US Distribution to the state of :  OR., and Internationally to Argentina.
SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND REF SPMA_S LOT Expiration DO NOT FREEZE/NE PAS CONGELER FertiPro N.V.  Label on box: SpermMar Test IGA 50 Determination Test Kit CONTENTS 1 vial SpermMar Latex Particles 0.7 ml REF SPMA_S FertiPro FertiPro N.V.  Label on box: SpermMar Test IgA 50 Determination Test Kit Contents: 1 vial SpermMar latex particles, 0.7ml FertiPro N.V. For In Vitro Diagnostic Use SpermMar IqA Test Manufacturer's Product Number/Catalog Number: SPMA_S Lot/Serial Number Expiration Date FP14A09 02/29/2016 FP14A10 04/30/2016 FP14A11 04/30/2016 Product is a solution in filled into clear plastic bottles that is placed into a cardboard box. Both packages contain labeling information.
Manufacturer's Product Number/Catalog Number: SPMA_S   Lot/Serial Number                       Expiration Date  FP14A09                                      02/29/2016  FP14A10                                      04/30/2016  FP14A11                                      04/30/2016
The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation causing the motility of sperm cells to reduce in certain samples when the new bead solution was added.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
GA, NC, SC, MD, VA, WV, IL, OH, KY, AR, OK, TX, CO, NM, WY, UT, IN, MI, FL, KS, IA, MO, NE, CA, AZ, MN, ND, SD, WI, CT, MA, ME, NH, RI, VT, NJ, AL, LA, MS, TN, NY, DE, PA, NV, AK, ID, MT, OR, WA, Hawaii and Puerto Rico
PureLife Naturals Adult Multi-Plus Multi-Vitamins & Minerals Plus Herbs, 60 Pure Caps HDPE bottle
Labels indicate ''no wheat'' ''no gluten'' and the products contain gluten and wheat or a wheat related allergen.
PureLife Naturals Multi-Action Immunity 90 Pure-Caps HDPE bottle
The affected product was distributed to the following states: OH and PA.
OHIO CITY PASTA Four Cheese Net Weight 12oz. (340g) FOUR CHEESE RAVIOLI CONTAINS: MILK, EGGS, WHEAT KEEP FROZEN UPC 8 38735 00011 4 FOOD DESIGNS, INC. 3117 Detroit Ave., Cleveland, Ohio 44113
The firm was notified by two of their customers that the Four Cheese Ravioli contained undeclared lobster and the Smoked Mozzarella Ravioli contained undeclared shrimp.
OHIO CITY PASTA FOOD DESIGNS INC Smoked Mozzarella Ravioli Ingredients:***CONTAINS MILK, EGG, WHEAT 12oz.(340.19 g) KEEP FROZEN OHIO CITY PASTA STAND E-3
Whole Foods Salted Caramel Crispies Cookies, 12 pack  packaged in cellophane with tie closure
NATURAL EARTH PRODUCTS, NATURAL EARTH SPICES Ground Cumin, 5 lb.  Natural Earth Products Brooklyn, NY 11207.
Cumin may contain undeclared peanut protein.
AL, AR, CO, FL, GA, IN, KY, LA, MI, MO, NC, NY, OH, SC, TN & TX.
Culinary Masters, SCHWARMA SPICE BLEND 1/50 LB, Shelf Life: 180 days.
Products were manufactured with cumin found to contain undeclared peanuts.
Culinary Masters, SPICE MIX FULTON'S CRAB HOUSE, Pack Size 50 LB
Culinary Masters, UNIVERSAL STUDIOS CHILI MIX, Net Wt. 1.87 lbs, Distributed by Atlanta, Foods International, Atlanta, GA 300303.
Culinary Masters, MASTER TACO SEASONING, Net Wt. 26 oz.
Joe Paatis, CAJUN SEAFOOD SEASONING, 3.5oz., Joe Pattis.com 524 South B Street, Pensacola, FL 32501.
Culinary Masters, CHILI LIME SEASONING BLEND STEAK RUB, Net Wt. 20oz.
Culinary Masters, SPICE BLEND PORK PAPRIKA, Net Wt. 30 lbs., Distributed by Gourmet Foods International, Atlanta, GA 30303.
Culinary Masters, SPICE BLEND BBQ COFFEE, 30 lbs., Distributed by Gourmet Foods International, Atlanta, GA 30303.
Culinary Masters, STEAK DUST FULTONS SPICE, Pack Size 50 LB
Culinary Masters, SPICE FULTONS BBQ, Net Wt. 50 LB, Distributed by Gourmet Foods International, Atlanta, GA 30303.
Culinary Masters, BBQ SPICE LEVY, Pack Size 30 lbs.
Culinary Masters, TACO SPICE LEVY, Pack Size 30 lbs.
Culinary Masters, HD1 SPICE BLEND, Pack Size, 51 lbs.
Culinary Masters, SEASONING TANDOORI RUB, Net Wt. 30 oz. Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, GARAM MASALA PREMIUM SPICE BLEND, Net Wt. 15oz.
Culinary Masters, MASTERS CAJUN SEAFOOD SPICE BLEND, Net Wt. 20 oz. and 7 lbs., Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, MASTERS CAJUN STEAK SEASONING BLEND, Net Wt. 20 oz. and 7 lbs, Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, MASTERS PREMIUM FAJITA SEASONING, Net Wt. 24 oz. Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, MASTERS MOROCCAN SEASONING BLEND, Net Wt. 20 oz and 7 lbs. Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, MASTERS MUSTARD SPICE SEASONING RUB, Net Wt. 7 lbs. Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, WILLYS SIGNATURE SPICE, Net Wt. 4.4 lbs, Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, CHILI POWDER LIGHT PREMIUM MEXICO, Net Wt. 20 oz. and 6 lbs, Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, CUMIN FANCY FINE GROUND TURKEY, Net Wt. 16 oz. and 5 lbs., Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, RUB EXECUTIVE G.HILL MARRIOT, Net Wt. 7 lbs. Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, BBQ SPICE BLEND JW MARRIOTT, Pack Size 30 lbs.
Culinary Masters, BBQ RUB WILD DUNES, Net Wt. 7 lbs., Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, SEASONING TEDS BUTCHERBLOCK, Net Wt. 7 lbs. Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, SPICE BLEND CHORIZO HOT, Net Wt. 6 lbs, Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, BOURBON HONEY BBQ RUB, Net Wt. 7 lbs, Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, UNIVERSAL STUDIOS TACO MEAT SEASONING, Net Wt. 1.87 lbs, Distributed by Atlanta Foods International, Atlanta, GA 30303.
Culinary Masters, STEAK RUB, Net Wt. 5 lbs
Culinary Masters, MASTERS BBQ SEASONING BLEND, Net Wt. 24 oz. and 7 lbs., Distributed by Atlanta Foods International, Atlanta, GA 30303.
Ground Cumin, Net Wt: 5 LBS (2.25KG) Best By: 09/10/2016, Product of Turkey, Packed By: Vintage Food Corporation, 849 Newark Tpke, Kearny, NJ 07032, UPC 603608270037
Ground Cumin may be contaminated with peanut protein.
Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manufactured by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 for Sandoz, Inc., Princeton, NJ 08540 Repackaged by Cardinal Health Zanesville, OH 43701
Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mEq and 10 mEq strength instead of the potassium chloride 10 mEq and 20 mEq strength was packaged with the product.
AL, CO, CT, FL, GA, MA, ME, MO, NC, NJ, NY, OH, PA, RI, SC, TX, VA
GROUND CUMIN, Net Wt. 5 lbs (2.3 Kg), UPC 7 52186 82560 0.
Product is picked up at Middle East Bakery by independent drivers that supply markets in their territory.  The headquarters representative for each firm that potentially received product was notified as a result the downstream customers (retail stores) were notified by their corporate offices.     The Josephs brand name products were distributed in markets in Vermont, New Hampshire, Maine, Massachusetts and Connecticut, and in the following stores: Market Basket, Stop & Shop, Shaws, Hannaford and Big Y.  The Trader Joes products were distributed only in Trader Joe's stores in Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, and Washington D.C.
Joseph's Mini Whole Wheat Pita, labeled as 100% STONE GROUND Whole Wheat Bread NET WT. 8 OZ (227g), UPC 074117000420. Product is packaged in a plastic bag.
Josephs Mini White Pita, labeled as Josephs Enriched Pita bread NET WT. 8 OZ (227 g), UPC 074117000413.  Product is packaged in a plastic bag.
Josephs White Lavash, labeled as Josephs Lavash Roll-Ups Six Square Breads NET WT. 14 OZ (397 g), UPC 074117000697.  Product is packaged in a plastic zip top bag.
Trader Joe's 8 oz. Apocryphal 100% Whole Wheat Pita, UPC 00146326 and Trader Joe's 10 oz. Apocryphal 100% Whole Wheat Pita, UPC 00146333
Sell By FEB 05 printed on the plastic closure tab
Trader Joe's Pocketful of Fiber Pita Bread, UPC 00945097
ALL sell by dates printed on the plastic closure tab.
Trader Joe's 8 oz. Pita Bread, UPC 00146340 and Trader Joe's 10 oz. Pita Bread, UPC 00146142
Sell By FEB 05 and FEB 06 printed on the plastic closure tab
Trader Joes Organic Pita Pocket Bread 100% Whole Wheat, UPC 00721196, with a sell by date of FEB 03 printed on the plastic closure tab.
Joseph's Pita Bread, NET WT. 11 OZ, UPC 074117000147, with a sell by date of February 5, 2015 printed on the plastic closure tab.  Product is packaged in a plastic bag.
Sell by date of ''FEB 05'' printed on the plastic closure tab.
Trader Joe's Mini Whole Wheat Pitas, UPC 00637138
Product was distributed to six hotels and restaurants in Massachusetts.
Cumin may be contaminated with peanut protein.
Shanghai Ceramic Spoons; SKU 487874; UPC 2487874
Some ceramic spoons may exceed FDA guidance levels for leachable lead and cadmium.
Worldwide Distribution-US (nationwide) including the states of AL, AZ, CA, CO, CT, DE, FL, GA, IL, KY, LA, MA, MD, MI, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA, WA and HI and the countries of Austria, Australia, Canada, France, Germany, Italy, Japan, Netherlands, New Zealand, Portugal, Spain, Turkey, Taiwan, and United Kingdom.
3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm   Dental Implants.
Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.
OSSEOTITE Tapered Certain Implant  Rx Only; 3.25 x 18.5 - 15.0 mm.   Dental Implants.
OSSEOTITE  Certain 2 Implant Rx only; 3.25  x 8.5 - 18 mm.   Dental Implants.
Implant PN # XIFOSM311 Lot # 2014051368 Exp date 12/03/2018
SAZON IBERIA CON CULANTRO Y ACHIOTE Coriander & Annatto: 1) NET WT. 3.52 OZ. 100g, 18/20 PACKS, UPC 0 75669 10832 9, 2) NET WT. 6.34 OZ. 180g, 15/36 PACKS, UPC 0 75669 10831 2
Cumin may contain undeclared peanut protein
VITARROZ SAZON CON CULANTRO Y ACHIOTE CORIANDER & ANNATTO, NET WT. 6.34 OZ. 180g, Jumbo SOBRES 36 PACKETS,  UPC 0 72670 04255 0.
504 cases total (441 cases 60/36 and 63 cases 15/36)
Worldwide Distribution: US Distribution to states of: CA, CT, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, NC, NE, NH, NY, SD, TX, UT, WV, including Puerto Rico and country of: Canada.
Master Drug Library Software version 8.0, Product Code 35723V080, to be used with SIGMA Spectrum Infusion System (Pump) version 8.0, Product Code 35700BAX2     The SIGMA Spectrum Infusion Pump with Master Drug Library (MDL) is intended to be used for the controlled administration of fluids.
Software version 8.0, Product Code 35723V080
Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ.  MDL drug dose time in seconds will round to the nearest integer in minutes on the pump dose setup screen (20 sec may show as 1 min on the pump display). The pump will administer drugs as configured.   The discrepancy may cause therapy delay or unintended rate of delivery.
Stop & Shop Clear Splash Orange Mango, 1 liter plastic bottle Flavored Sparkling Water Beverage  Distributed by Foodhold U.S.A., LLC  Landover, MD 20785  UPC Codes: 6-882677-14066
Inova Health Care Services, Inova Blood Donor Services
Blood products, collected from an ineligible donor due to improper HIV re-entry, were distributed.
Blood and Blood Products for Reprocessing
Crown Confectionery Co. Corn Bba, Net Wt. 72g packed in Polypropylene,  Manufactured by Crown Confectionery Co., Ltd. (Choong Chung Nam Do, S. Korea), UPC 8801111910743
T. Up Trading, Inc. is recalling Crown Confectionery Co. Corn Bba, banana with real banana cream frosting, because it may contain undeclared milk.
Cinnamon Almonds, Net Wt. 16 oz, UPC # 00761437, 24 units per case
Trader Joes Company is recalling its 16 ounce packages of Trader Joes Cinnamon Almonds because they may contain undeclared peanuts.
Bromfenac Ophthalmic Solution 0.09%, Rx Only. Mfg For: Apotex Corp., Weston, FL, 33326.  Available in a) 1.7 mL Bottle, NDC: 60505-0595-5; b) 2 x 1.7 mL Bottles, NDC: 60505-0595-6; c) 2.5 mL Bottles, NDC: 60505-0596-4.
CGMP Deviations: Product excipient was not re-tested at the appropriate date.
DE, FL, IL, IN, KY, LA, MD, ME, MS, NJ, NY, OH, PA, TN, VA and VT
Twin Tree Gardens Premium Rubs ''bunkhouse'' Chicken Rub, Net Wt. 2.75 oz. (77g), Distributed by: Flavor Delight, Inc., Richburg, South Carolina, UPC 041278582362
Lot #'s 081817CHSASV55SV and 081917CHSA55SV
Haddon House Food Products, Inc. is recalling Twin Tree Gardens Chicken Rub because it may contain undeclared Peanut Allergen.
Worldwide Distribution: US (nationwide) and countries of: Denmark, Spain, Finland, France, Ireland, Israel, Italy, Netherlands, Poland, Japan and Pakistan.
Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm (22mm), Product Code: 121416; Monopty Biopsy, Product Code: 000441; Monopty 14g x 10cm (22mm), Product Code: 121410; Monopty 14g x 10cm (11mm), Product Code: 211410.   The BARD MONOPTY Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The actuator button and arrow in the ready window are color coded according to the various gauge sizes, e.g., Yellow=20 gauge, Pink=18 gauge, Purple=16 gauge, Green=14 gauge, and Light Blue=12 gauge. (Only the 14 gauge size has been reported to be affected by this issue). The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.
Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues.
Worldwide Distribution - US Distribution to the states of : CA and MA., and to the countries of : SPAIN, INDIA, JAPAN, AZERBAIJAN, BULGARIA, BELARUS, SWITZERLAND, CZECH REPUBLIC, GERMANY, EGYPT, FINLAND, FRANCE, UNITED KINGDOM, GUYANA, IRELAND, ISRAEL, ITALY, NIGERIA and NORWAY.
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.
Worldwide Distribution - US Distribution and to the countries of and to the countries of Greece, France, Italy, Spain, Switzerland, South America, Turkey and United Kingdom.
Integra Flowable Wound Matrix  Size 3cc 1 unit/box  single use, sterile device Rx Only   Model Number FWD301 (US) & FDR301 (Non-US)    Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray:  - An empty plastic syringe with Luer-Lok'' tip  - A plastic syringe with Luer-Lok'' tip containing the Flowable Wound Matrix material  - A syringe-to-syringe Luer-Lok'' adapter / connector  - A flexible plastic tube (injector) with Luer-Lok'' connector  Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.
The following Lot Numbers on the packaged kits are affected: -  305000293250, 305000293251, 305000298616    The syringes within the packaged kits are also Lot numbered.  For the packaged kit Lot Numbers above, the corresponding respective syringe Lot Numbers are:   -  10500028786, 105000288118, 105N00288965
A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of visual appearance during dispensing and force vs. displacement (force needed for product to be extruded from the syringe).
Nationwide and to Azerbaijan, Canada, China, Germany, Great Britain,Hong Kong, Indonesia, Japan, Malaysia, Mexico, Panama, Russia, Singapore, Spain, Switzerland, Ukraine.
Klaire Labs Ther-Biotic FACTOR 6 100+ Billion CFU's Multi-Species Probiotic Supplement  60 Vegetarian Capsules.  UPC 7 09616 01248 2  Manufactured by ProThera Inc . Klaire Labs is a division of ProThera, Reno, NV.
K-TF6 (60 capsules) Lot Number: H4496, Exp 10/15  and K4786, Exp 1/16.
lot H4496 = 1,337 total bottles; lot K4780 = 1,336 total bottles
Firm is recalling three lots of Ther-Biotic dietary supplements due to reports of shards of blue glass found in the bottles, not the in supplement.
Klaire Labs Ther-Biotic Children's Chewable 125+ Billion CFU's Multi-Species Probiotic Supplement  60 Chewable Capsules.  UPC 7 09616 01247 5  Manufactured by ProThera Inc . Klaire Labs is a division of ProThera, Reno, NV.
K-TCC (60 capsules) Lot Number: J4694, Exp 12/15
Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-6650-8
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
*** US: Nationwide ( AL, AR, AZ, CA, CT, FL, GA, HI, IL, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, VA, VI, WA, WI) *** FOREIGN: Bahamas, El Salvador, Guyana, Saint Kitts and Nevis, Panama
Kraft Macaroni & Cheese Boxed Dinner Original Flavor, 7.25oz.,packaged in blue and yellow cardboard box. There are four different package types affected by this recall: 1) single 7.25 oz boxes, 3-pack box of 7.25 oz boxes, 4-pack shrink wrap of 7.25 oz boxes, and 5-pack shrink wrap of 7.25 oz boxes.
This voluntary recall has been initiated because Kraft Macaroni & Cheese Boxed Dinners may contain metal pieces.
Worldwide Distribution -- U.S., including the states of TX, CA, AZ, WA, PR, and IA; and the countries of Canada and NSW.
Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shigella)     Cat no: G327   Container type: 15x100mm monoplate  Packaged: 10 plates/sleeve  Storage: 2 to 8 degrees C. on receipt in dark    A selective chromogenic medium for the primary screening isolation, and differentiation of Salmonella & Shigella spp.
The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack of color development in Shigella organisms in the referenced lot.
Product was distributed in Massachusetts.
Whole gutted haddock.  Product was sold refrigerated in 100 pound fish totes.
Firm received complaints that fish smelled like diesel fuel.
Blood products, in which donor was incorrectly deleted from deferral list and/or prior deferral due to history, were distributed.
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Blood products, in which donor gave history which warranted deferral or follow up questions were not asked, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood product, in which Quality Control and Distribution of product did not meet specifications, was distributed.
Natus neoBLUE blanket LED Phototherapy system which includes the following items:   006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad    006254 neoBLUE blanket LED Light Box    006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad    007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR    007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR      007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK    007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK    007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS    007302 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS
2611 units (1911 units in the US and 700 units outside the US)
neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system fiberoptic pads. These failures involve discoloration and melting of the fiberoptic bundle at the connector that is inserted in the neoBLUE blanket light box.
Oklahoma Blood Institute - Sylvan N Goldman Center
Platelets Pheresis Leukocytes Reduced Irradiated
Blood products, in which Donor Deferral/Donor missing or incorrectly identified on deferral list and/or donor should have been previously deferred due to history, were distributed.
Red Blood Cells (Apheresis) Leukocytes Reduced
Worldwide Distribution - US (nationwide) and Internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Fed., Saudi Arabia, Sweden, Singapore, Turkey, and United Arab Emirates.
Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.
Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.
NobelReplace CC NP 3.5x10mm, Article No. 36700.
NobelReplace CC NP 3.5x11.5mm, Article No. 36701.
NobelReplace CC NP 3.5x13mm, Article No. 36702.
NobelReplace CC RP 4.3x8mm, Article No. 36704.
NobelReplace CC RP 4.3x10mm, Article No. 36705.
NobelReplace CC RP 4.3x11.5mm, Article No. 36707.
NobelReplace CC RP 4.3x13mm, Article No. 36708.
NobelReplace CC RP 5.0x8mm, Article No. 36710.
NobelReplace CC RP 5.0x10mm, Article No. 36711.
NobelReplace CC RP 5.0x13mm, Article No. 36713.
NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.
NobelReplace CC PMC NP 3.5x13mm, Article No. 37288.
NobelReplace CC PMC RP 4.3x8mm, Article No. 37290.
NobelReplace CC PMC RP 4.3x10mm, Article No. 37291.
NobelReplace CC PMC RP 5.0x10mm, Article No. 37296.
NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
Potential for inadvertent scalpel stick injury involving the safety scalpel.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Worldwide Distribution - Nationwide Distribution to the states of : AK, AL, AR, AZ, CA, CO, DC, FL, GA, HI, IL, IN, KY, LA, MA, MD, MI, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA and WV,. and to the countries of : CANADA, COLOMBIA, EL SALVADOR, ENGLAND, GUATEMALA, HONG KONG, INDONESIA, SINGAPORE and  ZIMBABWE.
WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162
Internal gas line may malfunction causing the line to burst under pressure.
Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.  Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equipment cabinet has not been installed correctly. The potentially defective connection in the equipment cabinet will be inspected and, if necessary, corrected.
Nationwide Distribution-including the states of CA, IA, NY, FL, PA, UT, NC, SC, KY, CO, MA, GA, WA, TX, OK, and IL.
LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E.    Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have been anodized gold per the print.
Worldwide Distribution - US Distribution including Puerto Rico and the countries of :  Austria, Belgium, Germany, France, Greece, Iran, Ireland, Israel, Martinique, Netherlands, Portugal, Russia, Slovenia, South Africa, Spain, United Arab Emirates (UAE), United Kingdom, Canada, Korea, Taiwan, Singapore, Thailand, Chile, Guam, Mexico, Malaysia and Australia.
Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues.
Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
Magellan Robotic System; Model No(s). 11132 and 11139.  A steerable catheter control system used at clinical sites.
Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter.  Retraction of catheter may not stop when equipment button is released.
Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90
Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell
Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV.    Product was also sent to the following countries: ARGENTINA, AUSTRALIA, BELGIUM, CANADA, ESTONIA, FRANCE, MEXICO, NEW ZEALAND, SAUDI ARABIA & SWEDEN.
Talon Grasping Device, 160 cm US endoscopy intended for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.
A wire component on the distal grasping assembly of the device became detached.
US Nationwide Distribution - US Nationwide in the states of MO, MA, OH, CA, AR, MA, FL, GA, CO, TX, KY, NY, MI, WI, OR
ProTrack Microcatheter;    Product Usage:  The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.
U.S. Nationwide, including Puerto Rico; United Kingdom.
Flurandrenolide Tape, USP, 4 mcg per sq cm, Rx Only.  Distributed By: Actavis Pharma, Inc., Parsippany, NJ 07054, Manufactured By: 3M Company, St. Paul, MN, 55144.  Labeled as A) Cordran Tape, Small Rolls, 24 in x 3 in, NDC: 52544-044-24, B) Cordran Tape, Large Rolls, 80 in x 3 in, NDC: 52544-044-80, C) Haelan Tape (Fludroxycortide), Bulk Rolls, NDC: 55515-014-00.
Subpotent Drug: Flurandrenolide is subpotent.