Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Signature brand FEP-862S Q STATUS PELLET FORMULA Pelleted Maintenance & Light Exercise Ration 50 lb bag (paper bags, poly-lined, sewn at both ends)
Lot Number 14-280 Manufacture Date: October 7
Samples collected by the Colorado Department of Agriculture and tested in FDA laboratory tested positive for Salmonella
Primal Formula for Cats; Turkey - 93% Turkey, 7% produce and supplements.  1 oz. nuggets - Keep Frozen:  Net wt. 3 lbs. (1.35 kg)  Feline Turkey Formula    Ingredients: Turkey, Turkey Necks, Turkey Hearts, Turkey Livers, Organic Collard Greens, Organic Squash, Organic Celery, Cranberries, Blueberries, Organic Pumpkin Seeds, Organic Sunflower Seeds, Minerals (Zinc Sulfate, Copper Carbonate, Selenium), Almonds, Organic Apple Cider Vinegar, Sardine Oil, Taurine, Organic Quinoa Sprout Powder, Dried Organic Kelp, Organic Cilantro, Organic Coconut Oil, Cod Liver Oil, Organic Ginger, Natural Vitamin E.    Primal Pet Foods Inc.
52 cases (8 x 3 lb. bags per case) (1248 lbs.
One lot of Feline Turkey Raw Frozen Formula 3 pound bag tested FDA was found to be low in Thiamine.
CT, MA, NH, NY, WI, OH, TX, AZ, MO, MN, MI, CA, CO, OR, NM, IN, FL, SC, PA, WA, RI, IL, MD
Product tested positive for Salmonella spp. Poly A
Product did not test positive for Salmonella, but is being voluntarily recalled out of an abundance of caution because it was manufactured in the same manufacturing facility on the same day as the product that tested positive for Salmonella spp. Poly A.
Philips Electronics North  America Corporation
Distributed in the states of NY, WI, MA, AL, FL, GA, RI, CA, KS, and  TX, and the countries of Canada, Australia, Austria, Belgium, France, Germany, Ireland, Italy, Netherlands, New Zealand, Portugal, South Africa, Spain, and Switzerland.
Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
399 distributed, 262 are subject to this event
If arm is not fastened securely it could fall down.
All TraumaDiagnost products that were delivered before the week of July 2, 2007.
START A300 PAC, 2000# tote, Manufactured by Provimi North America, Inc., Brookville, Ohio 45309
Elevated levels of vitamin A can lead to elevated levels of morbidity and mortality in swine.
Approximately 335,000 additional cases of the recalled product were shipped by Kraft Heinz to retailers in the U.S. and Puerto Rico, Anguilla, Bahamas, Belize, Bermuda, Cayman Islands Grand Cayman, Netherland Antilles, Saint Kitts and Nevis, South Korea, St. Lucia, and British Virgin Islands.
Kraft Singles White American singles packaged in a blue box with white lettering.
12, 3 lb. cartons, 8, 4 lb. cartons, 12, 1 lb. cartons.
Kraft Singes wrapped American slices due to the possibility that a thin strip of the individual packaging film may remain adhered to the slice after the wrapper has been removed. If the film sticks to the slice and is not removed, it could potentially cause a choking hazard.
Best When Used By date between 12 DEC 15 and 13 FEB 16, Best When Used By date of 12 JAN 16, Best When Used By date of 11 JAN 16
Kraft Singles Deli Deluxe American Slices packaged in a blue box with white lettering.
Best When Used By date between 21 JAN 16 and 02 MAR 16
Kraft Singles American packaged in a blue box with white lettering.
6, 3 lb. cartons. 36, 1 lb. cartons. 12, 3 lb. cartons. 8, 4 lb. cartons.
CORDEL GF5 DDG 20 C-M, Swine Grower/Finisher, Complete to Increase the Digestibility of Phytin-Bound Phosphorus in Swine Diets
US nationwide distribution including FL, NJ, OK, and MO.
The treatment table positioning belt can slip gear positions, resulting in deviation of patient setup and treatment positions from the time of slippage until the discovery of slippage and the halting of treatment.
Manufacturing Lot or Serial Number: S250-0004
DQ Goat Grower 15% RU-27 Medicated - A Feed for Goats, Monensin Sodium 27 g/ton, packaged as bulk in 1000 lb. plastic totes.  The responsible firm is MFA Incorporated, Columbia, MO 65201.
Product contains monensin and excess copper.
U.S. distribution to the following; VT, CO, PA.  No foreign distribution.
OC Raw Dog Chicken, Fish & Produce Raw Frozen Canine Formulation   3lb Meat Rox  UPC Code: 022099069171    4lb Sliders  UPC Code: 095225852640    6.5lb Doggie Dozen Patty Bags  UPC Code: 022099069225
OC Raw Dog, LLC is recalling OC Raw Dog Chicken, Fish & Produce Raw Frozen Canine Formulation due to potential Salmonella contamination.
Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL Monoject Barrel Syringes in Sodium Chloride 0.9%, Rx only, Contains Sulfites, Compounded Drug, Not for Resale, Hospital/Office Use only, IV use only, NDC 61553-401-44.
Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay.
The firm distributed the product to 86 domestic firms. The spread sheet is attached.
Inclusion bar-Cocao Nibs, caramel almonds, and sea salt.
Undeclared Milk on the labels of various dark chocolate bars. FDA samples came back positive for milk.
Meltaway bar- French Vanilla & salted Almond.
Inclusion chocolate bar 66% Cacao topped with pistachios, cranberries & Sea Salt  in a white and green wrapping with white and gray lettering.
Sku: CB1022 expiration date range of 10/21/2015 to 4/15/2016
Inclusion bar-macadamia nuts, raspberries, and kaffir lime
Inclusion bar-strawberries, rose petals, and pink peppercorns.
Meltaways- 3 piece peppermint meltaways.
Meltaways- 3 piece Blood Orange meltaways.
Inclusion bar-expresso, cherries, and hazelnuts.
Inclusion bar-candied ginger, candied orange peel, and coriander.
Inclusion bar-cherries, cocoa nibs, cayenne.
Mendiant- Pistachio, Rose Petal & Candied Ginger.
Sku: MDPRC Expiration date range: 10/21/2015 - 1/15/2016
Meltaway bar- Blood Orange & Vanilla bean.
Mendiant Orange apricot & carmelized hazelnut packaged in a clear plastic bag with brown label with white lettering.
Sku: MDOACH Expiration date range: 10/21/2015 - 4/15/2016
Meltaway bar- Sweet basil & Cherry blossom.
Inclusion bar-scorpion pepper, bourbon, smoked sea salt, and caramel pecans.
Meltaways- 3 piece Vanilla Sea Salt meltaways.
Inclusion bar-strawberries, mangoes, and chiles.
Meltaways- 3 piece Tahitian Vanilla Lemon Meltaways.
Worldwide Distribution.  US states of TN and IN and the countries of Australia, Belgium, Egypt, France, Germany, Japan, Republic of Korea, Netherlands, and Saudi Arabia.
Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
Normally, movement of the C-arc is initially stopped by the motor (holding torque) then by the electromagnetic brake, leading to a full stop of the C-arc. Because of improper adjustment and tolerances, when the C-arc is initially stopped in an unbalanced position, the air gap of the brake can become too large, resulting in continued C-arc movement (C-arc is looking for balanced position).
Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
Nationwide Distribution-DC 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, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
Arctic Sun 5000 and Arctic Sun 2000;  Intended for monitoring and controlling patient temperatures.
Improper targeted temperature therapy was delivered to patients because the Temperature Simulator Key was connected to the patient temperature cable instead of the patient temperature probe.
All lots/serial numbers sold prior to August 2014.
Worldwide Distribution-US (nationwide) and the countries of Canada, Costa Rica, Libya, Mexico, and Philippines.
VS300 radiographic Cassette Holder or Wall Stand. For use in radiology department.
The wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground and contact patient.
VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.
WATCHAREE'S Thai Massaman curry sauce (UPC 094368999984), product is in a glass jar, NET WT 11.5 OZ (326 g)
Sauces may not meet quality standards due to the presence of mold.
WATCHAREE'S thai peanut sauce (UPC 094368999977), product is in a glass jar, NET WT 11.75 OZ (333 g)
Watcharee's Thai Green Curry Sauce (UPC 094368999991), product is in a glass jar, NET WT 11.5 OZ (326 g)
SyrSpend SF, Suspending Base, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-9.
Microbial Contamination of Non-Sterile Products: Syrspend SF and Syrspend SF Grape Flavor are being recalled due to the presence of yeast.
SyrSpend SF, Suspending Base, Grape Flavored, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 4 L bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1167-9.
SyrSpend SF, a convenient, sweetened, sugar-free syrup-suspending vehicle specially formulated to assist in extemporaneous preparation of oral liquid dose forms, Rx Only, Shake Well, 500 mL bottle, Manufactured by Fagron Inc., St. Paul, MN 55120, NDC 51552-1079-5.
RA Food Brokerage, Corp. distributed the affected product to retailers located in Puerto Rico only.
Product in Import Alert (99-38) inadvertently released for distribution.
Product in Import Alert  (99-38) inadvertently released for distribution.
Worldwide Distribution - US (nationwide), Guam, and countries of: Australia, Canada, Croatia, Turkey, New Zealand, Saudi Arabia, Japan, Korea, and Italy.
Moog Curlin Infusion, Ambulatory Infusion Pump   The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps.   Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038.
Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out of tolerance and may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed.
All manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015.  Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038.
US, South Africa, Japan and United Arab Emirates.
Mizuho OSI Trios, Table Base;  Voltage: 100-240V ~ 50/60 Hz  Amps: 5,0-5.0A;  Model 7803 and 7803AP    Orthopaedic:  Operating room tablebase - an electronically powered mobile operating table is created, designed for temporary (<24 hours) support and positioning of a patient in a prone, supine, or lateral position depending on the specific table top utilized.
Table Bases may have been assembled incorrectly, missing a retaining ring from the head end assembly.  Over time, the parts could go out of alignment, making clutch engagement or disengagement difficult.  If the clutch cannot disengage, the user would be unable to rotate the patient from supine to prone.
Model numbers 7803, 7803AP.    Serial numbers 228-261.
Haloperidol Oral Solution, USP (Concentrate) 2 mg/mL 15 mL  amber bottle, Rx Only,  Manufactured by Silarx Pharmaceuticals Inc. Carmel, NY 10512, Packaged by Safecor Health, Woburn, MA 01801, NDC 54838-0501-40.
Defective Container: Confirmed customer complaints of leaking bottles.
Domestic: MI, NY, OH, CA, IA, IL, NH, DC, PA, TX, AZ, CO, GA, MT, MS, NV, TN, VA  Foreign: None    VA/DOD: None
Zzang! Holiday 4 pack Candy Bars, 10.5 oz., packaged in preprinted cardboard boxes
14,433 Original Candy Bars; 3,242 Cashew Candy Bars ; 1,499 Wowza Candy Bars
Product recalled due to undeclared soy; and undeclared allergen milk (cream and butter declared).
Lot and Batch Nos are the sell-by dates 12/17/2015  03/16/2016, Product/Catalog No. 100
Zzang! Cashew Cow Candy Bar,2 oz., packaged in reprinted cardboard boxes, UPC 8 44397 00015 7
Product recalled due to undeclared sub-ingredient soy.
Lot and Batch Nos are sell-by dates 12/17/2015  02/16/2016, Product/Catalog No. 120
Chocolate Marshmallows, 8 oz., packaged in plastic bags, UPC 8 44397 00077 5
Lot and Batch No is sell-by date 12/24/15 (only 1 batch).
Zzang! Wowza Candy Bar,3 oz., packaged in reprinted cardboard boxes, UPC 8 44397 00072 0
Product recalled due to undeclared soy; and undeclared milk (cream declared).
Lot and Batch Nos are sell-by dates 12/17/2015  02/16/2016, Product/Catalog No. 160
Zzang! Original Candy Bar, 2.5 oz., packaged in preprinted cardboard boxes, UPC 8 44397 00014 0
Product recalled due to undeclared soy and milk (butter declared).
Bearded Brothers BOLD The Greek Net Wt. 1.5 oz/43 g  UPC: 8-50430-00414-2.
Bearded Brothers BOLD Coconut Curry Net Wt. 1.5 oz/43 g  UPC: 8-50430-00513-5.
Worldwide Distribution-US (nationwide) including Guam and Puerto Rico and the countries of  Algeria, Angola, Argentina, Australia, Bahrain, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guadeloupe, Guatemala, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela, and Yemen.
Mavig Monitor Suspension System, Model GD60, contained in the following Fluoroscopic imaging systems:  Advantx LCV+, Advantx LCN+, Advantx LCLP+, Advantx LCA,  INNOVA 2000, INNOVA 4100, INNOVA 3100, INNOVA 3131IQ, INNOVA 2121IQ, INNOVA 2100IQ, INNOVA 3100IQ, and INNOVA 4100IQ
GE Healthcare has recently become aware of a reported incident in which a Mavig suspension arm with monitor assembly fell to the floor.
Midazolam HCl Syrup, 10 mg/5 mL, 5 mL unit dose cups, packaged in 2 shelf boxes, one shelf box containing 72 cups and one shelf box containing 60 cups, Cherry Brandy Flavor, Rx only, MFG: Roxane; PKG BY Safecor, Woburn, MA; Barcode 0054356605.
Presence of Foreign Substance: customer complaint that one unit dose cup contained a small piece of cardboard contaminant.
Worldwide Distribution -- US, including Washington D.C. Puerto Rico, Virgin Islands, and Guam; and the countries of Afghanistan, Albania, Anguilla, Antigua and Barbuda, Armenia, Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, Ethiopia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, Iceland, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Lebanon, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Nigeria, Norway, Pakistan, Panama, Papua New Guinea, Paraguay, Philippines, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad , Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
GE Healthcare,  Optima XR220amx, Mobile Digital Ready Radiographic System    Designed to generate diagnostic radiographic images.
Potential safety latch mechanism failure.  The safety latch, within the column that supports the horizontal arm, is a backup in the unlikely event the primary safety cable breaks. A fall of the arm assembly could result in bodily harm to a person.
GE Healthcare, Brivo XR285amx Mobile Digital Ready Radiographic System    Designed to generate diagnostic radiographic images.
GE Healthcare, Optima XR200amx,  Mobile Digital Ready Radiographic System    Designed to generate diagnostic radiographic images.
distributed in CA, OR, and TX.  Products sold from bulletproof.com to internet customers nationwide and Canada.
FATwater bottle, 16.9 fl. oz., Berry flavor, UPC 6 09015 50477 2
FATwater bottles, Berry flavor, are recalled due to microbial growth detection.  No E.coli or other pathogens were detected.
FATwater bottle, 16.9 fl. oz., Tangerine flavor, UPC 6 41871 93693 9
FATwater bottles, Tangerine flavor, are recalled due to microbial growth detection.  No E.coli or other pathogens were detected.
LOT number:  B151005-4U.    EXPIRATION DATE: 10/5/2016.
FATwater bottle, 16.9 fl. oz., Lemon flavor, UPC 6 09015 50475 8
FATwater bottles, Lemon flavor, are recalled due to microbial growth detection.  No E.coli or other pathogens were detected.
Nationwide Distribution to the states of : MN, WI, IL, PA, AL,  MO, MT, AZ, CA, OH, FL, SC, MI, TN, CO, NV, IN, NY, MD, AR, KS, NY, IN, IA, TX, OK, NC, WA and DC.
Potential incorrect Standardized Uptake Values (SUV)  measurements in RadSuite.
Worldwide Distribution. US Nationwide  in the states of NY, CA, KS, NJ, CO, MI, MD, WA, CT, KY, OR, OH, IA, SC, AZ, AK, IN, TN, WI, FL, AL, UT, WY, MA, PA, MN, IL, MI, GA, ND, RI, including Puerto Rico; and the countries of Thailand, France, Germany, Colombia, Hungary, Netherlands, Saudi Arabia, Poland, Spain, and Italy
IMPLANT,TM, MTX  3.7 mm x 11.5 mm  diameter 3.5 mm  Catalog #TMMB11    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Information specific to the 3.7 mmD and 4.1 mmD Trabecular Metal Zimmer Dental Implants was omitted from the latest revision of the applicable IFU in the Indications, Contraindications, and Precautions sections.
IMPLANT,TM, MTX FULL  3.7 mm x 11.5 mm  diameter 3.5 mm  Catalog #TMTB11    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
IMPLANT,TM, MTX FULL  4.1 mm x 10 mm  diameter 3.5 mm  Catalog #TMT4B10    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
IMPLANT,TM, MTX FULL  4.1 mm x 11.5 mm  diameter 3.5 mm  Catalog #TMT4B11    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
IMPLANT,TM, MTX FULL  3.7 mm x 10 mm  diameter 3.5 mm  Catalog #TMTB10    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
IMPLANT,TM, MTX FULL  4.1 mm x 13 mm  diameter 3.5 mm  Catalog #TMT4B13    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
IMPLANT,TM, MTX  3.7 mm x 13 mm  diameter 3.5 mm  Catalog #TMMB13    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
IMPLANT,TM, MTX  4.1 mm x 13 mm  diameter 3.5 mm  Catalog #TMM4B13    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
IMPLANT,TM, MTX  4.1 mm x 10 mm  diameter 3.5 mm  Catalog #TMM4B10    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
IMPLANT,TM, MTX FULL  3.7 mm x 16 mm  diameter 3.5 mm  Catalog #TMTB16    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
IMPLANT,TM, MTX  4.1 mm x 11.5 mm  diameter 3.5 mm  Catalog #TMM4B11    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
IMPLANT,TM, MTX  3.7 mm x 10 mm  diameter 3.5 mm  Catalog #TMMB10    Product Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
IMPLANT,TM, MTX FULL  3.7 mm x 13 mm  diameter 3.5 mm  Catalog #TMTB13    Product Usage:  Zimmer Dental implant systems are designed for use in the maxilla or mandible for immediate loading or for loading after a conventional healing period. Implants may be used to replace one or more missing teeth. Immediate loading is indicated when there is good primary stability and an appropriate occlusal load.
Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.
Presence of Foreign Tablets/Capsules:  Presence of a comingled Carbimazole 5 mg tablet.
Distributed in the states of AL, TX, and CA.
Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm.  Intended for bypass or reconstruction of peripheral arterial blood vessels.
Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Product Code: DF8006SC  Lot Number: VTZE1783
Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm.  Intended for bypass or reconstruction of peripheral arterial blood vessels.
Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Product Code: DF6006SC  Lot Number: VTZE1782
Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540
Failed Impurities/Degradation Specifications; 9 month stability timepoint
Signature Kitchens Crushed Wheat Hot Dog;  8 buns; NET WT 12 oz   340 g  UPC 0 21130 18496 5;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.
Cloth material that is part of the production equipment may be in the product.
Signature Kitchens Enriched Hamburger Buns, Sesame;  8 buns; NET WT 12 oz   340 g  UPC 0 21130 18467 5;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.
Pantry Essentials Hot Dog Buns;  8 buns; NET WT 12 oz 340 g  UPC 0 21130 27084 2;  Distributed for: Lucerne Foods Inc.  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.
Signature Kitchens Enriched  Hot Dog;  8 buns; NET WT 12 oz   340 g  UPC 0 21130 18501 6;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.
Signature Kitchens 100% Whole Wheat Hot Dog Buns;  8 buns; NET WT 16 oz   454 g  UPC 0 21130 15456 2;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.
Pantry Essentials Hamburger Buns;  8 buns; NET WT 12 oz 340 g  UPC 0 21130 27085 9;  Distributed for: Lucerne Foods Inc.  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.
Coast to Coast San Francisco Style Sourdough 6 Hoagie Rolls;  6 Hoagie Rolls; NET WT 16.5 oz   468 g  UPC 0 21130 18091 2;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.
Safeway Kitchens Enriched Hamburger Buns;  8 buns; NET WT 17 oz (1 lb 1 oz) 482 g  UPC 0 21130 18456 9;  Distributed by:Safeway Inc.  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.
Old Fashioned Wheat Diner Rolls 8 Count  Pack size 20 oz.  UPC 2 24247 00000
Old Fashioned White Diner Rolls 8 Count  Pack size 20 oz.  UPC 2 24246 00000
Open Nature Whole Grain White Hot Dog Buns;  8 buns; NET WT 12 oz (340 g)  UPC 0 79893 11057 8;  Distributed by: Lucerne Foods, inc.  Pleasanton, CA 94566    Contains: Wheat, milk  May Contain egg, milk.
Coast to Coast Traditional Hawaiian Sweet 12 Dinner Rolls;  12 Dinner Rolls; NET WT 14 oz   397 g  UPC 0 21130 18580 1;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat. milk  May Contain eggs
Open Nature Seeded Sandwich Rolls;  8 buns; NET WT 21 oz (1 lb 5 oz) 595 g  UPC 0 79893 11439 2;  Distributed by: Lucerne Foods, inc.  Pleasanton, CA 94566    Contains: Wheat  May Contain egg, milk.
Coast to Coast Parisian Style French 6 Hoagie Rolls;  6 Hoagie Rolls; NET WT 16.5 oz   468 g  UPC 0 21130 18090 5;  Distributed by Living Better Brands, LLC,  Pleasanton, CA 94566    Contains: Wheat  May Contain eggs, milk.
US Nationwide Distribution in the states of FL, LA, TX and VA
PharmaCaribe PulmoSal 7% Sodium chloride, Inhalation Solution, 7% Sterile, Preservative -free, Non-pyrogenic, pH 7.4   For Inhalation Only Rx    Product Usage:  The contents of these vials are used in conjunction with a nebulizer for the induction of sputum production where sputum production is indicated.
Vials were labeled as USP 7% Hypertonic saline instead of PulmoSal 7% (pH+)
Lot # CIY Exp.Date August 2017  UPC Number: 030915339988 (on the box of 60 vials)  UPC Number: 10030915339985 (on the shipping case of 12 boxes)
Worldwide Distribution -- US, Spain, Italy, and Australia.
Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512)    Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).
There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization.  In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.
Apheresis products, in which leuko reduced units did not meet WBC count specification, were distributed.
Worldwide Distribution-US Nationwide, Armenia, Australia, Austria, Belgium, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia, Netherlands, New Zealand, Norway, P R China, Portugal, Poland, Russia, Singapore, Slovenia, South Africa, Spain, Sweden, South Korea, Switzerland, Thailand, Turkey, UAE, UK, and Brazil.
SIGMA HP MBT Non-Keel Punch Knee Instrument.  Designed to be used as an option in stabilizing the tibial trial during trial reduction.
Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin.  Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space.  Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.
Cat. No.  GTIN  Lot  Description    950502016  10603295227366  ABB92402  SIGMA HP MBT Cemented Punch size 1-1.5    950502017  10603295227373  ABB84491  SIGMA HP MBT Cemented Punch size SZ 2-3    950502018  10603295227380  ABB92358  SIGMA HP MBT Cemented Punch size SZ 4-7    950502020  10603295227403  ABC33125  SIGMA HP MBT Noncemented Punch size 2-3    950502020  10603295227403  ABB81733  SIGMA HP MBT Noncemented Punch size SZ 2-3    950502020  10603295227403  ABB81732  SIGMA HP MBT Noncemented Punch size SZ 2-3    950502021  10603295227410  ABB39952  SIGMA HP MBT Noncemented Punch size SZ 4-7    950502021  10603295227410  ABC33123  SIGMA HP MBT Noncemented Punch size SZ 4-7
INFX-8000V Bi-Plane X-Ray Interventional System        X-ray systems
Worldwide distribution.  US Nationwide and countries of AT, AU, BE, CA, CH, CL, CN, CZ, DB, DE, DK, EE, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, LT, LV, NL, NO, PL, PR, PT, RO, SE, SG, SI, TH, TR, and ZA.
Smith & Nephew BEAVER Blade 4.0mm  Part Number: 72203307  Orthopedic surgical instrument used in hip arthroscopy.
Blade exhibiting fracture during hip arthroscopy procedures
Reuseable rotary blade/abrader, product number 899751504.  The oval burr laterally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
Weak weld in the reusable rotary blade/abrader (burr) may result in inner part breaks at the distal or proximal end making the product dysfunctional.
Reuseable rotary blade/abrader, product number 899751514.  The oval burr frontally hooded is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
Reuseable rotary blade/abrader, product number 899751305.   The round burr is an attachment or accessory to the air-powered device intended for use during surgical procedures to cut hard tissue or bone and soft tissue. General hospital and plastic surgery use.
Nationwide distribution to Florida, North Carolina and Pennsylvania.
The product is labeled with an expiration date that is past its shelf life.
Worldwide Distribution - US including MA and TX; Foreign distribution to Austria, Azerbaijan, Belgium, British Virgin Islands, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Luxemburg, Morocco, Netherlands, New Caledonia, Norway, Poland, Portugal, Qatar, Romania, San Marino, Spain, Sweden and Switzerland.
Patient transport Shuttle with Trendelenburg quick adjustment function (Jupiter, Mars, Titan, TruSystem and Saturn operating table systems).  The shuttle is intended for the following applications: 1. Transfer, transport and storage of exchangeable table tops in the Trumpf Medical TruSystem 7500, JUPITER, and SATURN SM operating table systems 2. Patient transport to an operating table top (without a column) from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system 3. Transporting the TruSystem 7500 SM, JUPITER SM or SATURN SM operating table column with table top (without a patient) within the operating theatre.
Complaints were received of  the table top on the transporter (shuttle) tilting down quickly in a maximum Trendelenburg position.
Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.
T-piece Nebulizer with in-line connectors, Part number 8915-7-50.  Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.
Reports that the T-piece does not fit on the nebulizer.
Worldwide Distribution - US including AL, AK, AR, AK, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, MI, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to Canada, Japan, Europe.
Filling alveoli after tooth extraction. This product should not be used in non-peridontal mandibular applications.
Cytotoxicity tests were not passed at 36 months.  Use of Endobon-Xenograft Granules past 18 months of its specified shelf life may result in patient illness/injury.
Worldwide Distribution. US Nationwide, Venezuela, United Kingdom, Ukraine, Turkey, Thailand, Taiwan, Switzerland, Spain, Saudi Arabia, Russia, Poland, Pakistan, Myanmar, Mexico, Korea, Japan, Italy, Ireland, India, Greece, Germany, France, Finland, Czech Republic, Colombia, China, Canada, and Belgium.
CyberKnife Robotic; Catalog/part number 032000 and 033000 Cosmetic cover package.    Product Usage:  The CyberKnife Robotic Radiosurgery System is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
The gun box mounting bracket may fail to support the weight of the gun box when in vertical (inverted) position. If this failure occurs the gun box may become loose and could come into contact with a patient.