''Use By 3/2015'' date appear to read ''Use By8/2015''.