The Recall Desk

Archive

April 2016 recalls

764 recalls were announced in April 2016.

What the numbers show

Critical
20
Severe
134
High
348
Moderate
206
Low
56

Of the 764 recalls this month scored against our rubric, 3% are Critical, 18% are Severe.

Which agencies issued them

601–700 of 764

  • ModerateFDA (Devices)·Z-1325-2016·2016-04-13

    Fresenius 2008 Series Hemodialysis Machines Recalled for False Blood Leak Alarms

    Fresenius Medical Care is recalling 2008 Series hemodialysis machines because they may trigger false blood leak alarms when treating patients with Vitamin B-12.

    Product
    Fresenius 2008 Series Hemodialysis Delivery Systems: 2008T, 2008K2, 2008K and 2008K@home: Models: Fresenius 2008K and 2008K2 Dialysate Delivery System Fresenius 2008K@home Hemodialysis Machine with bibag System 2008T Hemodialysis Machine The Fresenius 2008¿ Series Machines…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0942-2016·2016-04-13

    BJ's Wholesale Club Recalls Deli Roast Beef for Cross-Contact Risk

    BJ's Wholesale Club is recalling D&W London Broil Roast Beef sold in deli bags because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    D&W LONDON BROIL ROAST BEEF, packaged in deli bag. This is a deli service item.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1321-2016·2016-04-13

    ArthroCare Recalls TOPAZ MicroDebrider Devices Due to Shelf-Life Failure

    ArthroCare Corporation is recalling 26,903 TOPAZ MicroDebrider devices because they failed to meet shelf-life requirements at their expiration dates.

    Product
    TOPAZ MicroDebrider 0.8 mm REF AC4040-01; TOPAZ MicroDebrider IFS 0.8 mm REF ACH4040-01; TOPAZ MicroDebrider 0.8 mm REF Q6000-01; TOPAZ EPF MicroDebrider 0.8 mm 45 REF Q6002-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0813-2016·2016-04-13

    Actavis Recalls Dextroamphetamine Tablets for Impurity Failures

    Actavis is recalling specific lots of 10 mg dextroamphetamine tablets because they failed impurity specifications. The recall covers 114,388 bottles distributed nationwide.

    Product
    Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0986-2016·2016-04-13

    BJ's Wholesale Club Recalls Citterio Sweet Capicolla Deli Meat

    BJ's Wholesale Club is recalling Citterio Sweet Capicolla deli meat because it may have been sliced on equipment used for mortadella with pistachios.

    Product
    Citterio Sweet Capicolla, sold in a deli bag. This is a deli service item
    Category
    Food
    Distribution
    8 states
  • LowFDA (Drugs)·D-0809-2016·2016-04-13

    Bio-pharm Recalls Ranitidine Syrup Due to Elevated Impurity Levels

    Bio-pharm, Inc. is recalling Ranitidine Syrup because routine stability testing detected elevated impurity levels.

    Product
    Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1013-2016·2016-04-13

    Immuno-Dynamics Recalls Colostrum Powder for Incorrect Allergen Labeling

    Immuno-Dynamics, Inc. is recalling PerCoBa and Synertek colostrum powder because the labels state 'contains dairy' instead of 'contains milk.'

    Product
    Colostrum Powder, Dietary Supplement, Allergen statement: contains dairy. Colostrum (bovine) packaged in the following sizes and brand names: 1. PerCoBa Extra Edge Net Weight 150 grams, UPC 90576-00099. 3,000 mg Colostrum (bovine) per 2 teaspoons. Immuno-Dynamics, Inc.…
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0801-2016·2016-04-13

    Virtus Pharmaceuticals Recalls Prenatal Supplement Due to Leaking Capsules

    Virtus Pharmaceuticals is recalling prenatal/postnatal folic acid supplements because the capsules may leak. The recall covers 688 bottles distributed nationwide.

    Product
    VP-CH-PNV PRENATAL/POSTNATAL Prescription Folic Acid-Containing Dietary Supplement, 30-count Softgel bottles, Rx, Manufactured for Vitrus Pharmaceuticals, LLC, Tampa, FL 33619, NDC 69543-224-30, UPC 369543224305
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0811-2016·2016-04-13

    Apace KY LLC Recalls Minocycline Capsules Due to Mislabeled Lot Numbers

    Apace KY LLC is recalling 291 cartons of Minocycline Hydrochloride Capsules because individual blisters are mislabeled with an incorrect lot number.

    Product
    Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1319-2016·2016-04-13

    Richard-Allan Scientific Recalls Type 3 Paraffin Due to Mislabeling

    Richard-Allan Scientific is recalling Type 3 Paraffin because customers found Type 6 Paraffin inside the boxes. The product is used for histology tissue processing.

    Product
    Richard-Allan Scientific Paraffin Type 3 For in vitro diagnostic use. For use as an infiltration and embedding medium in histology. Thermo Scientific" Richard-Allan Scientific" Type 1, Type 3, Type 6, and Type 9 Paraffin is specifically designed for tissue processing and…
    Category
    Medical Device
    Distribution
    12 states
  • SevereNHTSA·16V206000·2016-04-12

    Freightliner Trucks Recalled for Rear Brake Caliper Installation Error

    Daimler Trucks North America is recalling 2010-2017 Freightliner trucks because incorrectly installed rear brake calipers may contact the suspension, reducing braking effectiveness.

    Product
    FREIGHTLINER — FREIGHTLINER 108SD, COLUMBIA, BUSINESS CLASS M2, 114SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·028-2016·2016-04-12

    Mountain Products Recalls Pork Products Due to Undeclared Allergens

    Mountain Products Inc. is recalling approximately 467 pounds of bacon and pork sausage products because they contain undeclared milk, soy, and wheat allergens.

    Product
    Mountain Products Inc. — Mountain Products Inc. Recalls Pork Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereCPSC·16140·2016-04-12

    Coleman Recalls CTAC Lithium-Ion Flashlights Due to Fire Hazard

    Coleman is recalling about 8,500 CTAC lithium-ion flashlights sold in the U.S. because the batteries can overheat and catch fire.

    Product
    Coleman® CTAC Lithium-Ion Flashlights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V209000·2016-04-12

    GM Recalls 2014-2015 Silverado and Sierra Trucks for Seat Belt Defect

    General Motors is recalling 2014-2015 Chevrolet Silverado 1500 and GMC Sierra 1500 trucks because the seat belt tensioner cable may separate, increasing injury risk in a crash.

    Product
    CHEVROLET — CHEVROLET, GMC SILVERADO, SIERRA 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V207000·2016-04-12

    Freightliner Trucks Recalled for Front Tire Load Capacity Mismatch

    Daimler Trucks North America is recalling 2016 Freightliner trucks because the installed front tires have a lower load capacity than the axles, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER BUSINESS CLASS M2, 114SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V203000·2016-04-11

    Mazda Recalls CX-3, Mazda2, CX-5, and CX-9 for Steering Knuckle Defect

    Mazda is recalling specific 2013-2016 CX-3, Mazda2, CX-5, and CX-9 vehicles because front strut mounting bolts may loosen, potentially causing a loss of steering control.

    Product
    MAZDA — MAZDA CX-9, MAZDA2, CX-5, CX-3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V202000·2016-04-11

    Ram ProMaster City Recall for Electrical Harness Water Intrusion

    Chrysler is recalling 2015-2016 Ram ProMaster City vans because a low-voltage electrical harness connector may corrode, causing the transmission to unexpectedly shift into neutral.

    Product
    RAM — RAM PROMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V200000·2016-04-08

    Bugatti Recalls Veyron Models Due to Inaccurate Fuel Gauge

    Bugatti is recalling 2006-2011 Veyron and Veyron Grand Sport vehicles because the fuel gauge may display more fuel than is actually in the tank, increasing the risk of stalling and a crash.

    Product
    BUGATTI — BUGATTI VEYRON, VEYRON GRAND SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V193000·2016-04-07

    Nissan Recalls 2016 Maxima and Murano for Brake System Defect

    Nissan is recalling 2016 Maxima and Murano vehicles because a damaged O-ring in the ABS actuator may reduce brake fluid pressure, increasing crash risk.

    Product
    NISSAN — NISSAN MAXIMA, MURANO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V198000·2016-04-07

    Toyota Recalls 2016 RAV4, Lexus RX350, and ES350 for Brake Defect

    Toyota is recalling 2016 RAV4, Lexus RX350, and ES350 vehicles because a damaged O-ring in the ABS actuator may cause improper brake fluid pressure control, increasing crash risk.

    Product
    LEXUS — LEXUS, TOYOTA RX350, RAV4, ES350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·027-2016·2016-04-07

    Pilgrim's Pride Recalls Chicken Nuggets Due to Plastic Contamination

    Pilgrim's Pride is recalling fully cooked chicken nuggets that may contain plastic. No illnesses have been reported.

    Product
    Pilgrim's Pride Corporation — Pilgrim's Pride Corp. Recalls Poultry Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    13 states
  • SevereCPSC·16138·2016-04-07

    GolfBuddy GPS Bands Recalled by Deca International Due to Burn Hazard

    Deca International is recalling GolfBuddy BB5 GPS bands because charging ports can produce an electrical charge that burns exposed skin. Two consumer burn reports have been received.

    Product
    GolfBuddy golf GPS bands
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V197000·2016-04-07

    Toyota Recalls 2016 Sienna Vehicles Due to Front Seat Belt Defect

    Toyota is recalling 2016 Sienna minivans because incorrect front seat belt height adjusters may tear or separate during a crash, increasing injury risk.

    Product
    TOYOTA — TOYOTA SIENNA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16E031000·2016-04-07

    Soaring Recalls Vega XTV 7400 Helmets for Safety Standard Non-Compliance

    Soaring Helmet Corporation is recalling Vega XTV 7400 helmets that may not adequately protect users in a crash. Owners can exchange the helmets or receive a refund.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0902-2016·2016-04-06

    Lipari Foods Recalls Fancy Fruit & Nut Mix Due to Salmonella Risk

    Lipari Foods, Inc. is recalling Fancy Fruit & Nut Mix products because they may be contaminated with Salmonella.

    Product
    Fancy Fruit & Nut Mix 9-oz. retail plastic tub or 25-lb. bulk plastic bag. 12, 9-oz. tubs per case. 1, 25-lb. bag per case.
    Category
    Food
    Distribution
    14 states
  • CriticalFDA (Food)·F-1004-2016·2016-04-06

    Heritage International Recalls Trader Joe's Raw Cashew Pieces for Salmonella

    Heritage International is recalling Trader Joe's Raw Cashew Pieces due to potential Salmonella contamination. The product was distributed to specific U.S. Trader Joe's locations.

    Product
    Trader Joe's Nuts Raw Cashew Pieces NET Wt. 18 oz (1 LB) UPC Code: 0050 5154 Product of Thailand, Vietnam, & India Packaged in Thailand
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0817-2016·2016-04-06

    Kanan Enterprises Recalls Pistachios Due to Potential Salmonella Contamination

    Kanan Enterprises is recalling Favorites Natural Pistachios because the supplier notified them the product may contain Salmonella. The recall affects 408 cases distributed to five states.

    Product
    Favorites Natural Pistachios, roasted & salted, 4.5 oz (128g) pouch UPC 0 38445 12286 5 Proudly distributed by Circle K Stores, Inc. P.O. Box 52085 Phoenix, AZ 85072 www.circlek.com
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-1309-2016·2016-04-06

    ViewRay MRIdian Radiation Therapy System Software Recall

    ViewRay is recalling 5 MRIdian Radiation Therapy Systems due to a software defect that may fail to prompt users to shift the couch to a new isocenter during re-optimization.

    Product
    MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Delivery System (also known as the MRIdian¿ System) is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is…
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0786-2016·2016-04-06

    Walter's Pharmacy Recalls Cefazolin Ophthalmic Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling specific lots of Cefazolin 50 mg/mL Ophthalmic Solution because the sterility of the product cannot be assured.

    Product
    Cefazolin 50 mg/mL Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9999-69 / 89999-9001-04
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0901-2016·2016-04-06

    Lipari Foods Recalls Pistachios Due to Potential Salmonella Contamination

    Lipari Foods, Inc. is recalling raw whole shelled pistachios due to potential Salmonella contamination. The products were distributed to retail and foodservice establishments in 14 states.

    Product
    Pistachio Raw Whole Shelled 9-oz. retail plastic tub or 5-lb. bulk plastic bag. 12, 9-oz tubs per case. 1, 5# bag per case.
    Category
    Food
    Distribution
    14 states
  • SevereFDA (Drugs)·D-0795-2016·2016-04-06

    Walter's Pharmacy Recalls Edetate Disodium Eye Drops Due to Sterility Concerns

    Walter's Pharmacy is recalling specific lots of Edetate Disodium 2% Ophth Solution because the sterility of the product cannot be assured.

    Product
    Edetate Disodium 2% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0818-2016·2016-04-06

    Paradise Farm Organics Recalls Thai Fusion Products for Undeclared Milk

    Paradise Farm Organics Inc is recalling specific Thai Fusion products due to undeclared milk, a major allergen.

    Product
    Thai Fusion Outpost, net weight 5.1 oz. UPC 0 99853 34255 9. Thai Fusion Bulk bag, packaged in a ziploc plastic bag, net weight 3 lbs. UPC 0 99853 35255 8. Thai Fusion On the Go, packaged in microwave able paper cup with plastic lid, net wt. 3.4 oz. UPC 0 99853 38255 5.
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0816-2016·2016-04-06

    H-E-B Tartar Sauce Recalled for Undeclared Fish Allergen

    Fresh Creative Foods is recalling H-E-B Tartar Sauce because it contains undeclared fish due to a labeling error.

    Product
    H-E-B Tartar Sauce 8 oz. UPC: 41220 33244
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1003-2016·2016-04-06

    Healthy Solutions Recalls Super Elixir Pouches for Salmonella Risk

    Healthy Solutions LLC is recalling Super Elixir Pouches due to potential Salmonella contamination. The affected product was distributed in California.

    Product
    Wellco Super Elixir Pouches The Super Elixir 150g, 300g
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0790-2016·2016-04-06

    Walter's Pharmacy Recalls Silver Nitrate Ophthalmic Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling Silver Nitrate 1% Ophthalmic Solution due to a lack of assurance of sterility. The product is distributed in Pennsylvania.

    Product
    Silver Nitrate 1% Ophth Solution, 5mL bottle, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9991-92
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0794-2016·2016-04-06

    Walter's Pharmacy Recalls Acetylcysteine Eye Drops Due to Sterility Concerns

    Walter's Pharmacy is recalling two bottles of Acetylcysteine 10% Ophthalmic Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.

    Product
    Acetylcysteine 10% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9018-33
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0796-2016·2016-04-06

    Walter's Pharmacy Recalls Lidocaine Nebulizer Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling Lidocaine Nebulizer 1% Solution because the product lacks assurance of sterility. The recall affects five bottles distributed in Pennsylvania.

    Product
    Lidocaine Nebulizer 1% Solution, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9020-61
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-1000-2016·2016-04-06

    ProSupps Mr. Hyde Pre-Workout Recalled for Undeclared Picamilon Ingredient

    ProSupps USA LLC is recalling Mr. Hyde Intense Energy Pre-Workout supplements because they may contain the undeclared non-dietary ingredient Picamilon.

    Product
    Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT 30 SERVINGS WATERMELON NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 7.5 OZ (213 GRAMS) and Prosupps Mr. Hyde INTENSE ENERGY PRE WORKOUT WATERMELON NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 15.0 OZ (426…
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·026-2016·2016-04-06

    Ukrop's Recalls Ready-To-Eat Meat Products Due To Possible Foreign Matter

    Ukrop's Homestyle Foods is recalling approximately 2,881 pounds of ready-to-eat turkey, pork, and beef products due to possible contamination with foreign matter.

    Product
    Ukrop's Homestyle Foods — Ukrop's Homestyle Foods Recalls Ready-To-Eat Turkey, Pork, And Beef Products Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0997-2016·2016-04-06

    ProSupps Pre-Workout Supplement Recalled for Potential Picamilon Contamination

    ProSupps is recalling Dr. Jekyll Intense Pump Pre Workout due to potential mislabeling and the presence of the non-dietary ingredient Picamilon.

    Product
    Prosupps Dr. Jekyll INTENSE PUMP PRE WORKOUT, 30 SERVINGS, WATERMELON NATURAL AND ARTIFICIAL FLAVOR DIETARY SUPPLEMENT NET WEIGHT 11.1 OZ (315 GRAMS) packaged in red plastic jars with black lids.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0791-2016·2016-04-06

    Walter's Pharmacy Recalls Tobramycin Ophthalmic Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling Tobramycin 15mg/mL Ophthalmic Solution because the product lacks assurance of sterility. The recall affects specific lots distributed in Pennsylvania.

    Product
    Tobramycin 15mg/mL Ophth Solution, packaged in 5mL and 10mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9996-35
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0788-2016·2016-04-06

    Walter's Pharmacy Recalls Lidocaine Nebulizer Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling Lidocaine Nebulizer 2% Solution because the product lacks assurance of sterility. The recall affects 5 bottles distributed in Pennsylvania.

    Product
    Lidocaine Nebulizer 2% Solution, packaged in 50mL, 100mL, 120mL, and 150mL bottles, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9000-99
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1305-2016·2016-04-06

    Siemens Recalls SOMATOM CT Systems Due to Cardio License Malfunction

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction in cardio licenses that could hazard patients and personnel.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0795-2016·2016-04-06

    Jack and the Green Sprouts Recalls Alfalfa Sprouts Due to E. coli 0157 Risk

    Jack and the Green Sprouts, Inc. is recalling 5 oz packages of alfalfa sprouts that may be contaminated with E. coli 0157. The products were distributed in Minnesota, Wisconsin, and North Dakota.

    Product
    Jack and the Green Sprouts, Alfalfa Sprouts, Net Wt 5 oz (142 g), UPC 7 6324719891 5 Retail: 5 oz clam shell (cup) . Shipping cases hold 12 x 5 oz or 6 x 5 oz clam shells.
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·16E030000·2016-04-06

    Advics Recalls ABS Brake Actuators for Toyota and Nissan Vehicles

    Advics is recalling ABS brake actuators for Toyota and Nissan vehicles due to a damaged O-ring that may cause a lack of brake fluid pressure.

    Product
    SERVICE BRAKES, HYDRAULIC:ANTILOCK/TRACTION CONTROL/ELECTRONIC LIMITED SLIP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0793-2016·2016-04-06

    Walter's Pharmacy Recalls Atropine Ophthalmic Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling 22 bottles of Atropine 0.01% Ophthalmic Solution in Pennsylvania due to a lack of assurance of sterility.

    Product
    Atropine 0.01% Ophth Solution, 15mL bottle, Rx only, Walter's Pharmacy 401 N 17th St Allentown, PA 610-435-4706, NDC 99999-9019-09
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0787-2016·2016-04-06

    Walter's Pharmacy Recalls Edetate Disodium Eye Drops for Sterility Concerns

    Walter's Pharmacy is recalling 3 bottles of Edetate Disodium 3% Ophth Solution due to a lack of assurance of sterility. The product was distributed in Pennsylvania.

    Product
    Edetate Disodium 3% Ophth Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9019-47
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0797-2016·2016-04-06

    Walter's Pharmacy Recalls Vancomycin Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling Vancomycin 50mg/mL Solution because there is a lack of assurance of sterility. The recall affects 10mL bottles distributed in Pennsylvania.

    Product
    Vancomycin 50mg/mL Solution, 10mL bottle, Rx only, Walter's Pharmacy, 401 N 17th St, Allentown, PA 610-435-4706, NDC 99999-9991-54
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0792-2016·2016-04-06

    Walter's Pharmacy Recalls Vancomycin Solution Due to Sterility Concerns

    Walter's Pharmacy is recalling specific lots of Vancomycin 25mg/mL solution due to a lack of assurance of sterility. The affected products were distributed in Pennsylvania.

    Product
    Vancomycin 25mg/mL Solution, 10 mL bottles, Rx only, Walter's Pharmacy 401 N 17th St., Allentown, PA 610-435-4706, NDC 99999-9003-78
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0796-2016·2016-04-06

    Jack and the Green Sprouts Recalls Alfalfa and Onion Sprouts

    Jack and the Green Sprouts, Inc. is recalling specific batches of Alfalfa & Onion Sprouts due to potential E. coli O157 contamination.

    Product
    Jack and the Green Sprouts, Alfalfa & Onion Sprouts, Net Wt 5 oz (142 g), UPC 7 6324719594 5. Retail: 5 oz clam shell (cup) . Shipping cases hold 12 x 5 oz or 6 x 5 oz clam shells.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0808-2016·2016-04-06

    Linda's Salsa Medium Recalled Due to Insanitary Production Conditions

    Flowers For Less is recalling Linda's Salsa Medium in 16 oz. glass jars because the products were produced under insanitary conditions following a security breach.

    Product
    Linda's Salsa Medium in 16 oz. glass jars
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1266-2016·2016-04-06

    PMBS S.C.O.R.E.S. Unit Recall Due to Potential Sterility Compromise

    PMBS, LLC is recalling 58 S.C.O.R.E.S. Units because water retention in filters may compromise sterility. The units were distributed to seven states.

    Product
    The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization unit)
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0810-2016·2016-04-06

    Linda's Black Bean and Corn Salsa Recalled Due to Insanitary Conditions

    Flowers For Less is recalling Linda's Black Bean and Corn Salsa in 16 oz. glass jars because the product was produced under insanitary conditions following a security breach.

    Product
    Linda's Black Bean and Corn Salsa in 16 oz. glass jars
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0807-2016·2016-04-06

    Linda's Salsa Mild Recalled Due to Insanitary Production Conditions

    Flowers For Less is recalling Linda's Salsa Mild in 16 oz. glass jars because they were produced under insanitary conditions following a security breach.

    Product
    Linda's Salsa Mild in 16 oz. glass jars
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1258-2016·2016-04-06

    ICU Medical Recalls ChemLock I.V. Infusion Administration Sets

    ICU Medical is recalling specific I.V. infusion administration sets because a connection may develop a leak.

    Product
    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Integrated ChemoLock Drip Chamber, Spiros, Hanger, Drop-In Red Cap, Item No. CL 3011 Clerestories devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1304-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1299-2016·2016-04-06

    Siemens Artis zeego X-ray Systems Recalled for Mechanical and Electrical Defects

    Siemens is recalling 552 Artis zeego angiography systems due to risks of mechanical cable damage and high-voltage generator module failure.

    Product
    system, x-ray, angiographic, model # 10094135, 10094137, 10094139, 10094141, 10280959 Artis zee/ zeego is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2016·2016-04-06

    Mitsubishi VERO MHI-TM2000 Linear Accelerator Recall for Gantry Angle Error

    Mitsubishi Heavy Industries is recalling VERO MHI-TM2000 Linear Accelerators because the operator console may set an incorrect gantry angle for the first beam of an IMRT treatment.

    Product
    VERO MHI-TM2000 Linear Accelerator System --- Common Name: Medical Linear Accelerator MHI-TM2000 Linear Accelerator System is intended for radiation therapy of lesions, tumors and conditions anywhere in the body where radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1250-2016·2016-04-06

    Terumo Recalls CDI Blood Parameter Monitoring System 500 for Temperature Errors

    Terumo is recalling 222 CDI Blood Parameter Monitoring System 500 devices because a faulty thermistor may cause inaccurate temperature and analyte readings.

    Product
    CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0797-2016·2016-04-06

    Nestle Recalls Maggi Chicken Bouillon Tablets Due to Undeclared Wheat

    Nestle USA is recalling Maggi Chicken Flavor Bouillon tablets because they contain undeclared wheat, posing a risk to individuals with wheat allergies or celiac disease.

    Product
    MAGGI Chicken Flavor Bouillon 6Tab, 12Tab UPC Codes: 028000247959, 028000115678, 028000115678
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-1259-2016·2016-04-06

    ICU Medical Recalls ChemoLock IV Administration Sets Due to Leak Risk

    ICU Medical is recalling specific IV infusion administration sets with ChemoLock ports because the connection may develop a leak.

    Product
    30" (76 cm) Appx. 3.3 ml, Admin Set w/ 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, ChemoLock, Hanger, Item No. CL3511 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1277-2016·2016-04-06

    Roche Estradiol II Assay Recalled Due to Fulvestrant Cross-Reactivity

    Roche Diagnostics is recalling the Elecsys Estradiol II assay because fulvestrant treatment causes falsely elevated estradiol results.

    Product
    Estradiol II Elecsys and cobas e analyzers REF 03000079 190; M 6.5mL, R1 8 mL, R2 8 mL, IVD, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/mL; R1 Biotinylated polyclonal anti-estradiol antibody (rabbit) 45 ng/mL; Mesterolone 130 ng/mL; R2 Estradiol…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1300-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1302-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 SOMATOM Emotion and Sensation CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1303-2016·2016-04-06

    Siemens CT Systems Recalled for Potential Malfunction Hazard

    Siemens is recalling 124 CT systems due to a potential malfunction hazard when using specific cardio licenses.

    Product
    Siemens branded SOMATOM Emotion and SOMATOM Sensation families of CT systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes taken at…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1298-2016·2016-04-06

    Ossur Recalls Papoose Infant Spine Immobilizers and Other Medical Devices

    Ossur Americas is recalling Papoose Infant Spine Immobilizers and other orthopedic devices due to a defect described as 'the p'.

    Product
    Papoose Infant Spine Immobilizer Item # Item Description: PA-100 Papoose PAR-100 Papoose w/replacement pads PO-100 Papoose w/o PO front POR-100 Papoose w/o PO front w/pad Product Usage: The Papoose Infant Immobilizer is an external class I orthotic device used to…
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1265-2016·2016-04-06

    Biomet Vanguard XP Knee System Recall for Sizing Defect

    Biomet is recalling Vanguard XP Knee System porous femoral components because the AP dimension may be oversized, potentially causing loosening and revision surgery.

    Product
    Vanguard XP Knee System Porous Femoral Component various sizes and orientation a total knee replacement system. prosthesis, knee, patella/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1261-2016·2016-04-06

    ICU Medical Recalls I.V. Infusion Sets with Potential Leak

    ICU Medical is recalling 400 units of I.V. infusion administration sets because the connection between the drip chamber and ChemoLock port may develop a leak.

    Product
    31" (79 cm) Appx. 3.4 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, Spiros, Bag Hanger, Item No. SL3011 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1294-2016·2016-04-06

    Ossur Recalls Multiple Orthopedic Braces and Medical Devices

    Ossur Americas is recalling various orthopedic braces and medical devices due to unspecified product defects.

    Product
    Unloader XT Product Usage: Unloader XT Extreme is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Food)·F-0815-2016·2016-04-06

    Ventura Foods Recalls Cooking Oil Jugs Due to Plastic Contamination

    Ventura Foods is recalling 35 lb. jugs of cooking oil because plastic fragments may be present due to a manufacturing defect in the jugs.

    Product
    18168-BLN : Brilliance Clear Premium Frying Oil 35 lb. ; 16763-MFY : Mel-Fry Essential High Performance Liquid Frying Oil 35 lb. ; 16502-MFY : Mel-Fry Premium High Performance Liquid Frying Oil 35 lb. ;
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1284-2016·2016-04-06

    Siemens AXIOM Artis zee/zeego X-Ray Systems Recalled for Cooling Leak

    Siemens is recalling 986 AXIOM Artis zee/zeego angiography systems because a cooling system leak could cause equipment failure.

    Product
    AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1286-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Knee Undersleeves and Walkers

    Ossur Americas is recalling various medical devices, including knee undersleeves and walkers, due to a defect described in the source text.

    Product
    Knee Undersleeve Gray Product Usage: Knee undersleeves are worn as an accessory for comfort under knee braces.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1251-2016·2016-04-06

    IMCO Conforming Stretch Gauze Bandages Recalled for Sterility Failure

    Amd Ritmed is recalling IMCO Conforming Stretch Gauze Bandages because FDA testing found the product was not sterile and tested positive for Bacillus bacteria.

    Product
    IMCO brand Conforming Stretch Gauze Bandages, 4 x 4.1 Yds/10 cm x 3,7 cm, Reorder No. 704-IMC, Bar code 6 86864 04351 5, 96 per case (8 boxes x 12 sterile bandages), Single Use To cover and protect the primary dressing that is in contact with wounds from further injuries…
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1256-2016·2016-04-06

    ICU Medical Recalls IV Infusion Sets with Potential ChemoLock Port Leak

    ICU Medical is recalling specific IV infusion administration sets because the connection between the drip chamber or bag spike and the ChemoLock port may develop a leak.

    Product
    30" (76 cm) Appx 6.3 ml, 20 Drop Admin Set w/ Integrated ChemoLock Port Drip Chamber, 0.2 Micron Filter, ChemoLock, Hanger, Item No. 011-CL3528 sterile devices intended for the infusion and withdrawal of fluids.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1248-2016·2016-04-06

    Maquet Recalls Cardiosave Hybrid and Rescue IABP Devices

    Maquet is recalling Cardiosave Hybrid and Rescue IABP devices because the scroll compressor may not meet specifications for output pressure or vacuum at specific flow rates.

    Product
    Cardiosave Hybrid and rescue IABP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1254-2016·2016-04-06

    ICU Medical Recalls IV Administration Sets with ChemoLock Port Leak Risk

    ICU Medical is recalling specific IV administration sets because a connection may develop a leak. The sets are distributed in the US and several international locations.

    Product
    74" (188cm) approximately 9.0ml, 20 Drop Admin Set w/ Integrated ChemoLock Port sterile IV Administration sets are intended for the infusion and withdrawal of fluids. Drip Chamber, Rotating Luer, Bag Hanger, Item No. 011-CL3341.
    Category
    Medical Device
    Distribution
    14 states
  • HighFDA (Devices)·Z-1276-2016·2016-04-06

    Roche Estradiol III Assay Recalled Due to Fulvestrant Cross-Reactivity

    Roche is recalling the Estradiol III assay because fulvestrant treatment causes falsely elevated estradiol results, potentially leading to incorrect patient management.

    Product
    Estradiol III; Elecsys and cobas e analyzers; REF 06656021 190; M 6.5 mL, R1 9 mL, R2 9 mL, For USA: CONTENT M Streptavidin-coated microparticles 0.72 mg/ml; R1 Two biotinylated monoclonal anti-estradiol antibodies (rabbit) 2.5 ng/m and 4.5 ng/mL Mesterolone 130 ng/mL; R2…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1292-2016·2016-04-06

    Ossur Recalls Rebound Diabetic Walkers and Other Medical Devices

    Ossur Americas is recalling Rebound Diabetic Walkers and other medical devices due to a defect described as 'the p'.

    Product
    Rebound Diabetic Walker Product Usage: Rebound Diabetic Walkers are used for the treatment of plantar foot ulcers.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-1312-2016·2016-04-06

    Synthes Recalls 4.5 mm LCP Proximal Tibia Plate Systems

    Synthes (USA) Products LLC is voluntarily recalling 42 lots of 4.5 mm LCP Proximal Tibia Plate Systems due to a medical device defect.

    Product
    Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1296-2016·2016-04-06

    Ossur Recalls Multiple Medical Devices Including Knee Braces and Walkers

    Ossur Americas is recalling various medical devices, including knee braces and walkers, due to unspecified product issues.

    Product
    Unloader Custom Product Usage: Unloader Custom is an external knee braces to provide support for knee instability due to ligament injuries and osteoarthritis.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Food)·F-0809-2016·2016-04-06

    Linda's Salsa Hot Recalled Due to Insanitary Production Conditions

    Flowers For Less is recalling 71 units of Linda's Salsa Hot in 16 oz. glass jars because they were produced under insanitary conditions following a security breach.

    Product
    Linda's Salsa Hot in 16 oz. glass jars
    Category
    Food
    Distribution
    1 state

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