Recalling Firm
Implant Direct Sybron Manufacturing, LLC
Fresenius Medical Care Renal Therapies Group, LLC
Department of Army William Beaumont Army Medical Center
Blood Centers of the Pacific - Irwin Center

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
sent out to vaiours manufactures. A spreadsheet of customers is attached.
Nationwide Distribution through Tuesday Morning retail stores.
Worldwide Distribution - US (Nationwide) and Internationally to Albania Austria Belgium Bulgaria Burkina Faso Canada Croatia Cyprus Czech Republic Denmark Egypt Estonia Finland France French Polynesia Georgia Germany Great Britain Greece Guadeloupe Hungary Iceland Italy Kazakhstan Latvia Lithuania Luxembourg Macedonia Malta Martinique Netherlands Norway Poland Portugal Romania Russian Federation Serbia Slovakia Slovenia Spain Sweden Switzerland Tunisia Turkey United Arab Emirates and Uzbekistan.
Alabama, Arkansas, Colorado, Delaware, Florida, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Vermont, Wisconsin, and West Virginia Per Dutch Valley Distributors.
U.S. distribution to the following; CA, VA, MO, AR, KY, LA, OR, OH, NY, MT, MN, CO, IL, WV, UT, SD, PA, TX, NE, FL, KS, AZ, MA, IA, MD, NJ, CT, WI, TN, MI, VA, OK, WA, HI, PR. Foreign distribution to the following; Canada, Finland, Australia, Sweden, Hong Kong, Poland, Lebanon
Nationwide Distribution to UT, MA, OH, IN, NC, NY, VA, CA, IA and KY.
AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MD, MI, MN, MO, NE, NH, NY, OH, OR, PA, SD, TX, UT, VA, WI.
Distributed in the states of MA, CA, and WA and the countries of Australia, Denmark, Turkey, Germany, Russia, Slovenia, Netherlands and Zambia.
US Distribution to the states of : OR, IL, IA, NC, TX, CA, GA, OH, WI, AR, MI, MD, IN.
Batesville, MS for retail products; LA, MS, TN, AL, GA, KY, AR for caramel icing.
Worldwide Distribution - U.S. Nationwide in the states of OR, NE, VA, FL, MO, WA, TX and the countries of CZ, GB, NL, MF, DK, IT, IE, DE
Worldwide distribution. US nationwide; Portugal, Spain, Thailand, Italy, China, Romania, Egypt, India, France, Hungary, Mexico, Germany, Norway, Turkey, Pakistan, Malaysia, UK, Luxembourg, Israel, Canada, Switzerland, Taiwan, South Africa, Saudi Arabia, Korea, Singapore and Japan.
Nationwide directly to consumers through online purchase.
US Distribution to states of: CA, FL, KS, NE, NY, and PA.

Product Description
Pea protein 85% dry powder in a 20 KG bag.
Triple Ginger Brew, 25.4 FL OZ (750 mL) glass bottles, SKU 51857 Bottles are sold individually; there are 9 bottles per case
Germ Terminator, Toothbrush Steam Sterilization for Oral Health. Model GT100. The Germ Terminator uses steam heat to sanitize two manual toothbrushes or two toothbrush heads. Water is poured into a reservoir in the device's housing. The steam cycle is followed by a drying cycle.
Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems Cat No. 02789602/SMN 1031 7708 (100 test) Cat No. 02790309/SMN 10317709 (500 test)
Wicker's Black Label Steak Marinade, 16 Fl. Oz. (473.28 mL), Ingredients: Soy Sauce (Water, Salt, Hydrolyzed Soy Protein, Corn Syrup, Caramel Coloring), Vinegar, Herbs and Spices
Golden Gourmet Snacks Veggie Chips; Net Wt. 12 OZ; Bickel's Snack Foods, Inc., York, PA 17404 Lot codes: 26SEP16 Z4D1 and 26SEP16 Z5D1
Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01
Blood and Blood Products for Reprocessing
Let's Talk Health Energizer Drink Mix Citrus 0.3oz UPC #91131180631
Let's Talk Health Aqua Vitae Multi-Vitamin 32oz. UPC #91131181096
Let's Talk Health Energizer Drink Mix Pomegranate 0.3oz UPC #91131180525
Let's Talk Health Tox Elim Liquid 32oz. UPC #91131181119
Let's Talk Health Energizer Drink Mix Strawberry/Banana 0.3oz UPC #91131180624
Let's Talk Health Agua Vitae Kids Multi-Vitamin Liquid 16 oz. UPC #91131180280
Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls are used to detect antibodies in patient serum by the complement fixation (CF) procedure to aid in the diagnosis of four specific fungal diseases: Histoplasmosis, blastomycosis, coccidioidomycosis, and aspergillosis
Dakota Style Roasted & Salted Sunflower Kernels, Net Wt. 3.5 oz. plastic bag. UPC 84872-20172
Savory Bacon Sunflower Kernels, Net Wt. 4 oz and 8 oz.
NUTS Sunflower Seeds Roasted & Salted Vending Nut Co. Fort Worth, Texas 76107 Net Wt. 16 oz. (1 LB.) 454g packaged in plastic bags
NUTS Vending Nut Co. 2222 Montgomery St. Ft. Worth, TX 76107 817-737-3071 www.vendingnut.com Sunflower Seeds Roasted & No Salt Net Wt. (160 oz) 10lb UPC: 0-98301-00006-5 in cardboard container.
1% Clotrimazol cream, 30 mg tube, UPC 501318644335
tabcin NOCHE; Capsules,12-count box, UPC 501008485033
tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057
VERMOX Tablets 500 mg, 1-count box, UPC 501109900596
VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619
SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods.
SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 64-4R TruePoint w/TrueV, MATERIAL NUMBER 10097302 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow 20-3R, MATERIAL NUMBER 10528956 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow 20-4R, MATERIAL NUMBER 10528958 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow 40-4R, MATERIAL NUMBER 10529159 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 40 TruePoint, Material Number 10097303 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 40 - 3 Ring, Material Number 10097233 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH Sys 40-3R to 40-4R, MATERIAL NUMBER 10246388 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph 6 TP 3R to 4R Upgrade, Material Number 10246387 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph mCT-X 4R, MATERIAL NUMBER 10248670 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 6 TruePoint, Material Number 10097289 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 64 - 3 Ring, Material Number 08727450 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 40-3R to 64-3R Upgrade, Material Number 10246390 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow 40-3R, MATERIAL NUMBER 10529158 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH SYS 64-3R to 64-4R, MATERIAL NUMBER 10246389 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 6-4R TruePoint w/TrueV, MATERIAL NUMBER 10097290 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 40 TruePoint w/TrueV, Material Number 10097304 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH 64-3R TruePoint, MATERIAL NUMBER 10097301 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph Sys 16-3R to 16-4R upgrade, MATERIAL NUMBER 10525581 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Biograph 16 TruePoint TV, Material Number 10249556 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
white and dark chocolate peanut clusters
white and dark chocolate pecan krispie clusters
white and dark chocolate pecan turtles and tortoises
The Caramel Factory (TM) Caramel Icing, NET WT. 22OZ, 1 LB. 6OZ. (622 grams) and 2.5 GAL bucket
white and dark chocolate cashew turtles and tortoises
sugar free milk chocolate cashew cluster
white and dark chocolate cashew clusters
sugar free milk chocolate peanut cluster
(Albertsons/Safeway/Basha Hometown Grocers) Oriental Salad with Sesame Ginger Dressing, Net Wt.10 oz.(284g), 24 pieces per case, UPC 78279602691; (Food 4 Less) Oriental Salad with Sesame Ginger Dressing, Net Wt. 13 oz. (369 g), UPC 78277602840
Crit Line in a Clip (CLiC). CliC P/N: CL 10041001 CLiC is a continuous real-time monitor for non-invasive hematocrit oxygen saturation and percent change in blood volume measurement during hemodialysis treatment. Used in conjunction with the Fresenius 2008T Hemodialysis Machines as follows: Model: 190895 2008T GEN 2 BIBAG w/o CDX 190713 2008T Hemodialysis SYS with CDX 190858 2008T Hemodialysis System w/o CDX 190766 2008T Hemodialysis System w/o CDX
CytoVision Image Analysis and Capture System, an automated cell-locating device. The Cytovision is a rapid metaphase finder, image acquisition and computer aided chromosome analysis system which assists the operator in viewing chromosomes and looking for cellular anomalies. CytoVision enables a qualified Cytogeneticist to rapidly and accurately analyze the chromosome banding pattern.
Hyoscyamine Sulfate Sublingual Tablets, 0.125 mg, packaged in 100-count bottles, Rx only, Manufactured for: Virtus Pharmaceuticals OPCO II, LLC. Nashville, TN 37217. NDC 76439-0309-10
over-the-wire delivery system. The stent is cut from a Nitinol tube in an open lattice design, and has tantalum radiopaque markers at the proximal and distal ends of the stent. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency
Big Sur Breakfast Burrito; A delicious blend of roasted potatoes & red peppers, smoked seitan and seasoned tofu. Net Wt. 7.0 oz. (198 g). Ingredients: Filling: Russet Potatoes, tofu (water, soybeans, Calcium sulfate, Calcium chloride, Sweet Earth Traditional Seitan (water, wheat gluten, soy sauce (water soybeans, wheat, salt, alcohol), ginger, garlic, lemon, roasted red peppers, yellow onions, canola oil, nutritional yeast, sea salt, natural hickory smoke, turmeric and spices. Wrap - ,water. unbleached white flour , Non GMO expeller, pressed canola oil, salt, baking powder (sodium bicarbonate, sodium acid pyrophosphate, potato starch), yeast, citric acid. Contains, Soy, wheat. UPC - 7 oz. unit: #016741111127; UPC - 12-pack case: #016741111134 Sweet Earth Natural Foods, Moss Landing, CA 95039.
NatureBox Cheddar and Onion Sunflower kernels: 5 oz. (142g) customer stand up pouch. UPC: 8 54557 00531 1 Ingredients: Non GMO Sunflower kernels, Sunflower Oil, Sweet Onion and White Cheddar Seasoning Blend (cane sugar, onion and garlic powder, cheddar cheese powder {cheddar cheese (pasteurized milk, cheese cultures, salt, enzymes), buttermilk, whey, salt, disodium phosphate}, salt, natural flavors, lactic acid, spices, silicon dioxide (to prevent caking). Contains: Milk. Distributed by NatureBox, San Carlos, CA 94070
SunOpta Country Ranch Sunflower Kernels- 45lbs case 6075 lbs received (35 cases)
NatureBox Country Ranch Sunflower kernels; 5 oz. (142g) customer stand up pouch. UPC: 8 52523 00535 8 Ingredients: Sunflower kernels, Sunflower Oil, Buttermilk Powder, Salt, Rice Syrup Solids, Onion and Garlic, Sour Cream Powder (cultured milk, nonfat milk), Tomato Powder, Cheese Powder (cheddar cheese, cultures pasteurized milk, salt, enzymes), Torula Yeast, natural Flavors, Corn Flour, Citric Acid, Parsley. Green Bell Pepper Powder, Silicon Dioxide. Contains: Milk. Distributed by NatureBox, San Carlos, CA 94070
VP-CH-PNV Prenatal/Postnatal capsules, prenatal supplement, 30-count bottle, Rx only, Manufactured for: Virtus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30
Apheresis Red Blood Cells, Leukocytes Reduced
Mycophenolate Mofetil, Bulk Powder, Quantity 1000 g, For prescription compounding use and medical manufacturing or processing only, Attix Pharmaceuticals, Toronto, Canada
Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm Synapse PACS software version 4.4.004, Fujifilm Synapse PACS software version 4.4.010 and Fujifilm Synapse PACS software version 4.4.020 FUJIFILM Synapse Workstation Software (a Picture Archiving And Communications System) is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. Also intended for installation on an off-the-shelf PC networked with Fuji Synapse PACS.
Irbesartan and Hydrochlorothiazide Tablets, USP, 300/12.5 mg, Rx only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare U.S., LLC, Cranbury, NJ 08512, NDC 43547-331-09.

Reason for Recall
Undeclared Soy on label. RFR was generated by a customer who used the Pea Protein in a blended product that claims to be soy free. The Pea Protein tested positive for soy allergen.
Trader Joes recalling Triple Ginger Brew due to reports of unopened bottles potentially bursting.
CEG Enterprises, LLC is recalling Germ Terminator Toothbrush Sanitizer GT100 due to the following issues: UL label believed to be not genuine; discoloration of power cords (could indicate some degradation); reports of excessive heat.
Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Instructions for Use (IFU) states that specimens that have up to 10 ng/mL (41 nmol/L) of biotin
Steak marinade product contains undeclared wheat.
Golden Gourmet Veggie Chips are being recalled due to an undeclared milk allergen. Ranch Flavored Veggie Chips, which contain a milk ingredient, were packed in plain veggie chip bags.
Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Undeclared whey protein which contains milk and soy lecithin.
Blood product, in which labels applied to blood unit or product incorrect or missing information, was distributed.
The device was found to have bacterial contamination.
Dakota Style Foods is recalling certain Sunflower Kernel products because they may be contaminated with Listeria monocytogenes.
Product has the potential to be contaminated with Listeria monocytogenes.
Blood product,s which did not meet the acceptable product specifications, were distributed.
Blood products, collected in blood bags that had exceeded the manufacturer's instructions for use, were distributed.
Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an unacceptable IHC test result.
This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. The failure will result in the inability to cut tissue with the handpiece, rendering it non-functional. Should this failure occur, a replacement Myriad handpiece will be required. If a replacement handpiece is not available, alternate instrumentation for tissue removal will be necessary.
Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration.
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and soy (soybean oil and/or soy lecithin)
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared eggs, milk, wheat, and soy (soybean oil and/or soy lecithin)
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared milk and eggs
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared eggs, milk, wheat, tree nuts, and soy (soybean oil and/or soy lecithin)
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared tree nuts, milk, wheat, and soy (soybean oil and/or soy lecithin)
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared soy (soybean oil and/or soy lecithin)
Candy, baked goods, and Caramel icing contain undeclared allergens. undeclared milk and soy (soybean oil and/or soy lecithin)
Candy, baked goods, and Caramel icing contain undeclared allergens. Undeclared tree nuts, milk and soy (soybean oil and/or soy lecithin)
The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow, 6534-08N, causing a possible issue with the impression. This discrepancy may lead to the possibility of an oversized crown fabrication.
Papa John's Salad and Produce is voluntarily recalling Oriental Salad with Sesame Ginger Dressing due to possible Listeria monocytogenes contamination.
Blood products, which did not meet the acceptable product specifications, were distributed.
Blood product, possibly contaminated with air, was distributed.
/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.
Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood pump to stop.
Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. The system appears to be unlicensed. These systems cannot be re-activated using standard Windows licensing procedures and are requiring checks of each potentially affected system to confirm Windows 7 OS is properly activated.
Chemical Contamination: Bottles may contain broken dessicants
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood product, which did not meet the acceptable product specification, was distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, in which quality control and distribution of products did not meet specifications, were distributed.
Self-expanding Peripheral Stent Systems, model PRB35-08-040- 080, from lot A164580. The size on the outer box is labeled as 8x40x80mm while potentially containing a 6x40x120mm device as indicated by both the inner pouch and device labels. This potential issue is limited to two EverFiex stent system devices from lot A164580 that were repackaged by Medtronic and distributed. This does not affect any other Medtronic product or implantable devices.
Packaging error where a small quantity of Sana Cruz Burritos were packaged in Big Sur Burrito pouches and do not properly declare milk as an ingredient or allergen.
Blood products, collected from ineligible donors, were distributed.
Source Plasma, collected from an ineligible donor, was distributed.
Red Blood Cells, lacking proper labeling, were distributed.
Low platelet yield pheresis product was distributed.
Blood product, with an unacceptable pH, was distributed.
Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Firm was notified by supplier of sunflower seeds that they are being recalled due to Listeria Monocytogenes.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected from an ineligible donor, were distributed.
Blood product, collected from an unsuitable donor due to a donor screening deviation, was distributed.
Defective delivery system: Softgel capsules are leaking.
Apheresis products, which were not filtered according to specifications, were distributed.
Misbranded blood product was distributed.
cGMP deviation; manufacturer is Not Registered with the Food and Drug Administration
Blood product, collected from a donor for whom suitability to donate was inadequately determined, was distributed.
Human cornea, recovered without verifying supplies and reagents met specifications for use, and was distributed.
Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect lot number, 327B160012, appears on the case label, the correct lot number, 327B16002 appears on the immediate container.

Code Info
Lot codes: 26SEP16 Z4D1 and 26SEP16 Z5D1
Lots: 8B6M02 and 8B6M09 Expiration dates: February 1, 2017 through March 21, 2017
13ga, 13cm Myriad Handpiece Part number: NN-8004 Lots 1444664 and 1508994
System 23CAP001KXX001 with Serial Number 201021, System 23CAP001KXX001 with Serial Number 201020, System 23CAP001KXX001 with Serial Number 200994, System 23CAP001KFX001 with Serial Number 200752, System 23GSLXXXKFXUPG with Serial Number 201013, System 23GSLXXXKFXUPG with Serial Number 201050, System 23CAP007FXX001 with Serial Number 200930, System 23CAP002KFX001 with Serial Number 201000, System 23CAP001KXX001 with Serial Number 200969, System 23CAP001KFX001 with Serial Number 200942, System 23GSL120KFX001 with Serial Number 200910, System 23CAP001FXX001 with Serial Number 200710, System 23GSLXXXKFXUPG with Serial Number 200890, System 23GSL120KFX001 with Serial Number 201001System 23CAP002FXX001 with Serial Number 200889, System 23GSLXXXKFXUPG with Serial Number 201087, System 23CUP003CVX720 with Serial Number 201086, System 23GSL10XKXX001 with Serial Number 201085, System 23REV001XXX001 with Serial Number 201084, System 23REV001XXX001 with Serial Number 201083, System 23REV001XXX001 with Serial Number 201082, System 23REV001XXX001 with Serial Number 201081, System 23REV001XXX001 with Serial Number 201080, System 23REV001XXX001 with Serial Number 201079, System 23REV001XXX001 with Serial Number 201078, System 23REV001XXX001 with Serial Number 201077, System 23REV001XXX001 with Serial Number 201076, System 23CUP001CVX720 with Serial Number 201056 System 23CUP001CVMV4 with Serial Number 200921, System 23CUP001CVX720 with Serial Number 200920, System 23CAP001FXX001 with Serial Number 201004, System 23CUP001CVX720 with Serial Number 200922, System 23CUP003CVX720 with Serial Number 200749, System 23CUP001CVX720 with Serial Number 200748, System 23CUP001CVX720 with Serial Number 200747, System 23CUP001CVX720 with Serial Number 200996, System 23CUP003CVX720 with Serial Number 200980, System 23REV000KXX001 with Serial Number 200973, System 23REV000KXX001 with Serial Number 200972, System 23REV000KXX001 with Serial Number 200971, System 23CW4000UP002 with S
Lot Number: A3160A, Manufacturer batch number: 151201, Expiry November 2017