The Recall Desk

Archive

October 2015 recalls

479 recalls were announced in October 2015.

What the numbers show

Critical
22
Severe
124
High
217
Moderate
88
Low
28

Of the 479 recalls this month scored against our rubric, 5% are Critical, 26% are Severe.

101–200 of 479

  • ModerateFDA (Devices)·Z-0150-2016·2015-10-28

    B. Braun Recalls Perifix Epidural Anesthesia Trays Due to Discoloration

    B. Braun Medical is recalling 433 Perifix Continuous Epidural Anesthesia Pain Control Trays because the DuraPrep solution may be discolored from unintended sterilant exposure.

    Product
    Perifix Continous Epidural Anesthesia Pain Control Trays; Injection of anesthetics to provide regional anesthesia for pain management.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0135-2016·2015-10-28

    Philips MRI Systems Recalled for Incorrect Cross-Reference Lines in Spine Imaging

    Philips Medical Systems is recalling specific MRI systems due to a software defect that may cause cross-reference lines to be positioned incorrectly in spine clinical workflows.

    Product
    All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head,
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-0146-2016·2015-10-28

    ConFormis iTotal CR Knee Replacement System Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling 348 units of the iTotal CR Knee Replacement System because they may contain small amounts of ethylene glycol residue.

    Product
    ConFormis iTotal CR Knee Replacement System- iTOTAL CR, Right Knee Catalog Number: M57250600020 (US) M5725INT0600020 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0153-2016·2015-10-28

    OneTray Sealed Sterilization Containers Recalled for Incorrect Labeling

    Innovative Sterilization Technologies LLC is recalling OneTray Sealed Sterilization Containers because the labels list the wrong steam sterilization time.

    Product
    OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0143-2016·2015-10-28

    ConForMIS iDuo Knee Replacement Recalled for Ethylene Glycol Residue

    ConforMIS, Inc. is recalling 12 units of the iDuo Knee Bicompartmental Knee Replacement System because they may contain small amounts of ethylene glycol residue.

    Product
    ConForMIS iDuo Knee Bicompartmental Knee Replacement System , iDUO G2, Right Medial Catalog Number: M57230600220 (US) M5723INT0600220 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0035-2016·2015-10-28

    JBN Chocolate Whey Protein Powder Recalled for Missing Milk Labeling

    Nutrition Resource Services is recalling JBN Chocolate Confidence Nutritional Support for Bariatric Surgery because the whey protein product is not labeled as containing milk.

    Product
    JBN (Just Be Natural) Chocolate Confidence Nutritional Support for Bariatric Surgery 25G 100% WHEY ISOLATE; NET WT. 43.4 oz. (2.7 lb) 1,230g - packaged in plastic bottles, UPC code: 655455018225, DIETARY SUPPLEMENT MANUFACTURED BY NRS -Nutrition Resource Services, Inc. DISTRIBUT
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0140-2016·2015-10-28

    ConForMIS iUNI Knee Replacement Recalled for Ethylene Glycol Residue

    ConForMIS is recalling 6 units of the iUNI Unicondylar Knee Replacement System due to potential ethylene glycol residue.

    Product
    ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0131-2016·2015-10-28

    Encore Medical Recalls AltiVate Humeral Socket Shell Trial Due to Assembly Issues

    Encore Medical is recalling 20 units of the AltiVate Humeral Socket Shell Trial because the shell trial has difficulty assembling to the broach and the retaining ring disassembles from the screw.

    Product
    AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid baseplate is intended for cementless application with addition of screws for fixation. The humeral stem is intended for cemented or cementless use. This device may also be indicated in the salvage of previ
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0137-2016·2015-10-28

    Biomet Thinflap System Cases Recalled Due to Lid Opening Difficulty

    Biomet Microfixation is recalling 5 Thinflap System Cases because the lids require excessive force to open.

    Product
    Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0149-2016·2015-10-28

    Natus neoBLUE 3 Phototherapy System Recalled for Intensity Documentation

    Natus Medical is recalling 4,560 neoBLUE 3 Phototherapy systems because the instruction manuals did not accurately reflect the cleared intensity settings.

    Product
    Natus neoBLUE 3 Phototherapy system or Neonatal Phototherapy, Catalogue Part Number: 010066; Top Assembly Part Number: 001103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0134-2016·2015-10-28

    Synthes Recalls Spinal Pedicle Fixation Rods Due to Finishing Process Error

    Synthes (USA) Products LLC is recalling 492 spinal pedicle fixation rods because they were produced using a bead blast process not identified in the manufacturing specification.

    Product
    5.0mm Unit Rod 270mm, 5.0mm Unit Rod 290mm, 5.0mm Unit Rod 310mm, 5.0mm Unit Rod 330mm, 5.0mm Unit Rod 350mm, 5.0mm Unit Rod 370mm, 5.0mm Unit Rod 390mm, 5.0mm Unit Rod 410mm, 5.0mm Unit Rod 430mm, 5.0mm Unit Rod 450mm; Orthosis, Spinal, Pedicle fixation Intended to prov
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0054-2016·2015-10-28

    Hospira Recalls Amidate Etomidate Injection Due to Degradation Impurities

    Hospira Inc. is recalling 24,100 syringes of Amidate (Etomidate Injection) because stability testing confirmed out-of-specification degradation products.

    Product
    Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0028-2016·2015-10-28

    Wismettac Asian Food Recalls Seasoned Beanthread Salad for Regulatory Filing Issues

    Wismettac Asian Food is recalling Seasoned Beanthread Salad (Chuka Zensai) due to a lack of required acidified food filing and registration.

    Product
    Seasoned Beanthread Salad (CHUKA ZENSAI), net wt. 2.2 lbs (1kg), Item No. 82021. Chinese style appetizer labeled as SEASONED BEANTHREAD SALAD (CHUKA ZENSAI) packed in 1 kg clear plastic bags and placed in cardboard cartons containing twelve (12) bags per carton. The bags of
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0136-2016·2015-10-28

    Biomet Neuro Combo Set Case Lid Requiring Excessive Force Recalled

    Biomet Microfixation is recalling 37 Neuro Combo Set Cases because the lids require excessive force to open.

    Product
    Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0053-2016·2015-10-28

    Donnatal Prescription Drug Recalled for Incorrect Ingredient Labeling

    Rx PAK is recalling Donnatal tablets because the label incorrectly lists Scopolamine Hydrocodone instead of Scopolamine Hydrobromide.

    Product
    DONNATAL — DONNATAL (PHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, SCOPOLAMINE HYDROBROMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V712000·2015-10-27

    Ford Recalls 2009-2010 Edge and Lincoln MKX for Fuel Tank Leak

    Ford is recalling 2009-2010 Edge and Lincoln MKX vehicles in 22 states and D.C. because salt water corrosion may cause the fuel tank to leak, increasing fire risk.

    Product
    FORD — FORD, LINCOLN EDGE, MKX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V711000·2015-10-27

    Mercedes-Benz Recalls Vehicles Due to Air Bag Control Unit Corrosion

    Mercedes-Benz is recalling 2008-2010 C300, C350, C63, and GLK350 vehicles because the air bag control unit may corrode and malfunction, potentially causing air bags to deploy unexpectedly or fail to deploy.

    Product
    MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ C63, GLK350, C300, C350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V709000·2015-10-27

    Mercedes-Benz Recalls 2016 GLE450 and GLE63 Due to Drive Shaft Bolt Issue

    Mercedes-Benz is recalling 2016 GLE450 and GLE63 coupes because rear drive shaft bolts may loosen, causing the shaft to separate and the vehicle to stall.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE450, AMG GLE63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16018·2015-10-27

    LaRose Recalls Peanuts Flying Ace Ride-On Toys for Choking Hazard

    LaRose Industries is recalling Peanuts Flying Ace ride-on toys because blue hubcaps can detach, posing a choking hazard to young children.

    Product
    Peanuts Flying Ace Ride-On Toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V710000·2015-10-27

    Ford Recalls 2016 E-350 and E-450 Vans for Trailer Brake Defect

    Ford is recalling 2016 E-350 and E-450 vans because the trailer brake controller may fail to actuate trailer brakes, increasing stopping distance and crash risk.

    Product
    FORD — FORD E-450, E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·132-2015·2015-10-26

    Adolf's Meat Products Recalls Assorted Deli Meat Due to Listeria Risk

    Adolf's Meat Products is recalling approximately 224 pounds of assorted deli meats produced in October 2015 due to possible Listeria monocytogenes contamination.

    Product
    Adolf's Meat Products — Adolf's Meat Products Recalls Assorted Deli Meat Due to Possible Listeria Adulteration
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V701000·2015-10-26

    GM Recalls 1997-2004 Vehicles Due to Exhaust Fire Risk

    General Motors is recalling specific 1997-2004 Chevrolet, Buick, Pontiac, and Oldsmobile vehicles because engine oil may drip onto the hot exhaust manifold, posing a fire risk.

    Product
    CHEVROLET — CHEVROLET, BUICK, PONTIAC IMPALA, LUMINA, REGAL, MONTE CARLO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V703000·2015-10-26

    Terex Advance Concrete Mixers Recalled for Steering Pump Failure

    Terex Advance is recalling 288 model year 2011-2015 concrete mixers because steering gear pumps may fail, reducing steering ability and increasing crash risk.

    Product
    TEREX ADVANCE — TEREX ADVANCE MIXER FD4000B, MIXER FD7000B, MIXER FD5000B, MIXER FD6000B
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V705000·2015-10-26

    Volkswagen Recalls 2015-2016 Models for Brake Assist Loss Risk

    Volkswagen is recalling 2015-2016 Jetta, Beetle, Passat, and Golf vehicles because a camshaft lobe may shear off, causing a loss of brake assist.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA, BEETLE, PASSAT, GOLF
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V706000·2015-10-26

    Pierce Recalls 2015-2016 Models Due to Loose Front Drive Axle Hex Nuts

    Pierce is recalling 2015-2016 Arrow XT, Velocity, Enforcer, and Saber vehicles because front drive axle hex nuts may be loose, risking loss of propulsion.

    Product
    PIERCE — PIERCE ENFORCER, ARROW XT, VELOCITY, SABER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V704000·2015-10-26

    Isuzu Recalls 2006-2008 Trucks for Fuel Tank Corrosion and Leak Risk

    Isuzu is recalling 2006-2008 Chevrolet, GMC, and Isuzu trucks because the fuel tank may corrode and leak, increasing fire risk.

    Product
    CHEVROLET — CHEVROLET, GMC, ISUZU W3500, W4500, NPR, NPR HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·131-2015·2015-10-24

    Whole Foods Recalls Curry Chicken Salad Due To Possible Listeria

    Whole Foods Market is recalling approximately 234 pounds of curry chicken salad products in five states due to possible Listeria monocytogenes contamination.

    Product
    Whole Foods Market Recalls Curry Chicken Salad Product Due To Possible Listeria Adulteration
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·15V692000·2015-10-23

    Starcraft RV Recalls 2016 Autumn Ridge Trailers Due to Fire Risk

    Starcraft RV is recalling 36 model year 2016 Autumn Ridge trailers because unprotected propane lines and wires may be damaged by road debris, increasing the risk of fire.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT AUTUMN RIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V700000·2015-10-23

    Honda Recalls GL1800 Motorcycles for Rear Brake Dragging Hazard

    Honda is recalling specific GL1800, GL1800A, and GL1800B motorcycles because the rear brakes may drag after release, increasing the risk of a crash or fire.

    Product
    HONDA — HONDA GL1800B, GL1800, GL1800A
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V698000·2015-10-23

    Thor Motor Coach Recalls Four Winds Motorhomes Due to Fire Risk

    Thor Motor Coach is recalling specific Four Winds motorhomes because a transfer switch may overheat and cause a fire.

    Product
    FOUR WINDS — FOUR WINDS SERRANO, HURRICANE, WINDSPORT, MANDALAY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V699000·2015-10-23

    Thor Motor Coach Recalls 2016 Motorhomes for Parking Brake Defect

    Thor Motor Coach is recalling 2016 Challenger, Hurricane, and Windsport motorhomes because the parking brake may fail to hold the vehicle or disengage properly.

    Product
    THOR MOTOR — THOR MOTOR, THOR MOTOR COACH HURRICANE, WINDSPORT, CHALLENGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V697000·2015-10-23

    Honda Recalls 2015-2016 Fit Vehicles Due to Airbag Puncture Risk

    Honda is recalling 25,367 2015-2016 Fit LX vehicles because defective rear grab handle brackets may puncture side curtain airbags, increasing injury risk in a crash.

    Product
    HONDA — HONDA FIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V696000·2015-10-23

    Blue Bird Recalls One 2017 Vision Bus for Wiper Motor Defect

    Blue Bird is recalling one 2017 Vision transit bus because an incorrectly installed wiper motor connector may cause the wipers to stop working without warning.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V691000·2015-10-23

    Blue Bird Recalls 2016-2017 Vision School Buses for Wiper Defect

    Blue Bird is recalling 63 Vision school buses because an incorrectly installed wiper motor connector may cause the wipers to stop working, reducing visibility in bad weather.

    Product
    BLUE BIRD — BLUE BIRD VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V694000·2015-10-23

    AEV Type II Ambulance Seat Belt Cable Recall

    Halcore is recalling 2008-2014 AEV Type II ambulances because the rearward-facing attendant seat belt cable may break, increasing injury risk in a crash.

    Product
    AEV — AEV TYPE II AMBULANCE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V695000·2015-10-23

    2015 Rolls-Royce Ghost Recalled for Side Air Bag Performance Defect

    BMW is recalling one 2015 Rolls-Royce Ghost because its side air bags may fail to meet federal safety standards, increasing injury risk in a crash.

    Product
    ROLLS-ROYCE — ROLLS-ROYCE GHOST
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·130-2015·2015-10-22

    Rustico Foods Recalls Packaged Soup Products Produced Without Federal Inspection

    Rustico Foods is recalling approximately 2,659 pounds of packaged soup products produced without the benefit of federal inspection. The products were shipped to retail establishments in southern California.

    Product
    Rustico Foods Recalls Packaged Soup Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·129-2015·2015-10-22

    Shuler Meats Recalls Turkey Legs Packaged Without Inspection

    Shuler Meats is recalling approximately 25,920 pounds of fully cooked smoked turkey legs that were reconditioned without the benefit of FSIS inspection.

    Product
    Shuler Meats, Inc. — Shuler Meats Recalls Turkey Products Packaged Without the Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·16017·2015-10-22

    United States Stove Company Recalls Pellet Stoves Due to Fire Hazard

    United States Stove Company is recalling about 4,400 HomComfort 2400 pellet stoves because the internal fire box baffle can degrade and overheat, posing a fire hazard.

    Product
    Pellet Heater/Stove
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V690000·2015-10-22

    Mack Trucks Recalls 2014 Granite Trucks for Drive Axle Nut Issue

    Mack Trucks is recalling 2014 Granite trucks because improperly tightened hex nuts on the drive axle may cause the driveshaft to disconnect, increasing crash risk.

    Product
    MACK — MACK GRANITE (GU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V689000·2015-10-22

    Toyota Recalls Vehicles Due to Power Window Switch Fire Risk

    Toyota is recalling specific 2006-2011 models because inconsistent lubricant on the power window switch may cause overheating and fire.

    Product
    TOYOTA — TOYOTA, PONTIAC, SCION COROLLA MATRIX, COROLLA, TUNDRA, SEQUOIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15E086000·2015-10-22

    ECCO Recalls Portable LED Worklamps Due to Overheating Risk

    ECCO is recalling specific portable and magnetically mountable LED worklamps because the lithium-ion batteries may overheat, increasing the risk of injury or fire.

    Product
    EQUIPMENT recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15E087000·2015-10-22

    Atwood On Demand Water Heaters Recalled for Overheating Risk

    Atwood is recalling specific On Demand water heaters installed in RVs because a valve defect may cause water to overheat, posing a scalding risk.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER:LPG SYSTEMS:WATER HEATER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16704·2015-10-22

    L.L. Bean Recalls Hunting Knives with Sheath Due to Laceration Hazard

    L.L. Bean is recalling GTO Hunting Knives with Sheaths because the knife can cut through the sheath, posing a laceration hazard. No injuries have been reported.

    Product
    Hunting Knives with Sheath
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0042-2016·2015-10-21

    Bedford Pharmacy Recalls P-P (COBAL) Injection Due to Sterility Concerns

    Bedford Pharmacy is recalling four vials of P-P (COBAL) 30-2 /mL Injection because of a lack of assurance of sterility. The product was distributed in New Hampshire and Massachusetts.

    Product
    P-P (COBAL) 30-2 /mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0051-2016·2015-10-21

    Bedford Pharmacy Recalls P-P (COBAL) Injection Due to Sterility Concerns

    Bedford Pharmacy is recalling P-P (COBAL) 30-0.5/mL injections because there is a lack of assurance of sterility. The product was distributed in New Hampshire and Massachusetts.

    Product
    P-P (COBAL)30-0.5/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·15V686000·2015-10-21

    Maserati Recalls 2014 Quattroporte GTS for Electrical Fire Risk

    Maserati is recalling 984 model year 2014 Quattroporte GTS vehicles because an improperly secured battery cable may short to ground, potentially causing a fire or vehicle stall.

    Product
    MASERATI — MASERATI QUATTROPORTE GTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0010-2016·2015-10-21

    Nephron Recalls Ipratropium Bromide and Albuterol Sulfate Inhalation Solution

    Nephron Pharmaceuticals is recalling Ipratropium Bromide and Albuterol Sulfate inhalation solution due to a lack of assurance of sterility.

    Product
    IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE — IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE (IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0049-2016·2015-10-21

    Bedford Pharmacy Recalls P-P-P Injection Due to Sterility Concerns

    Bedford Pharmacy is recalling P-P-P (COBAL) 30-4-40/mL Injection vials because there is a lack of assurance of sterility. The product was distributed in New Hampshire and Massachusetts.

    Product
    P-P-P (COBAL) 30-4-40/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0052-2016·2015-10-21

    Bedford Pharmacy Recalls P-P (COBAL) Injection Due to Sterility Concerns

    Bedford Pharmacy is recalling P-P (COBAL) 300-30/mL injections because there is a lack of assurance of sterility. The affected product was distributed in New Hampshire and Massachusetts.

    Product
    P-P (COBAL) 300-30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·15V688000·2015-10-21

    Bentley Recalls Continental Models Due to Loose Battery Cable Fire Risk

    Bentley is recalling certain 2012-2015 Continental GT, GTC, and Flying Spur vehicles because a loose battery cable connection may overheat and cause a fire.

    Product
    BENTLEY — BENTLEY CONTINENTAL GT, CONTINENTAL GT CABRIO, CONTINENTAL FLYING SPUR, FLYING SPUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V687000·2015-10-21

    Spartan Gladiator Recall for Power Steering Fluid Overheating

    Spartan Motors is recalling 2009-2014 Gladiator and MetroStar vehicles because power steering fluid may overheat, causing the steering to lock unexpectedly.

    Product
    SPARTAN — SPARTAN GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0125-2016·2015-10-21

    Synthes Recalls Titanium Elastic Nail Inserters Due to Mechanical Failure Risk

    Synthes (USA) Products LLC is recalling 1,550 Inserter for Titanium Elastic Nails (TEN) devices due to a potential for mechanical failures such as breakage.

    Product
    Inserter for Titanium Elastic Nails (TEN), orthopedic device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0025-2016·2015-10-21

    Caravelle ABC Cookies Recalled for Lead and Labeling Errors

    Anhing Corporation is recalling Caravelle ABC Cookies due to lead levels and undeclared wheat flour.

    Product
    Caravelle ABC Cookies Banh Chu NET WT: 7oz (200gr) Product of Vietnam
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Drugs)·D-0041-2016·2015-10-21

    Bedford Pharmacy Recalls P-P-P Injection Due to Sterility Concerns

    Bedford Pharmacy is recalling 4 vials of P-P-P (COBAL) 30-1-20/mL Injection due to a lack of assurance of sterility. The product was distributed in New Hampshire and Massachusetts.

    Product
    P-P-P (COBAL) 30-1-20/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0047-2016·2015-10-21

    Bedford Pharmacy Recalls Testosterone Cypionate Injection Due to Sterility Concerns

    Bedford Pharmacy is recalling Testosterone Cypionate (Complete Formula) 200 mg/mL injections due to a lack of assurance of sterility. The product was distributed in New Hampshire and Massachusetts.

    Product
    Testosterone Cypionate (Complete Formula) 200 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0040-2016·2015-10-21

    Bedford Pharmacy Recalls Methylcobalamin Injection Due to Sterility Concerns

    Bedford Pharmacy is recalling Methylcobalamin 1 mg/mL Injection because there is a lack of assurance of sterility. The product was distributed in New Hampshire and Massachusetts.

    Product
    Methylcobalamin (preservative Free) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0046-2016·2015-10-21

    Bedford Pharmacy Recalls Testosterone Cypionate Injections Due to Sterility Concerns

    Bedford Pharmacy is recalling Testosterone Cypionate injections due to a lack of assurance of sterility. The affected products were distributed in New Hampshire and Massachusetts.

    Product
    Testosterone Cypionate (Complete Formula) 100 mg/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0044-2016·2015-10-21

    Bedford Pharmacy Recalls Hydroxocobalamin Injection Due to Sterility Concerns

    Bedford Pharmacy is recalling Hydroxocobalamin 20 mg/mL Injection due to a lack of assurance of sterility. The product was distributed in New Hampshire and Massachusetts.

    Product
    Hydroxocobalamin 20 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0009-2016·2015-10-21

    Apotex Recalls Bromfenac Ophthalmic Solution Due to Sterility Concerns

    Apotex Inc. is recalling specific lots of Bromfenac Ophthalmic Solution 0.09% because preservative testing failed, raising concerns about sterility.

    Product
    Bromfenac Ophthalmic Solution 0.09%, packaged in a) 1.7 mL bottle (NDC 60505-0595-05), b) 2.5 mL bottle (NDC 60505-0596-04), Rx Only, Mfg for: Apotex Corp., Weston, FL 33326.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0043-2016·2015-10-21

    Bedford Pharmacy Recalls Methylcobalamin Injection Due to Sterility Concerns

    Bedford Pharmacy is recalling Methylcobalamin (Bacteriostatic) 1 mg/mL Injection due to a lack of assurance of sterility. The product was distributed in New Hampshire and Massachusetts.

    Product
    Methylcobalamin (Bacteriostatic) 1 mg/mL Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0048-2016·2015-10-21

    Bedford Pharmacy Recalls P-P-P Injection Due to Sterility Concerns

    Bedford Pharmacy is recalling P-P-P (COBAL) 30-1-5/mL Injection vials because the agency could not ensure the product was sterile. The recall affects vials distributed in New Hampshire and Massachusetts.

    Product
    P-P-P (COBAL) 30-1-5/mL, Injection,Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
    Category
    Drug
    Distribution
    2 states
  • SevereNHTSA·15V684000·2015-10-21

    Micro Bird Recalls 2015 T-Series School Buses for Fire Risk

    Micro Bird is recalling 2015 T-Series school buses because an undersized electrical wire in the mirror system may overheat and cause a fire.

    Product
    MICRO BIRD — MICRO BIRD T-SERIES SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0115-2016·2015-10-21

    ViewRay MRIdian Radiation Therapy System Recalled for Unexpected Couch Movement

    ViewRay is recalling four MRIdian Radiation Therapy Systems because the patient couch may move unexpectedly if an encoder fails and the system is restarted.

    Product
    MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0123-2016·2015-10-21

    Clinical Innovations Recalls Ebb Complete Tamponade System Due to Balloon Leak Risk

    Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System due to a potential balloon leak that may prevent the device from delivering therapy when needed.

    Product
    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0008-2016·2015-10-21

    Old Time Candy Recalls French Burnt Peanuts Due to Allergen Mislabeling

    Old Time Candy is recalling 72 containers of French Burnt Peanuts because the packaging fails to list peanuts, sugar, artificial colors, and salt as ingredients.

    Product
    French Burnt Peanuts, NET WEIGHT 8 OZ (227g) Old Time Candy.com Distributed by Old Time Candy Company LaGrange, OH 44050 www.oldtimecandy.com Ingredients: Dextrose, Citric Acid, Calcium Stearate, Artificial Flavors, Artificial Colors***. May Contain Milk And Soy.
    Category
    Food
    Distribution
    29 states
  • HighCPSC·16015·2015-10-21

    Innopower Recalls Hawk Climbing Sticks Due to Fall Hazard

    Innopower is recalling specific Hawk climbing sticks because the folding steps can bend or break, posing a fall hazard. Consumers should stop using the products and contact the company for a free replacement.

    Product
    Climbing Sticks
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0050-2016·2015-10-21

    Bedford Pharmacy Recalls P-P-P Injection Due to Sterility Concerns

    Bedford Pharmacy is recalling P-P-P (COBAL) 30-2-30/mL injections because of a lack of assurance of sterility. The product was distributed in New Hampshire and Massachusetts.

    Product
    P-P-P (COBAL) 30-2- 30/mL, Injection, Bedford Pharmacy, 209 Route 101, Bedford, NH 03110, (603) 472-3919
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Devices)·Z-0121-2016·2015-10-21

    DJO Monode Shortwave Accessory Recalled for Overheating and Burning Insulation

    DJO, LLC is recalling Monode Shortwave Accessories due to overheating and burning of the wire insulation inside the applicator.

    Product
    Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0119-2016·2015-10-21

    Zimmer Natural Nail CM Long Intramedullary Fixation Rods Recalled for Packaging Defects

    Zimmer GmbH is recalling 57,603 units of Natural Nail CM Long intramedullary fixation rods because compromised outer trays may lead to periprosthetic infection.

    Product
    Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0013-2016·2015-10-21

    Sedalmex Pain Reliever Tablets Recalled for Potential Cephalosporin Contamination

    Midway Importing, Inc. is recalling Sedalmex pain reliever tablets due to potential cross-contamination with cephalosporin. Consumers should stop using the product and return it to the point of purchase.

    Product
    Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20-count tablets in blisters per box, Manufactured in Mexico by: Merck, S.A. de C.V./, Imported & Distributed by Midway Importing, Inc., 1807 Brittmoore Rd, Houston, TX 77043, UPC: 1 88436 00017 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0007-2016·2015-10-21

    Tastee Plain Caramel Apple Recall Due to Undeclared Peanut Allergen

    Tastee Apple Inc. is recalling Plain Caramel Apples because the product contains peanuts that are not listed on the label.

    Product
    TASTEE Plain Caramel Apple, www.tasteeapple.com NET WT. 3 OZ 85g 0 35266 00027 3 "THIS PRODUCT CONTAINS THE FOLLOWING ALLERGENS: MILK AND SOYBEAN***" TASTEE APPLE INC. NEWCOMERSTOWN, OH 43832
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Drugs)·D-0033-2016·2015-10-21

    Ohm Laboratories Recalls Loratadine Tablets for Out-of-Specification Assay

    Ohm Laboratories is recalling Premier Value Loratadine Orally Disintegrating Tablets because an assay test result was out of specification.

    Product
    Premier Value Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box; Distributed by Chain Drug Consortium, 3301 NW Boca Raton Blvd. Suite 101, Boca Raton, FL 33431, NDC 68016-527-31, UPC 8 4098601899 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0014-2016·2015-10-21

    Actavis Recalls Metformin Hydrochloride Extended-Release Tablets for Dissolution Failure

    Actavis is recalling 13,284 bottles of Metformin Hydrochloride Extended-Release Tablets, 1000 mg, because they failed dissolution specifications at the 8-hour timepoint.

    Product
    Metformin Hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA; NDC 0591-2720-60; UPC 3 05912 72060 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0015-2016·2015-10-21

    Ferring Recalls Bravelle 75 IU Vials Due to Subpotent Drug

    Ferring Pharmaceuticals is recalling 32,341 vials of Bravelle 75 IU because the drug was found to be subpotent. The recall is voluntary and nationwide.

    Product
    Bravelle 75 IU (urofollitropin for injection, purified) For Subcutaneous or Intramuscular Injection Only, 1 Carton (contains 5 single dose vials of Bravelle, 5 single dose vials of 0.9% Sodium Chloride Inj., USP, 2 mL, and 5 Q-Cap Vial Adaptors) , Rx Only, Manufactured for: Ferri
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0039-2016·2015-10-21

    Meijer Loratadine Tablets Recalled for Out-of-Specification Assay

    Ohm Laboratories is recalling Meijer Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result.

    Product
    Meijer Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Dist. By Meijer Distribution Inc. 2929 Walker Avenue NW, Grand Rapids, MI 49544. NDC 41250-527-31, UPC 7 6023662291 8
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0009-2016·2015-10-21

    Win Luck Recalls Glutinous Rice for Undeclared Alcohol Content

    Win Luck Trading Inc is recalling Grove Grow Notes Glutinous Rice because it contains undeclared alcohol. The product was distributed in New Jersey.

    Product
    Glutinous Rice, Net WT. 1000 g, packaged in plastic bottles, UPC 6958020881168, Made in China
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0023-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Strawberry, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Apple Strawberry, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Food)·F-0021-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Pumpkin Cinnamon, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Apple Pumpkin Cinnamon, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Food)·F-0016-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Banana, due to the potential presence of mold. The recall affects 34,573 cases distributed in the US and Canada.

    Product
    GoGo SQueeZ Applesauce, Apple Banana, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Food)·F-0014-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Peach Sweet Potato, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Apple Peach Sweet Potato, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Food)·F-0018-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Grape, due to the potential presence of mold.

    Product
    GoGo SQueeZ Applesauce, Apple Grape, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Drugs)·D-0030-2016·2015-10-21

    Ohm Recalls Loratadine Tablets Due to Out-of-Specification Assay Results

    Ohm Laboratories is recalling specific batches of Leader Loratadine Orally Disintegrating Tablets because they failed potency testing. Consumers should stop using the affected products.

    Product
    Leader Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-count tablets per box, Distributed by Cardinal Health, Dublin, OH 43017, NDC 37205-745-65, UPC 0 9629512322 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0018-2016·2015-10-21

    Mentholatum Recalls WellPatch Capsaicin Patches Due to Labeling Error

    The Mentholatum Company is recalling WellPatch Capsaicin Pain Relief Patches because the word 'not' was missing from safety instructions, potentially leading to improper use.

    Product
    WellPatch¿ Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External Analgesic, 4 Large Patches, Distributed by Consignor; The Mentholatum Company, Orchard Park, NY, Manufactured by Consignee; Mentholatum (China) Pharmaceuticals, Guangdong China --- NDC 10742-8126-2, UPC 31
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0014-2016·2015-10-21

    Toshiba Aquilion CT System Recall for Data Loss Risk

    Toshiba is recalling 459 Aquilion CT Systems because specific multi-phase scanning operations may prevent raw data from being saved.

    Product
    Toshiba Aquilion CT System TSX-301A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0017-2016·2015-10-21

    Materne Recalls GoGo SQueeZ Applesauce Due to Potential Mold Presence

    Materne North America is voluntarily recalling GoGo SQueeZ Applesauce, Apple Pear, due to the potential presence of mold. The recall affects 34,573 cases distributed in the US and Canada.

    Product
    GoGo SQueeZ Applesauce, Apple Pear, individually wrapped in foil pouch in cardboard carton; sizes include 4-pack, 12-pack, 16 pack, 18-pack, 20-pack, or 48-pack
    Category
    Food
    Distribution
    30 states
  • ModerateFDA (Drugs)·D-0029-2016·2015-10-21

    Ohm Recalls HEB Loratadine Tablets Due to Out-of-Specification Assay

    Ohm Laboratories is recalling HEB Loratadine Orally Disintegrating Tablets because an out-of-specification assay result indicated the drug was superpotent.

    Product
    HEB Loratadine Orally Disintegrating Tablets, USP, 10 mg, 10-count tablets per box, Made with pride & care for HEB, San Antonio, TX 78204, Item code: 188330, UPC 0 4122081968 3
    Category
    Drug
    Distribution
    Distributed nationwide

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