Ciprofloxacin Ophthalmic 4 gm tube (0.5%) in metal tubes; For Topical Ophthalmic Use, Rx.
Acth. Gel*R* (80 units/mL) and (40 units/mL) in 10 mL amber glass vials and 10 mL glass vials; For IM Use Only, Rx.
Ammonium Sulfate Sterile 100 mL Vial (0.75%) and (10%) in amber glass vials; For IV Use After Dilution, Rx.
Acetyl-D-Glucosamine 100 mL Vial (20%) in amber glass vials; For IM Injection Only, Rx.
Meloxicam (10 mg/mL) in 10 mL glass vials; Meloxicam (2.5 mg/mL) in 10 mL glass vials; Meloxicam Sterile 50 ml vial (5 mg/mL) in glass vials; For IV or SC Use, Rx.
B12/B2/B6/B3/B5/Cu Gluc/CACO Sterile 250 mL bottle (0.3mg/14.7/10 mg/100 mg/15 mg/0.2 mg/6.4 mg/mL) in plastic bottles; For IM Use Only, Rx.
Progesterone in Sesame Oil Sterile 100 mL Vial (150 mg/mL) in glass vials; Progesterone in Sesame Oil Sterile 100 mL Vial (100 mg/mL) in glass vials
Metronidazole (VET) Sterile 100 mL vial (100 mg/mL) in glass vials; For IM Use Only, Rx.
N-Butyl Alcohol Sterile 100 mL vial (7%) in glass vials; For IM Use Only, Rx.
Aspirin (100 mg/mL) in glass vials; For IV Use, Rx.
ATP/B12/NA Selenite/Potassium ASP/Magnesium ASP (2/1/2/20/30 mg per mL) in 100 mL glass vials; For IV or IM Use Only, Rx.
Atropine/Phenylpropanolamine/Chlorpheniramine 10 mL Vial (0.2 mg/12.5 mg/5 mg/mL) in glass vials; For IM Use Only, Rx.
FENH/B2/B6/B3/B5/Co Gluc./GU Gluc./Choline/CHL/Inositol/Methionine/Lysine/HCl/Glycine/Cyanocobalamin/Biotin (1.5 gm/1.075 gm/1 gm/10 gm/1.5 gm/0.07 gm) in 250 mL brown bottle; For IM or SC Injection, Rx.
Estradiol Cypionate Sterile 100 mL vial (2 mg/mL) in glass vials, Estradiol Cypionate Sterile 30 mL vial (5 mg/mL) in glass vials, Estradiol Cypionate Sterile 50 mL vial (2 mg/mL) (5 mg/mL) (10 mg/mL) in glass vials in glass vials; For IM Use Only, Rx.
Ammonium Chloride Sterile 10 mL Vial (5%) in glass vials; For IV Use After Dilution, Rx.
Buprenorphine HCl Sterile 100 mL Vial (0.6 mg/mL) in amber glass vials; Buprenorphine Sterile 10 mL (0.6 mg/mL) in glass vials; Buprenorphine Sterile 20 mL vial (0.6 mg/mL) in glass vials; Buprenorphine Sterile 30 mL Vial (0.6 mg/mL) in glass vials; Buprenorphine Sterile 50 mL Vial (0.6 mg/mL) in glass vials; Buprenorphine Sterile 5 mL Vial (0.6 mg/mL) in glass vials; Buprenorphine HCL Sterile 30 mL Vial (0.9 mg/mL) in glass vials; Buprenorphine Sterile 60 mL in 100 mL Vial (0.6 mg/mL) in glass vials; For IV or IM Use Only, Rx.
Neomycin/Bacitracin/Polymyxin-B Ophthalmic 4 gm Tube (3.5 mg/400 IU/10000 U/gm) in metal tubes; For Topical Ophthalmic Use, Rx.
Voriconazole Ointment (1% (10 mg/mL)) in 4 gm metal tubes; For Topical Ophthalmic Use, Rx.
Yohimbine-Compound Sterile (5 mg/mL (0.5%)) in 100 mL glass vials; Yohimbine HCl-Compound Sterile (5 mg/mL (0.5%)) in 100 mL glass vials; For IM Use Only, Rx.
Na Acet./KCl/CaCl/MgCl/Dextrose Sterile 100 mL Vial (100/0.7/0.3/0.2/50 mg/mL) in amber glass vials: For IV injection After Dilution, Rx.
Deslorelin Kit 10 mL Vial (15 mg) in amber glass vials; For IM Use Only, Rx.
Cyclosporine Ointment 4 gm tube (2%) in metal tube, Cyclosporine Ointment 4 gm tube (1%) in metal tube; For Topical Ophthalmic Use, Rx.
Methionine/Inositol/Choline Chloride/B12 Sterile 100 mL Vial (25 mg/50 mg/50 mg/0.2 mg/mL) in amber glass vials; For IM Use Only, Rx.
Tolazoline Sterile 100 mL Vial (10%(100 mg/mL)) in amber glass vials; For IV Use, Rx.
Progesterone in Sesame Oil Sterile 100 mL Vial (150 mg/mL) in glass vials; Progesterone in Sesame Oil Sterile 100 mL Vial (100 mg/mL) in glass vials; For IM Use Only, Rx.
Dexamethasone Sodium Phosphate 50 mL Vial (480 mg/mL) in amber glass vials; For IM or IV Use, Rx.
Estradiol 17B (10 mg/mL) in 10 mL glass vials; For IM Use Only, Rx.
Guaifenesin 1000 mL Bag (5%(50 mg/mL)) in 1000 mL IV Bags; Guaifenesin 500 mL bag (5%(50 mg/mL)); For IV Infusion or IV Injection, Rx.
Guanabenz Acetate (2 mg/mL) in 50 mL glass vials; For IM Use Only, Rx.
Desmopressin Acetate, Ophthalmic (0.1 mg/mL (10 mcg/0.1 mL) in 10 mL dropper bottle; For Topical Ophthalmic Use, Rx.
Ivermectin (2%) in 100 mL glass vials; For IM Use Only, Rx.
Xylazine HCl Preservative Free Sterile (333 mg/mL) in 20 mL glass vials; Xylazine Preservative Free (300 mg/mL) in 100 mL glass vials; For IM or IV Use.
Methocarbamol 100 mL Vial (100 mg/mL) in clear glass vials; For IV or IM Injection, Rx.
Bethanechol (5 mg/mL) in 100 mL amber glass vials; For IM or IV Use, Rx.
Naloxone (0.5 mg/mL) in 10 mL glass vial; For IM and IV Use, Rx.
Fluoxetine HCl*Sterile (32 mg/mL) in 50 mL glass vials; For Injection, Rx
Buprenorphine PF 1 mL Syringe (0.3 mg/mL) in 3 mL syringes; For IV or IM Use Only, Rx.
Chloral Hydrate Inj. Solution (1 gm/mL)  in 20 mL glass vials; For IM Use Only, Rx.
Stanozolol 10 mL Vial (50 mg/mL) in glass vials; Stanozolol 30 mL Vial (50 mg/mL) in glass vials; For IM Injection Only, Rx.
Pentosan 100 mL Vial (250 mg/mL) in amber glass vials; Pentosan 50 mL Vial (250 mg/mL) in amber glass vials; Pentosan 6 mL in 10 mL Vial (250 mg/mL) in amber glass vials; For IM Use Only, Rx.
Pluronic 30% Gel Sterile (30%) in 20 mL Syringe; For Wound Care, Rx.
Tripelennamine HCL injection (20 mg/mL) in 100 mL amber glass vials; For IV or IM Use Only, Rx
Progest./Estradiol-17B, Sesame Oil Sterile 100 mL Vial (50 mg/3.33 mg/mL) in glass vials; For IM Use Only, Rx.
Tranexamic Acid (100 mg/mL) in 100 mL glass vials; For IV Use, Rx.
Tryptophan (L) 100 mL Vial (100 mg/mL) in amber glass vials; For IM Use Only, Rx.
Triamcinolone Diacetate 100 mL Vial (2 mg/mL) in amber glass vials; For IM & Regional Injection, Rx.
CACODYLATE Cmpd (w/ Strych 0.00348%) Sterile (6.4/1/0.2 mg/mL) in 100 mL amber glass vials; For IV or IM Use Only, Rx.
Detomidine HCl/Xylazine HCl Sterile 50 mL vial (10 mg/10 mg/mL) in glass vials; Detomidine HCl/Xylazine HCl Sterile 50 mL vial (20 mg/10 mg/mL) in amber glass vials; For IM or IV Use, Rx.
Diclofenac Sodium Ointment (0.1%) in 4 gm metal tube; For Topical Ophthalmic Use, Rx.
Adenosine Monophosphate (200 mg/mL) in 100 mL amber glass vials; For IM Use Only, Rx.
Medroxyprogesterone 100 mL Vial (200 mg/mL) in amber glass vials; Medroxyprogesterone 100 mL Vial (100 mg/mL) in amber glass vials;  Medroxyprogesterone 30 mL Vial (200 mg/mL) in amber glass vials;  Medroxyprogesterone 30 mL Vial (100 mg/mL) in amber glass vials; For IM Use Only, Rx.
Chloramphenicol Ointment 4 gm tube (1%) in metal tubes; For Topical Ophthalmic Use, Rx.
Pen-G/Dexameth./Chlorpheniramine (200,000U/0.5 mg/5 mg/mL) in 100 mL glass vials; For IM Use Only, Rx.
Magnesium Sulfate 100 mL vial (500 mg/mL (4 meq/mL) in amber glass vial; Magnesium Sulfate 250 mL (500 mg/mL (4 meq/mL) in amber glass vial;   Magnesium Sulfate 500 mL (500 mg/mL (4 meq/mL) in amber glass vial; For IV or IM Injection, Rx.
Amikacin PF 2 mL (250 mg/mL) in glass vials; For Intra-Articular, IM, or IV Use Only, Rx.
Pyrilamine Maleate Sterile 100 mL Vial (20 mg/mL) in amber glass vials; Pyrilamine Maleate Sterile 100 mL Vial (100 mg/mL) in glass vials; For IV Use, Rx.
Folic Acid (15 mg/mL) in 100 mL glass vials; Folic Acid Sterile 100 mL vial (10 mg) in glass vials; For IM or IV use, Rx.
L-Arginine Sterile 100 mL Vial (200 mg/mL) in glass vials; L-Arginine Sterile 100 mL Vial (100 mg/mL) in glass vials; For IV Use, Rx.
Budesonide/Gentamicin (3 mg/120 mg/25 mL) in 250 mL glass vials; For IM Use Only, Rx.
B12/B2/B6/B3/B5/Cu Gluc/CACO/Dex Sterile 250 mL Bottle (0.3 mg/10.75 mg/10 mg/100 mg/15 mg/0.2 mg/6.4 mg/1 mg/mL) in plastic bottles; For IV Use After Dilution, Rx.
Deslorelin & HCG Kit 10 mL Vial (15 mg/20,000 units) in amber glass vials; Deslorelin & HCG Kit 1 mL Vial (1.5 mg/2,000 units) in amber glass vials; Deslorelin & HCG Kit 2 mL Vial (1.5 mg/2,000 units) in amber glass vials; For IM Use Only, Rx.
CACO CMPD 100 mL Vial (6.4 mg/1 mg/0.2 mg/mL) in amber glass vials; For IV or IM Use Only, Rx.
Ketoprofen 100 mL (10%) in amber glass vials; For IV or IM Injection, Rx.
Miconazole Ointment 4 gm tube (1%) in metal tubes; For Topical Ophthalmic Use, Rx.
Triamcinolone Diacetate PF 2 mL vial (6 mg/mL) in amber glass vials; For IM & Regional Injection, Rx.
Pen-G/Dexameth./Chlorphenir/Gentamicin (200,000U/0.5/5/20 mg/mL) in 100 mL glass vials; For IM Use Only, Rx.
Betamethasone Combo 5 mL in 10 mL Vial (7 mg/mL) in amber glass vials; For IM & Regional Injection, Rx.
Camphor in Olive Oil (20%) in 100 mL glass vials; For IM Use Only, Rx.
Sesame Oil, Sterile 10 mL Vial (100% oil) in glass vials; For IM Use Only, Rx.
Voriconazole Ophthalmic (1% (10 mg/mL)) in 15 mL dropper bottles; For Topical Ophthalmic Use, Rx.
Idoxuridine Solution (0.1%) in 5 mL dropper bottle; For Topical Ophthalmic Use, Rx.
Diclofenac Sodium Solution (0.1%) in 10 mL dropper bottles; For Topical Ophthalmic Use, Rx.
Cimetidine (150 mg/mL) in 100 mL glass vials; For IM Use Only, Rx.
Praziquantel/Lidocaine Injection (VET) (56.8/5 mg/mL) in 50 mL glass vials; For IM Use Only, Rx.
Cyclosporine (A) in oil 10 mL dropper (2%) in 15 mL dropper bottle, Cyclosporine (A) in oil 10 mL in 15 mL dropper (1%), Cyclosporine (A) in Oil 15 mL dropper (1%), Cyclosporine (A) in Oil 15 mL dropper (2%), Cyclosporine (A) in Oil 8 mL in 10 mL dropper (2%), Cyclosporine (A) in Oil in 8 mL in 10 mL dropper (1%), Cyclosporine (A) in Oil in 8 mL in 15 mL dropper (2%), Cyclosporine (A) in Oil in 8 mL in 15 mL dropper (1%); For Topical Ophthalmic Use, Rx.
CACO/Ferric Cl/Cu Gluc./Strychnine Sterile 100 m: (6.4 mg/1 mg/0.2 mg/mL) in 100 mL amber glass vials; For IV or IM Use Only, Rx.
Triamcinolone Diacetate 5 mL in 10 mL (6 mg/mL) amber glass vials; For IM & Regional Use Only, Rx.
Estrone AQ 100 mL Vial (5 mg/mL) in amber glass vials; Estrone AQ 30 mL Vial (5 mg/mL) in amber glass vials; For IM Use Only, Rx.
Apomorphine 1 mL Vial (1 mg/mL) in 2 mL amber glass vial; Apomorphine 1 mL Vial (10 mg/mL) in 2 mL amber glass vial; Apomorphine 10 mL Vial (1 mg/mL) in 10 mL glass vial; Apomorphine 10 mL Vial (3 mg/mL) in 10 mL glass vial; Apomorphine 1 mL Vial (3 mg/mL) in 2 mL amber glass vial; Apomorphine Sterile 30 mL Vial (1 mg/mL) in 30 mL glass vials, For IV or IM Injection/For SC or IV Use, Rx.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Desmopressin 0.01% Ophtalmic Solution Sterile, For Dogs.  Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
Butternut Squash Triangoli, Net Wt. 8.8 oz (250g)
Trader Joe's is recalling Trader Giotto's Butternut Squash Triangoli because it may contain undeclared tree nuts.
Product was shipped to the following states: NC, NY, PA, SC & VA..
FOOD LION CHEESE microwaveable crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: FOOD LION, LLC, SALISBURY, NC 28147 UPC 0 35826 08821 5
The product contains the Kosher symbol on its retail packaging.  This symbol is a trademark of the Orthodox Union representing Kosher status.  None of our products are not Kosher.
FOOD LION CHEESE crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: FOOD LION, LLC, SALISBURY, NC 28147 UPC 0 35826 08815 4
Hannaford CHEESE crispy thin crust pizza KEEP FROZEN NET WT 5.2 OZ (147Gg) (U) INGREDIENTS: CRUST***SAUCE***MOZZARELLA CHEESE BLEND***CONTAINS: WHEAT, SOY, MILK. DISTRIBUTED BY: HANNAFORD BROS. CO., SCARBOROUGH, ME 04074 UPC 0 41268 19400 1
Smith's Country Cheese -Creamy Gouda Spread packaged in  8 oz. plastic container
Contaminated with non pathogenic E. Coli
Smith's Country Cheese-Gouda with with Onion and Chive  Spread  packaged in  8 oz. plastic container
Gouda Cheese packaged under the brand names:  Smith's Farmstead Gouda and Jansal Valley Mountain Gouda,  Packaged in 11 lb. waxed wheel in saran wrap. 5 lb. Half wheels wrapped in shrink pack packaging.
Smith's Country Cheese-Gouda with Herb Spread  packaged in  8 oz. plastic container
Smith's Country Cheese- Creamy Gouda with Wine Spread packaged in  8 oz. plastic container
Smith's Country Cheese-Gouda with with Sundried Tomato & Basil  Spread  packaged in  8 oz. plastic container
Smith's Country Cheese-Gouda with Horseradish Spread  packaged in  8 oz. plastic container
Smith's Country  Cheese -Gouda Spread Garlic packaged in  8 oz. plastic container
Smith's Country Cheese-Gouda with Bacon Spread  packaged in  8 oz. plastic container
Products are distributed nationwide in the US and in Canada, Japan, and Germany
Cinnamon Red Maca - Sprouted Almond Spread is recalled because it has the potential to be contaminated with Salmonella
Lot/Batch # 1685-2022. Best by dates range from 062116 through 103016 (means 6/21/2016 through 10/30/2016).      The lot/batch numbers are a sequential number, starting with the beginning of operations. The number is independent of the product being manufactured. The digits themselves have no specific meaning.
Hazelnut Raw Cacao - Sprouted Hazelnut Spread is recalled because it has the potential to be contaminated with Salmonella
Superberry Maqui Camu - Sprouted Almond Spread is recalled because it has the potential to be contaminated with Salmonella
Cashew Cardamom - Sprouted Cashew Almond Spread is recalled because it has the potential to be contaminated with Salmonella
.    ***THIS ITEM BEING PHASED OUT AND DISCONTINUED.  THE FIRM RECALLED IT AFTER THE PRESS RELEASE ISSUED ON 12/2/15 SO THIS ITEM IS NOT LISTED IN THE PRESS RELEASE.
Coconut Cardamom- Sprouted Almond Spread is recalled because it has the potential to be contaminated with Salmonella
Haemonetics PCS2 Plasma Collection System-Automated Blood Cell Separator.  Catalog Numbers:06002-CP-110, 06002-CP-220-XX, 06002-CPL-110, 06002-110-XX-XX, 06002-220-XX
Haemonetics' Rotor Cleaning Updated User Manual Addendum was distributed.
Haemonetics MCS+ 8150 Apheresis System-Automated Blood Cell Separator  Catalog number: 08150-110-XX, 08150-220-XX
Haemonetics MCS+ 9000 Apheresis System-Automated Cell Separator  Catalog number: 09000-110-XX, 09000-220-XX
Haemonetics Model 215 Automated Glycerolization/Deglycerolization  System List number: 02215-110-XX, 02215-220-XX
Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, FL, GA, IL, IN, IA, KS, ME, MA, MN, MS, MO, NV, NH, NJ, NY, NC, OH, OR, PA, SC, TX VA, WA, WI, and countries of: Australia, Belgium, Burma, Canada, Denmark, Egypt, Estonia, Faroe Islands, Finland, France, Germany, Israel, Italy, Jordan, Kenya, Kuwait, Netherlands, Norway, Russia, Saudi Arabia, Sweden, Switzerland, United Kingdom & Vietnam.
Nebulizer Masks Opti-Mist and Opti-Mist Clear    Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
The Nebulizer mask malfunctions in that there is reduced or no aerosol output.  The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.
Columbus Revision Knee System, EnduRo Knee System    Product Usage:  The Columbus Revision Knee System and EnduRo Knee System are indicated for use in reconstruction of the diseased knee joint.
Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem implant packaging that are used for Columbus Revision/Enduro Knee Implants because it is labeled as Cementless. US product is indicated in the US for use with Bone Cement only.
Capecitabine tablets USP 500 mg, Cytotoxic Agent, Rx Only, 120 tablets per bottle, Manufactured in Czech Republic by: Teva Czech Industries sro, Czech Republic, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7474-89
Failed Dissolution: Out of Specification test results (low) at the 18 month time-point.
Baclofen, 2.5 mg/mL INJ, in 100 mL vial, Rx Only, TexasStar Pharmacy, Plano, Texas 75023
NeoCoil 3.0T GEM Flex Coil.   The 3.0T GEM Flex coil system includes three sizes of coil arrays and one interface box.    3.0T GEM Flex, Interface 16ch Fixed, P -Connector, NC032204, GEHC part number 5430008-5.  3.0T GEM Flex Coil16-L Array, NC040200, GEHC part number 5430008-2.  3.0T GEM Flex Coil 16-M Array, NC033000, GEHC part number 5430008-3.  3.0T GEM Flex Coil 16-S Array, NC034200, GEHC part number5430008-4.    The 3.0T GEM Flex Coil (interface box and arrays) is used in conjunction with a 3.0T GE Magnetic Resonance Scanner
Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient warming or burns.
Worldwide Distribution-US (nationwide) including the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV & WY, and in DC and PR and in the countries of Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Cayman Islands, China, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Gabon, Germany, Greece, India, Indonesia, Iran, Ireland, Italy, Japan, Korea, Lebanon, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Palestinian, Panama, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom & Viet Nam.
BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.
The firm discovered four issues with the BrightView Family systems.    Issue 1:   During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet.  If this occurs, collision sensors would pause the scan.    Issue 2:  During a scan, the gantry motion may halt prematurely.  This cause
BrightView are gamma cameras; Designed for single or dual detector nuclear imaging.
BrightView X are gamma cameras; Designed for single or dual detector nuclear imaging.
Worldwide Distribution and US in the state of CA.
Dimension Vista System  B2 Microglobulin Flex reagent cartridge and urine stabilizer       Catalog #K7024  SMN: 10445889	Lot #15246MA    Product Usage:  The B2MIC method is an in vitro diagnostic test for the quantitative measurement of B2-microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista System. Measurements of B2-microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease.
Lot #: 15037MA - foreign  15175MA - foreign  15204MA- foreign  15246MA (Distributed in US)  15267MA - foreign
Nationwide distribution including AZ, CA, GA, IL, MO, MS, MT, NC, NH, NY, OH, OK, and PA..
Kopans Breast Lesion Localization Needle  The Kopans Breast Lesion Localization Needle consists of a bevel-tip needle with centimeter markings and a hookwire. The hookwire features a burnish mark that allows the operator to ensure that the hookwire is within the needle tip during needle manipulation. The Kopans Breast Lesion Localization Needle is intended for preoperative marking of nonpalpable breast lesions.
Product potentially exposed to body fluids during processing.  Potential adverse events that may occur as a result of the foreign matter include blood borne pathogen transmission. However, the risk of transmission of blood borne pathogens is thought to be minimal to non-existent since these devices were sterilized after the potential exposure to body fluids.
Catalog # DKBL-20-7.0-A  Lot # 6215428  date of manufacture 09/17/2015
Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
(51 cm); Catalog Number: 461701.    Intended for pediatric feeding.
(91 cm), Sterile; Catalog Number: 461438.    Intended for pediatric feeding.
US: ND, WA, CA, RI, SD,  IL.    OUS: CANADA
Heartland Flax 14 Mesh Brown RCM Flax Certified Organic, Net WT 50 lbs. Product packaged in 50 lb Food Grade Plastic bags.
Heartland Products Inc., has initiated a recall due to potential contamination with Salmonella involving Milled Flax.
distributed in CA, KY, NC, ND, NV, PA and Canada.  The firm also sold product online.
Freeze Dried Mango Powder, Item no. 30042. Nutrifruit brand.  Each plastic jar has a net wt. 5 oz. The UPC is 0 79947 00110 4.
Label error in the supplement facts panel indicating 625.7 grams of carbohydrates in each serving. The correct amount is 6 grams carbohydrate per serving.
Freeze Dried Black Raspberry Powder, Item no. 30007 or 30041. Nutrifruit brand. Each plastic jar has a net wt. 5 oz. The UPC is 0 79947 00019 0.
Label error in the supplement facts panel indicating 0 gram of sugar in each serving. The correct amount is 2 grams of sugar per serving.
Cole Slaw with Carrots Separate, 5 lb. bag, Dole brand.     All marketed Dole and private label salads produced in the Springfield, OH facility.   Product may be identified by an A in the upper right hand corner of the package.
Dole is suspending operations and withdrawing all marketed Dole and private label salads produced at the Springfield OH facility.  Products may be identified with a product code beginning with the letter A in the upper right hand corner of the package.
50/50 mix, 5.5 oz. bag - Kroger;  50/50 blend, 10 oz. bag - Dole      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3024.  Dole production code - 938
Baby Spinach with Tender Reds,  5 oz. clamshell, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 943.
Mediterranean, 8 oz. bag. Dole brand.      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 645
Caesar Kit, 10 oz. bag,  - Aldi; Dole  14.53 oz bag, 22.30 oz.  - Walmart;  Value Size All Natural Caesar Kit , 15 oz. bag - Dole       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Aldi - production code 3214;   Walmart - Production code 3124, Family size 3114;  Dole - production code 678 (10 oz), 158 (15 oz.).
Spring Salad Mix,  5 oz. bag,  - Aldi; Walmart;   5 oz, and 10 oz. clamshell - Kroger;  Dole - 3 lb. bag,  11 oz and 5 oz.. clamshell       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Aldi - production code 3213;   Walmart - production code 3145;  Kroger - production code 3017 (10 oz. ) 3023 (5 oz.);  Dole - production cide 682 (3 lb),  665 and 336 (11 oz. clamshell), 946 (5 oz. clamshell)
Ultimate  Caesar, 11.3 oz. bag, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 953.
All Natural Chopped BBQ Ranch Kit; 14.4 oz.  and Chopped BBQ Ranch 14.4oz. bag - Dole brand.      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 611 (14.4 oz all natural) and  991 (14.4 oz)
Italian Blend, 9 oz. bag,  - Aldi; Kroger; Dole.     All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Aldi - production code 3215;   Kroger - production code 3010;  Dole - production code 686.
Organic Baby Romaine  - 5 oz. clamshell - Loblaw      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Loblaw production code -  3226.
Chopped Sesame Ginger Kit, 13.6 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 996.
Chop Romaine Display,  2 lb. bag - Sam's Club;  Chopped Romaine - 16 oz. bag  and 2 lb bag- Dole      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Sam's Club production code -  501;  Dole production code- 963 (16 oz) and 675, 78 (2 lb)
Field Greens, 8 oz. bag - Kroger;        All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3008.
Southwest Salad, 13 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 2976
Classic Iceberg Blend w/Red Cabbage and Carrots Separate, 5 lb. bag, Dole brand.     All marketed Dole and private label salads produced in the Springfield, OH facility.   Product may be identified by an A in the upper right hand corner of the package.
Baby Spinach ,  6 oz. bag,  - Walmart;  6 oz and 10 oz. clamshell -  Kroger;  11 oz and 5 oz. clamshell - Dole     All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Walmart - production code 3131 (10 oz) and  3025 (6 oz.)  Kroger - production code 3015;  Dole - production code 337 (11 oz), 949 (5 oz.).
All Natural Chopped Chipotle & Cheddar Kit; 12.9 oz. bag and Chopped Chipotle & Cheddar kit, 12,9 oz. - Dole brand.      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 613 (all natural) and 993
Sweet Kale Kit Bag, 9.5 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 704.
Kale Caesar Kit Bag, 9.2 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 703.
Endless Summer Kit Bag, 8.8 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 2701.
Spinach,  8 oz. bag,  - Aldi;  Teen Spinach -  10 oz. bag - Walmart.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Aldi - production code 3211;   Walmart - production code_ 34123.  Walmart - production code- 3123.
All Natural Chopped Sesame Asian Family Kit,  27.2 oz. bag - Sam's Club; 13.6 oz. Dole Brand    All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Sam's Club production code -  618;
Organic Baby Spinach - 11 oz.  and 5 oz. clamshell - Loblaw  5 oz and 16 oz, Clamshell - Kroger    All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Loblaw production code -  3220 (11 oz) and 3224 (5 oz);  Kroger production code - 3031 (5 oz) nd 3032 (16 oz).
Baby Arugula with Spinach Clamshell, 5 oz. clamshell, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 941.
Greener Supreme , 12 oz. bag - Kroger;  Greener Selection, 12 oz. bag - Dole  Value Size Greener Selection , 18 oz. bag - Dole      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3004.  Dole production code - 695 (12 oz. and  159 (18 oz.).
Veggie Blend, 12 oz. bag - Kroger;  Very Veggie, 12 oz. bag - Dole      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3013.  Dole production code - 694
Arugula, 5 oz. clamshell, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 950.
Leafy Romaine Salad, 10 oz.  10 oz. bag,  - Walmart;  Leafy Romaine, 10 oz. bag - Kroger  Romaine Blend - 10 oz. bag - Kroger       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Walmart - production code 3141;  Kroger- production code: 3005, 3011 (leafy romaine)
Chopped Italienne Kit, 12.6 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 992.
Classic Iceberg Blend, 5 lb. bag, Dole brand.     All marketed Dole and private label salads produced in the Springfield, OH facility.   Product may be identified by an A in the upper right hand corner of the package.
Organic Baby Arugula  - 5 oz. clamshell - Loblaw      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Loblaw production code -  3225.
All Natural Chopped Sunflower Family Crunch,  27.2 oz.  bag - Sam's Club; 13.6 oz. Dole brand    All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Sam's Club production code -  619;
Caesar Bacon Salad Kit, 14.54 oz. bag - Walmart;      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Walmart - production code 3111.
All Natural Chopped Bacon & Bleu Kit; 12.9 oz.  bag - Dole brand.      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 612
Baby Romaine, 5 oz. clamshell, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 942.
Sweet Baby lettuces,  5 oz. clamshell, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 948.
Shredded Lettuce , 11 oz. bag - Kroger  Value Size Shredded Lettuce -  16 oz. bag - Dole; 1/4'' Shredded Lettuce-Dole brand  Chopped lettuce  5 lb bag - Dole.      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3029.  Dole production code - 157 (186 oz) 75 (5 lb. bag) and 72 (1/4')
Colorful Coleslaw Display,  2 lb. bag - Sam's Club;  Colorful Coleslaw  - 14 oz. bag- Dole      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Sam's Club production code -  503;  Dole production code- 2662.
Classic Garden Salad, 12 oz. bag: Aldi, Kroger  24 oz. bag. - Kroger      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Aldi Production code 3210:  Kroger production codes: 3007  (12 oz.) and 3009. (24 oz.).
Organic Baby Kale  - 5 oz. clamshell - Loblaw      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Loblaw production code -  3227.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 2976.
Coleslaw, 12 oz. bag - Kroger;        All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3000.
Asian Island Crunch, 13 oz. bag, Dole brand.       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 930.
Light Caesar, 10 oz. bag, Dole brand. .       All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Dole production code - 699.
House Ranch, 10.6 oz. bag - Kroger;      All marketed Dole and private label salads produced in the Springfield, OH facility.  Product may be identified by an A in the upper right hand corner of the package.
All packaged salads with manufacturing code beginning with the letter A.  Kroger production code -  3021
Blood products, for which donor eligibility was inadequately determined, were distributed.
U.S. distribution to the following states -- WA, CA, NY, and TX.
Karma Flexx Wheelchair    Manual Wheelchair.
Karman Healthcare, Inc. is recalling Karma Flexx Wheelchair because incorrect size screws and corresponding hardware were installed on the front caster fork brackets.
Stryker Instruments Div. of Stryker Corporation
Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.
50000  (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
50000  Lot numbers: 61305001, 61310001, 61312001, 61404006  Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.
(Stryker) AccuPlace Straight Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
50001  (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
50001  Lot numbers: 61303001, 61309001, 61310001, 61404006  Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.
(Stryker) AccuPlace Round Level Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.
Stryker Model: 0900-400-000; With lot numbers: 61406002, 61505003.  Devices distributed between 5-1-2013 and 5-31-2014 are labeled with Inrads name and product number. Devices distributed between 6-20-2014 and 12-3-15 are labeled with Strykers name and product number.
Nationwide in US: AZ, CA, CO, FL, GA, ID, KY, LA, MD, NY, OR, PA, TX, VA, WA, and WI.   Worldwide to Canada, Chili, Colombia, Mexico
Apple Caramel Almond Tea, Bag Size -  2lbs Minimum, Bulk Packaging, Item No. FB-004
International Tea Importers is recalling Apple, Caramel & Almond Tea because it contains undeclared milk.
No codes, Distributed from 01/01/2014 To 01/25/2016.
OR, FL. CA and internet sales  in the following states:  Washington D.C.        Connecticut                 Oregon  Georgia                       Texas                           Indiana  Illinois                         Massachusetts             New Mexico  California                    Pennsylvania               Ohio  Michigan                     Arizona                       Colorado  Maryland                     Kansas                         North Dakota  Virginia                       North Carolina            New Jersey  New York                   Mississippi                   New Hampshire  Missouri                      Utah                            Alaska  Tennessee                    Maine                          Rhode Island  Washington                 Wisconsin                    South Dakota  Idaho                           Nevada                        Louisiana  Alabama                      Delaware                     Montana  Florida                         West Virginia              Hawaii  Minnesota                   Oklahoma                    South Carolina
Braga Organic Farms Organic Pistachio Kernels, Raw;  Certified Organic, USDA Organic.  Packed in 8 oz. 1 lb. 2. lb and 5 lb clear or green standup bags.  Ingredients: Organic Pistachios    Braga Organic Farms, Madera, CA.
IEH sample had a positive result for Salmonella in Braga Organic Pistachios
Braga Organic Farms Organic Nut l Mix, Raw;  Certified Organic, USDA Organic.  GMO Free, Peanut Free, Gluten Free  Packed in 8 oz. 1 lb. 2. lb and 5 lb and 25 lb. clear or green standup bags.    Ingredients: Organic Pistachios, Organic almonds, Organic Cashews, Organic walnuts.     Braga Organic Farms, Madera, CA.
Braga Organic Farms Organic Trail Mix, Raw;  Certified Organic, USDA Organic.  GMO Free, Peanut Free, Gluten Free  Packed in 8 oz. 1 lb. 2. lb and 5 lb and 25 lb. clear or green standup bags.    Ingredients: Organic Pistachios, organic almonds, Organic walnuts, Organic Jumbo Flame Raisins, Organic Cranberries, Organic Evaporated Cane Juice, Organic Sunflower oil.    Braga Organic Farms, Madera, CA.
Worldwide Distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, LA, MI, MS, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, and WY ; and countries of: Italy, Scotland, Turkey, Greece, Germany, and Singapore.
Restoris Multicompartmental Knee (MCK) System    RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
Worldwide Distribution -  US including AZ and MO.  Foreign distribution to Australia, Austria, Bahrain, Belgium, Brazil, Canada, Denmark, Ecuador, Estonia, Finland, France, Germany, Hong Kong, India, Italy, Japan, Latvia, Malaysia, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Serbia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, and Venezuela.
Maquet Getinge Group 1180.19XO Extension Device.  Manufacturer MAQUET GmbH,   Used to support the upper and lower extremities immediately before, during and after fracture surgery. The Extension Device (1180.19F0) is a table top module for use with the Maquet MAGNUS operating table system and it is attached to the base mounting point of the MAGNUS operating table.
MAQUET Medical Systems USA is initiating a field action for correction of the MAQUET Extension Device (Part No 1180.19F0).  The Extension Device is manufactured by Maquet GmbH, in Germany, and is a table top module for use with the Maquet MAGNUS operating table system.  Maquet GmbH was made aware of a potential issue that can result in the Extension Device becoming unlocked from the table top, cau
Catalog Number 1180.19F0; Serial numbers 00003 and 00004.
Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Bangladesh, Canada, Hong Kong, India, and Israel.
PINPOINT Endoscopic Fluorescence Imaging System
It has been determined that the PINPOINT Operator's Manual does not contain validated parameters for gravity-cycle autoclave sterilization of the PINPOINT laparoscopes and light guide cable in the reprocessing tray.
Rev. J, Rev. K, Rev. L and Rev. M    Model Number : PC9000
0.9% Sodium Chloride Irrigation, USP, 500 mL bottle, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product code 2F7123, NDC 0338-0048-03
PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
Nationwide distribution to MO, NE and TX .
PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC.  This kit is used by clinicians to change dressings
Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling
Distributed US (nationwide) and the countries of Australia, South Africa, Canada, New Zealand, Belgium, Japan, and Paraguay.
Volcano R100 Sterile Equipment Cover; Sterile;    General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.
Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Covers may have the incorrect expiry date on the outer shipping box; individually wrapped inner product bears the correct expiry date.
REF numbers: PBKGB and PBKBG-10 (10 pack): all lots
Volcano SpinVision Sterile Equip cover II; Sterile;    General Hospital: These Sterile Equipment covers are provided to cover equipment that is mean to be used in the sterile surgical field but cannot be sterilized. The sterile drapes are put over this equipment in case any sterile items may come into contact with them.
REF numbers: 891BG and 891BG-10 (10 pack): all lots
Worldwide Distribution - US including US: AK, AZ, CA, DE, FL, HI, IL, LA, MD. MA. MN, MS, MO, NE,  NJ,. NHY, NC, ND, OH, OR, PAM TN, TX, VA, WA, WV, and WI.  Internationally to Australia, Belgium, Canada, Czech Republic, Denmark, Dominican Republic, France, Germany, Israel, Japan, Netherlands, Serbia, South Africa, and Switzerland.
Distributed US (nationwide) and in the countries of Australia and Germany.
Virage OCT Spinal Fixation System.  Intended to promote fusion of the  Occipital-Cervical-Thoracic spine (Occiput-T3).
Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual.
Surgical Technique Manual  L1637 Rev B (2014-06)
Nationwide, Puerto Rico and Malaysia, Taiwan, Brazil, and Israel.
Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only, Two vials per Carton, Carton contains 2 vials of Thyrogen, Dilute with Sterile Water for Injection, Storage: store at 2-8 C, Manufactured by: Genzyme Corporation, Northborough, MA 01532 USA, Marketing Authorization holder: Sanofi-Aventis, NDC 58468-0030-2.
Presence of Particulate Matter: Glass particles found in the product after reconstitution.
Thyrogen (thyrotropin alfa for injection), 0.9 mg/mL after reconstitution, For intramuscular injection only, Rx Only,  Four vials per Carton, Carton contains 2 vials of Thyrogen and 2 vials of diluent, Storage: store at 2-8 C, Genzyme Corporation, Cambridge, MA 02142, NDC 58468-1849-04.
Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.
Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and  Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
Complaints were received claiming the material failed to polymerize under the curing light.  After investigation, it was determined that a wrong photo-initiator was used in the production batch U30755 of Helioseal Clear.  This failure can lead to incomplete curing of the sealant, if mono-wave LED curing lights are used.
sulfur8 medicated LIGHT FORMULA (sulfur) anti-dandruff hair & scalp conditioner, 2%, packaged in a) 2 OZ (57g) jar (UPC 0 75610 43510 8), and b) 4 OZ (113g) jar (UPC 0 75610 43610 5), 1 dozen jars per case, J. Strickland & Co., PO Box 1637, Olive Branch, MS 38654
Subpotent Drug: failed at the 3 and 6 month stability time points.
Philips Electronics North  America Corporation
US: Nationwide  OUS: Canada, Afghanistan  Albania  Algeria  Andorra  Argentina  Australia  Austria  Azerbaijan  Bahamas  Bangladesh  Belarus  Belgium  Bolivia  Bosnia and Herzegovina  Botswana  Brazil  Burkina Faso  Chile  China  Colombia  Columbia  Congo, Democratic  Costa Rica  Croatia  Cyprus  Czech Republic  Denmark  Dominican Republic  Ecuador  Egypt  Estonia  Ethiopia  Finland  France  Georgia  Germany  Ghana  Greece  Guadeloupe  Hong Kong  Hungary  Iceland  India  Indonesia  Iran  Iraq  Ireland  Israel  Italy  Japan  Jersey  Jordan  Kazakhstan  Kenya  Korea, Republic of  Kuwait  Kyrgyzstan  Latvia  Lebanon  Libya  Lithuania  Luxembourg  Malaysia  Malta  Martinique  Mauritius  Mexico  Monaco  Mongolia  Morocco  Mozambique  Nepal  Netherlands  New Caledonia  New Zealand  Norway  Oman  Pakistan  Palestinian territory, occupied  Panama  Papua New Guinea  Peru  Philippines  Poland  Portugal  Puerto Rico  Romania  Russian Federation  Rwanda  Saudi Arabia  Serbia  Singapore  Slovakia  Slovenia  South Africa  Spain  Sri Lanka  Sudan  Sweden  Switzerland  Syrian Arab Republic  Taiwan  Tanzania  Thailand  Tunisia  Turkey  Uganda  Ukraine  United Arab Emirates  United Kingdom  Venezuela  Viet Nam  Yemen  Zimbabwe
SENSE Body Coil 1.5T with identification;  used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns.
ClosureFast Micro Introducer Sheath Set 7Fr/Ch(2.3mm) x 7 cm REF MIS-F707 and ClosureFast Introducer Sheath Set 7Fr/Ch(2.3mm) x 11 cm REF IS-7F11.  Indicated for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
The incorrect sheath was assembled to the device so that the size 7 products received 11 cm sheaths and the size 11 product received 7 cm sheaths.
Blood products, collected from an ineligible donor, were distributed.
Blood and Blood Products for Reprocessing
Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ  08512; NDC 41616-638-68, UPC 3 41616 63868 4.
Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceeding specification limit at the 3 month stability time point.