Bimbo 100% Whole Wheat Bread, 16oz,  On bag: SEP 01,  UPC: 7432309230    Sara Lee 100% Whole Wheat Bread 16 oz	On bag: SEP 01   UPC: 7294561103;     Sara Lee 100% Whole Wheat Bread  20 oz	On bag: SEP 01    UPC: 7294560134;     Kroger 100% Whole Wheat Round Top Bread, 16 oz, On bag: SEP 01, UPC: 1111000132;    Nature's Harvest Stone ground 100% Whole Wheat Bread, 20oz, On bag: SEP 01, UPC: 7870080162;     Great Value 100% Whole Wheat Roundtop Bread, 16oz, On bag: SEP 01, UPC: 7874207448;     Great Value 100% Whole Wheat Bread,  20oz, On bag: SEP 01, UPC: 7874236690
Certain bread products under multiple brands, including supermarket brands, recalled due to possible glass contamination.
Sara Lee Delightful 100% Whole Wheat made with Real Honey Bread  20oz  On bag: AUG 29 UPC: 7294571589;     	  Sara Lee Honey Wheat Bread; 20 oz; On bag: SEP 01   UPC: 7294560136;   Sara Lee Honey Wheat Bread Twin pack 2 lbs 8oz  On bag: SEP 01	 UPC: 7294561159;
Fit & Active Multigrain Bread,  20 oz, On bag: AUG 31, UPC: 4149821093
Sara Lee Delightful Healthy Multi-Grain Bread Twin pack, 2 lbs 8 oz, On bag: AUG 29, UPC:  7294561169;   Sara Lee Delightful Healthy Multi-Grain Bread,  20 oz, On bag: SEP 01, UPC: 7294571588
Peru Food Mote Corn Maiz Mote Net Wt. 15 oz.   Imported and distributed by: Peru Food Import Inc.PO Box 419 West New York, NJ 07093    UPC 812125009628
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Whole Foods Market Midwest Distribution Center  480 West 45th Street Munster, IN 46321
Wild Mushroom Soup packaged in a 24 oz clear plastic container with green and white label and green lettering.
33 cases, 6, 24 oz containers of soup per case.
The Wild Mushroom soup was MIS-la bled and does not declare chestnuts.
Christmas Cookie Tray INGREDIENTS: ***Butter, Margarine***Nuts***1.51lb(682gr) EUROPEAN SPECIALTIES Cincinnati, Ohio 45227 UPC 0 36746 03992 9
The firm was notified by the Ohio Dept of Agriculture that the labeling on the product is misleading.  The firm does not accurately describe the allergens on their label.
67/8 oz. pkgs, 274/14 oz. pkgs, 3/5 lbs. pkgs
Peppered flavor of Native Catch Salmon Bacon product is recalled because it has the potential to be contaminated with Clostridium botulinum.  The potential for contamination was noted after a routine Washington State Department of Agriculture (WSDA) inspection discovered that the product had potentially been under processed.
Traditional flavor of Native Catch Salmon Bacon product is recalled because it has the potential to be contaminated with Clostridium botulinum.  The potential for contamination was noted after a routine Washington State Department of Agriculture (WSDA) inspection discovered that the product had potentially been under processed.
Distributed to firms in Florida and Georgia
Cucumbers packed in 1 1/9 cardboard bushel boxes (~55-lb) and 1000-lb cardboard bins.  Refrigerate at 40-60 degF. Pick date of 12/15/2015.
L.G. compounded Asafoetida powder has the potential to be contaminated with Salmonella.
Sebastian Super Lump Pasteurized Crab Meat, Blue Swimming Crab Meat, Wild Caught, 16 ounce
European Natural Foods & Trading Company, Inc.
Brian's Cauliflower may contain undeclared sulfites.
Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.
Robotic Arm Interactive Orthopedic System (RIO)
Distribution US Nationwide and Hong Kong
Ossur Lil Angel Vest P2 Kodel.  Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest.
P/N: 545100K  units from 2008 to current
Ossur Lil Angel Vest P3 Lambswool. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
P/N: 545150L  units from 2008 to current
Ossur Lil Angel Vest P2 Lambswool.  Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
P/N: 545100L  units from 2008 to current
Ossur  Lil Angel Vest P2 Sorbatex.  Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
P/N: 545100S  units from 2008 to current
Ossur Lil Angel Vest P3 Kodel.  Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
P/N: 545150K  units from 2008 to current
Ossur Lil Angel Vest P3 Sorbatex. Pediatric sized vest is a support structure used with the halo system for traumatic or chronic disorders requiring traction along the cervical spine.
P/N: 545150S  units from 2008 to current
True Nature Original Hummus is being recalled due to undeclared soy from the ingredient Tamari.
All products dated prior to 3/9/16 - specifically best-by dates of 3/5, 2/28, and 2/21
True Nature Garlic Hummus is being recalled due to undeclared soy from the ingredient Tamari.
All products dated prior to 3/9/16 - specifically best-by 3/5, 2/28. and 2/21
True Nature Arugula Hazelnut  Pesto is being recalled due to undeclared milk in the parmesan cheese ingredient.
All products dated prior to 3/9/16 - specifically 3/8, 3/1, and 2/23
33 Kopobbi A WHOLE MILK CHEESE, Ricotta, Net Weight: 17.14 lb.
The Massachusetts Department of Public Health sampled the product which tested positive for the  presence of  Listeria monocytogenes.
Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4.
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
CO, AZ, and CA. See distribution spreadsheet in the attached email.
Almonds, dry roasted, not salted, packaged in 25 lb. cardboard cartons
Cashews were mixed with almonds but allergen was not declared on outside packaging.
Item number ALMO-033; Manufacturer lot number 1050188-1-16007 (on container label); Warehouse lot number LV0206674
Domestic: Nationwide- AL; AR; AZ; CA; CO;CT; DE; FL; GA; HI; IA; ID; IL; IN; KS; KY; LA; MA; MD; ME; MI; MN; MO; MS; NC; ND; NE; NH; NJ; NM; NV; NY; OH; OK; OR; PA; SC; SD;TN; TX; UT; VA; VT; WA; WI    No VA/DOD    Foreign: Canada, France
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, 6 x12, Apple/Banana Flavor Variety
, and followed by  01, 02, 03, 04, 05, 06, 07 or 08; Cases have a 6-digit code ending in the last two digits 01, 02, 03, 04, 05, 06, 07 or 08.
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Peach/SweetPotato (Pedal Pedal Peach) Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Grape/Sweet Potato (Grateful Grape) Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, Apple/Peach Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Pear/Carrot (Zippin'Zingin'Pear) Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, 6 x12, 1 x 18, 1 x 48, 1 x100, 36 x 4,  Mighty Mango Fruit & Veggies on the Go, (Apple/Mango/ButternutSquash) Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, 6 x 12, Apple/Grape Flavor Variety
Gogo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Strawberry Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Pineapple Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Mixed Berry/Carrot (Boulder Berry) Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, Apple/Pear Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 4 x 16, 120 x 12, 180 x 4, 360 x 4, 6 x 12, 7/16, 1 x 20, 1 x 24, and 36 x 4; Variety Packs/Multi-Packs with Multiple Flavor Varieties
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Pumpkin Spice  Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 4x18, Apple/Berry Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12 x4, 6 x12, 1x18, 4 x16, Apple/Cinnamon Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, Apple/Yellow Carrot/Banana (Boatin' Banana) Flavor Variety
GoGo squeeZ, non-organic Apple Sauce pouches, 3.2 oz., 12x4, 6 x 12, Apple/Mango Flavor Variety
Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-7077-14
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Dextrose Injection, USP, 70%, Packaged as  500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5
Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2
Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5
Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL  60045,  NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2
Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL  60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9
Starbuck's Cheese & Fruit Bistro Box NET WT 5.3 OZ/150g packaged in non-flexible plastic container.
The recall is being issued as a precaution after a limited number of product tested positive for the presence of Listeria monocytogenes.
Stryker received two reports indicating that during screw insertion under a high lateral angle a bone screw went through a oblong hole.
Worldwide Distribution - USA (nationwide) Distribution to the states of :  AL, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, LA, MA, ME, MD, MI,  MO, NH, NJ, NY, NC, OH, PA, RI, SC, TN, TX, UT, VT, VI, WA, WV, WI, and District of Columbia and to the countries of UK and Germany.
Aluminum rivets holding the base squab to the framer under prolonged customer use were seen to elongate and subsequently break.
Serial Numbers: 140401487591 to 140410249946.  All models manufactured before April 2012
Aurora Area Blood Bank Dba Heartland Blood Centers
Blood and Blood Products for Reprocessing
Blood products, collected from an ineligible donor, were distributed.
Products were distributed to several distributors in the chicagoland area.
Korea white Kimchee packaged in 1 gallon, 1/2 gallon, packaged in glass jars inside plastic containers with multi colored label and black lettering.
1 gallon: 3 boxes, 4 jars/box, 1/2 gallon: 1 box, 6 jars/box
Undeclared anchovies in Kimchee product.
This product does not contain any codes or expiration dates.
Korea chopped Kimchee packaged in 1 gallon, 1/2 gallon, 1/4 gallon, and 1/8 gallon packaged in glass jars inside plastic containers with multi colored label and black lettering.
1 gallon: 401 boxes, 4 jars/box 1/2 gallon: 167 boxes, 6 jars/box 1/4 gallon: 371 boxes, 12 jars/box 1/8 gallon: 113 boxes: 12 jars/box
Korea whole Kimchee packaged in 1 gallon packaged in glass jars inside plastic containers with multi colored label and black lettering.
Worldwide Distribution - US Nationwide in the states of NC, CA, NY, TX, NJ, CO and the countries of: Ontario and Canada.
Cervical Spine Locking Plate (CSLP) System, 4mm Cancellous Self Tapping Screw, Length 16mm Lot # 9666776 and 4mm Cortex Standard Screw, Length 16mm Lot # 9671879
30 units of Lot # 9666776 and 11 units of Lot # 9671879
DePuy Synthes is initiating a Voluntary Medical Device Recall of lot # 9666776 and 9671879 of Cancellous and Cortex 4.0 mm Screws, which are a part of the Cervical Spine Locking Plate (CSLP) System due to discovery of a single lot of 450.136 screws (4mm Cancellous Self Tapping Screw, Length 16mm, lot 9666776) being swapped with a single lot of 450.016 (4mm Cortex Standard Screw, length 16 mm, lot
Worldwide Distribution-US (nationwide) including Puerto Rico and the states of  MA, CA, SC, NJ, TX, CO, FL, PA, NY, MO, WI, NC, UT, ID, AZ, MI, KY, CT, OR, , IL, AL, MN, MT, OH, NE, GA, IN, SD, TN, OK, AK, KS, NV, NM, , ND, VA, WA, WY and MD, and the countries of China, Belgium, France, Germany, Great Britain, Italy, Norway, Portugal, Spain, Sweden, Switzerland, India, Japan, Argentina, Chile, Colombia, Mexico, Peru, Belarus, Egypt, Greece, Morocco, Poland, Qatar, Romania, Russian Fed., Saudi Arabia, South Africa, Turkey, Canada, , Australia, Malaysia and Taiwan.
Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device.  Intended for improving the visibility of objects through magnification and illumination.
An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope.
Hill Country Fare Chunk Light Tuna in pure vegetable oil NET WT. 5 OZ (142g) packaged in a metal can.
The product may have been under processed.
Worldwide Distribution - US Distribution including Puerto Rico and to the states of : California, Illinois, Washington and Wisconsin., and to the countries of :  Angola, Austria, Canada, Chile, Colombia, Czech Republic, France, Germany, India, Italy, Kenya, Netherlands, Norway, Portugal, Singapore, Slovenia, Spain, Turkey, Uganda and United Kingdom.
ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD    The ADVIA 560 Hematology System is a fully-automated, high-quality hematology system for in vitro diagnostic use in clinical laboratories
Software anomaly; Siemens identified that software version 1.4.2133 on the ADVIA 560 Hematology System does not trigger the following flags: The G or L morphology flags for immature granulocytes (IG) and atypical lymphocytes (ATYP), respectively.  The results from patient samples which have immature granulocytes or atypical lymphocytes will not generate the flags when they should.  As defined in t
All serial numbers of ADVIA 560 Hematology Systems.
Nationwide Distribution-including DC, and Puerto Rico and the states of AK, AL, AR, AZ, CA, CO, CT,  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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Siemens SOMATOM Definition: Intended to produce cross-sectional images of the body.  Computed tomography (CT) x-ray system.
Software bugs in these SOMATOM systems could possibly cause scan aborts, re-scans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.
Model Number: 7740769 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.
Siemens SOMATOM Definition Flash; Intended to produce cross-sectional images of the body.  Computed tomography (CT) x-ray system.
Software bugs in these SOMATOM systems could possibly cause scan aborts, rescans of patients with additional dose, delayed diagnosis and as worst case scenarios, could possibly cause the need of additional contrast medium, accidental x-radiation to the user or impede customer workflow.
Model Number: 10430603 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.
Siemens SOMATOM Definition, SOMATOM Definition AS, SOMATOM Definition Flash and SOMATOM Definition Edge; Intended to produce cross-sectional images of the body.  Computed tomography (CT) x-ray system.
Model Number: 10590000 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.
Siemens SOMATOM Definition AS; Intended to produce cross-sectional images of the body.  Computed tomography (CT) x-ray system.
Model Number: 8098027 SOMATOM Definition family of CT systems running on software versions VA44A_SP3a, VA44A_SP3b, VA44A_SP3c.
US nationwide distribution to MO, OK, FL, and NJ.
MEVION S250 for Proton Radiation Therapy
Possibility of Gantry Motion with Aperture or Compensator only partially inserted.  An Aperture may fall out during Gantry motion.  It is possible that it can hit a patient and cause traumatic injury or death.
US Nationwide Distribution in the states of: AL, AR, C, FL, IL KY, LA, MD, MA, MI, MN, MO, NJ,NY, NC, OK,OR, PA, TN, TX, VA and WA.
Coloplast Corp. is voluntarily recalling a single lot of Self-Cath Pediatric French Size CH 06 catheters  because a small portion of the lot was identified to have missing eyelets. This recall is based upon a  complaint Coloplast received regarding a catheter malfunction.
International Distribution only in countries of: Germany and Switzerland.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
The Affected Devices may contain a dimensional deviation that could potentially result in the  surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base  plate during surgery.
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N 7500282, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG    Product Usage: Tibial knee prosthesis
Zemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.
Domestic: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI    Foreign: None  VA/DOD: None
GERBER Organic 2ND FOODS Pears, Carrots & Peas, 3.5 oz., film pouches,  6 pouches per display box/ 2 display boxes per case; Asst Ecom PK2 18 pc, 3.94 Lbs.
Smart Lipo Dietary Supplement capsules, 950 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011
Multiple dietary supplement regulation violations.
Worldwide Distribution - US (nationwide) including DC &  VI except DE, ID, SD, and WY and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Chile, Croatia, Cyprus, Ecuador, France, Germany, Great Britain, Hungary, Italy, Japan, Jordan, Korea, Malaysia, Mauritius, Mexico, Netherlands, Philippines, Portugal, South Africa, Spain, Sweden, Thailand, Trinidad, Tobago, and Uruguay.
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001.      Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving reports from the field of catheter shaft breaks; including cases requiring the use of a snare or other intervention to retrieve the http://webapps.cdrh.fda.gov/division-tracking/images/trash.pngbroken shaft from the patient.
Nationwide Distribution -- AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI.
OraQuick HCV Visual Reference Panel     Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Panel instead of an OraQuick HCV Visual Reference Panel.
Worldwide Distribution-US (nationwide) including  Puerto Rico and the countries of Austria, Bosnia & Herze, Cameroon, Egypt, Germany, Indonesia, Iraq, Lebanon, Mali, Montenegro, Netherlands, Philippines, Tanzania, Thailand, UAE, New Zealand, Malaysia, Mexico, South Korea, Jamaica, Turks & Caicos, Italy, Canada, Vietnam, Singapore, Argentina, Colombia, France, Paraguay, Australia, Uruguay, Bahrain, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Ethiopia, Finland, Greece, Switzerland, United Kingdom, Brazil, Hong, Kong, Hungary, India, Ireland, Israel, Kazakhstan, Kenya, Kuwait, Latvia, Lithuania, Luxembourg, Turkey, Jamaica, St. Martin, Nigeria, Oman, Pakistan, Philippines, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, Slovenia, Spain, Guatemala, Peru, and Uruguay.
CELL-DYN Emerald Cleaner, product number 09H46-02.  960mL.   IVD;    Hematology:  The CELL-DYN Emerald Cleaner is designed for use on the CELL-DYN Emerald System, which is an automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories. The CELL-DYN Emerald Cleaner is an enzymatic cleaner used to clean the measurement system and the fluidics.
Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT.
Lot 6853, Expiration date: 31 JUL2017;  Lot 6901, Expiration date: 31JUL2017;  Lot 6953, Expiration date: 30SEP2017;
Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10
Distributed in the states of GA and  MI, and the countries of FRANCE, UNITED KINGDOM, COLOMBIA, and  BRAZIL.
Ad-Tech Electrode Connection System/Cables.  Lightweight TECH-ATTACH Cable Models:    1.  L-DCL-4DINX (4 contacts:  1 terminal block with 4 connectors each);    2.  L-DCL-6DINX (6 contacts:  1 terminal block with 6 connectors each);     3.  L-DCL-8DINX (8 contacts:  1 terminal block with 8 connectors each);     4.  L-DCL-16BDINX (16 contacts:  1 terminal block with 16 connectors each);     5.  L-DCL-32BDINX (32 contacts:  2 terminal blocks with 16 connectors each);    6.  L-DCL-64BDINX (64 contacts:  4 terminal blocks with 16 connectors each).    FO TECH-ATTACH Connection Cable model FO-LDC-4DINX (4 contacts:  1 terminal block with 4 connectors each).  Tech-Attach:  these cables require the use of an additional component - the connector block.  The tail of the electrode is inserted into the block and the block in turn mates with the cable.  A key-pin is used to ensure proper orientation.  The cable terminated in EEG compatible connector sockets.    Lightweight CABRIO Cable, model L-SRL-64BDINX (64 contacts:  4 terminal blocks with 16 connectors each).  Cabrio cables are similar to Tech-Attach cables except that the block portion is pre-attached.  The tail of an electrode is inserted into this portion which then hinges shut.
Ad-Tech is recalling unopened/unused sterile cables intended to be used only with all compatible Ad-Tech electrodes for the purpose of connecting these electrodes to third party monitors/stimulators.  This recall has been initiated due to package failures (i.e. compromised sterile barriers) that were identified during the execution of a shipping simulation investigation.
Worldwide Distribution: US (nationwide) including states of: OH, CO, WA, IL, MI, CA, TX and countries of: Hong Kong, Italy, Germany, France, Spain, Australia, Canada, Sweden, India, Turkey, Cyprus, Belgium, Switzerland, Czech Republic, Uruguay, Mexico, Saudi Arabia, Russia, Brazil, Netherlands, and Ukraine.
GDC-10 360 SOFT 10MM X 20CM SR Detachable Coil  Sterile;  Model number: M0033471020SR0;    Neurology: GDC 360 Detachable Coils are intended for embolization of those intracranial aneurysms that  because of their morphology, their location, or the patients general medical condition  are considered by the treating neurosurgical team to be  a) very high risk for management by traditional operative techniques, or  b) inoperable.
The incorrect DFU was packaged with two lots of GDC 360 degree Detachable Coils.
Platelet products, not prepared according to specifications, were distributed.
US Nationwide Distribution in the states of: KS, CA, AZ, OR, FL, KS, CO, MA, KY, NY, IL, OR, MO, NC, TX, PA, OK. SC, TN, PA, TN, GA, and OR.    Hungary, Canada, Boliva
Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit;  Catalog number M4U534L;  For In Vitro Use    Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient's clinical history and other diagnostic tests by a qualified pathologist.
Biocare Medical has identified a single lot (082715) of its Mach 4 HRP Polymer kit in which some few Mach 4 Mouse Probe vials may have been mislabeled as HRP-Polymer.
Worldwide Distribution -- US, including the states of CO, DE, FL, GA, IL, IN, KS, MO, NC, NV, NY, OH, OR, PA, TN & TX; and, the countries of Australia, Austria, Belgium, Canada, China, Denmark, Egypt, France, Germany, Greece, Ireland, Israel, Italy, Lebanon, Malaysia, Saudi Arabia, Slovenia, South Africa, Switzerland, Turkey, & United Kingdom.
Extended Brilliance Workspace NM Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH.    Provides software applications used to process, analyze, and display medical images/data.
IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medical Systems, Cleveland, OH.    Provides software applications used to process, analyze, and display medical images/data.
Extended Brilliance Workspace NM Special Nuclear medicine image display and processing application suite. AutoSPECT Pro Software Application. Philips Medical Systems, Cleveland, OH.    Provides software applications used to process, analyze, and display medical images/data.
Central Texas Regional Blood & Tissue Center
Apheresis red cells, not meeting product specifications, were distributed.
Blood product, collected from an ineligible donor, was distributed.