The Recall Desk

Archive

January 2016 recalls

400 recalls were announced in January 2016.

What the numbers show

Critical
14
Severe
111
High
159
Moderate
107
Low
9

Of the 400 recalls this month scored against our rubric, 4% are Critical, 28% are Severe.

1–100 of 400

  • SevereUSDA FSIS·012-2016·2016-01-30

    Noble Spoon Recalls Uninspected Chicken and Beef Entrees

    The Noble Spoon is recalling approximately 289 pounds of beef and chicken entrees produced without federal inspection. The products were sold in Marin and Sonoma counties, California.

    Product
    The Noble Spoon Recalls Chicken and Beef Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·16V051000·2016-01-29

    C&B Quality Trailer Works Recalls Horse Trailers Due to Axle Weld Failure

    C&B Quality Trailer Works is recalling 2015-2016 horse trailers because a weld on the rear axle may fail, causing the wheel assembly to separate and increasing crash risk.

    Product
    C&B QUALITY TRAILER WORKS — C&B QUALITY TRAILER WORKS HORSE TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V047000·2016-01-29

    Chrysler Recalls 2008-2009 Minivans and Journey for Air Bag Defect

    Chrysler is recalling 110,482 vehicles because corroded air bag control units may fail to deploy or deploy unexpectedly, increasing crash risk.

    Product
    DODGE — DODGE, CHRYSLER GRAND CARAVAN, TOWN AND COUNTRY, JOURNEY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V044000·2016-01-28

    Chrysler and Dodge Minivans Recalled for Windshield Mounting Defect

    Chrysler is recalling 2014-2016 Town and Country and Grand Caravan minivans because expired primer may allow the windshield to dislodge in a crash.

    Product
    CHRYSLER — CHRYSLER, DODGE TOWN AND COUNTRY, GRAND CARAVAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V045000·2016-01-28

    Volkswagen Recalls 2015 Tiguan and Audi Q5 for Air Bag Defect

    Volkswagen is recalling 2015 Tiguan and Audi Q5 vehicles because seat-mounted air bag inflators may rupture in a crash, potentially causing serious injury or death.

    Product
    AUDI — AUDI, VOLKSWAGEN Q5, TIGUAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16084·2016-01-28

    Tristar Recalls AquaRug Shower Rugs Due to Fall Hazard

    Tristar Products is recalling AquaRug shower rugs because the suction cups can fail, causing slips and falls. Consumers should stop using the rugs and contact the company for a free replacement.

    Product
    AquaRug shower rugs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·16725·2016-01-28

    RNG Recalls 100-Watt Bendable Solar Panels Due to Fire Hazard

    RNG Group Inc. is recalling Renogy 100-watt bendable solar panels because they can overheat and cause fires. Consumers should stop using the panels and return them for free replacements.

    Product
    100-watt bendable solar panels
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V046000·2016-01-28

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

    Ford is recalling 2016 E-350 and E-450 vans with 6.8L engines and trailer brake controllers because the braking system may fail, increasing stopping distance.

    Product
    FORD — FORD E-450, E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V043000·2016-01-28

    Dodge Charger Recall: Tire Jack Failure Risk Without Wheel Chocks

    Chrysler is recalling 2011-2016 Dodge Chargers because the body-side sill may fail if the vehicle is lifted with the supplied tire jack without chocking the wheels, increasing injury risk.

    Product
    DODGE — DODGE CHARGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V057000·2016-01-28

    Hyundai Recalls 2011 Tucson Vehicles for Transmission Fluid Leak Risk

    Hyundai is recalling 11,176 model year 2011 Tucson vehicles because a defective transmission fluid cooler hose may leak, potentially causing the vehicle to stop moving and increasing crash risk.

    Product
    HYUNDAI — HYUNDAI TUCSON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16086·2016-01-28

    Varaluz Recalls Longfellow Light Fixtures Due to Fire and Shock Hazards

    Varaluz is recalling about 80 Longfellow lighting fixtures because improper wiring can cause melting, shorting, fire, and shock. Consumers should stop using the fixtures and contact the company for a replacement or refund.

    Product
    Longfellow lighting fixtures for indoor and outdoor use
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·16087·2016-01-28

    i play Recalls Glass Food Storage Cubes Due to Injury Hazard

    i play is recalling green sprouts glass food storage cubes because the glass can break unexpectedly, posing a risk of injury.

    Product
    green sprouts® glass food cubes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-0660-2016·2016-01-27

    St. Jude Medical Recalls Optisure Dual Coil Defibrillation Leads

    St. Jude Medical is recalling Optisure Dual Coil Defibrillation Leads due to potential insulation cuts in the SVC shock coil.

    Product
    Optisure Dual Coil Defibrillation Leads, Model No. LDA220, LDA220Q, LDA230Q, LDP220Q. St. Jude Medical. Designed for long term attachment to an Implantable Cardioverter Defibrillator (ICD).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0570-2016·2016-01-27

    Amerita Recalls Baclofen and Clonidine Syringes Due to Sterility Concerns

    Amerita Specialty Infusion Services is recalling specific lots of compounded intrathecal syringes because the company cannot ensure they are sterile.

    Product
    IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0581-2016·2016-01-27

    Pine Pharmaceuticals Recalls Bevacizumab Syringes Due to Silicone Oil Particulates

    Pine Pharmaceuticals is recalling Bevacizumab syringes for intravitreal use because they contain silicone oil microdroplets.

    Product
    Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·009-2016 expansion·2016-01-27

    Home Maid Ravioli Recalled for Undeclared Allergens and Lack of Inspection

    Home Maid Ravioli Company is recalling approximately 38,950 pounds of meat and poultry ravioli and pasta products due to undeclared allergens and lack of federal inspection.

    Product
    Home Maid Ravioli Company, Inc. Recalls Meat and Poultry Ravioli and Pasta Products Produced Without Benefit of Inspection and Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0663-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Blankets Due to Overheating Risk

    MWT Materials, Inc. is recalling 49 Accusorb MRI blankets because they may overheat and lead to patient injury when not used correctly.

    Product
    Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0665-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Radio Frequency Shielding Products

    MWT Materials, Inc. is recalling Accusorb MRI radio frequency shielding blankets and body-part covers because they may overheat and lead to patient injury when not used correctly.

    Product
    Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0575-2016·2016-01-27

    FDA Recalls Energique Homeopathic Skin Spray Due to Microbial Contamination

    Grato Holdings, Inc. is recalling 118 bottles of Energique homeopathic skin spray due to out-of-specification microbial counts.

    Product
    Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0584-2016·2016-01-27

    Pine Pharmaceuticals Recalls Bevacizumab Syringes Due to Silicone Oil Particulates

    Pine Pharmaceuticals is recalling specific lots of bevacizumab syringes for intravitreal injection because they contain silicone oil microdroplets.

    Product
    Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E007000·2016-01-27

    Continental Air Bag Control Units Recalled for Corrosion Risk

    Continental is recalling Air Bag Control Units manufactured between 2006 and 2010 because a power supply component may corrode, potentially preventing air bags from deploying in a crash.

    Product
    AIR BAGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0677-2016·2016-01-27

    GE Aespire Anesthesia Systems Recalled for Potential Barotrauma Risk

    GE Medical Systems is recalling Aespire 7900 and Aespire View anesthesia systems because a stuck valve could cause excessive pressure and barotrauma.

    Product
    GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000. The family of GE Datex-Ohmeda Aespire anesthesia systems with 7900 ventilator (Aespire 7900 and Aespire View) is intended to provide general inhalation anesthesia and ventilatory support to a wide range
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0580-2016·2016-01-27

    FDA Recalls Energique Homeopathic Pain Spray for Microbial Contamination

    Grato Holdings is recalling Energique First Aid Pain & Trauma Relief homeopathic spray due to out-of-specification microbial counts.

    Product
    Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, First Aid Pain & Trauma Relief, Topical Homeopathic Spray, NDC 50845-0216-1, Dist By Liddell
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0672-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Shielding Blankets Due to Overheating Risk

    MWT Materials, Inc. is recalling Accusorb MRI MAC7010 radio frequency shielding blankets and body-part covers because they may overheat when not used correctly, posing a risk of patient injury.

    Product
    Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0585-2016·2016-01-27

    Mylan Bromfenac Ophthalmic Solution Recalled for Sterility Assurance Failure

    Mylan Pharmaceuticals is recalling specific lots of Bromfenac Ophthalmic Solution 0.09% because the preservative failed an effectiveness test, raising concerns about sterility.

    Product
    Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0569-2016·2016-01-27

    Amerita Recalls Baclofen Syringes Due to Sterility Assurance Concerns

    Amerita Specialty Infusion Services is recalling specific lots of compounded Baclofen syringes because the FDA identified a lack of assurance of sterility.

    Product
    Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0680-2016·2016-01-27

    GE Aisys Anesthesia System Recalled for Potential Barotrauma Risk

    GE Medical Systems is recalling 13 Aisys Anesthesia Systems because a stuck valve could cause excessive pressure in the patient breathing circuit, potentially resulting in barotrauma.

    Product
    GE Healthcare, Aisys, 1011-9000-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventila
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0671-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Leg Wrap Blankets Due to Overheating Risk

    MWT Materials, Inc. is recalling 47 units of Accusorb MRI Leg Wrap Blankets because they may overheat when not used correctly, posing a risk of patient injury.

    Product
    Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0577-2016·2016-01-27

    Energique Joint Pain Spray Recalled for Microbial Contamination

    Grato Holdings is recalling Energique Joint Pain & Stiffness Relief Topical Spray due to microbial contamination. Testing revealed out-of-specification results for total aerobic microbiological count.

    Product
    Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Joint Pain & Stiffness Relief, Topical Homeopathic Spray, NDC 50845-0218-1, Di
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0582-2016·2016-01-27

    Pine Pharmaceuticals Recalls Bevacizumab Syringes Due to Silicone Oil Microdroplets

    Pine Pharmaceuticals is recalling specific lots of bevacizumab syringes for intravitreal use due to the presence of silicone oil microdroplets.

    Product
    Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0668-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Radio Frequency Shielding Blankets

    MWT Materials, Inc. is recalling 14 Accusorb MRI radio frequency shielding blankets and body-part covers because they may overheat and lead to patient injury when not used correctly.

    Product
    Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0666-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Breast Shields Due to Overheating Risk

    MWT Materials, Inc. is recalling six Accusorb MRI Breast Shields because they may overheat when not used correctly, posing a risk of patient injury.

    Product
    Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0679-2016·2016-01-27

    GE Healthcare Aestiva MRI Ventilator Recalled for Valve Defect

    GE Medical Systems is recalling 84 Aestiva MRI anesthesia systems because a drive gas check valve may become stuck open, potentially causing excessive pressure in the patient breathing circuit.

    Product
    GE Healthcare, Aestiva MRI, 1006-9310-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during sur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0583-2016·2016-01-27

    Pine Pharmaceuticals Recalls Bevacizumab Syringes Due to Silicone Oil Microdroplets

    Pine Pharmaceuticals is recalling specific lots of Bevacizumab syringes for intravitreal use because they contain silicone oil microdroplets.

    Product
    Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0514-2016·2016-01-27

    Yoli Inc. Recalls Roasted Pumpkin Seeds Due to Undeclared Wheat

    Yoli Inc. is recalling roasted pumpkin seeds with salt because the product contains undeclared wheat, a major food allergen.

    Product
    Roasted pumpkin seeds with salt in a clear plastic bag with a yellow and red label attatched.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0513-2016·2016-01-27

    Eaton Farm Peanut Butter Bar Recalled for Soy Allergen Mislabeling

    Eaton Farm Confectionaries is recalling Peanut Butter Lust Bars because the packaging lists 'Lecithin' without specifying it contains soy, a major allergen.

    Product
    Peanut Butter Lust Bar, Net weight 2 ounces, UPC: 1425361001
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0676-2016·2016-01-27

    Rymed InVision-Plus IV Connector Recall Due to Cracking Risk

    Rymed Technologies is recalling 46,600 InVision-Plus CS Needleless IV Connectors because the female luer component may crack during use.

    Product
    InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. Disposable, Single Use. Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2016·2016-01-27

    Cyberonics VNS Therapy AspireSR Generator Recall for Sensing Delays

    Cyberonics is recalling 29 Model 106 VNS Therapy AspireSR Generators due to delays in heartbeat sensing and potential decreased battery longevity.

    Product
    Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0684-2016·2016-01-27

    Abeon Medical Recalls TLC Self Retaining Retractor System Due to Sterility Compromise

    Abeon Medical Corporation is recalling 2,570 units of the TLC Self Retaining Retractor System because some sealed pouches contain tears that compromise the product's sterility.

    Product
    TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY. Indicated for use in the retraction of soft tissue away from the operative surface.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0681-2016·2016-01-27

    GE Healthcare Anesthesia Systems Recalled for Potential Barotrauma Risk

    GE Medical Systems is recalling certain Aisys and Avance anesthesia systems because a stuck valve could cause excessive pressure in the patient breathing circuit, potentially leading to barotrauma.

    Product
    GE Healthcare, Aisys CS2,1011-9050-000; Avance Amingo,1009-9002-000, & Avance CS2, 1009-9050-000. The GE Datex-Ohmeda Aisys Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0670-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Large Torso Wrap Due to Overheating Risk

    MWT Materials, Inc. is recalling five units of Accusorb MRI Large Torso Wraps because they may overheat when not used correctly, posing a risk of patient injury.

    Product
    Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0675-2016·2016-01-27

    Rymed InVision-Plus IV Connectors Recalled for Cracking Risk

    Rymed Technologies is recalling InVision-Plus IV connectors because the female luer component may crack during use.

    Product
    InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0659-2016·2016-01-27

    Cyberonics Recalls VNS Therapy AspireSR Generators Due to Stimulation Failure

    Cyberonics is recalling 4,935 VNS Therapy AspireSR Generators worldwide after three reports of device resets that disabled stimulation output.

    Product
    VNS Therapy AspireSR Generator Model 106. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0573-2016·2016-01-27

    Freedom Pharmaceuticals Recalls Baclofen Powder Due to Foreign Substance

    Freedom Pharmaceuticals is recalling specific lots of Baclofen USP powder because of the presence of a foreign substance.

    Product
    Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d) 523
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·16724·2016-01-27

    Lunera Recalls Helen GX23 LED Lamps Due to Fire and Shock Hazards

    Lunera is recalling approximately 60,000 Helen GX23 LED lamps because they can overheat, posing fire, burn, and electric shock hazards. No injuries have been reported.

    Product
    Helen GX23 LED lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V041000·2016-01-27

    Newmar Recalls 2016 Dutch Star and Ventana for Incorrect Tire Label

    Newmar is recalling 283 model year 2016 Dutch Star and Ventana vehicles because an incorrect tire inflation label could lead to overinflation and tire failure.

    Product
    NEWMAR — NEWMAR DUTCH STAR, VENTANA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0664-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Arm Sleeves Due to Overheating Risk

    MWT Materials, Inc. is recalling 31 Accusorb MRI arm sleeves distributed in New York and Massachusetts because they may overheat and injure patients when not used correctly.

    Product
    Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2016·2016-01-27

    Abeon Wilson Penile Implantation System Retractor Frame Recalled for Sterility Compromise

    Abeon Medical Corporation is recalling Wilson Penile Implantation System Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.

    Product
    Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY Rx ONLY. Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0685-2016·2016-01-27

    Abeon Medical Recalls Self-Retaining Retractor Frames Due to Sterility Compromise

    Abeon Medical Corporation is recalling 1,035 units of TLC Self-Retaining Retractor Frames because some sealed pouches contain tears that compromise the product's sterility.

    Product
    TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indicated to aid in tissue retraction during a surgical procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0630-2016·2016-01-27

    Arkray SPOTCHEM II Glucose Reagent Test Strips Recalled for Inaccurate Results

    Arkray Factory USA, Inc. is recalling SPOTCHEM II Glucose Reagent Test Strips because a lowered reaction rate causes inaccurate high glucose readings.

    Product
    arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Devices)·Z-0667-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Radio Frequency Shielding Products

    MWT Materials, Inc. is recalling 15 Accusorb MRI radio frequency shielding blankets and body-part covers. The products may overheat when not used correctly, posing a risk of patient injury.

    Product
    Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0669-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Leg Wraps Due to Overheating Risk

    MWT Materials, Inc. is recalling 18 Accusorb MRI Leg Wraps because they may overheat when not used correctly, posing a risk of patient injury.

    Product
    Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·16083·2016-01-27

    LocknCharge iQ10 Charging Stations Recalled for Electrical Shock Hazard

    LocknCharge is recalling iQ10 charging stations due to a defective USB hub that can cause electrical shock. Consumers should stop using the units and contact the company for a free replacement.

    Product
    Charging stations
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2016·2016-01-27

    GE Medical Systems Recalls Anesthesia Device Service Kits Due to Valve Defect

    GE Medical Systems is recalling 240 anesthesia device service kits because a drive gas check valve could become stuck open, potentially causing excessive pressure in the patient breathing circuit.

    Product
    Anesthesia device service kits. ASSY-MSN, VENT ENGINE ASSY, 1503-8101-000 ASSY-MSN, VENT ENGINE ASSY 7900, 1009-8216-000 ASSY-MSN, VENT ENGINE ASSY AESPIRE 7900 1009-8423-000 ASSY-MSN, VENT ENGINE ASSY, AESTIVA 7900 MRI 1503-8102-000 ASSY-MSN, VLV ASSY DR GAS CHK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2016·2016-01-27

    MWT Materials Recalls Accusorb MRI Shielding Blankets Due to Overheating Risk

    MWT Materials, Inc. is recalling Accusorb MRI MAC7030 shielding blankets and covers because they may overheat and cause patient injury when not used correctly.

    Product
    Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2016·2016-01-27

    GE Healthcare Aestiva 7900 Ventilator Recall for Stuck Valve Risk

    GE Medical Systems is recalling two Aestiva 7900 ventilators because a stuck valve could cause excessive pressure and barotrauma.

    Product
    GE Healthcare, Aestiva 7900, 1006-9305-000. This version of the Datex-Ohmeda 7900 ventilator is used in Datex-Ohmeda Aestiva/5 anesthesia systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0683-2016·2016-01-27

    IBA Dosimetry Lift Table Recalled for Uncontrolled Movement Risk

    IBA Dosimetry GmbH is recalling Lift Table Type 4320 units because they may move up in an uncontrolled manner when connected to power.

    Product
    IBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0598-2016·2016-01-27

    Brainlab Cranial Navigation System Recalled for Potential Software Inaccuracy

    Brainlab AG is recalling its Cranial Navigation System software due to a potential error that may cause inaccurate instrument display during surgery.

    Product
    Brainlab Cranial Navigation System: An Image Guided Surgery System / Stereotactic. Radiology Departments. The BrainLAB Cranial IGS System is intended to be an intra-operative image guided localization system to enable minimally invasive surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0579-2016·2016-01-27

    Energique Headache Spray Recalled for Microbial Contamination

    Grato Holdings is recalling Energique Headache Pain & Sinus Pressure Relief Topical Spray due to microbial contamination.

    Product
    Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0662-2016·2016-01-27

    Innovasis Recalls Excella II Titanium Spine Rods Due to Labeling Error

    Innovasis is recalling two lots of Excella II titanium spine rods because they were packaged with each other's labels.

    Product
    Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod Cat. No.: SR 55110 5.5 x 110 mm LOT 1502 Packaged in heat-sealed plastic bag. Also provided in reusable steam sterilization tray as implant set. Intended for use in the non-cervical area of the spine
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0631-2016·2016-01-27

    Arkray SPOTCHEM II Reagent Test Strips Recalled for Glucose Error

    Arkray Factory USA is recalling specific lots of SPOTCHEM II test strips because they may display inaccurate glucose results for high values.

    Product
    arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine
    Category
    Medical Device
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-0571-2016·2016-01-27

    Morton Grove Recalls Lindane Lotion Due to Out-of-Specification Assay

    Morton Grove Pharmaceuticals is recalling specific lots of Lindane Lotion because stability samples failed assay testing. Consumers should stop using the product and return it to their pharmacy.

    Product
    Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0661-2016·2016-01-27

    Fukuda Denshi Patient Monitors Recalled for Battery Malfunction

    Fukuda Denshi is recalling 95 DynaScope patient monitors in the US due to a potential short-term battery error caused by a damaged Lithium-Ion capacitor.

    Product
    Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda Denshi DynaScope Model DS-8100N/8100M Patient Monitor is meant to acquire and monitor physiological signals from patients.
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-0656-2016·2016-01-27

    DePuy Mitek Recalls FMS neXtra 3.5mm Cutter Shaver Blades Due to Labeling Error

    DePuy Mitek is recalling FMS neXtra 3.5mm Full Radius Cutter Shaver Blades because the blade configuration does not match the label description.

    Product
    FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0576-2016·2016-01-27

    Energique Homeopathic Spray Recalled for Microbial Contamination

    Grato Holdings is recalling Energique homeopathic topical spray due to out-of-specification microbial counts. The product was distributed nationwide and to Canada and Guatemala.

    Product
    Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1, Dist. by Energique, Inc. Woodbine, IA 51579; ALSO LABELED AS --- Liddell Laboratories, Muscle/Tendon Pain & Stress Relief, Topical Homeopathic Spray, NDC 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0572-2016·2016-01-27

    Mutual Pharmaceutical Recalls Sulfamethoxazole and Trimethoprim Tablets Due to Foreign Substance

    Mutual Pharmaceutical Company is recalling specific lots of Sulfamethoxazole and Trimethoprim tablets due to the presence of a polyethylene piece.

    Product
    Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0658-2016·2016-01-27

    DePuy Mitek Recalls FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades

    DePuy Mitek is recalling 115 units of FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades because the blade configuration does not match the label description.

    Product
    FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0657-2016·2016-01-27

    DePuy Mitek Recalls FMS neXtra 3.5mm Aggressive Cutter Shaver Blades

    DePuy Mitek is recalling 45 units of FMS neXtra 3.5mm Aggressive Cutter Shaver Blades because the blade configuration does not match the label description.

    Product
    FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 Intended to provide controlled cutting, shaving, and abrading of tissue during orthopedic procedures.
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0578-2016·2016-01-27

    Grato Holdings Recalls Energique Shingles Pain Spray Due to Microbial Contamination

    Grato Holdings is recalling Energique Shingles Pain & Ulceration Relief Topical Spray due to out-of-specification microbial counts. The recall covers 371 bottles distributed nationwide and to Guatemala and Canada.

    Product
    Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Shingles Pain & Ulceration Relief Topical Homeopathic Spray, NDC 50845-021
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0674-2016·2016-01-27

    Valeant SPAG-2 Nebulizer Recalled for Incorrect Serial Labels and Manual Information

    Valeant is recalling 1,178 SPAG-2 nebulizer units because serial ID labels and operation manuals contain incorrect or outdated information.

    Product
    Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0574-2016·2016-01-27

    PD-Rx Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

    PD-Rx Pharmaceuticals is recalling 1,685 bottles of Phentermine Hydrochloride capsules because stability tests showed impurities exceeded specifications.

    Product
    PHENTERMINE HYDROCHLORIDE — PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0687-2016·2016-01-27

    Siemens e.cam Gamma Camera Recall for Missing Operator Manuals

    Siemens is recalling 10 refurbished e.cam Dual Signature Gamma Camera systems because complete operator instruction manuals were not sent to customers.

    Product
    The e.cam Dual Signature Gamma Camera system. Used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
    Category
    Medical Device
    Distribution
    8 states
  • SevereNHTSA·16V037000·2016-01-26

    Altec Recalls 2015 Effer Knuckle Boom Cranes Due to Pedestal Cracks

    Altec Industries is recalling 2015 Effer 440 and 470 Knuckle Boom Cranes because pedestal welds may crack, potentially causing the crane to fall and injure people.

    Product
    EFFER — EFFER 440 KNUCKLE BOOM CRANE, 470 KNUCKLE BOOM CRANE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V038000·2016-01-26

    New Flyer and NABI Buses Recalled for Seat Belt Anchor Defect

    New Flyer is recalling specific 2009-2015 New Flyer and NABI buses because missing welds on seat brackets could allow seat belts to separate during a crash.

    Product
    NEW FLYER — NEW FLYER, NABI MD30, XN60, XN35, XDE35
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V039000·2016-01-26

    ShowHauler Recalls 2007-2011 Motorhomes Due to Unstable Entry Steps

    ShowHauler is recalling 2007-2011 motorhomes, garage coaches, and toter coaches because electric entry steps may become unstable, increasing injury risk.

    Product
    SHOWHAULER — SHOWHAULER MOTORHOME, GARAGE COACH, TOTER COACH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalNHTSA·16V036000·2016-01-25

    Ford Recalls 2004-2006 Rangers for Air Bag Inflator Rupture Risk

    Ford is recalling 2004-2006 Ranger vehicles because the driver's air bag inflator may rupture during deployment, potentially causing serious injury or death.

    Product
    FORD — FORD RANGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E006000·2016-01-25

    Takata Recalls Driver-Side Air Bag Inflators in Multiple Vehicle Brands

    Takata is recalling driver-side air bag inflators in Audi, Ford, Mazda, Sprinter, and Volkswagen vehicles that may rupture during deployment.

    Product
    AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V035000·2016-01-25

    Volkswagen Recalls Touareg Hybrids for Battery Fire Risk

    Volkswagen is recalling 2011-2015 Touareg Hybrid vehicles because water in the battery tray may cause an electrical short and fire.

    Product
    VOLKSWAGEN — VOLKSWAGEN TOUAREG HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E005000·2016-01-25

    Takata Recalls Driver-Side Frontal Air Bag Inflators Due to Rupture Risk

    Takata is recalling specific driver-side frontal air bag inflators that may rupture during deployment, potentially causing serious injury or death to vehicle occupants.

    Product
    AIR BAGS:FRONTAL:DRIVER SIDE:INFLATOR MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·010-2016·2016-01-25

    Whole Foods Recalls Frozen Pepperoni Pizza Due to Undeclared Pork

    Whole Foods is recalling frozen pepperoni pizzas because they contain undeclared pork pepperoni. No adverse reactions have been reported.

    Product
    Whole Foods Recalls Frozen Pizza Products Due to Misbranding
    Category
    Food
    Distribution
    7 states
  • CriticalUSDA FSIS·009-2016·2016-01-23

    Home Maid Ravioli Recalled for Undeclared Allergens and Misbranding

    Home Maid Ravioli Company is recalling beef ravioli products containing undeclared whey and pork. The products were also produced without federal inspection.

    Product
    Home Maid Ravioli Company, Inc. Recalls Beef Ravioli Products Due to Misbranding and Undeclared Allergens and Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·16V029000·2016-01-22

    Nissan Recalls 2013-2015 Altima Vehicles for Hood Latch Defect

    Nissan is recalling 2013-2015 Altima vehicles because the secondary hood latch may fail to engage, allowing the hood to open while driving.

    Product
    NISSAN — NISSAN ALTIMA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V033000·2016-01-22

    Vintage Trailers Recall Triple Axle Models Due to Incorrect Weight Labeling

    Vintage Trailers is recalling 2009-2016 triple axle trailers because the Federal Certification Label incorrectly lists the gross axle weight rating, potentially leading to axle failure if overloaded.

    Product
    VINTAGE — VINTAGE BANDIT, AERO, OUTLAW, INTIMIDATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V031000·2016-01-22

    Collins Recalls 2015 School Buses Due to Peeling Stop Arm Decals

    Collins is recalling 867 model year 2015 school buses because reflective decals on the stop arms may peel off, reducing visibility to other drivers.

    Product
    COLLINS — COLLINS DE500, DE416, DE516, DE516WR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateUSDA FSIS·008-2016·2016-01-22

    Pinnacle Foods Recalls Chili Products Due To Undeclared MSG

    Pinnacle Foods is recalling approximately 549,539 pounds of Armour Chili No Beans because the products contain Monosodium Glutamate (MSG), which is not declared on the label.

    Product
    Pinnacle Foods, Inc. Recalls Chili Products Due To Misbranding
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V025000·2016-01-21

    Vanguard Recalls 2014-2015 Dry Freight Van Trailers Due to Brake Drag

    Vanguard is recalling 2014-2015 Dry Freight Van Trailers because improperly seated brake diaphragms may cause drag, potentially leading to wheel end fires.

    Product
    VANGUARD — VANGUARD DRY FREIGHT VAN TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V027000·2016-01-21

    Rosenbauer Recalls 2015 Commander Fire Trucks Due to Axle Nut Issue

    Rosenbauer is recalling 2015 Commander fire trucks because improperly tightened axle nuts could cause the driveshaft to disconnect, increasing crash risk.

    Product
    ROSENBAUER — ROSENBAUER COMMANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16E004000·2016-01-21

    Meritor Trailer Axle Recall for Brake Drag Fire Risk

    Meritor is recalling certain trailer axle assemblies equipped with specific air brake actuators that may experience brake drag, posing a risk of wheel end fire.

    Product
    SERVICE BRAKES, AIR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V026000·2016-01-21

    Winnebago Recalls 2015-2016 Motorhomes Due to Ignition Switch Defect

    Winnebago is recalling 2015-2016 Travato, Trend, and Itasca Viva! motorhomes because an ignition switch defect may cause the vehicle to stall or disable safety systems.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA TREND, TRAVATO, VIVA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V024000·2016-01-21

    Rosenbauer Commander Fire Trucks Recalled for Steering Control Loss Risk

    Rosenbauer is recalling 2014-2015 Commander fire trucks because loose ball joints in certain front suspension assemblies could separate, causing a loss of steering control.

    Product
    ROSENBAUER — ROSENBAUER COMMANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16723·2016-01-21

    Chillafish Recalls Children's Balance Bikes Due to Laceration Hazard

    Chillafish is recalling BMXie, Jack, and Josie balance bikes because overinflated tires can cause plastic rims to crack and send pieces flying, posing a laceration hazard.

    Product
    Children's bikes
    Category
    Consumer Product
    Distribution
    Distributed nationwide

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