The Recall Desk

Archive

July 2015 recalls

1,183 recalls were announced in July 2015.

What the numbers show

Critical
342
Severe
229
High
358
Moderate
233
Low
21

Of the 1,183 recalls this month scored against our rubric, 29% are Critical, 19% are Severe.

1101–1183 of 1183

  • CriticalFDA (Food)·F-2592-2015·2015-07-01

    Blue Bell No Sugar Added Ice Cream Recalled for Listeria Infections

    Blue Bell is recalling No Sugar Added Lowfat Ice Cream because five patients in Kansas were infected with Listeria monocytogenes.

    Product
    Blue Bell No Sugar Added Lowfat Ice Cream Dutch Chocolate HALF GALLON (1.89L)
    Category
    Food
    Distribution
    24 states
  • CriticalFDA (Food)·F-2587-2015·2015-07-01

    Blue Bell Ice Cream Recalled Due to Listeria Infections in Kansas

    Blue Bell Creameries is recalling 636,991 units of Tin Roof Still a 1/2 Gal ice cream after five patients in Kansas were infected with Listeria monocytogenes.

    Product
    Blue Bell Ice Cream Tin Roof Still a 1/2 Gal (2 QTS)
    Category
    Food
    Distribution
    24 states
  • SevereFDA (Food)·F-2736-2015·2015-07-01

    Hemisphere Group Recalls Vietnamese Cashew Kernels Due to Salmonella Contamination

    The Hemisphere Group is recalling Vietnamese cashew kernels found to be contaminated with Salmonella. The product was distributed in Michigan, Massachusetts, New York, and Canada.

    Product
    Vietnamese LP Cashew Kernels, 50 lbs. bulk cartons, HONG DUC COMPANY LIMITED, FDA No. 16153193186 --- The imported cashews are shelled and raw, and were distributed in bulk cartons/cases weighing 50 lbs. --- NOTE: The shelf life is 12 months from pack date which is November 3,
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-2775-2015·2015-07-01

    Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria Risk

    The Santa Barbara Smokehouse is recalling approximately 250,000 pounds of Atlantic smoked salmon products due to potential Listeria monocytogenes contamination.

    Product
    - Channel Island Atlantic Smoked Salmon Sliced Side - North Shore Atlantic Smoked Salmon Sliced Side - Coastal Harbor Beechwood Smoked Salmon Sliced Side - S.F. Specialty Ocean Pro Atlantic Norwegian Style Smoked Salmon Sliced Side - Nova Atlantic Smoked Salmon Sliced Side -
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Devices)·Z-1834-2015·2015-07-01

    Stryker Recalls Fios First Entry Trocars Due to Fracture Risk

    Stryker is recalling Fios First Entry trocars because some may fracture at the distal tip, leaving fragments at the surgical site.

    Product
    Fios First Entry; 5mm x 100mm and 12mm x 100mm; Model #:CTF03 and CTF73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal proce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1820-2015·2015-07-01

    Hill-Rom Steriseal-Cannula Ophthalmic Recall Due to Dislodgement Risk

    Hill-Rom is recalling Steriseal-Cannula Ophthalmic handpieces because the metal cannula can rotate and become dislodged from the plastic handpiece.

    Product
    Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2768-2015·2015-07-01

    Fruit Juice Candy Recalled for Lead Contamination in Florida and New York

    Fine Land Corp is recalling Fruit Juice Candy Bonbons de Jus de Fruits after a sample tested positive for lead. The product was distributed in Florida and New York.

    Product
    Fruit Juice Candy Bonbons de Jus de Fruits, Net Wt 8 oz (227g), UPC Code 6 923648 832113, Manufacturer. Jin Shun FA Food Co., Ltd. 147 community shops Southwest District Luoshan Street Jinjiang of Fujian, Sole Agent of U.S.A.: Fine Land Corp. 376 Vernon Ave, Brooklyn, NY 11206, S
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1835-2015·2015-07-01

    Stryker Recalls Optical Access Systems Due to Fracture Risk

    Stryker is recalling specific Optical Access Systems because they may fracture at the tip, leaving fragments at the surgical site.

    Product
    Optical Access System; 5mm x 100mm and 12mm x 100mm; Model #: CTR03 and CTR73. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdomina
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1836-2015·2015-07-01

    Stryker Recalls Trocars Due to Reported Fracture at Distal Tip

    Stryker is recalling specific cannula and seal models because they may fracture at the tip, leaving fragments at the surgical site.

    Product
    Cannula and Seal; 5mm x 100mm and 12mm x 100mm Model #: CTS02 and CTS22. Indicated for use to establish a port of entry fro endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal proc
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V420000·2015-07-01

    Gillig Recalls 2010-2015 Low Floor Buses Due to Fire Risk

    Gillig is recalling 2010-2015 Low Floor transit buses because a power cable may chafe a fuel line, increasing fire risk.

    Product
    GILLIG — GILLIG LOW FLOOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2779-2015·2015-07-01

    Santa Barbara Smokehouse Recalls Smoked Salmon for Listeria Risk

    The Santa Barbara Smokehouse is recalling fresh and frozen cold smoked salmon due to potential Listeria Monocytogenes contamination.

    Product
    - Private Reserve Rope Hung Smoked Scottish Salmon 4oz. Products are packaged in Reduced Oxygen Package (ROP). Product is priced per pound.
    Category
    Food
    Distribution
    21 states
  • SevereFDA (Devices)·Z-1827-2015·2015-07-01

    Fresenius NaturaLyte Liquid Bicarbonate Concentrate Recalled for Bacterial Contamination

    Fresenius Medical Care is recalling NaturaLyte Liquid Bicarbonate Concentrate due to bacterial contamination. The product is used in hemodialysis machines.

    Product
    NaturaLyte Liquid Bicarbonate Concentrate (Dialysate Concentrate for Hemodialysis (liquid), 6.4 Liter Bottle Catalog Number: 08-4000-LB This concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1831-2015·2015-07-01

    Stryker Recalls SERFAS 90 Degree Energy Probes Due to Fragmentation

    Stryker Endoscopy is recalling 22,063 SERFAS 90 degree Energy Probes because fragments of the probe have been reported to break off into patients during arthroscopic procedures.

    Product
    SERFAS 90 degree Energy Probe, Part Number 279-350-101; SERFAS Energy Probes are indicated for arthroscopic procedures of the knee, shoulder, ankle, hip, elbow and wrist. Specifically, the probes are used for resection, ablation and coagulation of soft tissue, as well as the h
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2737-3015·2015-07-01

    Natural Grocers Raw Macadamia Nuts Recalled for Salmonella Contamination Risk

    Vitamin Cottage Natural Food Markets is recalling specific lots of Natural Grocers Raw Macadamia Nuts due to potential Salmonella contamination.

    Product
    Natural Grocers Raw Macadamia Nuts, Net Wt. 10 oz. package, Sealed plastic bag.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V418000·2015-07-01

    Nissan Recalls Juke, Cube, Versa for Sticking Start/Stop Button

    Nissan is recalling 2013-2014 Juke, Cube, and 2014 Versa vehicles because the engine start/stop button may stick, potentially causing the engine to shut off while driving.

    Product
    NISSAN — NISSAN CUBE, JUKE, VERSA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2749-2015·2015-07-01

    Epi White Hoagie Sliced Bread Recalled for Undeclared Peanut and Tree Nut

    Lavoi Corporation is recalling Epi White Hoagie Sliced Bread because it was made with wheat gluten containing undeclared peanut and/or tree nut residue.

    Product
    Epi breads, 12" White Hoagie Sliced, 45 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighCPSC·15739·2015-07-01

    Otteroo Recalls Inflatable Baby Floats Due to Drowning Risk

    Otteroo is recalling about 3,000 inflatable baby floats because seams can leak air and deflate, posing a drowning risk. No injuries have been reported.

    Product
    Otteroo Inflatable Baby Floats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2747-2015·2015-07-01

    Epi Sliced Multigrain Boule Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Epi Sliced Multigrain Boule bread because it was made with wheat gluten containing undeclared peanut and/or tree nut residue.

    Product
    Epi breads, Sliced Multigrain Boule, 48 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-2752-2015·2015-07-01

    Epi Bread Foot Long Sub Rolls Recalled for Undeclared Allergens

    Lavoi Corporation is recalling Epi Bread Foot Long Sub Rolls because they were made with wheat gluten containing undeclared peanut and/or tree nut residue.

    Product
    Epi breads, Foot Long Sub Roll, Net Weight 11.6 lbs, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-1837-2015·2015-07-01

    DeRoyal Recalls Custom Surgical Kits with Defective Medtronic Gloves

    DeRoyal Industries is recalling custom surgical kits containing Medtronic Devon Light Gloves due to splits or holes.

    Product
    Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-347
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2763-2015·2015-07-01

    Osamu Recalls Frozen Ground Tuna Due to Potential Salmonella Contamination

    Osamu Corporation is recalling specific lots of frozen ground tuna due to potential Salmonella contamination. The product was distributed to restaurants in California, Arizona, New Mexico, and Nevada.

    Product
    Frozen Tuna Ground Indonesia/Wild Caught Label on outer shipping cardboard box: Frozen Tuna Fillet Restaurant Supply Only Packed For: Mutual Trading Co., Inc. LA, CA 90013 Product of Indonesia Product is ROP. Packages are packed in a white cardboard box and then i
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2762-2015·2015-07-01

    Walmart Brand Bread Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Walmart brand bread because it was made with wheat gluten containing undeclared peanut and/or tree nut residue.

    Product
    Walmart brand bread, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-2748-2015·2015-07-01

    Lavoi Epi Italian Loaf Bread Recalled for Undeclared Peanut and Tree Nut

    Lavoi Corporation is recalling Epi Italian Loaf breads because they were made with wheat gluten containing undeclared peanut and/or tree nut residue.

    Product
    Epi breads, Italian Loaf, Net Weight 12.0 lbs, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-2744-2015·2015-07-01

    Lavoi Epi Sourdough Hoagie Breads Recalled for Undeclared Allergens

    Lavoi Corporation is recalling Epi Sourdough Hoagie breads because they were made with wheat gluten containing undeclared peanut and/or tree nut residue.

    Product
    Epi breads, 7" Sourdough Hoagie, 72 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-1841-2015·2015-07-01

    Remel VersaTREK Instrument Series 240 Recalled for False Positive Reports

    Remel Inc. is recalling 143 VersaTREK Instrument Series 240 devices because their use may result in false positive reports. The devices are used to cultivate microorganisms from blood and other sterile bodily fluids.

    Product
    VersaTREK Instrument Series 240 REF 6240, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2769-2015·2015-07-01

    Crystal Fresh Recalls Cheesecake Shave Ice for Undeclared Milk Allergen

    Crystal Fresh is recalling SNOBIZ Cheesecake Shave Ice Flavor due to an undeclared milk allergen. The product was distributed in multiple US states and Canada.

    Product
    SNOBIZ CHEESECAKE SHAVE ICE FLAVOR, 10 pouches/carton; 8 cartons/case (80 pouches total per case), 104 gram per pouch, metallized pouch.
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-1821-2015·2015-07-01

    Unomedical Infusion Set Needles Recalled for Potential Breakage During Use

    Unomedical is recalling specific infusion sets because the steel needle can break during use, interrupting medication delivery.

    Product
    Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Food)·F-2754-2015·2015-07-01

    Lavoi Epi Bread Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Epi breads because wheat gluten used in manufacturing contained undeclared peanut and/or tree nut residue.

    Product
    Epi breads, 7" Wheat Hoagie Wide, Net Weight 10.8 lbs, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-2760-2015·2015-07-01

    Zaxbys Brioche Buns Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Zaxbys Brioche Buns because they were made with wheat gluten containing undeclared peanut and/or tree nut residue.

    Product
    Zaxbys, Brioche Bun, 90 count case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-2759-2015·2015-07-01

    Zaxbys Nibbler Buns Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Zaxbys Nibbler Buns because they were made with wheat gluten containing undeclared peanut and/or tree nut residue.

    Product
    Zaxbys, Nibbler Bun, 180 count case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-2755-2015·2015-07-01

    Lavoi Epi Breads Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Epi Breads Sliced Wheat Hoagie products because they were made with wheat gluten containing undeclared peanut or tree nut residue.

    Product
    Epi breads, 7.75" Sliced Wheat Hoagie, 54 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-2757-2015·2015-07-01

    Fire House Subs Bread Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Fire House Subs bread rolls due to undeclared peanut and/or tree nut residue in the wheat gluten used.

    Product
    Fire House Subs, Medium White Sub Roll, and Large White Sub Roll, 48 and 45 count case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighUSDA FSIS·pha-070115·2015-07-01

    USDA Issues Alert for Raw Frozen Stuffed Chicken Due to Salmonella

    USDA FSIS issued a public health alert for raw, frozen stuffed chicken products linked to Salmonella Enteritidis illness clusters in Minnesota.

    Product
    FSIS Issues Public Health Alert For Frozen Raw Stuffed Chicken Products Due To Possible Salmonella Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2764-2015·2015-07-01

    Deskins Chocolate No Bakes Recalled for Undeclared Peanut Butter

    Deskins Wholesale is recalling Chocolate No Bakes containing undeclared peanut butter. The product was distributed to West Virginia, Virginia, Ohio, and North Carolina.

    Product
    Deskins Candies, Chocolate No Bakes, Net Wt. 16-oz., packaged in 1 lb. plastic containers containing 8-10 cookies / 12 containers per case. Deskins Wholesale, Bluefield, WV.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-2753-2015·2015-07-01

    Lavoi Epi Bread Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling specific Epi bread products because they were made with wheat gluten containing undeclared peanut and tree nut residue.

    Product
    Epi breads, 8" Extra Wide Sliced Hoagie, 7" Hoagie Butterfly Sliced, 54 count per case and 9.5" Crusty Hoagie, 45 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-1825-2015·2015-07-01

    GE Healthcare T2100 Treadmill Recalled for Uncontrolled Walking Belt Motion

    GE Healthcare is recalling 11,423 T2100 Treadmills due to a potential safety issue involving uncontrolled motion of the walking belt.

    Product
    GE Healthcare, Treadmill T2100. For Exercise Testing, facilitating accurate blood pressure measurements and exercise testing within speed range of 0-13.5 miles per hour.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2745-2015·2015-07-01

    Epi Bread Products Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling specific Epi bread products because they were made with wheat gluten containing undeclared peanut and/or tree nut residue.

    Product
    Epi breads, 12" French Sub-roll, 36 count per case, Epi breads, 12" Unsliced French Hoagie, 45 count per case, and 7.75" French Hoagie, 48 count per case per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-1846-2015·2015-07-01

    Siemens Artis zee/zeego Systems Recalled for Position Sensor Fault

    Siemens is recalling 475 Artis zee/zeego angiography systems because a position sensor fault could cause the system to exceed its usual speed and collide.

    Product
    Artis zee/ zeego systems; Product Usage: Usage: Artis zee/ zeego systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2742-2015·2015-07-01

    Epi Breads French Baguette Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Epi Breads French Baguette Unsliced because the wheat gluten used contained undeclared peanut and/or tree nut residue.

    Product
    Epi breads, French Baguette Unsliced, 24 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-2758-2015·2015-07-01

    Fire House Subs Wheat Rolls Recalled for Undeclared Peanut or Tree Nut

    Lavoi Corporation is recalling Fire House Subs wheat rolls because they were made with wheat gluten containing undeclared peanut or tree nut residue.

    Product
    Fire House Subs, Medium Wheat Sub Roll, and Large Wheat Sub Roll, 48 and 45 count case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-1822-2015·2015-07-01

    Smith & Nephew Recalls Ultra-Fast Fix Knot Pusher Suture Cutters

    Smith & Nephew is recalling Ultra-Fast Fix Knot Pusher Suture Cutters because the device's sterility may be compromised.

    Product
    ULTRA-FAST FIX Knot Pusher Suture Cutters Product Number: 72201537 Intended for Meniscal Repair.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2773-2015·2015-07-01

    Mi Costenita Bocadin Wafers Recalled for Undeclared Milk Allergen

    Yoli, Inc. is recalling Mi Costenita Bocadin chocolate-covered wafers due to undeclared milk allergens. The product was distributed nationwide in 26 states.

    Product
    Chocolate covered wafers (Bocadin) in plastic packaging sold under the Mi Costenita brand and packaged and distributed by Yoli, Inc.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2740-2015·2015-07-01

    Orca Bay Mediterranean Seasoned Wild Alaska Salmon Recalled for Undeclared Allergens

    Orca Bay Seafoods is recalling Mediterranean Seasoned Wild Alaska Salmon due to undeclared wheat and soy. The product was distributed in Ohio.

    Product
    Mediterranean Seasoned Wild Alaska Salmon, brand name Orca Bay, IVP frozen packages, ready to cook product. Products are keta salmon fillets with a brown spice rub. Each fillet is individually vacuum-packed in a clear plastic film and ranges from 1-2 lbs. UPC 2 08617 60XXX X
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2751-2015·2015-07-01

    Epi Garlic Italian Bread Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Epi Garlic Italian Bread because it was made with wheat gluten containing undeclared peanut and tree nut residue.

    Product
    Epi breads, Garlic Italian Bread, 14.6 lbs., Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-1829-2015·2015-07-01

    Varian Leipzig-style Brachytherapy Applicator Set Recalled for Dose Rate Discrepancy

    Varian Medical Systems is recalling 46 Leipzig-style Surface Applicator Sets because the actual dose rate is approximately 14% higher than the rate published in the Instructions for Use.

    Product
    Surface Applicator Set with Leipzig-style Cone. Brachytherapy applicator set.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2750-2015·2015-07-01

    Epi Bread Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Epi breads because they were made with wheat gluten containing undeclared peanut or tree nut residue.

    Product
    Epi breads, 7" Extra Wide and 7" Extra Wide Sliced Hoagie 54 count per case, 4 case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighNHTSA·15V419000·2015-07-01

    Subaru Recalls 2012 Impreza Vehicles Due to Passenger Air Bag Defect

    Subaru is recalling 2012 Impreza vehicles because the Occupant Detection System may deactivate, preventing the front passenger air bag from deploying in a crash.

    Product
    SUBARU — SUBARU IMPREZA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2746-2015·2015-07-01

    Lavoi Epi Breads Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Epi Breads 8-inch sub-rolls because they were made with wheat gluten containing undeclared peanut and/or tree nut residue.

    Product
    Epi breads, 8" Sub-roll, 48 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-2741-2015·2015-07-01

    Epi Bread Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Epi breads because they were made with wheat gluten containing undeclared peanut and tree nut residue.

    Product
    Epi breads, 7" French Hoagie Sliced, Net Weight 10.4 lbs., Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-2756-2015·2015-07-01

    Lavoi Charleys Hoagie Bread Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Charleys Fresh Baked Hoagie Sliced bread in multiple sizes due to undeclared peanut and/or tree nut residue.

    Product
    Charleys, 7.75", 9" and 12" Fresh Baked Hoagie Sliced, 96, 64 and 60 count case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-1819-2015·2015-07-01

    Orthofix Centurion POCT System Drill Guide Recall for Depth Setting Risk

    Orthofix is recalling 36 Centurion POCT System Drill Guides because the thumb button may remain unlocked, allowing the drill stop to rotate unintentionally and change the depth setting.

    Product
    ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1842-2015·2015-07-01

    Remel VersaTREK Instrument Series 528 Recalled for False Positive Reports

    Remel Inc. is recalling 21 VersaTREK Instrument Series 528 devices because their use may result in false positive reports.

    Product
    VersaTREK Instrument Series 528 REF 6528, Manufactured for Remel Inc. The VersaTREK System is for cultivating and recovering microorganisms, especially bacteria and yeasts, from blood and other normally sterile bodily fluids.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2738-2015·2015-07-01

    Whole Foods Recalls Jivara Milk Chocolate for Undeclared Hazelnut Allergen

    Whole Foods Market is recalling Jivara Lactee Milk Chocolate Valrhona because one retail location failed to declare hazelnuts on the label.

    Product
    Jivara Lactee Milk Chocolate Valrhona; 40% Ingredients: Cocoa Butter, whole powdered milk, sugar, cocoa beans, brown sugar, natural vanilla extract, soya lecithin, malt extract, Natural Vanilla Flavor. Contains: Soy,. May contain trace amounts of dairy, eggs, nuts and gluten as
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2761-2015·2015-07-01

    Popeyes Po Boy Bread Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Popeyes 12-inch Po Boy Bread because it was made with wheat gluten containing undeclared peanut and/or tree nut residue.

    Product
    Popeyes, 12" Po Boy Bread, 45 Pieces per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • HighFDA (Food)·F-2767-2015·2015-07-01

    Natural Creations Recalls Glucosamine MSM Supplement for Unlabeled Shellfish Allergen

    Natural Creations Inc is recalling Glucosamine MSM dietary supplements because they contain an unlabeled shellfish allergen. The recall affects 644 bottles distributed nationwide.

    Product
    Natural Creations Glucosamine MSM 90 capsules packaged in 250 cc white plastic containers with 52 bottles per case.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2743-2015·2015-07-01

    Epi Breads Recalled for Undeclared Peanut and Tree Nut Allergens

    Lavoi Corporation is recalling Epi Breads French Mini-Baguettes because they were made with wheat gluten containing undeclared peanut and/or tree nut residue.

    Product
    Epi breads, 10" French Mini-Baguette, 54 count per case, Lavoi Corporation, EPI Breads, 4710 West Ledbetter, Dallas, TX 75236.
    Category
    Food
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-1149-2015·2015-07-01

    Indiana Botanic Gardens Recalls Dr Blue Pain Relieving Gel Due to Blending Issues

    Indiana Botanic Gardens is recalling Dr Blue Pain Relieving Gel because the product may not be uniformly blended, resulting in non-uniform distribution of the active ingredient menthol.

    Product
    Dr Blue Pain Relieving Gel, (4.6% menthol), For temporary relief of minor aches and pains of muscles and joints, a) 2 oz. Tube, NDC 10578-035-05, b) 5 oz. Jar, NDC 10578-035-04, Manufactured by Indiana Botanic Gardens, Hobart, IN 46342
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1823-2015·2015-07-01

    X Spine Systems Recalls Fortex Pedicle Screw System Rods

    X Spine Systems is recalling 75 Fortex Pedicle Screw System Continuous Radius Rods because they measure 45mm instead of the specified 50mm.

    Product
    Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-1809-2015·2015-07-01

    Teleflex Recalls Lifesaver Manual Resuscitators Due to Potential Intake Port Blockage

    Teleflex Medical is recalling 9,333 units of Lifesaver Single Patient Use Manual Resuscitators because the intake port may be blocked, causing the bag to fail to fill.

    Product
    Lifesaver Single Patient Use Manual Resuscitator Product Usage: The Hudson RCI Lifesaver Single Patient Use manual resuscitator with pressure monitoring port is a disposable medical device intended for use on patients requiring temporary augmentation of ventilation with or w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1844-2015·2015-07-01

    Volcano PV .035 Catheter Recalled for Incorrect Shelf Life Labeling

    Volcano Corporation is recalling 162 PV .035 Catheters because they were labeled with incorrect shelf life dates during a relabeling procedure.

    Product
    Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2733-2015·2015-07-01

    Golden Chocolate Papaya Recalled for Undeclared Food Colorings

    Golden Chocolate International is recalling 513 lbs of ROGALIK PAPAYA due to undeclared FD&C food colorings. The product was distributed in New York and Pennsylvania.

    Product
    Golden Chocolate ROGALIK PAPAYA, Net Wt. 1Lb. (454 g). Manufactured for and Distributed by: Golden Chocolate, Brooklyn, NY 11231.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1830-2015·2015-07-01

    Cook Inc. Recalls LapSac Surgical Tissue Pouches Due to Labeling Error

    Cook Inc. is recalling 123,184 LapSac Surgical Tissue Pouches because the labeling includes information not stated in the intended use.

    Product
    LapSac Surgical Tissue Pouch. The current intended use for the LapSac Surgical Tissue Pouch is for isolating tissue during, or prior to, surgical removal and/or morcellation. The device is a reinforced pouch with an inner liner and drawstring closure. The device may be used t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1845-2015·2015-07-01

    Volcano Prestige Plus J-Tip Wire Recalled for Incorrect Shelf Life Labeling

    Volcano Corporation is recalling 162 Prestige Plus 185cm J-Tip pressure wires because they were labeled with incorrect shelf life dates during a relabeling procedure.

    Product
    Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or any interventional procedures. Blood pressure m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2772-2015·2015-07-01

    Refreshe Lime Flavored Electrolyte Water Recalled for Coliform Contamination

    The Sweetwater Co. is recalling Refreshe Lime Flavored Electrolyte Water due to high total coliform testing results.

    Product
    Lime Flavored Electrolyte bottled Water, sold under brand Refreshe. Each bottle is 1 Liter (33.8 Fl. oz.). This brand has the UPC 0 21130-24208 5.
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1832-2015·2015-07-01

    ArthroCare EVAC 70 XTRA Plasma Wand Recall for Component Failure

    ArthroCare Medical Corporation is recalling EVAC 70 XTRA plasma wands due to potential component failure that may cause the device to become inoperable.

    Product
    EVAC 70 XTRA with Integrated Cable REF EICA5872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1843-2015·2015-07-01

    Siemens IMMULITE 2000 Italian Cypress Allergy Test Recall

    Siemens is recalling specific lots of the IMMULITE 2000 Italian Cypress 3g Allergy test because they fail to meet shelf-life stability specifications.

    Product
    IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Material Number (SMN) 10386079, IVD. For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1824-2015·2015-07-01

    CooperSurgical Recalls Vaginal Speculums Due to Incorrect Packaging

    CooperSurgical is recalling 9,400 McKesson Medi-Pak Vaginal Speculums because small-sized speculums were incorrectly packaged in bags labeled for medium-sized speculums.

    Product
    McKesson Medi-Pak Vaginal Speculum, 10/bag Reorder No. 11-8309 Used to expose interior of the vagina to facilitate visualization during gynecological and obstetrical procedures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2735-2015·2015-07-01

    Golden Chocolate OREX Recalled for Undeclared Food Colorings

    Golden Chocolate International is recalling Golden Chocolate OREX because it contains undeclared FD&C Yellow #5, FD&C Yellow #6, and FD&C Red #40.

    Product
    Golden Chocolate OREX, Net Wt. 1Lb (454 g). Keep Refrigerated. Manufactured for and Distributed by: Golden Chocolate, Brooklyn, NY 11231.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-2771-2015·2015-07-01

    Sweetwater Recalls Mixed Berry Electrolyte Water for Coliform Testing

    The Sweetwater Co. is recalling Mixed Berry Flavored Electrolyte Water sold under HyVee, Raleys', and Refreshe brands due to high total coliform testing results.

    Product
    Mixed Berry Flavored Electrolyte bottled Water, sold under brand HyVee, Raleys' Purely Made, and Refreshe. Each bottle is 1 Liter (33.8 Fl. oz.). HyVee brand has the UPC 0 75450 12723 2; Raley's brand has the UPC 0 46567 02874 3; Refreshe has the UCP 0 21130 24209 2
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-1833-2015·2015-07-01

    ArthroCare Medical Recalls PROcise XP Wand Due to Component Failure

    ArthroCare Medical is recalling 2,355 PROcise XP Wand units because a potential component failure may cause the device to become inoperable during use.

    Product
    PROcise XP Wand with Integrated Cable REF EICA8872-01 Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, ora
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2734-2015·2015-07-01

    Golden Chocolate Recalls Raisin Pound Cake for Undeclared Food Colorings

    Golden Chocolate International is recalling Raisin Pound Cake because it contains undeclared FD&C Yellow #5, Yellow #6, and Red #40 food colorings.

    Product
    Golden Chocolate RAISIN POUND CAKE, Net Wt. To be Weighed at Time of Sale. Manufactured for and Distributed by: Golden Chocolate, Brooklyn, NY 11231.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1828-2015·2015-07-01

    Terumo Recalls Custom Cardiovascular Procedure Kits and Safety Valves

    Terumo is recalling 163 custom cardiovascular procedure kits and over-pressure safety valves because the valves are not cleared for use on the arterial side of the bypass circuit.

    Product
    Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1826-2015·2015-07-01

    Merit Medical Prelude Pro Sheath Introducer Recalled for Incorrect Dilator Packaging

    Merit Medical Systems is recalling Prelude Pro Sheath Introducers packaged with a 0.035-inch dilator instead of the labeled 0.038-inch size.

    Product
    Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Food)·F-2739-2015·2015-07-01

    Eating Right Black Bean Soup Recalled for Potential Mispackaging

    San Francisco Spice Company is recalling Eating Right Black Bean Soup because some containers may contain Spicy Thai Noodle soup instead.

    Product
    Eating Right Black Bean Soup; 1.3 oz paper container. Dried soup to which consumer adds hot water. USPC: 79893-80026; Ingredients: Ingredients: Black Beans*, Vegetables* (Tomato, Potato, Corn, Peppers, Garlic), Natural Flavor (Yeast Extract, Maltodextrin, Sunflower Oil, Silicon
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Food)·F-2766-2015·2015-07-01

    Coca-Cola Recalls Diet Dr. Pepper Labeled as Regular Dr. Pepper

    Coca-Cola is recalling 4,772 cases of Diet Dr. Pepper that were incorrectly labeled as containing regular Dr. Pepper. The product was distributed in six southeastern states.

    Product
    Diet Dr. Pepper, 8 x 12 fl. oz. PET bottle, Bottled under the authority of Dr. Pepper Company, 5301 Legacy Drive, Plano, TX 85024.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-2770-2015·2015-07-01

    Sweetwater Recalls Lemon Flavored Electrolyte Water Due to Coliform Testing

    The Sweetwater Co. is recalling Lemon Flavored Electrolyte water sold under four brands due to high total coliform testing results.

    Product
    Lemon Flavored Electrolyte bottled water, sold under brand HyVee, Raleys' Purely Made, Refreshe, and Simple Truth. Each bottle is 1 Liter (33.8 Fl. oz.). HyVee brand has the UPC 0 75450 12722 5; Raley's brand has the UPC 0 46567 02873 6; Refreshe brand has the UPC 0
    Category
    Food
    Distribution
    10 states
  • LowFDA (Devices)·Z-1840-2015·2015-07-01

    Bio-Rad Anti-HBs Cutoff Calibrator Recalled for Incorrect Expiration Date

    Bio-Rad Laboratories is recalling 20 vials of Anti-HBs Cutoff Calibrator because the expiration date printed on the label is incorrect.

    Product
    The spare component Anti-HBs Cutoff Calibrator, 10 mLU/mL, Catalog number 26154. The spare component is sold separately from the MONOLISA Anti-HBs EIA Kit contains an expiration date of 2016-04-30 in error.
    Category
    Medical Device
    Distribution
    5 states
  • LowFDA (Drugs)·D-1147-2015·2015-07-01

    Bracco Recalls E-Z-CAT Dry Barium Sulfate Due to Viscosity Failures

    Bracco Diagnostic Inc. is recalling E-Z-CAT Dry Barium Sulfate for Suspension because the product failed stability specifications for viscosity.

    Product
    E-Z-CAT Dry Barium Sulfate for Suspension (2% w/w after mixing), 23 g foil pouches, Rx only, Manufactured by E-Z-EM Canada Inc. a subsidiary of E-Z-EM Inc., Lake Success NY NDC 32909-727-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1839-2015·2015-07-01

    Ethicon Recalls Surgical Sutures Due to Incomplete Labeling

    Ethicon is recalling specific lots of Fast Absorbing Plain Gut sutures because the box and foil labels are incomplete.

    Product
    Ethicon Fast Absorbing Plain Gut - MultiPass Needles, Sterile, Absorbable Surgical Suture, 5-0 (1.5 metric), 18" (45 cm), Conventional Cutting, Lot #JD6163, Exp: July 2019. Fast absorbing surgical gut suture is a strand of collagenous material prepared from the submucosal layers
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1148-2015·2015-07-01

    Actavis Recalls Lutera Birth Control Due to Outdated Package Inserts

    Actavis Inc is recalling Lutera birth control tablets because the packs were distributed with out-dated package inserts.

    Product
    Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP), 28 day Regimen, 6 Tablet Dispensers per box, 28 Tablets Each, Rx Only, Manufactured for: Watson Pharm, Inc., a subsidiary of Watson Pharmaceutical, Inc., Corona, CA 92880, Manufactured by: Patheon, Inc., Mi
    Category
    Drug
    Distribution
    Distributed nationwide

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