Vital Essentials Frozen Chicken Patties Entree for Dogs, Net Wt. 6 lbs. (2.72kg).  Keep Frozen. UPC 33211-00807.
Carnivore Meat Company is recalling one batch (lot # 11475) of Vital Essentials 6 lb. Frozen Chicken Patties Entree for Dogs  because it has the potential to be contaminated with Salmonella.
One customer in Nebraska received the recalled product.
PURINA COMMERCIAL STARTER BASE 1200, Manufactured by Purina Animal Nutrition LLC, Shoreview, MN 55126-2910
Analytical testing revealed the presence of monensin in the swine starter feed. Monensin is toxic to pigs. User of the final feed reported a mortality of 100 pigs out of 2000.
AL, AZ, AR, CA, CO, CT, DC, FL, GA, HI, ID, KS, KY, LA, MD, MS, NJ, NM, NC, NV, NY, OH, OK, PA, SC, TX, TN, VT, VA, Canada
365 Everyday Value Mango Frozen Fruit Bars 4 Bars-4 fl. oz. (118 mL) each-Net 16 fl. oz. (472 mL) in a cardboard carton, UPC: 0-99482-41344-6, Distributed By: Whole Foods Market Austin, Texas 78703
US only:  MN, NC, IA, FL, UT, AR, KS, IN, NE, SD, MO, CA, IL, OK, OH, GA, TX, MI
2.3% Concentrate Solution contains 23 mg florfenicol. Florvio is for use in swine drinking water only.  Rx.  Florvio is packaged in a 4 liter plastic bottle containing 2.17 liters of solution. Florvio are packed 4 bottles per case. Florvio is distributed to distributors by the case.
analytical test results that fall outside of the Florvio  US stability specifications. This failure may directly impact the performance of the marketed  product.
Item code 613117  Lot P811 all batches   Expiration dates 1/2016 thru 5/2016
PUR STARTER 2 NO PORCINE, custom started feed manufactured from Purina's Commercial Starter Base 1200, bulk feed.
Feed was being refused by pigs. Testing later revealed the presence of Rumensin in the feed.
Delivery ticket numbers 201199 and 201392
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
One lot of frozen Duckbatch Sliders for dog food is recalled due to contamination with Salmonella and Listeria monocytogenes.
Meadow Gold Dairy Pure Fresh Half & Half One Quart (946 mL)
Meadow Gold Dairy Pure Fresh Heavy Whipping Cream One Gallon (3.78L) in plastic one gallon container; Fresh Meadow Gold Dairy Pure Heavy Whipping Cream Half Pint (236 mL) in waxed cardboard carton; Meadow Gold Dairy Pure Fresh Heavy Whipping Cream One Quart (946mL) in waxed cardboard carton.
Old Style Meadow Gold Heavy Whipping Cream Grade A Pint (473 mL) in waxed cardboard container
Domestic: Puerto Rico and US Virgin Islands (St. Croix and St. John); International: St. Marteen, Anguila, Tortola, Curacao, and Aruba.
Goya Honey with Comb product tested by FDA showed presence of 2, 6 Dichlorobenzamide which is not EPA registered for use in honey.
distributed nationwide in the US and in Australia, Canada, and United Kingdom.
Bounce Energy Ball Cashew & Pecan Vitality Lift, each loose unit has net wt 42 gram.    The bulk pack (contains 60 pieces) has UPC 9335805000872 and 9335805000308.  The jar (contains 40 pieces) has UPC 9335805000254.    Bounce Energy Ball Cashew & Pecan Vitality Lift unit has UPC 9335805000094 (61,764 balls); 9335805001077 (7,200 balls); and 9335805000049 (257 balls).
Bounce Energy Ball Cashew & Pecan Vitality Lift is recalled because it has the potential to be contaminated with Listeria monocytogenes.  This product contains sunflower kernels that were recalled by supplier SunOpta.
US - Bounce Apple Cinnamon Protein Punch Energy Balls (old name), net wt. 1.48 oz. (42g).  Product UPC Codes are 852949003723 (individual packs) and 852949003730 (12-unit boxes).    US - Bounce Apple Cinnamon Protein Energy Balls (new name), net wt. 1.48 oz. (42g). Product UPC codes are 852949003723 (individual packs) and 852949003730 (12-unit boxes).      Australia - Bounce Energy Ball Apple Cinnamon Protein Punch, individual pack has a net wt. 42g and UPC 19335805000374 and 40 pc. jar has UPC 9335805000469.    Canada - Bounce Energy Ball Apple & Cinnamon Protein Punch, net wt. 42g, individual pack has UPC 852949003471.    United Kingdom- Bounce Energy Ball Apple Cinnamon Protein Punch -  individual pack has a net wt. 42g.  The 60 pieces bulk pack has UPC 9335805000841;the 40 pieces jar has UPC 9335805000469; the 30 pieces tub has UPC 19335805000435; Other indiviual balls has UPCs 9335805000360; 9335805001060; 9335805001152; and 9335805000308.         .
2450 cases in US; 223,252 loose packs in UK; 83,338 loose packs in Australia; 15,900 units in Canada
Apple Cinnamon Protein Punch Energy Ball product is recalled because it has the potential to be contaminated with Listeria monocytogenes.  This product contains sunflower kernels that were recalled by supplier SunOpta.
Distributed to retail stores in Nebraska only (Omaha and Papillion).  No foreign or military/government distribution.
Norm's Gourmet Sauces & Blends Orange Jalapeno-Glaze Net Wt. 16 Fl. Oz., UPC code 837654919033, exp 12-31-2016, no lot code. Product contains butter. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.
Unknown.  A total of approximately 110 cases were distributed.
Undeclared milk protein. Products were also produced without a filed scheduled process.
There is no lot or batch code.  Exp is 12-31-2016.
Norm's Gourmet Sauces & Blends Apple Net Wt. 16 Fl. Oz., UPC code 837654919040, exp 12-31-2016, no lot code.  Product contains anchovies. The most responsible firm on the label is www.NormsGourmet.com, Manufactured & Distributed in Omaha, NE.
Unknown, total of approximately 110 cases total distributed
Undeclared fish .Products were also produced without a filed scheduled process.
Norm's Gourmet Sauces & Blends Apricot-Chipotle Net Wt. 16 Fl. Oz., UPC code 837654919088, exp 12-31-2016, no lot code. Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.
Undeclared fish.Products were also produced without a filed scheduled process.
Norm's Gourmet Sauces & Blends Medium Net Wt. 16 Fl. Oz., UPC code 837654919019, exp 12-31-2016, no lot code.  Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.
Undeclared fish. Products were also produced without a filed scheduled process.
Norm's Gourmet Sauces & Blends Fire & Brimstone Net Wt. 16 Fl. Oz., UPC code 602573053102, exp 12-31-2016, no lot code.  Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.
Norm's Gourmet Sauces & Blends Bournero Net Wt. 16 Fl. Oz., UPC code 837654919101, exp 12-31-2016, no lot code. Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.
Norm's Gourmet Sauces & Blends Original Net Wt. 16 Fl. Oz., UPC code 837654919064, exp 12-31-2016, no lot code. Product contains anchovies and butter. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.
Undeclared fish and milk protein on product labeled to contain worcestshire sauce and butter.  Products were also produced without a filed scheduled process.
Norm's Gourmet Sauces & Blends Mild Net Wt. 16 Fl. Oz., UPC code 837654919002, exp 12-31-2016, no lot code.  Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.
Norm's Gourmet Sauces & Blends Hot Net Wt. 16 Fl. Oz., UPC code 837654919026, exp 12-31-2016, no lot code.  Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.
Undeclared fish.  Products were also produced without a filed scheduled process.
Norm's Gourmet Sauces & Blends Sweety Que Net Wt. 16 Fl. Oz., UPC code 837654919163, exp 12-31-2016, no lot code.  Product contains anchovies. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.
Norm's Gourmet Sauces & Blends Carolina Gold Net Wt. 16 Fl. Oz., UPC code 837654919095, exp 12-31-2016, no lot code.  Product contains butter. Most responsible firm on the label is www.NormsGourmetSauces.com, Manufactured & Distributed in Omaha, NE.
Undeclared milk protein.  Products were also produced without a filed scheduled process.
Worldwide Distribution: US(nationwide) and countries of: Canada, Australia and United Arab Emirates.
Alaris Syringe Module Model 8110 with software version 9.15    The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.
A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.
US and Mexico, Finland, Estonia, Japan, Italy, Finland, Japan, South Africa.
NeolifeBar: Fruit & Nuts;  10 g Protein; 5 g Fiber. 320 mg Omega-3s.  Net Wt. 1.6 oz. (45 g). Product is sold as a package of 15 bars:    Distributed by GNLD International, LLC, Fremont, CA.  Not sold in retail stores
309 cases in US, 4384  cases foreign distribution
Product was manufactured with Sunflower Kernels provided by SunOpta, which are under recall for possible contamination with Listeria Monocytogenes.
Lot 3285A, (US and foreign distribution)  Best By 12/2016 and lot  3425A  and 0476A (foreign distribution only.
Distribution was made to MN, ND, and NE.
Frozen cinnamon rolls packaged under the following labels:    (1) Fetting's Cinnamon Rolls, packaged in 15-oz. plastic bags, 8 rolls per bag, 15 bags per case, product #79211, UPC #075812792115.  The firm name on the label is Top Taste, Inc., Finley, ND; and    (2) Abby's Bakery Homestyle Cinnamon Rolls, packaged in 23-oz. plastic bags, 12 rolls per bag, 12 bags per case, product #93599, UPC 74073093599.  The firm name on the label is Abby's Bakery, Wadena, MN.
2,500 cases (Fettings-1,898 cases and Abby's-602 cases)
CA, CO, IA, IL, MD, MI, MN, MO, ND, NE, OH, PA, TX
No-Salt-Added Black Beans, 15 oz. (425 g), packaged under the following brands:  1.  HEB, UPC 41220-91262;     2.  Kuner's UPC  72273-13613.  Distributed by Kuner-Empson, Division of Faribault Foods, Inc., 128 NW 18th Street, Faribault, MN  55021;     3.  Mrs. Grimes, UPC  71891-47607.  Distributed by:  Mrs. Grimes, Division of Faribault Foods, Inc., 128 NW 18th Street, Faribault, MN  55021;    4.  HyVee, UPC 75450-10519.  Distributed by Hy-Vee, Inc., 5820 Westown Parkway, West Des Moines, IA  50266;      5.  LaPreferida, UPC 71524-01769.  LaPreferida, Inc. Chicago, IL;    6.  Sprout's Farmers Market, UPC 74875-00724.  Manufactured exclusively for:  Sprouts Farmers Market, Phoenix, Arizona  8502;     7.  Our Family, UPC 70253-26394.  Distributed Y:  Nash Finch Company, Minneapolis, MN  55435
Faribault Foods is recalling 15 oz.No-Salt-Added Black Beans due to potential presence of plastic and/or metal pieces.
Domestic only: MI, OH, PA, MA, FL    Foreign: None  VA/DOD: None
GFS Honey Roasted Peanuts, 38 oz PET (Polyethylene terephthalate) plastic jar marked with lot number 176-16 stamped above the UPC code 093901252562 and GFS reorder number
Krispak, Inc. of Grand Rapids, MI, is recalling a small quantity of Honey Roasted Peanuts packed under the GFS label because they may contain undeclared allergen tree nuts, pecans following a supplier's recall.
GFS Honey Roasted Peanuts, 38 oz PET (Polyethylene terephthalate) plastic jar marked with lot number 176-16 stamped above the UPC code 093901252562 and GFS reorder number.
Worldwide Distribution-US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, FL, GA, 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 Puerto Rico and countries of: Austria, Bangladesh, Cambodia, Canada, Pakistan, Sri Lanka, Thailand, Turkey, United Kingdom, and Vietnam.
TRUEread Blood Glucose Test Strips (Glucose Oxidase) are used with TRUEresult and TRUE2go meters. TRUEread Blood Glucose Test Strips are available in vials with 10 ct., 25 ct., 50 ct., and sold as 10 ct. with meters.    Quantitatively measure whole blood glucose in a professional setting or by self-testing.
5,527,921 In total =4,621,639 strips & 393,808 kits domestically; 500,058 strips & 22,416 kits internationally
Product gives incorrect low blood glucose levels.
Worldwide Distribution - US Nationwide and including the countries of Canada, Austria, Australia, Belgium, Brazil,  Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Libya, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, South Africa, South Korea, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam, and areas of Middle East, Africa, Asia & Pacific.
Adaptor for Small Battery Drive and Small Battery Drive II.    Product Usage:  The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The Adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) to operate the Small Battery Drive and Small Battery Drive II.
There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.
Model/Catalog:   Adapter for Small Battery Drive and Small Battery Drive II for Electric Pen Drive 05.001.024;  Lot/Set/Serial:  All Manufactured Lots/Serial Numbers.
Light Adaptor for Small Battery Drive and Small Battery Drive II.     Product Usage:  Adaptors (05.001.024 ) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) to operate the Small Battery Drive and Small Battery Drive II. The adapter can be inserted into the SBD or SBD II handpiece and removed like a battery pack.  The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone.
Model/Catalog: Light Adapter for Small Battery Drive and Small Battery Drive II (05.001.108)  Lot/Set/Serial:  All Manufactured Lots/Serial Numbers.
Worldwide Distribution: US (nationwide) to states of: AZ, CA, MO, TX, and PR  and countries of: Canada, Germany, Hong Kong, Italy, Malaysia, and Taiwan.
DRI Salicylate Serum Tox Assay, Catalog number 0977.    Toxicology:  The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.
Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL.
Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL  35243, NDC 23359-032-16.
CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product contamination with the bacteria B. cepacia.
Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI  48150, NDC 0536-1001-85.
Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz (120 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI  48150, NDC 0536-1025-47.
Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160 mg/12.5 mg/12.5 mg in each 5 mL, 16 fl oz (473 mL) bottle, Manufactured for: Centurion Labs, LLC, Birmingham, AL  35243, NDC 23359-033-16.
Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bayshore Pharmaceuticals, Tampla, FL  33619, NDC 76518-100-08.
Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI  48150, NDC 0904-6289-09.
Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI  48150, NDC 0536-1000-59.
Leyden  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.
All product on market.  Any manuafcturing date prior to 8.1.16; date printed immediately below the cheese variety name represents the manufacturing date
Onion n Garlic  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.
Chili Cheese  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.
Gouda  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.
Country Dill  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.
Polkton Corners  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.
Crofters  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.
Lamont Cheddar  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.
Fait Fras  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.
Edam  12 pound wheels, Six pound half wheels, and wedges of various sizes ranging from less than 12 pounds to 1/3 pound.  Wheels and half wheels are sold packaged in cheese paper and wedges are sold packaged in clear plastic cryovac.     Refrigerated, Organic raw milk cheese.
Administration Set potential filter leaking
Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico.
Tape  (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Tape product codes are being supplied with an incorrect Instructions for Use (IFU) insert.
Recalled product was distributed to 3 customers in MO and 1 customer in PA.
Felimazole (methimazole) Coated Tablets, 5mg, packaged in 100 tablets per bottle, 144 bottles packed per case, most responsible firm on the label is: Distributed by: Dechra Veterinary Products, 7015 College Blvd, Ste 525, Overland Park, KS 66211.
Batch of Felimazole 5mg tablets analyzed for Assay test at 3 months was found to be subpotent.
Worldwide Distribution - Nationwide Distribution including the countries of:    Argentina                   Australia                Brazil                   Canada                   Chile                    China                   Ecuador                    India                   Japan                   Korea                    Mexico                    Malaysia                    Peru                    Philippines                    Saudi Arabia                  Singapore                   Taiwan                    Vietnam                   South Africa
' systems: Myoglobin cTnl  Cat No. ADVIA Centaur Calibrator U (2 Pack) - 03684480 (SMN 1 0309996)
Failure of analytical sensitivity with Calibrator U kit lots ending in 63 and 64 and a drift from the internal standardization
Nationwide Distribution to TN, MN, and WA
CareLink iPro Version 1.10, Catalog No. MMT-7340  With data obtained from the iPro2 recorder and blood glucose meter, the CareLink iPro software retrospectively calibrates sensor data and provides reports of continuous glucose information. CareLink iPro reports show up to seven calendar days of study data. The reports are created in PDF format, so they can easily be printed or stored electronically.
Medtronic MiniMed is recalling the CareLink iPro Therapy Management Software due to a time stamp error.
Eastern Feast, Green Raisin, 7 oz plastic container.
Initiated by the Florida Department of Agriculture and Consumer Services due to undeclared sulfites on the finished product label.
US: CA, CO, KY, LA, MD, MA, NJ, OH, RI, UT, VA, WA.    OUS: AUSTRALIA, China, INDIA, INDONESIA, ISRAEL, JAPAN, MEXICO, SOUTH KOREA, UNITED KINGDOM.
Worldwide distribution.  US nationwide including Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and United Kingdom.
Spacelabs Healthcare Xhibit Central Station, Model 96102.  Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
798 units total (488 units in the US and 310 units outside US)
The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.
Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280.  Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
316 XTR units total (248 units in the US and 68 units outside US)
Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006	    The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed.  Prismatik failed to properly identify the lots as quarantined product.
US Nationwide Distribution in states of: AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WY.
The EKOS cart has the catalog number 700-60101.    The EKOS cart is a custom infusion stand/cart used to hold and transport the EkoSonic Control Unit. The cart is designed with three poles to hold infusion pumps and fluid bags, a tray on which the EkoSonic Control unit sits and a base designed to hold an Uninterruptable Power Supply (UPS). The cart mounts on 4 wheels, two locking and two non-locking.
Casters on the EKOS carts may be missing washers which can cause premature wear and dislodgement of the casters/wheels leading to failure.
US: IL, PA, NY, GA, WA, FL, SC.    Affected geographies: Angola, Australia, Belgium, Botswana, Canada, Chile, Columbia, Czech Republic, Denmark, Finland, France, Germany, Ghana, Israel, Italy, Malaysia, Nambia, Netherlands, Panama, Poland, Romania, Slovakia, South Africa, Spain, Sweden, Switzerland, Uganda, United Kingdom and Zambia
AQUIOS CL Flow Cytometer, Catalog No. B30166; Intended for use with in vitro diagnostic flow cytometry applications using up to four florescent detection channels.
Beckman Coulter is recalling the AQUIOS CL System because the use of the reagent carousel can lead to misalignment of the carousel and damage to the prep probe.
Syngo RT Therapist, Accelerator, Linear, Medical  Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording
Software patch installation to address several safety issues.
PRIMUS, Accelerator, Linear, Medical  The PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer
ARTISTE, Accelerator, Linear, Medical  The intended use of the SIEMENS branded ARTISTETM family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
distributed in CA, FL, NC, PA, WA and in Canada
347 cases of Venison & Apples Entree and 8 cases of Brushtail & Vegetables Entree
New Zealand Venison & Apple Canned Dog Food are recalled due to  elevated levels of Vitamin A and slight variance in calcium and phosphorous ratios.
Lot Number: 8936:01Dec2018  Expiration date: December 2018
Lot Number:  8940:02 Dec2018  Expiration date: December 2018
Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cartons of 10 x 10 unit dose blister cards, Rx only, Manufactured by: Dr. Reddy's Laboratories, Inc., 200 Somerset Corporate Blvd Floor 7, Bridgewater, NJ 08807, NDC 63739-0555-10
181 unit cartons of 10 x 10 blister cards
Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but the outer secondary packaging was mislabeled Lansoprazole Delayed-Release 30mg Capsules.
Spiegelberg Brain Pressure Monitoring System  Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P    Product Usage:  lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg.    The observed measurement error was particularly at the lowest end of the range (to 0 mmHg) up to 8 mmHg.
Pharmacy Plus, Inc. dba Vital Care Compounder
Morphine Sulfate 15mg/ml Injection, 20 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Hydroxyzine HCl, 50mg/ml Inj, 10ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402
Autologous Serum Tears, 2 vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Hyaluronidase, 150 u/ml, 10 ml SDV, Vital Care Compounder, Hattiesburg, MS 39402
Papaverine 150 mg/Phentolamine 5 mg and Prostaglandin 50 mcg, packaged as 5.5 mL in a 10 mL MDV, Rx only, Vital Care Compounder, Hattiesburg, MS 39402
Apomorphine HCl 3mg/ml Sterile Injection Solution, 10 mL, MDV, Rx, Vital Care Compounder, Hattiesburg, MS
Moxifloxacin HCl 1 mg/ml (0.1mg/0.1ml) and BSS solution, 2ml Single use vial, Rx, Vital Care Compounder, Hattiesburg, MS 39402
C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402
DMSO 50% with Lidocaine 0.5%, 50ml SDV, Sterile, Rx, Vital Care Compounder, Hattiesburg, MS
Buprenorphine, 0.6 mg/ml Injection, 20ml MDV Sterile, Rx, Vital Care Compounder, Hattiesburg, MS
Olopatadine 0.8% Ophthalmic Solution, 3ml bottle, Rx, Vital Care Compounder, Hattiesburg, MS
Moxifloxacin 0.5% + Dexamethazone 0.1%, 15ml vial Contains: Moxifloxacin 5mg/ml, Dexamethasone Sodium Phosphate 1mg/ml,  Rx only, For ophthalmic use only, Vital Care Compounder, Hattiesburg, MS
Pre-Op Pledget Soln, Ophthalmic Drops (Tropicamide (1%) 0.33ml, Phenylephrine (10%) 0.66ml, Ketorolac (0.5%) 0.33ml, Ofloxacin (0.3) 0.67ml, 2ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
MOXI/DEX/KETOROLAC 0.5%/0.1%/0.4%, #15, Vital Care Compounder, Hattiesburg, MS 39402
C-PAP/PHEN/PROST/Atrop 150/7.5 (Papaverine 150mg/Phentolamine 7.5mg/Prostaglandin 75mcg/Atropine 1mg injection), 10 ml vial containing 5.9ml solution, Rx, Vital Care Compounder, Hattiesburg, MS
Trypan Blue 0.3%, 0.5ml vials, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Chlorpheniramine Maleate 10 mg/ml, 30 ml MDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Brilliant Blue G (BBG) 0.025%, 0.5 ml SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Methylcobalamin 5,000mcg/ml, 1mL SDV, Rx, Vital Care Compounder, Hattiesburg, MS 39402
Pre-Op Pledget Soln + Tetracaine, (Tropicamide (1%) 0.47ml, Phenylephrine (10%) 0.93ml, Ketorolac (0.5%) 0.47l, Ofloxacin (0.3) 0.95, Tetracaine (0.5%), 3ml vial, Rx, Vital Care Compounder, Hattiesburg, MS
Federico's Mexican Cookies Excelente Variedad, Net Wt. 21oz, 10packs/case, UPC 9154450521.
Federico's Bakery is recalling Mexican Cookies because it contains undeclared milk as the sub ingredient for butter.
Syngo.plaza VB10A, Picture Archiving and Communication System
Software upgrade to eliminate several issues
Syngo.plaza, Picture Archiving and Communication System
Domestic: MI only    Foreign:None  VA/DOD: None
480 bags of the 1.5 oz; and 240 bags of the 3.0 oz.
Four Brothers Packaging, Inc.dba Jake's Candy is voluntarily recalling Assorted Starlight Kisses Mints due to undeclared FD&C colors Red 40, Blue 1, and Red 3.
Jakes Candy Gummies Worms. o	Product label(s): ***Jakes Candy *** GUMMIES WORMS *** Net Wt.  1.1 oz. *** Exp. 12/2020 *** INGREDIENTS: Corn syrup, sugar, citric acid, natural and artificial flavors, artificial colors, including FD&C #5. ***   12 bags per case
Four Brothers Packaging, Inc.dba Jake's Candy is voluntarily recalling Gummy Worms due to undeclared FD&C colors Red 40, Yellow 6 and Blue 1.
Expiration Date:12/2020 None Listed, UPC: 815136012052
Jakes Candy Assorted Jelly Fruit Slices, Product label(s):***Jakes Candy *** ASST. JELLY FRUIT SLICES *** Net Wt.  3.5 oz. *** INGREDIENTS: Corn syrup, sucrose, corn starch, natural flavor, red #3, red #40, yellow #6.  12 bags per case
Four Brothers Packaging, Inc.dba Jake's Candy is voluntarily recalling Assorted Jellies due to undeclared FD&C colors Yellow 5 and Blue 1.
Expiration Date: None Listed, UPC: 815136010098
Triana Family Brioche Donuts Bavarian Cream Net Wt. 0.75 LBS (340 g)  12 -24 Jabez St., Newark, NJ 07106 UPC 000260003995    packaged in a clear plastic clam shell container
Brioche Donuts- Bavarian Cream contain undeclared FD&C yellow #5 and FD&C yellow #6.
Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only,  Manufactured by: Unichem Laboratories LTD., Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511 India; Marketed by: Unichem Pharmaceuticals (USA), Inc ., Rochelle Park, NJ 07662; NDC 29300-113-05.
Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets.
Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz  Inc., Princeton, NJ 08805, NDC  63739-669-10
3,492 unit cartons of 10 x 10 blister cards
Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.