Label reads in part: TWIN FIN DELI; Salami; Net WT. 1lb (453g); P.O. Box 399 Thomson IL, FDA# 1481764 Thomason
Label reads in part: TWIN FIN DELI; Gefilte Fish; Kosher Fish Products Inc., Fulton, IL. FDA# 1481764; Net WT. 24 OZ (680G)
*** 1) Fish hot dogs total 1 lb in weight vacuum packaged in plastic bags; Label reads in part: TWIN FIN DELI; Franks; Net WT. 1lb (453g); Kosher Fish Products Inc. Fulton, IL FDA# 1481764;   *** 2) Fish hot dogs total 15 lbs in weight packaged 120 x box with a poly liner
Worldwide Distribution - US: Nationwide, including Washington D.C., and Puerto Rico. and the countries of: Poland, France, Austria, Czech Republic, Ireland, Germany, Italy, Japan, Canada, United Arab Emirates, Turkey, Netherlands, United Kingdom, Brazil, South Africa, Kuwait, Belgium, Russia, Taiwan, Australia, Bangladesh, Bulgaria, Brazil, Switzerland, Chile, China, Colombia, Denmark, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, Hong Kong, Croatia, Hungary, Indonesia, Iran, Israel, India, South Korea, Kuwait, Kazakhstan, Lithuania, Latvia, Morocco, Mexico, Norway, New Zealand, Peru, Phillipines, Pakistan, Portugal, Qatar, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Thailand, Tunisia, Taiwan, Venezuela, and Vietnam.
The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally and vertically by four linear bearing cars. There is a potential for the linear bearing car to fail allowing the ball bearings to fall out.
Oasis Dietary Supplement Capsules, 500 mg, 45 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
Marketed without an Approved NDA/ANDA; FDA analysis found them to contain sibutramine and phenolphthalein
Jenesis Dietary Supplement Capsules, 350 mg, 60 count bottles, Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104, distributed by BeeXtreme LLC, Punxsutawney PA
La' Trim Plus Dietary Supplement Capsules, 350 mg, 60 count bottles,  Manufactured for Timeless Solutions, 1810 E Sahara Ave #100, Las Vegas, Nevada 89104,   distributed by BeeXtreme LLC, Punxsutawney PA
The products were distributed to cabela's and bass pro shops throughout the U.S. (nationwide).  It was sent to 134 locations total.  Including 2 consignees in Canada.
Cabela's classic candies Maple nut packaged in 2.7 oz. clear plast ice bag with brown label attached with brown lettering.
product label does not include peanuts as an ingredient. Peanuts are an allergen.
Uncle Buck's Maple Nut candy packaged in a clear plastic 2.7 oz. bag with attached green, orange, and white label with Organe and black writing.
5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32
Non-Sterility: fungal contamination due to leaking containers.
lidocaine HCl 1%, 10 mg per mL (50 mg per 5 mL), Preservative Free, 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3391.
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
atropine Sulfate Injection, 0.4 mg per mL, 1 mg per 2.5 mL, 2.5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3324.
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 3 mL in a syringe, Rx only, PharMEDium, Product code 2R3343.
ePHEDrine Sulfate, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a  syringe, For IV Use, Rx only, PharMEDium, Product code 2R3308.
methadone HCl, 10 mg per mL, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6149.
fentaNYL Citrate Injection, 50 mcg per mL (100 mcg per 2 mL), 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium,  Product code 2R3303.
fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a 3 mL BD Syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6107.
HYDROmorphone HCl, 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3352.
lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3450.
lidocaine HCl, 1%, in 0.9% Sodium Chloride, Preservative Free, Total Volume 1 mL in a syringe, Rx only, PharMEDium, Product code 2R3345.
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3153.
Subpotent Drug and Stability Data Does Not Support Expiry: confirmed subpotency and potential loss of potency in drugs packaged and stored in syringes.
ketamine HCl, 10 mg per mL, 20 mg per 2 mL, in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3330.
lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3110.
labetalol HCl, 5 mg per mL, 20 mg per 4 mL, 4 mL total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3117.
fentaNYL Citrate, 5 mcg per mL (10 mcg per 2 mL) in 0.9% Sodium chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3339.
lidocaine HCl, 2%, Preservative Free, Total Volume 2mL, Product code 2R3323, NDC 61553-323-79
Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium Chloride, Total Dose 25.005 mcg/1.5 mL Fentanyl Citrate, Content Volume 1.5 mL in 3 mL BD Syringe, Intended for Epidural Use, Rx only, PharMEDium, Product code 2T6228.
morphine Sulfate, 1 mg per mL (5 mg per 5 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 5 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3181.
morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 2 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3259.
morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3353.
atropine Sulfate Injection, 0.4 mg per mL, 0.8 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3335.
fentaNYL Citrate Injection, 50 mcg per mL, 250 mcg per 5 mL, 5mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3306.
lidocaine HCl, 1%, 30 mg per 3 mL, 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3104.
methadone HCl, 2.5 mg per 0.5 mL, in 0.9% Sodium Chloride, 0.5 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6134.
PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3346.
midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3356.
glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3217.
glycopyrrolate, 0.2 mg per mL, 1 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3340.
fentaNYL Citrate, 5 mcg per mL, 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3479.
lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product code 2R3441, NDC 61553-441-80
lidocaine HCl, 0.5%, 5 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3140.
ketamine HCl Injection, 50 mg per mL, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product  code 2R3348.
midazolam HCl, 1 mg per mL (3 mg per 3 mL), in 0.9% Sodium Chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product Code 2R3351.
ePHEDrine Sulfate, 5 mg per mL, 25 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3301.
Buffered Lidocaine, 2%, In Sodium Bicarbonate 8.4%, 3 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2475.
rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3321.
neostigmine Methylsulfate, 1 mg per mL, 5 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3326.
HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6165
lidocaine HCl, 2%, 40 mg per 2 mL, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3112.
fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3318.
methadone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use Only, Rx only, PharMEDium, Product code 2T6120.
Stability Data Does Not Support Expiry:potential loss of potency in drugs packaged and stored in syringes.
ketamine HCl Injection, 50 mg per mL (100 mg per 2 mL), 2 mL Total Volume in a syringe, Rx only, PharMEDium, For IV Use, Product code 2R3500.
morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2T6455.
HEPARIN Sodium Inj. USP, 3,000 USP Heparin Units per 3 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 Heparin USP Units per mL, Rx only, PharMEDium, Product code 2K1926.
morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3119.
remifentanil HCl, 50 mcg per mL, 100 mcg per 2 mL, in 0.9% Sodium Chloride, Preservative Free, 2 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3300.
lidocaine HCl 2%, Preservative Free, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3384.
fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3174.
fentaNYL Citrate Injection, 50 mcg per mL, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Product code 2R3118, NDC 61553-118-40
PHENYLephrine HCl, 40 mcg per mL, 200 mcg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3376.
succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3357.
fentaNYL Citrate, 10 mcg per mL (25 mcg per 2.5 mL), in 0.9% Sodium Chloride, 2.5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3424.
midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3196.
HEPARIN Sodium Inj., USP, 5,000 USP Heparin Units per 5 mL Total Volume in a syringe, NOT FOR LOCK FLUSH, 1,000 USP Heparin Units per mL, Rx only, PharMEDium, Product code 2K1925.
HYDROmorphone HCl, 0.2 mg per mL, (0.4 mg per 2 mL), in 0.9% Sodium Chloride, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3162.
morphine Sulfate, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (Contains Sulfites), 1 mL Total Volume in a syringe, For IV use, Rx only, PharMEDium, Product code 2R3017.
neostigmine Methylsulfate, 1 mg per mL, 3 mg per 3 mL, 3 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3551.
fentaNYL Citrate, 25 mcg per mL in 0.9% Sodium chloride, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3236.
ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3234.
lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3106.
ketamine HCl, 10 mg per mL, 50 mg per 5 mL, 0.9% Sodium Chloride, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3320.
PHENYLephrine HCl, 100 mcg per mL, 0.5 mg per 5 mL, in 0.9% Sodium Chloride, Preservative Free, 5 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3109.
glycopyrrolate, 0.2 mg per mL, 0.4 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3329.
neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3550.
lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2R3102.
Subpotent Drug: confirmed subpotency in one lot of this product that was packaged and stored in syringes.
ePHEDrine Sulfate, 10 mg per mL, in 0.9% Sodium Chloride, Preservative Free, 1 mL Total Volume in a syringe, For IV Use, Rx only, PharMEDium, Product code 2R3347.
HEPARIN Sodium Inj. USP, 15,000 USP Heparin Units per 3 mL Injection 3 mL Total Volume in a syringe, Rx only, PharMEDium, Product code 2K1210.
Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a syringe, Local anesthetic use, Rx only, PharMEDium, Product code 2K2466.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Doctor Kracker Pumpkin Seed Cheddar Crispbreads Net Wt. 7 oz. (200g) in cardboard container.
Undeclared milk in the ingredient statement although the product name contains Cheddar.
Doctor Kracker Klassic 3 Seed Crispbreads Net Wt 7 oz (200g) in cardboard container.
Milk declared in the ingredient statement although the product does not contain milk.
Nationwide through direct purchase on web site.
Dark Cocoa Nom Noms  4.5oz. (128g)  UPC: 8 54557 00533 5  Lot 16083    Product is shipped directly to customers per individual order or to corporate customers in 20 x 4.5 oz. bags cases.    Ingredients:  Rolled Oats, Almonds. For address freshness (Grape juice, rice dextrin), honey, sugar, canola oil, dark chocolate flavored chips (sugar, vegetable far {palm, palm kernel}, cocoa processed with alkali, dry buttermilk, soy lecithin (an emulsifier), natural flavors, Cocoa Powder, Egg Whites, Unsweetened Chocolate, unsweetened coconut, Brown Rice Syrup, natural flavor, pumpkin seeds, cocoa processed with alkali, salt.    Contains: Tree nuts (almonds, coconut, Milk, Soy and Egg).    Packed in a facility that also processes tree nuts, peanuts, milk, wheat, egg and soy.    Distributed by Nature Box, San Carlos, CA
Firm was notified by third party warehouse that some Peanut Butter Nom Nom product was packaged in Dark Cocoa Nom Nom packaging and therefore did not declare peanuts in the ingredient or allergen information.
Product was distributed to CA, FL, MI, MO, MN, OR, PA, and WI.  There was no foreign/military/government distribution.
easOtic (hydrocortisone aceponate 1.11 mg / miconazole nitrate 15.1 mg / gentamicin sulfate 1.5 mg/ml) suspension for dogs packaged in 10 mL size canister, 1 canister per carton, Net Contents 10 mL, NDC 51311-360-10. NADA 141-330. The responsible firm name on the label is Virbac Animal Health, Fort Worth, TX 76137.
Out of specification result for gentamicin sulfate at 18-month stability time-point.
Worldwide Distribution - US including MD, MN, & MS; **Internationally** AE, AT, AU, BE, BR, CA, CN, DE, DK, EG, ES, FI, FR, GB, GP, HU, IN, IT, JO, JP, KR, MY, NO, NZ, PH, PT, QA, SA, SE, SG, TR & VN
292 units Total (3 domestically & 289 internationally)
Distributed to multiple locations within the U.S. (nationwide): No foreign consignees.
Quaker Quinoa Granola Bars, chocolate nut medley packaged in a multi colored box with brown lettering. Wrapper UPC: 000 30000 00243 8
77,448 cases, 12 units per case, 5 bars per unit.
SunOpta expanded their recall of listeria Monocytogenes in sunflower kernels. These sunflower kernels were used in the manufacturing of quinoa bars at the quaker oats company.
Best by dates: all dats prior to November 15, 2016 (NOV 15 16 K)
Quaker quinoa granola bars, yogurt fruit and nut flavor packaged in a multi colored box with brown lettering. Wrapper UPC: 000 30000 00195 0
106, 436 cases, 12 units per case, 5 bars per unit.
Taylor Farms Cranberry Walnut Salad;  Salad kit for one:  Baby Lettuce Blend, Feta Cheese, Flat Bread Chips, Dried cranberries and Walnuts and Raspberry Vinaigrette dressing.    Distributed by: Taylor Farms Inc., Salinas, CA.
Some packages of Taylor Farms Cranberry Walnut Salad kits may have the incorrect back label with ingredients for Taylor Farms Spinach Salad with Bacon and not properly declare walnuts or wheat.  The Walnuts are clearly visible through the packaging.
Neo-Terramycin 100/100D (neomycin-oxytetracycline), Type A Medicated Article Antibiotic, Net Weight 50 lb (22.7 kg), packaged in a Multi-wall bag, Phibro Animal Health Corporation, NDC #66104-8851-0
Out of Specification for Neo Terramycin 100/100 D Type A Medicated Article.
US Nationwide Distribution to states of: AL, AR, CA, Washington, D.C., FL, GA, IA, IL, IN, KY, LA, MI, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX & VA.
ID tubing, ITEM BB14, STERILE,    Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.
Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
TAZORAC (tazarotene) Gel 0.05%, Rx only, packaged in 15 x 3.5 g professional sample containers, Manufactured by: Allergan Inc., Irvine, CA 92512. UPC: 300238335159.
TAZORAC (tazarotene) Gel 0.05%, Rx only, For Dermatologic Use Only, Not for Ophthalmic Use, packaged in a) 30 g tubes (NDC: 0023-8335-03, UPC: 300238335036) and b)100 g tubes,(NDC: 0023-8335-10, UPC: 300238335104), Manufactured by: Allergan Inc., Irvine, CA 92512.
US Distribution to the states of : AL, CA, FL, IL, IN, KY, LA, MA, MS, NJ, NY, OK, PA, SC and VA,  and Internationally to Pakistan.
The Medix NatalCare LX Intensive Care Incubator.  Neonatal incubator.  Item numbers: DMNCLX1; KITNC-STLX0003; KITNC-STLX0006; and KITNC-STLX0007.
NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate.  There were several complaints of wheels bending out of alignment.
Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby Laboratories, Livonia, MI --- NDC 0536-0590-85
Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
Radiation Therapy Treatment Planning System, Model 5.0
491 units (187 domestically & 304 internationally)
For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose.  The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.
Amikacin Sulfate Injection, USP, 500 mg/2 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9032-01 (individual pack), NDC 0703-9032-03 (shelf-pack carton of 10 vials).
Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).
Products were distributed to: PA,NJ,NY,MD,VA
Gourmet Banana Nut Monster Muffins (4 count)
WEIS MARKETS IS ISSUING A VOLUNTARY RECALL FOR 30 BAKERY PRODUCTS INCLUDING MUFFINS, COOKIES, AND SHORTBREAD AND BAKED BREAD ITEMS DUE TO THE POTENTIAL PRESENCE OF SMALL METAL FRAGMENTS (2-9MM) IN THE SUGAR TOPPING USED ON THESE PRODUCTS. THE VOLUNTARY ACTION IS BEING TAKEN DUE TO OUR SUPPLIERS RECALL OF THE SUGAR INGREDIENT.
Gourmet Raisin Bran Monster Muffins (4 count)
Gourmet Double Dutch Monster Muffins (4 count)
Gourmet Apple Spice Monster Muffins (4 count)
Gourmet Cinnamon Chip Monster Muffins (4 count)
Gourmet Lemon Poppy Monster Muffins (4 count)
Gourmet Cranberry Orange Monster Muffins (4 count)
Gourmet Cherry Almond Monster Muffins (4 count)
Gourmet Red Velvet Monster Muffins (4 count)
Gourmet Chocolate Chip Monster Muffins (4 count)
Gourmet Pumpkin Monster Muffins (4 count)
Monster Size Pina Colada Muffins (4 count)
Gourmet Orange Pineapple Monster Muffins (4 count)
Sour Creme Cookies with Chocolate Chips (6 count)
Gourmet Butter Rum Monster Muffins (4 count)
Gourmet Blueberry Monster Muffins (4 count)
Gourmet Pistachio Flavored Monster Muffins (4 count)
Banana Chocolate Chip Loaf Bread (1 count)
Worldwide Distribution -- USA, including AR, CA, CO, CT, FL, GA, IL, KS, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, VA, WA, WI, and Puerto Rico;  and the countries of Canada, Australia, Italy, Panama, Switzerland and Taiwan.
TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair.    Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.
TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair.    Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair.    Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment.
CANNIBAL RIOT, SUPER STIMULANT PRE-WORKOUT ENERGY COMPLEX, UNICORN BLOOD, Chaos and Pain, DIETARY SUPPLEMENTS, NET.WT. 10.5 oz (300g), UPC 610563314669
The products are being recalled because they contain 750 mg of Agmatine and 50 mg 1,3 Dimethylamyamine per serving which is not declared on the label. 1,3   Dimethylamyamine is not permitted for use in dietary supplements in the EU.
CANNIBAL RIOT, SUPER STIMULANT PRE-WORKOUT ENERGY COMPLEX, FIVE FINGER DEATH PUNCH, Chaos and Pain, DIETARY SUPPLEMENTS, NET.WT. 10.5 oz (300g), UPC 610563314652
Worldwide Distribution - US, in the states of AL, AR, AZ, CA, DC, FL, IL, IN, KY, LA, MA, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, SC, TX, UT, VA, and WI; and, the countries of Argentina, Belarus, Bosnia, Herzegovina, Brazil, Canada, Chile, Colombia, Hong Kong, India, Israel, Kazakhstan, Kuwait, Lebanon, Malaysia, New Zealand, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Taiwan, Turkey, and Vietnam.
HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103;  and International Product:  Model No.: 1104XX.      Product Usage:  For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults.
All sterile un-implanted stock manufactured prior to HW25838 is subject to removal.
Worldwide Distribution n- US (Nationwide) and Foreign distribution to the following countries:  Argentina, Bangladesh, Brazil, Bulgaria, China, Colombia, Costa Rica, Cyprus, Egypt, France, Germany, Greece, Guatemala, India, Indonesia, Israel, Italy, Kazakhstan, Macedonia, Mexico, Paraguay, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Syria, United Arab Emirates, and Uruguay.
SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD ---    For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age
Siemens received multiple customer complaints indicating an increase in false positive and indeterminate patient sample results and increased imprecision for several lots of Rubella IgM assay on the IMMMULITE 2000/IMMULITE 2000 XPi platforms.
SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD ---    For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
Wegmans ITALIAN CLASSICS Organic BLUSH SAUCE, NET WT 23.5 OZ (1 LB 7.5 OZ) 667g
Incorrect rear panel label was applied to jars of cream sauce which declared milk allergen
Worldwide Distribution - US Nationwide in the states of:  CA, HI, IL, IN, KS, LA, MA, NC, NM, NY, OH, OK, PA, TN, TX, UT, WA and WI; plus Foreign distribution to Australia, Canada, France, Germany, Italy, Spain, Czech Republic, Lithuania, Netherlands, Poland, Korea,Morocco, Malaysia, Mexico, Taiwan, and South Africa.
CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only   Product Usage:  The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.
Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430, USA, A Subsidiary of Stryker Corp.
Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.
Catalog No: 2101-0200, Lot Nos. SMM7A00, SMM7A00L, SMM7A02, SMM7A02A, SMM7A02E, SMM7A02EE, SMM7A01T, SMM7A01TT, SMM7A01TD, SMM7A01TDD, SMM7C02H, SMM7C02, SMM7C01, SMM7C01T, SMM7C01TT, SMM7C01W, SMM7E03, SMM7E03A, SMM7E00, SMM7A00E, SMM7E02, SMM7E02A, SMM7E01, SMM7E01A, SMM7K00. SMM7K01, SMM7K01A, SMM7K03, SMM7K03L, SMM7K02, SMM7K02T, SMM7K03X, SMM7K03Y, SMM7C02J, SMM7L00H, SMM7L00J, SMM7L00K, SMM7L00, SMM7C01TW, SMM7M01, SMM7A02T, SMM7M00, SMM7M00A, SMM7M02H, SMM7M02, SMM7E02M, SMM7E01JK, SMM7K03J, SMM7K00A, SMM6N04, SMM7N01J, SMM7N01, SMM7M06, SMM7M09, SMM7N03, SMM7N03A, SMM7M06A, SMM7M09, SMM7N00, SMM7M05, SMM7M08A, SMM7M10, SMM7N00A, SMM7N02L, SMM7M05J, SMM7M08, SMM7N02, SMM7N04, SMM7N04J, SMM8C00, SMM7M01R, SMM7M01RW, SMM7M01W, SMM7M07, SMM7M07J, SMM6C00, SMM7M03, SMM7M03A, SMM7M03D, SMM7M03E, SMM7M03L, SMM7M04, SMM7M04L, SMM7M03K, SMM8C00J, SMM8L05, SMM8L05A, SMM8L02X, SMM8L04, SMM6N00, SMM6N01, SMM6N01A, SMM6N02, SMM6N03, SMM6N04A, SMM8L07T, SMM8L08, SMM8M00K, SMM8M00L, SMM8M01, SMM8M01E, SMM8M01EE, SMM8N02, SMM8N02A, SMM8M01A, SMM8N00, SMM8N00A, SMM8N00D, SMM8N01, SMM8N01A, SMM8N01T, SMM8S00, SMM8S00T, SMM8S00TT, SMM8S01, SMM8S01A, SMM8S01D, SMM8T00, SMM8N02T, SMM8S02, SMM8V00, SMM8V00A, SMM8V00E, SMM8T00A, SMM8V01, SMM8V01A, SMM8W02, SMM8W03A, SMM8V02, SMM8W01, SMM8W01A, SMM8W02X, SMM8W03M, SMM8W03P, SMM8W04, SMM8W04A, SMM8W05, SMM8W05A, SMM8W03D, SMM8W03, SMM8W05D, SMM8W00A, SMM8W00E, SMM8W00J, SMM8W00K, SMM8W00, SMM8V02J, SMM8W00D, SMM8V07, SMM8W06H, SMM8W05H, SMM8W00H, SMM8W07, SMM8W07K, SMM8W07L, SMM8W08, SMM8W08E, SMM8W07A, SAMPLE25, SMM8W08EE, SMM9A00, SMM9A00R, SMM9A00T, SMM9A01, SMM9A01E, SMM9A01EL, SMM9A02, SMM9A02E, SMM9A03, SMM9A03K, SMM9A03L, SMM9A03P, SMM8L01, SMM8L03, SMM8L07, SMM8L00T, SMM8L07, SMM9A05, SMM9A06, SMM9A06E, SMM9A07, SMM9A08, SMM9A12, SMM9A12J, SMM9A12T, SMM9A09, SMM9A09K, SMM9A09L, SMM9A10, SMM9A11, SMM9A11D, SMM9A07L, SMM9E01, SMM9E02, SMM9E02A, SMM9E03, SMM9E00, SMM9C00A, SMM9C00D, SMM9C00, SMM9C00J, SMM9C00K, SMM9E05A, SMM9E04, SMM9E04A, SMM9E04D, SMM9E04E, SMM9E05, SM
Publix Almond Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802
The Bakery Raspberry Crumb Coffee Cake| Net Wt 15 OZ (425g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 078742052953
Cheese Decadent Danish | NET WT 14 OZ  (397g) | Gold Standard Baking, Chicago, IL 60632 | UPC: 087745050019
The Bakery Strawberry Cheese Danish | Net Wt 14 OZ (397g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 078742100401
The Bakery Raspberry Danish | Net Wt 14 OZ (397g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 605388124487
Archer Farms Strawberry Danish | NET WT 14 OZ  (397g) | Distributed by Target Corporation Minneapolis, MN 55403 | UPC 085239101094
Kroger Raspberry Danish Strip, Naturally and Artificially Flavored  | NET WT 14 OZ  (396g) | Distributed by The Kroger Co., Cincinnati, Ohio 45202 | UPC: 011110836489
Publix Maple Walnut Strip Danish | Count, 1 | NET WT 14.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802
Publix Cherry Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802. UPC: 002-19562-00000
UPC: 002-19562-00000  All date codes through expiration date 1/19/2017
Publix Guava Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802. UPC: 002-19562-00000
Cherry Decadent Danish | NET WT 14 OZ  (397g) | Gold Standard Baking, Chicago, IL 60632 | UPC: 087745050033
The Bakery Apple Crumb Coffee Cake| Net Wt 15 OZ (425g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 078742052953
Archer Farms Cheese Danish | NET WT 14 OZ  (397g) | Distributed by Target Corporation Minneapolis, MN 55403 | UPC 085239101094
Publix Raspberry Strip Danish | Count, 1 | NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802
The Bakery Cheese Danish | Net Wt 14 OZ (397g) | Distributed By WAL-MART Stores, Inc, Bentonville, AR 72716 | UPC: 605388124487
Strawberry Cheese Decadent Danish | NET WT 14 OZ  (397g) | Gold Standard Baking, Chicago, IL 60632 | UPC: 087745050064
Publix Apple Strip Danish | Count, 1 |  NET WT 15.00 oz | Distributed by Publix Supermarkets, Inc., Lakeland, FL 33802
US Distribution to states of: AZ, CA, FL, NY, NC, and TX.
Teleflex Percuaneous Solutions, Gripper Grasper, Ref ML003EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709    The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery.
The product is being recalled due to a labeling error.  The Gripper Graspers are labeled as Johans Graspers and the Johans Graspers are labeled as Gripper Graspers.
Teleflex Percuaneous Solutions, Johans Grasper, Ref ML004EE, Rx Only Sterile Manufactured for: Teleflex Medical, Park, NC 27709    The Percutaneous Surgical System with 5 mm attachments is indicated for the means to penetrate soft tissue to access certain areas of the human abdomen and used to grasp, hold and manipulate tissue during laparoscopic surgery.
C. H. Guenther & Son, Inc.dba Morrison Milling
Texas via direct account.  Within the Southwestern region of the US via sub-accounts.
The Baker's Scoop 100% WHOLE WHEAT FLOUR NET WT. 5 LB (2.27 kg) packaged in white paper bag
Potential for the presence of soft nylon fragments in the whole wheat flour.
U.S. Consignee located in the following states: IL, WI, WE, OR, NY, UT, IN, NE, PA, MO, OH, AZ, MA, CT  and NC.*** Foreign Consignee: Canada.
The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
The Introes Pocket Bougie an endotracheal tube introducer size 14 Fr (4.7mm) x 60 cm may break during intubation.
nationwide.  No foreign or govt/military/VA consignees.
Dietary Supplement Acidophilus Blend, 90 capsules, Product No. E-420, packaged in 225cc HDPE white bottle, room temp, sold individually
Nature's Power Solutions Acidophilus Blend due to undeclared milk allergen.
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1610-50.
Lack of Assurance of Sterility and Subpotent Drug: defect in glass vial prevented stopper from forming a seal allowing water to ingress and dilute the product causing it to be less than the labeled potency.
Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1587-50.
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
3,858 prescription packs (115,680 capsules)
Blood Pressure Monitor UA-767PBT-Ci for small cuff.  Designed to be used by end users who are eighteen (18) years and older at home to monitor their blood pressure (systolic and diastolic) and pulse rate.
A&D may have shipped blood pressure monitors that were not labeled for use with small cuff.
Fujifilm Synapse PACS, Software versions: 4.0.xxx,  4.1.xxx, version 4.2.xxx, version 4.3.xxx    Medical imaging and information management system, SYNAPSE allows the archiving and distribution of image information from all modalities
Software versions: 4.0.xxx,  4.1.xxx, version 4.2.xxx, version 4.3.xxx
Corra Lin Sheep Milk Cheese; Raw Sheep's Milk, Starter and Ripening Cultures, Salt and Rennet  Sold in wheels, wt.  range of 13.24 to 15.90 lb.  Neal's Yard Dairy, London    Neal's Yard Dairy - exporter  Manufactured by Errington Cheese Ltd., South Lanarkshire, United Kingdom.
4 wheels - wt. range of 13.24  to 15.90 lbs.
Food Standards Scotland (FSS) has ordered all cheese from Errington Cheese to be pulled from distribution after detection of O157 and O157 E. Coli.
CO, CT, DE, GA, IA, IL, IN, KS, MA, MD, ME, MI, MN, MO, ND, NE, NH, NJ, NY, OH, PA, VA, VT, WI, WY
Potential to be contaminated with Listeria monocytogenes.
UPC: 38000 40370    Better If Used Before Date:   NOV21 17 ER   and  NOV22 17 ER    The date code can be found on the side of the package.
Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic  Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-011-39
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
All unexpired lots;  Expirations dates of 11/13/2016 to 01/02/2017
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water  for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-002-35
All unexpired lots;  Expirations dates of 10/03/2016 to 12/19/2016
Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1  mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
All unexpired lots;  Expirations dates of 10/05/2016 to 01/10/2017
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
All unexpired lots;  Expirations dates of 10/11/2016 to 01/16/2017
Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride  (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-007-35
All unexpired lots;  Expirations dates of 09/24/2016 to 02/06/2017
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Volume (NDC 70360-017-38) and b) 10 mL Total Volume (NDC 70360-017-39) in a 15 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-017-38
All unexpired lots;  a) Expirations dates of 10/03/2016 to 11/06/2016 and b) 09/25/2016 to 10/01/2016
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS)  Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-003-35
All unexpired lots;  Expirations dates of 09/21/2016 to 2/2/2017
Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection  (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-005-35
All unexpired lots;  Expirations dates of .11/05/2016 to 12/10/2016.
Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Compounding, San Jose, CA --- NDC 70360-008-35
All unexpired lots;  Expirations dates of .09/20/2016 to 10/10/2016
US Nationwide Distribution in the states of: MI, UT, SD, OH, WA, KS, MO, NJ, GA, and TX.
Phoenix Recon Targeting Arm  Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm    Product Usage:  The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. These instruments are used in support of the surgery.
Old revisions and new revisions of the soft tissue sleeve and recon targeting arm are not interchangeable, as the new revision tissue sleeve will not fit into the old revision targeting arm. The old revision tissue sleeve has too much clearance with new revision targeting arm.  Risks of encountering the affected product include: the correct instrument may not be readily available for the procedure causing the surgeon to complete the procedure by hand; or a delay in surgery greater than 30 minutes may occur while another Recon Targeting Arm or Recon Soft tissue Sleeve is located or while the surgeon completes the procedure by hand.
Phoenix Recon Soft Tissue Sleeve  Guide, Surgical, Instrument for the sleeve and Orthopedic Manual Surgical Instruments for the Arm    Product Usage:  The Phoenix Femoral Nail System is to be implanted into the femur for alignment, stabilization and fixation of fractures caused by trauma or disease, and the fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity, and for arthrodesis. These instruments are used in support of the surgery.
Item number: 14-442008  Lot number: 2095181
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA  92618, NDC 0703-4685-01.
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
NJ, NY, PA via Retail stores and restaurants
BIKAJI Chowpati BHELPURI,  NET WT : 300 g [ 10.58 OZ ], Item No: B022, PRODUCT OF INDIA
FDA sample analysis revealed the presence of Salmonella contamination
BATCH NO: 2016 F 97  BEST BEFORE: JUNE 2017
Nationwide. Canada.  AUSTRALIA  AUSTRIA  BELGIUM  BRUNEI  CHINA  FRANCE  GERMANY  INDA  INDONESIA  ISRAEL  ITALY  KSA  MALAYSIA  NETHERLANDS  POLAND  QATAR  QUEBEC  SAUDI ARABIA   SINGAPORE  SOUTH AFRICA  TAIWAN (R.O.C.)
Zero-Gravity Radiation Protection System  Radiology  Personnel protective shield.
Two customer complaints  suggest that excessive rotation of the cable in one direction (clockwise or counter-clockwise)  without allowing the cable to unwind to its normal condition may cause the cable to break  suddenly and the body shield to fall. While no injuries or deaths occurred in either failure, the  Zero-GravityTM body shield weighs 55 pounds, and in the event of a cable failure, the body  shield will fall immediately. A fall of this nature places the user, associated staff and the patient  at risk for a potential injury.
The product was distributed in NJ and NY
COW GHEE, Ingredients: 100% clarified butter
Surgical Specialties Mexico S DE RL DE CV
Corredor Tijuana - Rosarito 2000-24702 B
US: OH, PA, CO, MA, DE, CA, NY, VA, WA, NJ, CT, FL, TX, NH, ID, OK, AZ, GA, PA, NV, VT.    Worldwide: Spain, Italy, United Kingdom, Portugal, Turkey, Germany, Denmark,
BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.
Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.
Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/  Sideport. Laproscopic Use- Sterile Single Use Only  Product Code 400-009
Potential lack of assurance of sterility
Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula.  For Laproscopic Use- Sterile Single Use Only.  Product Code 400-008
Worldwide Distribution - US Nationwide in the states of CO, KA, NE, MI, MO, OH, WA and country of Switzerland
O-arm O2 Surgical Imaging System Spatial calibration may be erroneous in Stealth Station navigated images
Blood products, collected from a donor with a history of intravenous drug use, were distributed.
US Distribution and Internationally to 1 site in Canada, India and Morocco
Varian Head Frame - Model number HHF -ALL Head Frame Posts (PN1008016 ) and Post Kits (PN1008016).      The Varian Head Frame System is for use with a computed tomography scanner to perform imaging for treatment planning and a charged particle accelerator to perform immobilization of the treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial lesions, tumors and conditions where radiation treatment is indicated.
Varian Medical Systems has received a report that a user was able to easily rotate the head frame posts when attached to the mounting cam on the metal head ring. There was no report of serious injury due to this issue
Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Germany, New Zealand, Saudi Arabia, South Africa, Switzerland and Thailand.
V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.
Potential risk associated with corrosion demonstrated on the distraction screw surface.
Blood products, collected from donors who lived in  malarial endemic areas, were distributed.
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Worldwide Distribution - US to CA, FL, KY, MD, MO, MT, NJ, NC, PA, WA, WI.  Internationally to Algeria. Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, China, Columbia, Croatia, Czech Republic, Ecuador Estonia, France, Germany, India, Iran, Israel, Italy, Japan, Malaysia, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Panama, Peru, Philippines, Portugal, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, and Zimbabwe.
Monaco RTP System  The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two or three dimensional radiation dose distribution inside patients for given treatment plan set-ups
When creating 3D plans using either MU or Dose weighting modes, if the user changes the Physician's Intent Rx Dose and/or the number of fractions, and then modifies the wedge angle, the MU value is scaled incorrectly.
Consignees were notified via email on 09/25/2016.
RW Garcia, 3 Seed, Sweet Potato Crackers, (Flaxseed, Sesame & Chia), Gluten Free, Net Wt., 30 oz., Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., San Jose, CA 95112 and Lincolnton, NC 28092.
Foreign material (metal fragments) detected in raw material.
Harris Teeter, Multigrain, Tortilla Chips, Net Wt. 12 oz. (340g), Produced by Harris Teeter, Mathews, NC 28105.
RW Garcia, 3 Seed.Graines, Kale Crackers, Craquelins de Kale, Gluten Free, Net Wt. 180g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., Las Vegas, NV 89115 and Lincoln, NC 28092, Distributed by Clean Foods, Ltd, Legion House, 75 Lower Road, Kenley, Surrey, CR8 5NH.
Item #3086, PO numbers: RWGC140, Date Code: 4/15/2017.
365, White Corn, Tortilla Chips, Lightly Salted, Net Wt. 16 oz. (1 lb.) 454g., Distributed by Whole Foods Market, Austin, TX 78703.
RW Garcia, 3 Seed, Kale Crackers, Gluten Free, Net Wt. 180g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., Las Vegas, NV 89115 and Lincoln, NC 28092, Distributed by Clean Foods, Ltd, Legion House, 75 Lower Road, Kenley, Surrey, CR8 5NH.
365, Lightly Salted Tortilla Chips, Multigrain, Net Wt. 16oz. (1 lb.) 454g, Distributed by Whole Foods Market, Austin, TX 78703.
Central Market, Tortilla Chips, Veggie & Seed Blend, Net Wt.; 12oz (340g), Distributed by H.E.B Central Markets, Austin, TX 78735.
RW Garcia, 3 Seed, Sweet Potato Crackers, (Flaxseed, Black & White sesame Seeds), Gluten Free, Net Wt., 180g and 850g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., San Jose, CA 95112 and Lincolnton, NC 28092.
365, White Corn, Tortilla Chips, Unsalted, Net Wt. 16 oz. (1 lb.) 454g., Distributed by Whole Foods Market, Austin, TX 78703.
Apheresis product, in which platelet yield did not meet specifications, was distributed.
Worldwide Distribution - US Nationwide  in the states of AL, AZ, CA, FL, KS, MS, NJ, NV, NY, PA, TX, UT, and WV. No Candaian or Va/govt/military consignees. There are 133 other foreign consignees.
OEC Brivo 715 Prime, OEC Brivo 785 Essential, OEC Brivo 865 Advance    Product Usage:  The OEC Brivo Mobile C-Arm X-Ray Products are designed to provide digital spot film imaging and fluoroscopic image guidance for all adult and pediatric populations for orientations between patient anatomy and surgical instruments. The product is used for general surgical applications and musculoskeletal procedures to visualize, for example, implant localizations or needle positions for aspirations, injections or biopsy. The OEC Brivo is not indicated for interventional use.
GE Healthcare Surgery announces a voluntary field action for the OEC Brivo 715 Prime, OEC Brivo 685 Essential, and OEC Brivo 865 Advance because the circuit board that controls vertical motion of the C-arm may fail, resulting in the C-Arm moving up or down without command.
Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC 60687-106-25); each blister card containing 6 individually blistered capsules (NDC 60687-106-95), Rx only, Distributed by: American Health Packaging, Columbus, OH, 43217.
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Worldwide Distribution - US to CA, FL, IL, WI, IN, OR, PA, MA, NY, KY, TX, MI, MD, NV, WA, OH, MN, and Internationally to Germany, Turkey, Hong Kong, Italy, Portugal
Lot 1599211, Expiry Date: 18SEP2015 (12 days after calibration)
Blood and Blood Products for Reprocessing
Allergenic Extract, associated with an error in the assignment of bulk lots for filling, was distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Lifesouth Community Blood Centers - Montgomery Region
Plateletpheresis products, for which the quality control testing for pH did not meet specifications, were distributed.
A total of 13 product vails were distributed
Allergenic Extracts, labeled with an incorrect PNU measurement, were distributed.