The Recall Desk

Archive

July 2014 recalls

688 recalls were announced in July 2014.

What the numbers show

Critical
18
Severe
140
High
292
Moderate
204
Low
34

Of the 688 recalls this month scored against our rubric, 3% are Critical, 20% are Severe.

Which agencies issued them

201–300 of 688

  • ModerateFDA (Food)·F-2193-2014·2014-07-23

    Ducal Prepared Sauce Queso Recalled for pH Above 4.4

    Industrias Alimenticias Kern's y Cia. S.C.A. is recalling Ducal Brand Prepared Sauce Queso/Cheese because lab analysis detected a pH greater than 4.4.

    Product
    Ducal Brand Prepared Sauce Queso/Cheese, UPC 088313-08328-6, Net Wt 4 oz, Product of Guatemala, C.A. Central American product made with quality by: Industrias Alimenticias Kern's Y/Cia, S.C.A., Km. 6 1/2 Carretera al Atlantico. Reg. D.G.R.V.C.S.D.R.C.A. B 658 The product was
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2178-2014·2014-07-23

    Naturex Echinacea Powder Recalled for Azoxystrobin Residue

    Naturex Inc. is recalling Echinacea powder containing Azoxystrobin, a pesticide for which no tolerance is allowed.

    Product
    Echinacea Agustifolia PE 4& echinosides The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Food)·F-2177-2014·2014-07-23

    Naturex Echinacea Root Powder Recalled for Azoxystrobin Residue

    Naturex Inc. is recalling Echinacea Agustifolia Root Powder because it contains Azoxystrobin, a pesticide for which no tolerance is allowed.

    Product
    Echinacea Agustifolia Root PE 4:1 The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2043-2014·2014-07-23

    Siemens Symbia E Camera System Recalled for Loose Rear Casters

    Siemens Medical Solutions USA is recalling 531 Symbia E camera systems because the collimator cart rear casters may become loose.

    Product
    Symbia E camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2179-2014·2014-07-23

    Naturex Echinacea Root Powder Recalled for Azoxystrobin Residue

    Naturex Inc. is recalling Echinacea Angustifolia Root Powder because it contains Azoxystrobin, a pesticide for which no tolerance is allowed.

    Product
    Echinacea Angustifolia Root PE 4: The product is in powder form extracted from the Echinacea root packed in varying size lined cardboard boxes containing 10 kg or 25 kg.
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-2075-2014·2014-07-23

    Siemens syngo RT Dosimetrist 2.7 software update addresses data storage issue

    Siemens Medical Solutions is updating syngo RT Dosimetrist 2.7 software to fix a safety issue where structure names were not stored correctly.

    Product
    Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems is as an accessory to the linear accelerator system to aid and support in the planning and delivery of x-ray radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2044-2014·2014-07-23

    MTI Precision Products Recalls Lynx TM20 Torquemaster Low Speed Handpieces

    MTI Precision Products LLC is recalling 134 Lynx TM20 Torquemaster Low Speed Handpieces due to a sharp edge on the body or housing.

    Product
    Lynx TM20 Torquemaster Low Speed Handpiece MTI Dental Products
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2072-2014·2014-07-23

    Integra Recalls Camino ICP Catheters for MRI Safety Labeling

    Integra LifeSciences is recalling Camino Intracranial Pressure Monitoring Kits to update labeling indicating they are unsafe in MR environments.

    Product
    Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters, Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2184-2014·2014-07-23

    Mt. Olive Jalapeno Slices Recalled for Undeclared Sulfites

    Mt. Olive Pickle Company is recalling PepperPAK Jalapeno Slices due to undeclared sulfites. The product was distributed in Florida and New York.

    Product
    Mt. Olive, PepperPAK Jalapeno Slices, 4-3.7fl oz cups, Net fl oz 14.8 (438 ml), Mt Olive Pickled Co., Inc., Corner of Cucumber and Vine, P.O. Box 609, Mt. Olive, NC 28365-0609.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-2172-2014·2014-07-23

    CTF Brand Tapioca Pearl Recalled for Unapproved Undeclared Colors

    New B.C.N. Trading Inc. is recalling CTF Brand Tapioca Pearl because it contains unapproved and undeclared colors. The product was distributed in MA, MD, NJ, NY, and PA.

    Product
    CTF Brand Tapioca Pearl Net Wt: 14 oz. (400G.) Exporter: Combine Thai Foods Co., Ltd. 359/716-17 Spot Chalaem Nimit, Chalaem Nimit Rd. (Pradu 1) Bangkro, Bangkholaem, Bangkok 10120 Thailand Product of Thailand UPC 8851381560506
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2067-2014·2014-07-23

    Innovasis Recalls Excella II Pedicle Screws Due to Mislabeling

    Innovasis is recalling 32 units of Excella II Standard Pedicle Screws because the size and catalog number are mislabeled.

    Product
    Excella II Standard Pedicle Screw, Catalog No. E2S47525 and E2S47535, 4.75 mm x 25 mm. For spinal fixation. Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1434-2014·2014-07-23

    Axcentria Recalls Hemo-Stat Solution for Lack of FDA Approval

    Axcentria Pharmaceuticals is recalling Hemo-Stat Solution because it was marketed without an approved NDA/ANDA and lacks an NDC number.

    Product
    Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2050-2014·2014-07-23

    Zimmer Dental Tapered Screw-Vent Implant Recalled for Potential Vial Crack

    Zimmer, Inc. is voluntarily recalling a specific lot of dental implants due to a potential crack in the outer vial cap.

    Product
    Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2194-2014·2014-07-23

    Kraft Recalls Velveeta Cheese Product Due to Low Preservative Levels

    Kraft Foods is recalling Velveeta Original Pasteurized Ripe Cheese Product because a preservative ingredient was found at levels below specification.

    Product
    Velveeta Original Pasteurized Ripe Cheese Product sold under the Kraft brand and individually wrapped in plastic and sold in a card stock carton with a net weight of 2 lb. (32 oz.).
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2073-2014·2014-07-23

    Laser Peripherals Recalls Mislabelled Bare Laser Fibers Due to Date Error

    Laser Peripherals LLC is recalling 25 units of DBLF-60-2 Bare Laser Fibers because a sterility expiration date was misprinted as '2016-16' instead of '2016-06'.

    Product
    LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. Laser surgical instrument for use in general and plastic surgery and in dermatology
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2042-2014·2014-07-23

    Siemens e.cam camera systems recalled for loose rear casters

    Siemens Medical Solutions USA is recalling 2,458 e.cam camera systems because the collimator cart rear casters may become loose.

    Product
    e.cam camera system. Emission Computed Tomography System used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. Nuclear med
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1431-2014·2014-07-23

    Poly Pharmaceuticals Recalls Poly-Tussin AC Liquid Due to Labeling and Specification Issues

    Poly Pharmaceuticals is recalling 208 bottles of Poly-Tussin AC Liquid because phenylephrine levels are below specifications and the label inaccurately states 'Rx Only'.

    Product
    POLY-TUSSIN AC LIQUID, Each 5 mL (1 teaspoonful) contains: Brompheniramine Maleate 4 mg, Codeine Phosphate 10 mg, Phenylephrine HCl 7.5 mg, 16 fl oz. (473 mL) Bottle, Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals,
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1441-2014·2014-07-23

    Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns

    Fougera Pharmaceuticals is recalling 3,594 bottles of Triamcinolone Acetonide Lotion because the pH may not meet specifications at expiry.

    Product
    Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1437-2014·2014-07-23

    Teva Recalls Mircette Tablets Due to Out-of-Specification Impurities

    Teva Pharmaceuticals is recalling Mircette tablets because impurity test results were out of specification. The recall covers 984 blister packs distributed nationwide.

    Product
    Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1435-2014·2014-07-23

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Institutional, Inc. is recalling Diltiazem HCl Extended-Release Capsules, 120 mg, due to high out-of-specification results for a related compound found during routine stability testing.

    Product
    Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1439-2014·2014-07-23

    Teva Recalls Velivet Birth Control Pills Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 5,265 blister packs of Velivet birth control pills nationwide because impurity test results were out of specification.

    Product
    VELIVET — VELIVET (DESOGESTREL AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1443-2014·2014-07-23

    Pfizer Recalls Viracept Tablets Due to Incorrect Expiration Date Labeling

    Pfizer is recalling Viracept (nelfinavir mesylate) tablets because some bottles were labeled with an incorrect expiration date of 11/2016 instead of 09/2016.

    Product
    VIRACEPT — VIRACEPT (NELFINAVIR MESYLATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1440-2014·2014-07-23

    Fougera Recalls Triamcinolone Acetonide Lotion Due to pH Specification Concerns

    Fougera Pharmaceuticals is recalling specific lots of Triamcinolone Acetonide Lotion because the pH may not meet specifications at expiry.

    Product
    Triamcinolone Acetonide Lotion USP, 0.1%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0337-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1432-2014·2014-07-23

    Poly Pharmaceuticals Recalls Lortuss Ex Due to Labeling and Specification Issues

    Poly Pharmaceuticals is recalling 102 bottles of Lortuss Ex because the product does not meet monograph specifications and has inaccurate labeling.

    Product
    LORTUSS EX, Each 5 mL (1 teaspoonful) contains: Codeine Phosphate 10 mg, Guaifenesin 100 mg, Psuedoephedrine HCl 22.5 mg, 16 fl oz. (473 mL), Rx Only. Manufactured by: Great Southern Laboratories, Houston, TX 77099, Distributed for: Poly Pharmaceuticals, Mobile, AL 36619. NDC:
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2041-2014·2014-07-23

    BBL CrystaLEAD E/NF Identification Kits Recalled for Incorrect Expiration Dates

    Becton Dickinson is recalling specific lots of BBL CrystaLEAD E/NF Identification kits because some contain fluid bottles that expire before the date printed on the kit carton.

    Product
    BBL CrystaLEAD Enteric/Nonfermentor (E/NF) Identification (ID) System, catalog number 245000. in vitro diagnostic for the identification of aerobic gram-negative bacteria that belong to the family Enterobacteriaceae as well as some of the more frequently isolated glucose fermen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·14236·2014-07-22

    Oeuf Recalls Sparrow Cribs Due to Entrapment Hazard

    Oeuf LLC is recalling about 14,000 Sparrow cribs because slats and top rails can detach, posing an entrapment hazard to children.

    Product
    Sparrow Cribs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·047-2014·2014-07-22

    Sara Lee Foodservice Recalls Smoked Sausage Due to Undeclared Soy Allergen

    Sara Lee Foodservice is recalling smoked sausage products because they contain undeclared soy protein, a known allergen. No adverse reactions have been reported.

    Product
    Wisconsin Firm Recalls Sausage Product Due To Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V438000·2014-07-21

    Chrysler Recalls Jeep Grand Cherokee and Commander for Ignition Switch Defect

    Chrysler is recalling 2005-2007 Jeep Grand Cherokee and 2006-2007 Jeep Commander vehicles because the ignition key may be accidentally knocked out of the run position, turning off the engine and safety systems.

    Product
    JEEP — JEEP COMMANDER, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V439000·2014-07-21

    PACCAR Recalls 2013-2015 Kenworth and Peterbilt Trucks for Electrical Defect

    PACCAR is recalling 2013-2015 Kenworth K300 and Peterbilt 210, 220, and 320 trucks because loose electrical connectors may cause the engine to shut off unexpectedly.

    Product
    PETERBILT — PETERBILT, KENWORTH MODEL 220, 320, K300, 210
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V442000·2014-07-21

    Forest River Recalls 2013-2015 F33-CKTS Fifth Wheels for Fire Risk

    Forest River is recalling 2013-2015 F33-CKTS fifth wheels because the LP gas pipe may be damaged by the axle suspension, potentially causing a vehicle fire.

    Product
    FOREST RIVER — FOREST RIVER F33-CKTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·046-2014·2014-07-18

    B. Roberts Foods Recalls Grilled Chicken Strips for Undeclared Milk Allergen

    B. Roberts Foods is recalling 202 pounds of grilled chicken strips due to misbranding and an undeclared milk allergen. The product was distributed to retail stores in nine states and D.C.

    Product
    North Carolina Firm Recalls Grilled Chicken Product Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    9 states
  • SevereNHTSA·14V436000·2014-07-18

    Blue Bird Recalls 2013-2014 All American School Buses for CNG Leak Risk

    Blue Bird is recalling 2013-2014 All American school buses with CNG systems in four states due to a potential natural gas leak that could cause fire or explosion.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V433000·2014-07-18

    Hyundai Recalls 2011 Sonata Vehicles for Brake Line Leak Risk

    Hyundai is recalling 2011 Sonata vehicles because brake lines may leak fluid, increasing stopping distance and crash risk. Dealers will replace the hoses free of charge.

    Product
    HYUNDAI — HYUNDAI SONATA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V437000·2014-07-18

    Koenigsegg Agera Recalled for Tire Pressure Monitoring System Defect

    Koenigsegg is recalling one 2013 Agera vehicle because the tire pressure monitoring system may fail to illuminate the warning light upon restart, increasing crash risk.

    Product
    KOENIGSEGG — KOENIGSEGG AGERA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E043000·2014-07-18

    Helmet City Recalls 1,755 Non-Compliant Motorcycle Helmets

    Helmet City is recalling 1,755 Model 100 motorcycle helmets that fail to meet federal safety standards, increasing the risk of head injury in a crash.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V445000·2014-07-18

    Capacity Terminal Tractors Recalled for Exhaust Fire Risk

    Capacity is recalling 2008-2014 terminal tractors because condensation in the intake manifold may freeze, causing sensor failure, elevated exhaust temperatures, or flames.

    Product
    CAPACITY — CAPACITY TERMINAL TRACTOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14234·2014-07-17

    GT Mountain Bicycles Recalled Due to Wheel Hub Failure and Crash Risk

    Cycling Sports Group is recalling 2014 GT Fury Expert and Team downhill mountain bicycles because wheel hubs can break, causing brake failure and crash hazards.

    Product
    GT downhill mountain bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·14233·2014-07-17

    Popkiller Recalls USB Chargers and Cables Due to Fire and Shock Hazards

    Popkiller is recalling USB car chargers, power adapters, and cables due to fire and electric shock risks. No injuries have been reported.

    Product
    USB car charger adapters, power adapters and 8-pin charger cables
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2082-2014·2014-07-16

    Trader Joe's Egg White Salad Recalled for Listeria

    Hot Mama's Foods is recalling Trader Joe's Egg White Salad with Chives because the product tested positive for Listeria monocytogenes.

    Product
    Egg White Salad with Chives, 6 oz., packaged in round plastic containers with film seals and snap lids under the Trader Joe's brand. This is a ready-to-eat refrigerated deli salad sold at retail locations.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2085-2014·2014-07-16

    Humei Foods Dried Lily Recalled for Undeclared Sulfites

    Humei Trading Inc. is recalling 30 packages of Humei Foods Dried Lily due to undeclared sulfites detected by New York State authorities.

    Product
    Humei Foods DRIED LILY, Net Wt. 340 g 12 oz +- 5 g -- PRODUCT OF CHINA --- Firms on label: Shanghai Dingmei International Trade Co., LTD, Add: Room 516B, No. 1218, Walma Road, Shanghai, China 200011 Tel: 86 21 33761911 Fax: 86 21 33761933 -- Shanghai Huipu Food Co., LTD, Add: No
    Category
    Food
    Distribution
    0 states
  • SevereNHTSA·14V429000·2014-07-16

    Toyota Recalls Modified Tundra Trucks Due to Lug Nut Coating Failure

    Gulf States Toyota is recalling 16,249 modified 2013-2014 Toyota Tundra vehicles because lug nut coatings may fail, causing wheels to loosen or studs to fracture.

    Product
    TOYOTA — TOYOTA TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1994-2014·2014-07-16

    Intuitive Surgical Recalls Patient Side Cart Battery Boxes for Overheating Risk

    Intuitive Surgical is recalling 2,606 Patient Side Cart Battery Boxes used with the da Vinci A surgical system because they may overheat and bulge during charging.

    Product
    Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system. Intuitive Surgical Inc. Sunnyvale, CA 94086
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-2084-2014·2014-07-16

    Sunrise Meats Recalls Hot Smoked Coho Salmon Due to Botulism Risk

    Sunrise Meats is voluntarily recalling hot smoked Coho salmon because inadequate salt levels may allow Clostridium botulinum growth.

    Product
    Hot smoked Coho salmon; Gold foiled, vacuum packaged units, approximately ¿ pounds each. Adhesive label affixed to front or back of package. Label reads in part, "**Smoked Coho INGREDIENTS, SALMON CURED WITH WATER, DEXTROSE, FLAVORING, SODIUM NITRITE. PROCESSED BY SUNRISE MEATS**
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1425-2014·2014-07-16

    Hospira Recalls Heparin Sodium Bags Due to Sterility Concerns

    Hospira is recalling 142,152 bags of Heparin Sodium in 5% Dextrose Injection due to a confirmed report of fluid leaking from the primary container, which compromises sterility.

    Product
    HEPARIN SODIUM AND DEXTROSE — HEPARIN SODIUM AND DEXTROSE (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2023-2014·2014-07-16

    Invacare Aquatec Fixed Backrest Recalled for Structural Failure Risk

    Invacare is recalling 465 Aquatec Fixed Backrests because they may detach from the frame under uneven load, posing a risk of injury.

    Product
    Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean E-VIP family.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1424-2014·2014-07-16

    Hospira Recalls Labetalol Hydrochloride Injection Due to Particulate Matter

    Hospira Inc. is recalling Labetalol Hydrochloride Injection due to the presence of particulate matter, including metal embedded in glass vials and visible particles in the solution.

    Product
    LABETALOL HYDROCHLORIDE — LABETALOL HYDROCHLORIDE (LABETALOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2014·2014-07-16

    Steris 4085 General Surgical Table Recalled for Pressure Switch Defect

    Steris Corporation is recalling 3,689 STERIS 4085 General Surgical Tables because a defective pressure switch may cause the hand control to incorrectly indicate that floor lock feet are locked.

    Product
    The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table designed to support all general surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2163-2014·2014-07-16

    Vanilla Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling vanilla ice cream distributed in Indiana and Kentucky because the bulk product lacked required labels, including ingredient statements and allergen declarations.

    Product
    Vanilla Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2170-2014·2014-07-16

    Surma Distributors Recalls Golden Raisins Due to Undeclared Sulfites

    Surma Distributors LLC is recalling HAQUE brand Golden Raisins because they contain undeclared sulfites, which can cause serious or life-threatening allergic reactions in sensitive individuals.

    Product
    HAQUE brand GOLDEN RAISINS, WT 7 OZ. --- SURMA DISTRIBUTORS LLC Brooklyn, NY 11237 --- Nutrition Facts: Serving Size 1/4 tsp (0.5 g), Servings 204
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-2107-2014·2014-07-16

    Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Freshly Roasted Coffee and Policeman's Special Ice Cream because bulk products lacked required labels, including ingredient statements and allergen declarations.

    Product
    Freshly Roasted Coffee Ice Cream and Policeman's Special Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·14E042000·2014-07-16

    Trans National Trading Recalls Outlaw T-70 XL Motorcycle Helmets

    Trans National Trading is recalling 486 Outlaw T-70 XL motorcycle helmets manufactured in August 2012 because they fail to comply with federal safety standards.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2153-2014·2014-07-16

    Dulce de Leche Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Dulce de Leche de Salte Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Dulce de Leche de Salte Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2102-2014·2014-07-16

    Bourbon Maple Walnut Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Bourbon Maple Walnut Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Bourbon Maple Walnut Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2169-2014·2014-07-16

    German Chocolate Cake Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling German Chocolate Cake Ice Cream because bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Ze German Chocolate Cake Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2152-2014·2014-07-16

    Mocha Almond Fudge Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Mocha Almond Fudge Ice Cream because bulk products lacked labels declaring direct allergens and facility processing information.

    Product
    Mocha Almond Fudge Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2106-2014·2014-07-16

    Egg Noggin' Ice Cream Recalled for Missing Allergen Labeling

    Koogee-Queen Anne, LLC is recalling Egg Noggin' Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Egg Noggin' Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2098-2014·2014-07-16

    Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Banana Puddin' Y'all Ice Cream because the bulk product lacked labels, failing to declare direct allergens and facility processing information.

    Product
    Banana Puddin' Y'all Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·14V430000·2014-07-16

    Tiffin Allegro Bus Recalled for Defective Seat Belt Attachments

    Tiffin is recalling 2013 Allegro Bus vehicles because seat belts may be incorrectly attached and fray, reducing their strength and increasing injury risk in a crash.

    Product
    TIFFIN — TIFFIN ALLEGRO BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2146-2014·2014-07-16

    Shorty's Strawberry Shortcake Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Shorty's Strawberry Shortcake Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Shorty's Strawberry Shortcake Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighNHTSA·14E041000·2014-07-16

    Ricon Recalls Wheelchair Lifts Due to Platform Side Plate Cracking Risk

    Ricon is recalling specific wheelchair lift models because the platform side plate may crack, potentially causing the platform to fall and injure the operator.

    Product
    EQUIPMENT ADAPTIVE/MOBILITY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2144-2014·2014-07-16

    Raspberry Lemonade Sorbet Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Raspberry Lemonade Sorbet because the product lacked required ingredient and allergen labels, including facility processing information.

    Product
    Raspberry Lemonade Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2140-2014·2014-07-16

    Peaches and Cream Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Peaches and Cream Ice Cream because bulk products lacked labels declaring direct allergens and facility processing of peanuts, tree nuts, wheat, milk, and eggs.

    Product
    Peaches and Cream Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2000-2014·2014-07-16

    Vascular Technology Recalls Sterile Doppler Probes Due to Barrier Penetration

    Vascular Technology, Inc. is recalling 34 sterile Doppler probes because the sterile barrier may have been penetrated, potentially rendering the devices unsterile.

    Product
    07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-2141-2014·2014-07-16

    Pistachio Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling pistachio ice cream sold in Indiana and Kentucky because the product lacked required ingredient and allergen labels.

    Product
    Pistachio Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2137-2014·2014-07-16

    Jack and Cola Float Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Jack and Cola Float Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Jack and Cola Float Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2156-2014·2014-07-16

    Bourbon Ball Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Bourbon Ball Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Bourbon Ball Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2143-2014·2014-07-16

    Raspberry Sorbet Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Raspberry Sorbet because the bulk product lacked labels, failing to declare direct allergens and facility processing information.

    Product
    Raspberry Sorbet, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1996-2014·2014-07-16

    RGI Medical Recalls 300psi I.V. Catheter Extension Sets

    RGI Medical is recalling 19,200 units of Henora 300psi I.V. Catheter Extension Sets due to a defect that may cause the tubing to separate from the luer connection during use.

    Product
    Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high pressure procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2119-2014·2014-07-16

    Banana Walnut Fudge Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Banana Walnut Fudge Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Banana Walnut Fudge Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2034-2014·2014-07-16

    Zimmer Hip Joint Prosthesis Recalled for Black Residue in Sterile Pouches

    Zimmer, Inc. is recalling 852 units of M/L Taper Reduced Neck hip joint prostheses because black residue was observed in the sterile pouches.

    Product
    Zimmer M/L Taper Reduced Neck Standard & Extended Offset, HIP JOINT PROSTHESIS, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2150-2014·2014-07-16

    Simply Southern Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Simply Southern Ice Cream because the bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    Simply Southern Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2025-2014·2014-07-16

    CareFusion Recalls SmartSite Infusion Sets Due to Unlabeled Filter

    CareFusion is recalling SmartSite Low Sorbing Infusion Sets because the drip chamber contains a 15-micron filter not listed in the instructions, posing a risk of occlusion if used with blood.

    Product
    SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Food)·F-2097-2014·2014-07-16

    Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Say "Cheeeeeesecake" Ice Cream because bulk product lacked labels declaring ingredients and direct allergens.

    Product
    Say "Cheeeeeesecake" Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2123-2014·2014-07-16

    Ice Cream Recalled for Missing Allergen and Facility Labeling

    Koogee-Queen Anne, LLC is recalling Brown Butter Peanut Brittle Ice Cream because bulk products lacked labels declaring direct allergens and facility processing information.

    Product
    Brown Butter Peanut Brittle Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2109-2014·2014-07-16

    Ginger 2 Snaps Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Ginger 2 Snaps Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Ginger 2 Snaps Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2038-2014·2014-07-16

    Pall Medical Breathing Circuit Filter Recall for Possible Air Leak

    Pall Corporation is recalling specific lots of Medical Breathing Circuit Filters due to a possible leak at the filter end cap junction.

    Product
    PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. The filters are individually packaged in a clear, plastic pouch with black writing - 50 per case, or in bulk packaged 100 filters/bag and two
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-2121-2014·2014-07-16

    Blueberry French Toast Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Blueberry French Toast with Bacon Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Blueberry French Toast with Bacon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2114-2014·2014-07-16

    Sorghum & Grits Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Sorghum & Grits Ice Cream because the product lacked required ingredient and allergen labels, including facility processing warnings.

    Product
    Sorghum & Grits Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2130-2014·2014-07-16

    Chocolate Peanut Butter Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling chocolate peanut butter ice cream because it lacked required ingredient and allergen labels.

    Product
    Chocolate Peanut Butter Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2020-2014·2014-07-16

    Intuitive Surgical Recalls Large Clip Applier Instruments Due to Jamming Risk

    Intuitive Surgical is recalling Large Clip Applier instruments used with da Vinci S and SI systems because a manufacturing defect may cause the instrument to jam during insertion.

    Product
    Intuitive Surgical Inc. Large Clip Applier instruments used in conjunction with da Vinci S and da Vinci SI Surgical Systems Intuitive Surgical Inc., 'Sunnyvale, CA 94086
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2165-2014·2014-07-16

    Chocolate Squared Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Chocolate Squared Ice Cream because the product lacked required ingredient and allergen labels.

    Product
    Chocolate Squared Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1997-2014·2014-07-16

    FDA Recalls Devon Surgical Positioning Kits Due to Strap Separation Risk

    The FDA is recalling 264 Devon Supine, Lithotomy and Trendelenburg Positioning Kits because straps may separate from the foam pad.

    Product
    Devon Supine, Lithotomy and Trendelenburg Positioning Kit; Product Code: 31151090 Product Usage: The device is intended to provide padding under the patient, and help maintain the position of an anesthetized patient during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2105-2014·2014-07-16

    The Doctor's Cure Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling The Doctor's Cure Ice Cream because bulk product lacked labels declaring direct allergens and facility processing information.

    Product
    The Doctor's Cure Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2093-2014·2014-07-16

    Cinnamon Ice Cream Recalled for Missing Allergen and Ingredient Labels

    Koogee-Queen Anne, LLC is recalling Cinnamon Ice Cream because the bulk product lacked labels, failing to declare direct allergens and facility processing information.

    Product
    Cinnamon Ice Cream, Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2099-2014·2014-07-16

    Black Raspberry Chip Ice Cream Recalled for Missing Allergen Labels

    Koogee-Queen Anne, LLC is recalling Black Raspberry Chip Ice Cream because bulk product lacked labels declaring direct allergens and facility processing of peanuts, tree nuts, wheat, milk, and eggs.

    Product
    Black Raspberry Chip Ice Cream. Manufactured by: Koogee-Queen Anne, LLC, d/b/a The Comfy Cow 2221 Frankfort Ave, Louisville, KY 40206.
    Category
    Food
    Distribution
    2 states

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