The Recall Desk

Archive

October 2014 recalls

501 recalls were announced in October 2014.

What the numbers show

Critical
33
Severe
108
High
200
Moderate
147
Low
13

Of the 501 recalls this month scored against our rubric, 7% are Critical, 22% are Severe.

1–100 of 501

  • SevereNHTSA·14V685000·2014-10-31

    Eldorado Recalls 2008-2009 Vehicles Due to Accelerator Pedal Spring Defect

    Eldorado is recalling 2008-2009 Axess, E-Z Rider II, XHF, Escort RE-A, and Transmark RE vehicles because accelerator pedal springs may break, causing unintended acceleration.

    Product
    ELDORADO — ELDORADO TRANSMARK RE, ESCORT RE-A, XHF, AXESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V684000·2014-10-31

    Forest River Recalls 2014-2015 Parcelport and Cargoport Vehicles for Ball Joint Defect

    Forest River is recalling 2014-2015 Parcelport, Cargoport, Workport, and Rockport vehicles because an upper ball joint pinch bolt may not be sufficiently tightened, risking loss of vehicle control.

    Product
    FOREST RIVER — FOREST RIVER PARCELPORT, CARGOPORT, WORKPORT, ROCKPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V686000·2014-10-31

    Eldorado Krystal K40 Recalled for Fuel Filter Defect

    Eldorado is recalling 2014-2015 Krystal K40 vehicles because a fuel filter defect may cause the engine to stall unexpectedly, increasing crash risk.

    Product
    ELDORADO — ELDORADO KRYSTAL K40
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·075-2014·2014-10-30

    Richard's Boudin Recalled Due to Potential Bacillus Cereus Toxin

    Carlton Foods is recalling approximately 25,764 pounds of Richard's Boudin products due to potential temperature abuse that may have allowed Bacillus cereus toxin formation.

    Product
    Texas Firm Recalls Boudin Products Due To Possible Temperature Abuse
    Category
    Food
    Distribution
    2 states
  • HighCPSC·15018·2014-10-30

    Visonic Recalls Amber Personal Emergency Response Pendants and Kits

    Visonic is recalling Amber Pendants and Kits because battery drain may shorten the low-battery warning period. No injuries have been reported.

    Product
    Visonic Amber Pendants and Visonic Amber Kits
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15016·2014-10-30

    Tectron Recalls 3-in-1 USB Phone Chargers Due to Fire Hazard

    Tectron International is recalling 3-in-1 USB phone chargers because they can overheat and pose a fire hazard. Two incidents of melting were reported, with no injuries or property damage.

    Product
    3-in-1 USB phone charger
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0049-2015·2014-10-29

    BBM Chocolate Recalls Alprose Dark Chocolate for Undeclared Milk Allergen

    BBM Chocolate Distributors is recalling three Alprose Dark Chocolate products because they contain undeclared milk. Consumers with milk allergies should not eat these items.

    Product
    CHOCOLAT Alprose NAPOLITAINS SWITZERLAND, NET WT. 1 Kg (35 oz). Product packed as the following: 1) bulk in clear plastic bags, 230 pieces with gold, black and white labeling, each carton contains 6 x 1 Kg bags, 2) 100g packages (3.5oz/~24 pieces. UPC 712963000354. Produced i
    Category
    Food
    Distribution
    23 states
  • CriticalFDA (Food)·F-0076-2015·2014-10-29

    Lotte European Waffles Recalled for Undeclared Eggs

    Lotte International America Corp is recalling Lotte European Waffles because they contain undeclared eggs, posing a risk to consumers with egg allergies.

    Product
    Lotte European Waffle, Net Wt. 40g, 160g UPC 8801062518111, 8801062518135
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0044-2015·2014-10-29

    Glaser Organic Farms Recalls Carob Pudding Pie Due to Salmonella Risk

    Glaser Organic Farms is recalling All Raw Vegan Carob Pudding Pie because the carob powder ingredient may be contaminated with Salmonella.

    Product
    All Raw Vegan Carob Pudding Pie, Net WT. 4.0 oz. - Keep Refrigerated. Glaser Organic Farms, 19100 SW M13 Avenue, Miami, FL 33177. (305) 238-7747.
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0077-2015·2014-10-29

    Whole Herb Company Recalls Nettle Leaf Powder for Salmonella Contamination

    Whole Herb Company is recalling Nettle Leaf powder after testing revealed the presence of Salmonella. The product was distributed in California, Nevada, and Canada.

    Product
    Nettle Leaf powder Gross Wt: 55.5 Lbs. Net Wt: 55.0 Lbs. This material is being sold for further processing, and for Manufacturing use only. Distributed by Whole Herb Company
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-0071-2015·2014-10-29

    Oscar's Smoke House Cheddar Spread Recalled for Listeria Risk

    Oscar's Hickory House, Inc. is recalling Oscar's Smoke House "More Than" Cheddar Spread due to potential Listeria monocytogenes contamination.

    Product
    OSCAR'S SMOKE HOUSE "MORE THAN" CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0070-2015·2014-10-29

    Oscar's Smoke House Plain Cheddar Spread Recalled for Listeria Risk

    Oscar's Hickory House, Inc. is recalling Oscar's Smoke House Plain Cheddar Spread due to potential Listeria monocytogenes contamination.

    Product
    OSCAR'S SMOKE HOUSE PLAIN CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0072-2015·2014-10-29

    Oscar's Smoke House Tangy Horseradish Cheddar Spread Recalled for Listeria

    Oscar's Hickory House, Inc. is recalling Tangy Horseradish Cheddar Spread due to potential Listeria monocytogenes contamination. The product was sold nationwide online and in New York retail stores.

    Product
    OSCAR'S SMOKE HOUSE TANGY HORSERADISH CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0067-2015·2014-10-29

    Oscar's Smoke House Garlic Cheddar Spread Recalled for Listeria Risk

    Oscar's Hickory House, Inc. is recalling Oscar's Smoke House Garlic Cheddar Spread due to potential Listeria monocytogenes contamination.

    Product
    OSCAR'S SMOKE HOUSE GARLIC CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0043-2015·2014-10-29

    Glaser Organic Farms Recalls Carob Fudgy Brownies Due to Salmonella Risk

    Glaser Organic Farms is recalling All Raw Vegan Certified Organic Carob Fudgy Brownies because the carob powder ingredient may be contaminated with Salmonella.

    Product
    All Raw Vegan Certified Organic Carob Fudgy Brownie, Net WT. 5.5 oz. (156 g) - Keep Cool & Dry. Glaser Organic Farms, 19100 SW M13 Avenue, Miami, FL 33177. (305) 238-7747. UPC Code: 832910002061.
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-0064-2015·2014-10-29

    Oscar's Smoke House Jalapeno Pepper Cheddar Spread Recalled for Listeria Risk

    Oscar's Hickory House, Inc. is recalling Oscar's Smoke House Jalapeno Pepper Cheddar Spread due to potential Listeria monocytogenes contamination. The product was sold nationwide via internet mail order and in New York retail stores.

    Product
    OSCAR'S SMOKE HOUSE JALAPENO PEPPER CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0066-2015·2014-10-29

    Oscar's Smoke House Garlic Cheddar Spread Recalled for Listeria Risk

    Oscar's Hickory House, Inc. is recalling Oscar's Smoke House Garlic Cheddar Spread due to potential Listeria monocytogenes contamination.

    Product
    OSCAR'S SMOKE HOUSE GARLIC CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0089-2015·2014-10-29

    Codman EDS 3 Drainage System Recalled for Potential CSF Leakage

    Codman & Shurtleff is recalling EDS 3 Drainage Systems because tubing may leak or disconnect, risking improper fluid drainage or air introduction.

    Product
    Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0068-2015·2014-10-29

    Oscar's Smoke House Port Wine Cheddar Spread Recalled for Listeria Risk

    Oscar's Hickory House, Inc. is recalling Oscar's Smoke House Port Wine Cheddar Spread due to potential Listeria monocytogenes contamination.

    Product
    OSCAR'S SMOKE HOUSE PORT WINE CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V680000·2014-10-29

    Freightliner Trucks Recalled for CNG Fuel System Overheating Risk

    Daimler Trucks is recalling 2011-2015 Freightliner M2 and Cascadia trucks because the tailpipe placement may overheat the compressed natural gas fuel system, increasing fire risk.

    Product
    FREIGHTLINER — FREIGHTLINER M2, CASCADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0063-2015·2014-10-29

    Frozen Beer Battered Onion Rings Recalled for Glass Contamination

    McCain Foods USA is recalling specific lots of frozen beer battered onion rings due to potential glass contamination.

    Product
    Frozen beer battered onion rings packaged in 40 oz plastic bags, 6/case under the following private labels: (1) Intros Appetizers & Snacks Beer Battered Thin Cut Onion Rings, Marketed by Independent Marketing Alliance, Houston, Texas 77079, Product no.: 5791088, and UPC code:
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Food)·F-0073-2015·2014-10-29

    Oscar's Smoke House Bacon & Horseradish Cheddar Spread Recalled for Listeria

    Oscar's Hickory House, Inc. is recalling 6,241 units of Bacon & Horseradish Cheddar Spread due to potential Listeria monocytogenes contamination.

    Product
    OSCAR'S SMOKE HOUSE BACON & HORSERADISH CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0040-2015·2014-10-29

    American Family Pharmacy Recalls Subpotent Aspirin Tablets

    American Family Pharmacy is recalling 4.2 million bottles of Assured Aspirin 81 mg tablets because they failed to meet USP specifications for potency and uniformity.

    Product
    Assured Aspirin Enteric Safety Coated Tablets, 81 mg, Adult Low Strength, Pain Reliever (NSAID), 60-count bottle, Distributed by Greenbrier International, Inc., Chesapeake, VA 23320 UPC 639277018328.
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0039-2015·2014-10-29

    Qualitest Recalls Children's Acetaminophen Suspension for Assay Failure

    Qualitest Pharmaceuticals is recalling Children's Q-PAP Acetaminophen Oral Suspension due to a failure of the product assay at the 12-month timepoint.

    Product
    CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, GRAPE FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0843-54, OTC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0037-2015·2014-10-29

    Qualitest Recalls Children's Acetaminophen Suspension for Assay Failure

    Qualitest Pharmaceuticals is recalling Children's Q-PAP Acetaminophen Oral Suspension because the product failed an assay test at the 12-month timepoint.

    Product
    CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, BUBBLE GUM FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0841-54, OTC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0069-2015·2014-10-29

    Oscar's Smoke House Cheddar Spread Recalled for Listeria Risk

    Oscar's Hickory House, Inc. is recalling Tangy Horseradish Cheddar Spread due to potential Listeria monocytogenes contamination. The product was sold nationwide online and in New York retail stores.

    Product
    OSCAR'S SMOKE HOUSE TANGY HORSERADISH CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0038-2015·2014-10-29

    Qualitest Recalls Children's Acetaminophen Suspension for Assay Failure

    Qualitest Pharmaceuticals is recalling specific lots of Children's Q-PAP Acetaminophen Oral Suspension because the product failed an assay test at the 12-month timepoint.

    Product
    CHILDREN'S Q-PAP, Acetaminophen, ORAL SUSPENSION, CHERRY FLAVOR, Active ingredient (in each 5 mL = 1 tsp) Acetaminophen USP 160 mg, 4 FL OZ (118 mL), Made in the USA for Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-0842-54, OTC
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0065-2015·2014-10-29

    Oscar's Smoke House Cheddar Spread Recalled for Listeria Risk

    Oscar's Hickory House is recalling 1,510 units of Cheddar Spread & Blue Cheese due to potential Listeria monocytogenes contamination.

    Product
    OSCAR'S SMOKE HOUSE CHEDDAR SPREAD & BLUE CHEESE, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0074-2015·2014-10-29

    Oscar's Smoke House Bacon Cheddar Spread Recalled for Listeria Risk

    Oscar's Hickory House, Inc. is recalling Oscar's Smoke House Bacon Cheddar Spread due to potential Listeria monocytogenes contamination. The product was distributed nationwide via internet mail order and to New York retail stores.

    Product
    OSCAR'S SMOKE HOUSE BACON CHEDDAR SPREAD, NET WT 7 OZS, keep refrigerated. Distributed by: Oscar's Smoke House Warrensburg, NY 12885.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0091-2015·2014-10-29

    Codman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage

    Codman & Shurtleff is recalling Lumbar Drainage Catheter Kits because tubing may leak or disconnect, risking improper drainage or air entry.

    Product
    Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the inser
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0062-2015·2014-10-29

    McCain Recalls Frozen Battered Onion Rings Due to Glass Contamination Risk

    McCain Foods USA is recalling specific lots of frozen battered onion rings because they may be contaminated with glass.

    Product
    Frozen battered onion rings packaged in 40 oz plastic bags, 6/case under the following private labels: (1) Imperial Sysco 3/8" Battered Onion Rings, Distributed by Sysco Corporation, Houston, Texas 77077-2099, Product no.: 41010044, and UPC code: 074865 84822 0; and (2) Kic
    Category
    Food
    Distribution
    18 states
  • SevereFDA (Devices)·Z-0086-2015·2014-10-29

    Siemens Mammomat Inspiration Mammography Systems Recalled for Safety Switch Defect

    Siemens is recalling three Mammomat Inspiration mammography systems because a safety switch defect may allow the needle positioning device to move during a biopsy.

    Product
    Siemens Mammomat Inspiration mammography systems. The Mammomat Inspiration system is intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. Mammographic images can be interpreted by either hard copy film
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0042-2015·2014-10-29

    Ciprofloxacin 500 mg Tablets Recalled Due to Foreign Tramadol Tablets

    Aidarex Pharmaceuticals is recalling Ciprofloxacin 500 mg tablets because Tramadol 50 mg tablets were found in the bottles.

    Product
    Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E071000·2014-10-29

    Takata Driver Air Bag Inflator Recall for Incorrect Baffle Defect

    Takata is recalling certain SDI-X driver air bag inflators manufactured between June 2008 and June 2014. The defect may cause the inflator to rupture during a crash, potentially injuring occupants with metal fragments.

    Product
    AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0046-2015·2014-10-29

    Next by Nature Dark Chocolate Cherries Recalled for Undeclared Peanuts

    Tropical Valley Foods is recalling Next by Nature Dark Chocolate Cherries because the product may contain undeclared peanuts.

    Product
    next by Nature brand DARK CHOCOLATE CHERRIES, NET WT. 3 Oz (85 g), UPC 817582252006 --- Produced by Tropical Valley Foods PO Box 2994 Plattsburgh, NY 12901
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-0090-2015·2014-10-29

    Codman EDS 3 Drainage System Recalled for Tubing Leak Risk

    Codman & Shurtleff is recalling 93,558 EDS 3 Drainage Systems because tubing may leak or disconnect, risking improper fluid drainage or air introduction.

    Product
    Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0047-2015·2014-10-29

    BBM Recalls Alprose Dark Chocolate for Undeclared Milk Allergen

    BBM Chocolate Distributors is recalling Alprose Dark Chocolate products because they contain undeclared milk, a major food allergen.

    Product
    SWISS CHOCOLATE CHOCOLAT ALPROSE 52% CACAO PREMIUM DARK CHOCOLATE, within stand-up maroon colored gift box. NET WT 3.5 oz (100g). Packed as a carton containing 6 boxes x 20 units. UPC 689423025038. Product of Swtizerland. Distributed By: BBM CHOCOLATE DISTRIBUTORS, LTD. Broo
    Category
    Food
    Distribution
    23 states
  • HighFDA (Food)·F-0048-2015·2014-10-29

    Alprose Dark Chocolate Recalled for Undeclared Milk Allergen

    BBM Chocolate Distributors is recalling Alprose Dark Chocolate products because they contain undeclared milk, a major food allergen.

    Product
    Alprose Swiss Chocolate Dark Chocolate within a gold colored pillow gift box. NET WT 3.5 oz (100g). Packed as a carton with 6 boxes x 20 units. UPC 689423027308. Product of Switzerland. Distributed By: BBM CHOCOLATE DISTRIBUTORS, LTD. Brooklyn, NY 12205.
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-0098-2015·2014-10-29

    DeRoyal SafeLiner Suction Canister Kit Recalled for Insufficient Seal

    DeRoyal Industries is recalling 5,112 units of SafeLiner Suction Canister Kits due to an insufficient seal under low or intermittent suction conditions.

    Product
    DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0087-2015·2014-10-29

    Boston Scientific COGNIS CRT-D Recall for Premature Battery Depletion

    Boston Scientific is recalling COGNIS CRT-Ds and TELIGENT ICDs due to a capacitor defect that may cause the battery to deplete prematurely.

    Product
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0059-2015·2014-10-29

    Multiple Organics Recalls Organic Mango Fillets Due to Potential Metal Fragments

    Multiple Organics is recalling 687 cartons of organic mango fillets because they may contain metal fragments that could injure consumers if ingested.

    Product
    Outer Carton labeled in part as: Multiple Organics Certified 100% Organic Mango Fillets Net Weight 20 Lbs. (9.07 kgs) In 5 X 4 Lb. bags Product of Mexico Certified Organic by QAI www.multipleorganics.com USDA Organic Inner plastic bag labeled in part as: Organic Mang
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0058-2015·2014-10-29

    Plum Organics Little Cremes Recalled for Choking Hazard in Infants

    Plum, Inc. is recalling Little Cremes organic rice milk snacks because they are not softening as intended, posing a choking hazard to babies and young children.

    Product
    Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Reds: Pomegranate, Beet and Berry; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients:ORGANIC SWEET POTATO PUREE, ORGANIC STRAWBERRY PUREE, ORGANIC POMEGRANATE JUICE CONCENTRATE, ORGANIC RICE MILK
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0092-2015·2014-10-29

    DePuy Synthes Radiolucent Retractor Recalled for Adhesive Tape Residue

    Synthes, Inc. is recalling 11 DePuy Synthes Radiolucent Retractors due to adhesive tape residue that poses a risk of tissue or systemic reactions.

    Product
    DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0113-2015·2014-10-29

    Vygon Recalls Bionector Needleless Connectors Due to Membrane Elasticity Issues

    Vygon is voluntarily recalling Bionector Needleless connectors due to potential problems with membrane elasticity. The recall affects 42,250 units distributed worldwide.

    Product
    Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0027-2015·2014-10-29

    R.M. Palmer Recalls Creepy Peepers Caramel Balls for Undeclared Peanut

    R.M. Palmer Company is recalling Creepy Peepers Chocolaty Coated Soft Caramel Filled Eyeballs because the product contains undeclared peanut butter.

    Product
    soft caramel balls coated in chocolate in orange plastic bag with labeling: palmer Creepy Peepers Chocolaty Coated Soft Caramel Filled Eyeballs NET WT 9 OZ Creepy Peepers Lot/Code Date: 066113 UPC 00041269503734 MANUFACTURED ON EQUIPMENT WHICH PROCESSES WHEAT, PEANUT BUTTE
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-0042-2015·2014-10-29

    Glaser Organic Farms Recalls Raw Carob Powder Due to Salmonella Risk

    Glaser Organic Farms is recalling specific lots of Raw Carob Powder due to possible Salmonella contamination. Consumers in seven states and the Bahamas should stop using the product.

    Product
    All Raw Vegan, Raw Carob Powder, Net Wt. 8 oz. and 5 lb bag, - Keep Cool & Dry. Glaser Organic Farms, Miami, FL. (305) 238-7747. UPC Code: 83291005567
    Category
    Food
    Distribution
    7 states
  • HighFDA (Drugs)·D-0044-2015·2014-10-29

    Hospira Recalls Hydromorphone Hydrochloride Injection Due to Broken Vials

    Hospira Inc. is recalling 145,600 vials of Hydromorphone Hydrochloride Injection because customer complaints confirmed that some glass vials may be broken or cracked, compromising sterility.

    Product
    HYDROMORPHONE HYDROCHLORIDE — HYDROMORPHONE HYDROCHLORIDE (HYDROMORPHONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0040-2015·2014-10-29

    Venus Wafers Recalls PC Organics Crackers for Undeclared Sesame

    Venus Wafers Inc. is recalling PC Organics Original Stoned Wheat Crackers because the product contains undeclared sesame seeds.

    Product
    President's Choice- PC Organics brand Original Stoned Wheat Crackers, 200 g UPC: 0 60383 70928 0
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0106-2015·2014-10-29

    Ad-Tech Cueva Electrode Kits Recalled for Potential Wand Malfunction

    Ad-Tech Medical Instrument Corporation is recalling Cueva Electrode Kits because the applicator wand may malfunction, potentially preventing monitoring of the VII cranial nerve.

    Product
    Box Label: 3 mm Cueva Electrode Kit, Sterile EO, Rx Only, REF. CNE1-3KDINX . Pouch labels: Each kit contains 3 pouches. 3 mm Cueva Electrode CNE-3X, Cueva Electrode Applicator Wand CNE-100X, Cueva Electrode Leadwire CNE-LW-2DINX. Box Label: 2 mm Cueva Electrode Kit, Sterile E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0041-2015·2014-10-29

    Kupiec Rice Cakes Recalled for Undeclared Milk Allergen

    Markpol Distributors Inc. is voluntarily recalling Kupiec Rice Cakes with Dark Chocolate because they may contain undeclared milk.

    Product
    Kupiec Rice Cakes with Dark Chocolate, 3.1 oz (90g), 6 cakes packaged in white foil with a photo image of the rice cake on the front of the packaging. Sold to retail locations with 16 packages per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0056-2015·2014-10-29

    Plum Organics Little Cremes Recalled for Choking Hazard in Infants

    Plum, Inc. is recalling Little Cremes rice milk snacks because they are not softening as intended, posing a choking hazard to babies and young children.

    Product
    Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Greens: Kale, Apple and Sweet Potato; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients: ORGANIC SWEET POTATO PUREE, ORGANIC APPLE PUREE, ORGANIC RICE MILK (ORGANIC BROWN RICE, WATER), ORGANIC E
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2015·2014-10-29

    Siemens e.cam Gamma Camera Systems Recalled for Loose Bolts

    Siemens Medical Solutions is recalling e.cam gamma camera systems due to reports of loose bolts in the detector support structure.

    Product
    e.cam line of gamma camera systems Used to detect or image the distribution of radionuclides in the body or organ.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Food)·F-0057-2015·2014-10-29

    Plum Organics Little Cremes Recalled for Choking Hazard

    Plum, Inc. is recalling Little Cremes organic rice milk snacks because they are not softening as intended, posing a choking hazard to babies and young children.

    Product
    Plum Organics Little Cremes: Organic Rice Milk Snacks; Super Purples: Acai, Blackberry and Purple Carrot; Net Wt. 1 oz. (28 grams) 8 CT. USDA Organic; Dairy Free. Ingredients: ORGANIC SWEET POTATO PUREE, ORGANIC BLACKBERRY PUREE, ORGANIC APPLE PUREE, ORGANIC ACAI PUREE, ORG
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0045-2015·2014-10-29

    Glaser Organic Farms Recalls Raw Fruit Pie Due to Salmonella Risk

    Glaser Organic Farms is recalling specific lots of All Raw Vegan Carob Coconut Raspberry Raw Fruit Pie because the carob powder ingredient may be contaminated with Salmonella.

    Product
    All Raw Vegan Carob Coconut Raspberry Raw Fruit Pie, Net WT. 8.0 oz. - Keep Refrigerated. Glaser Organic Farms, 19100 SW M13 Avenue, Miami, FL 33177. (305) 238-7747.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0088-2015·2014-10-29

    Boston Scientific TELIGEN ICDs Recalled for Premature Battery Depletion

    Boston Scientific is recalling TELIGEN ICDs and COGNIS CRT-Ds due to a capacitor defect that may cause the battery to deplete prematurely.

    Product
    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models E103, E111, F102, F103, F110, F111. Sterilized using ethylene oxide. Product Usage: This family of implantable cardioverter defibrillator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0105-2015·2014-10-29

    Philips Avalon Fetal Monitors Recalled for Software Measurement Error

    Philips is recalling Avalon fetal monitors with specific software because automatic blood pressure measurements stop in certain modes.

    Product
    Philips Avalon Monitors with software revision J.30.58: Model Product FM20 M2702A ; FM30 M2703A ; FM50 M2705A Intended for: " Monitoring the physiological parameters of pregnant women " Non-invasive monitoring of fetal heart rates and movements.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0110-2015·2014-10-29

    Mortara Surveyor S12 and S19 Patient Monitors Recalled for Mounting Hazard

    Mortara Instrument is recalling 624 Surveyor S12 and S19 patient monitors due to a potential safety hazard when mounted with non-standard screws.

    Product
    Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Tempe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2015·2014-10-29

    Siemens ADVIA Centaur HBc Total Reagent Recalled for Increased Imprecision

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur HBc Total reagents due to increased imprecision and positive bias that may cause false reactive results.

    Product
    Siemens ADVIA Centaur¿ Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the cor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0097-2015·2014-10-29

    DeRoyal and Novaplus Suction Canisters Recalled for Insufficient Seal

    DeRoyal Industries is recalling 13,900 non-sterile suction canisters and lids because they may have an insufficient seal under low or intermittent suction conditions.

    Product
    Suction canisters labels as follows: 1) DeRoyal(R) SUCTION CANISTER, 1000cc, SEMI-RIGID, REF 71-6510, NON-STERILE, Rx Only. 2) NOVAPLUS(TM) SUCTION CANISTER, 1000 cc, SEMI-RIGID, Cat. No. V71-6510, NON-STERILE, Rx Only general hospital
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2015·2014-10-29

    Siemens Symbia E SPECT Systems Recalled for Loose Bolts in Detector Support

    Siemens Medical Solutions is recalling 562 Symbia E SPECT systems due to reports of loose bolts in the detector support structure.

    Product
    Symbia E is a multi-purpose SPECT system ideal for hospitals and outpatient centers. It is used to detect or image the distribution of radionuclides in the body or organ.
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-0104-2015·2014-10-29

    Philips IntelliVue Monitors Recalled for NBP Measurement Stoppage

    Philips is recalling IntelliVue monitors with specific software revisions because the automatic blood pressure measurement series stops in time-synchronized mode.

    Product
    Philips IntelliVue Monitors with software revisions J.21.03, J.21.19. Model Product MP5 M8105A; MP5SC M8105AS; MP5T M8105AT; MP5 Upgrade M8105AU ; MP5SC Upgrade 866327 The monitors are intended to be used for monitoring and recording of, and to generate alarms f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0008-2015·2014-10-29

    Respironics Esprit Ventilators Recalled for Power Supply Failure Risk

    Respironics is recalling Esprit V1000 and V200 ventilators because a power supply failure may cause loss of ventilator support, potentially leading to hypercarbia or hypoxemia.

    Product
    Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ve
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0103-2015·2014-10-29

    Siemens ADVIA Centaur HBc Total Kit Recalled for Increased Imprecision

    Siemens is recalling ADVIA Centaur HBc Total kits due to increased imprecision and positive bias that may cause false reactive results.

    Product
    ADVIA Centaur¿¿ Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Siemens Material Number: 10309508 The ADVIA Centaur HBc Total assay is an in vitro diagnostic test for the qualitative determination of total antibodies to the core antigen of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2015·2014-10-29

    Aerogen Recalls FRIWO Power Adapters for Aeroneb Nebulizer Systems

    Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.

    Product
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professiona
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0094-2015·2014-10-29

    Zimmer Recalls 19 Hip Prosthesis Shells Due to Missing Threads

    Zimmer, Inc. is recalling 19 Continuum Acetabular System hip prosthesis shells because they are missing polar boss threads.

    Product
    Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0123-2015·2014-10-29

    Zimmer Persona Tibial Articular Surface Inserter Recalled for Deformation Risk

    Zimmer, Inc. is recalling 618 units of the Persona Tibial Articular Surface Inserter because they did not undergo heat treatment, creating a risk of tip deformation.

    Product
    The Persona Tibial Articular Surface Inserter is a sterilizable instrument intended for use in multiple total knee arthroplasty procedures. Per the Persona Surgical technique, the Persona Tibial Articular Inserter is used to seat the articular surface implant onto the tibial b
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0075-2015·2014-10-29

    J F C International Recalls Hapi Pudding for Undeclared Milk Allergen

    J F C International Inc is recalling Hapi Pudding 3-packs because the label fails to declare milk. The product was distributed nationwide in the US.

    Product
    Hapi Pudding, 3-pack, net wt. 8.46oz, UPC 11152 13417, JFC item #13417
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0114-2015·2014-10-29

    Arrow International Recalls Epidural Anesthesia Kits with Incorrect Syringe Components

    Arrow International is recalling 300 units of an epidural anesthesia kit because the kit contains a Luer-Lock syringe instead of the labeled Luer-Slip syringe.

    Product
    ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D0029-2015·2014-10-29

    New GPC Inc. Recalls Alcosulph Moisturizing Cream for Labeling Deficiencies

    New GPC Inc. is recalling Alcosulph Moisturizing Cream because it lacks required OTC drug listings and labeling, and is marked not approved for sale in the U.S.

    Product
    alcosulph Moisturizing Cream, Net Contents: 60g. Product packaged within a plastic container individually placed in small carton. Country of Origin Guyana.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0036-2015·2014-10-29

    Forest Pharmaceuticals Recalls Bystolic Tablets for Dissolution Failure

    Forest Pharmaceuticals is recalling Bystolic (nebivolol) 20 mg tablets because they failed a dissolution specification at a 6-month stability time point.

    Product
    Bystolic (nebivolol) tablets, 20 mg/tablet, packaged as 7 tablets/bottle/carton, and 12 bottles/trays, Professional Sample, Rx only, Forest Pharmaceuticals, Inc., St. Louis, MO. --- NDC 0456-1420-07
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0121-2015·2014-10-29

    Aerogen Nebulizer Power Adapter Recall Due to Broken Cover

    Aerogen is recalling 323 FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover broke and dislodged from the adapter body.

    Product
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professiona
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D0030-2015·2014-10-29

    New GPC Inc. Recalls Alcosulph Astringent Lotion for Labeling Deficiencies

    New GPC Inc. is recalling Alcosulph Astringent Lotion because it lacks required drug listings and OTC labeling, and is labeled as not approved for sale in the U.S.

    Product
    alcosulph Astringent Lotion, Net Contents: 1) 60 mL and 2) 120 mL. Product packaged within a glass container individually placed in small carton. Country of Origin Guyana.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D0031-2015·2014-10-29

    New Gpc Inc. Recalls Mustarcreme for Labeling and Listing Deficiencies

    New Gpc Inc. is recalling Mustarcreme units in New York because the product lacks required drug listings, OTC labeling, and is marked not approved for U.S. sale.

    Product
    MUSTARCREME, Net Contents: 60g (21 oz) Country of Origin Guyana.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0051-2015·2014-10-29

    Golden Corral Meatloaf Mix Recalled for Egg Spoilage Risk

    Processed Foods, Inc. is recalling Golden Corral Meatloaf Mix because it contains eggs susceptible to premature spoilage.

    Product
    Golden Corral MEATLOAF MIX #18029, KEEP FROZEN, NET WEIGHT: 20 lbs (4 - 5 lb Bags), FOR INSTITUTIONAL USE ONLY, Manufactured Exclusively for GC Corporation, Raleigh, NC 27612
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0107-2015·2014-10-29

    Mindray V-Series Patient Monitor Recalled for Drug Calculator Function Issue

    Mindray DS USA is voluntarily recalling V-Series Patient Monitors due to a software issue with the Drug Calculator function.

    Product
    Mindray V21, Size: 515 mm X 335 mm X 685 mm, N.W.: 8 kg, G.W.: 11 kg, Qty:1 The V-Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for use include the monitoring of ECG waveform derived from 3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0099-2015·2014-10-29

    Intra Pump Infusion Systems Recalls CRN Crono Syringes Due to Needle Debris

    Intra Pump Infusion Systems is recalling CRN Crono Syringes because the needle tips may contain clear debris. The recall affects 25,440 units distributed in the US and Canada.

    Product
    CRN Crono Syringe CRN20 with 19G x 1 "Steel Needle"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0093-2015·2014-10-29

    McKesson Cardiology Hemo Software Recall Due to Insufficient Maintenance Communication

    McKesson Information Solutions LLC is recalling 625 McKesson Cardiology Hemo devices because communication regarding required annual maintenance testing was insufficient.

    Product
    McKesson Cardiology Hemo. McKesson Cardiology" Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0055-2015·2014-10-29

    Ovation Brands Bead Pudding Base Recalled for Egg Spoilage Risk

    Processed Foods, Inc. is recalling Ovation Brands Bead Pudding Base because the eggs used in the product are susceptible to premature spoilage.

    Product
    Ovation Brands Bead Pudding Base #67008, Keep Frozen, Net Weight: 20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0117-2015·2014-10-29

    Straumann Dental Implant Recall Due to Incorrect Component Assembly

    Straumann USA is recalling 6 units of Bone Level Tapered Dental Implants because they were assembled with the wrong transfer piece.

    Product
    Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentu
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Food)·F-0061-2015·2014-10-29

    Michael Foods Recalls Papetti's Pre-cooked Scrambled Eggs Due to Spoilage Risk

    Michael Foods is recalling Papetti's Table Ready Refrigerated pre-cooked scrambled eggs because the product may be contaminated with a spoilage microorganism.

    Product
    Papetti's Table Ready Refrigerated pre-cooked scrambled eggs. Keep refrigerated 33 - 40 degrees F. Packaged in two different size configurations: (1) 12- 1.85 pound bags, Net Wt. 22.2 lbs (10.06 kg). Product code: 46025-85878. UPC Code: 1 07 46025 85878 9, and (2) 8-
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D0034-2015·2014-10-29

    New GPC Inc. Recalls Whitfield's Ointment for Labeling Deficiencies

    New GPC Inc. is recalling 4,320 units of Whitfield's Ointment B.P. in New York due to missing drug listings and non-compliant labeling.

    Product
    Whitfield's OINTMENT B.P., Net Contents: 15g. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Food)·F-0053-2015·2014-10-29

    Perkins Meatloaf Mix Recalled Due to Egg Spoilage Risk

    Processed Foods, Inc. is recalling Perkins Meatloaf Mix because it contains eggs susceptible to premature spoilage.

    Product
    PERKINS Meatloaf Mix #31607, Keep Frozen, Net Weight: 20.125 Lbs. (7 - 2.875 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Food)·F-0060-2015·2014-10-29

    Michael Foods Recalls Papetti's Scrambled Eggs for Microbial Contamination

    Michael Foods is recalling Papetti's Table Ready scrambled eggs due to potential contamination with a spoilage microorganism. The product was distributed nationwide.

    Product
    Papetti's Table Ready Refrigerated pre-cooked scrambled eggs with butter flavor. Keep refrigerated 33 - 40 degrees F. Packaged in 12- 1.85 pound bags with Net Wt. 22.2 lbs (10.06 kg). Product code: 46025-85877. UPC Code: 1 07 46025 85877 2.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0052-2015·2014-10-29

    Logan's Roadhouse Meatloaf Mix Recalled for Egg Spoilage Risk

    Processed Foods, Inc. is recalling 380 units of Logan's Roadhouse Meatloaf Mix because the eggs used in the product are susceptible to premature spoilage.

    Product
    Logan's Roadhouse Meatloaf Mix #25018, Keep Frozen, Net Weight: 40 Lbs. (20 - 2 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Custom Foods of America, Knoxville, TN 37921
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0118-2015·2014-10-29

    Aerogen Recalls FRIWO Power Adapters for Aeroneb Nebulizer Systems

    Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.

    Product
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professiona
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0122-2015·2014-10-29

    Siemens IMMULITE 1000 Cortisol Assay Recalled for Positive Bias

    Siemens Healthcare Diagnostics is recalling specific lots of IMMULITE 1000 Cortisol Assay reagents due to confirmed positive bias on controls.

    Product
    IMMULITE /IMMULITE 1000 Systems COR Cortisol, REF/Catalog Number LKC01, SMN 10381388, IVD. For in vitro diagnostic use with the IMMULITE 1000 Systems Analyzers for the quantitative measurement measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0050-2015·2014-10-29

    Golden Corral Meatloaf Mix Recalled for Egg Spoilage Risk

    Processed Foods, Inc. is recalling Golden Corral Meatloaf Mix because the eggs used in the product are susceptible to premature spoilage.

    Product
    Golden Corral MEATLOAF MIX #18028, Keep Frozen, Net Weight: 20 Lbs. (4 - 5 Lb. Bags), FOR INSTITUTIONAL USE ONLY, Manufactured Exclusively for GC Corporation, Raleigh, NC 27612
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0120-2015·2014-10-29

    Aerogen Nebulizer Power Adapter Recall Due to Broken Cover

    Aerogen is recalling FRIWO AC/DC power adapters for Aeroneb nebulizers because the cover may break and dislodge before use.

    Product
    The Aeroneb Professional Nebulizer System is a portable medical device for multiple patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation or other positive pressure breathing assistance. The Aeroneb Professiona
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0100-2015·2014-10-29

    Gyrus Medical Recalls Sterile Surgical Forceps and Scissors Due to Seal Defects

    Gyrus Medical is recalling specific sterile surgical forceps and scissors because a packaging anomaly may compromise the sterile barrier.

    Product
    GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5m
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Drugs)·D-0041-2015·2014-10-29

    ZEE Aspirin Recalled for Incorrect Inactive Ingredient Labeling

    ZEE Medical is recalling ZEE Aspirin 325mg tablets because the product label incorrectly lists inactive ingredients.

    Product
    ZEE Aspirin 325mg - 24 tablets in single dose packets, OTC, Manufactured for ZEE Medical Inc., Irvine,CA 92606 by ULTRA Tab Laboratories, Inc. Highland, NY 12528
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D0032-2015·2014-10-29

    New GPC Inc. Recalls Ferrol Expectorant for Labeling Deficiencies

    New GPC Inc. is recalling Ferrol Expectorant because the product lacks required OTC drug listings and labeling, and is labeled as not approved for sale in the U.S.

    Product
    Ferrol EXPECTORANT, Net Contents: 100 mL. Product packaged within a plastic bottle individually placed in small blue carton. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D0033-2015·2014-10-29

    New GPC Inc. Recalls Whitfield Lotion for Labeling Deficiencies

    New GPC Inc. is recalling 360 units of Whitfield Lotion in New York because the product lacks required OTC drug listing and labeling.

    Product
    WHITFIELD LOTION, Net Contents: 60 mL. Manufactured by: NEW GPC INC. A1 Farm, EBD. Country of Origin Guyana.
    Category
    Drug
    Distribution
    1 state

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