The Recall Desk

Archive

June 2015 recalls

481 recalls were announced in June 2015.

What the numbers show

Critical
29
Severe
127
High
231
Moderate
74
Low
20

Of the 481 recalls this month scored against our rubric, 6% are Critical, 26% are Severe.

401–481 of 481

  • SevereCPSC·15156·2015-06-03

    Apple Recalls Beats Pill XL Speakers Due to Fire Hazard

    Apple is recalling Beats Pill XL speakers because the battery can overheat, posing a fire hazard. Consumers should stop using the product and contact Apple for a credit.

    Product
    Beats Pill XL speaker
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2336-2015·2015-06-03

    Regency Group Recalls Pizza Seasoning for Undeclared Wheat Allergen

    Regency Group is recalling specific lots of pizza seasoning because the product contains gluten (wheat) but the label does not declare it.

    Product
    Pizza Seasoning, stock code 03388, packaged in 20 lbs. or 50 lbs. container. The UPC is 0 23605 03388 4.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-2330-2015·2015-06-03

    EZ's Burger Deluxe Recalled for Undeclared Wheat Allergen

    Regency Group, Inc. is recalling EZ's Burger Deluxe Burger Blend due to undeclared wheat (gluten) contamination.

    Product
    EZ's Burger Deluxe -Burger Blend w/o MSG, stock code 12314, packaged in 50 lbs. container. No UPC.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1673-2015·2015-06-03

    DePuy LCS Knee Prosthesis Recalled for Higher Revision Rates

    DePuy Orthopaedics is recalling LCS COMPLETE RPS knee inserts because they show higher revision rates in Australia when the patella is not resurfaced.

    Product
    LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1655-2015·2015-06-03

    Philips Brilliance CT 6 Air Systems Recalled for Unexpected Couch Descent

    Philips is recalling 153 Brilliance CT 6 Air systems because the patient couch unexpectedly descended during exams. The units were distributed in China.

    Product
    Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1665-2015·2015-06-03

    United Surgical Associates Recalls Elastic Knee Supports for Missing Latex Label

    United Surgical Associates is recalling 1,260 Elastic Knee Supports because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.

    Product
    Elastic Knee Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1690-2015·2015-06-03

    Maquet Cardiovascular Recalls HLS/HIT Set Advanced Due to Blood Leakage Risk

    Maquet Cardiovascular is recalling HLS/HIT Set Advanced consoles because a potential issue could cause blood to leak from the gas outlet port.

    Product
    HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for peri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1651-2015·2015-06-03

    Philips Brilliance CT 16 Power Recalled for Unexpected Couch Descent

    Philips is recalling 153 Brilliance CT 16 Power systems because the patient couch may unexpectedly descend during an exam.

    Product
    Brilliance CT 16 Power. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·15V342000·2015-06-03

    Volvo Recalls 2016 XC90 Vehicles for Side Air Bag Wiring Defect

    Volvo is recalling 2016 XC90 vehicles because incorrect side air bag wiring may disable the safety feature, increasing injury risk in a crash.

    Product
    VOLVO — VOLVO XC90
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1656-2015·2015-06-03

    Philips Brilliance iCT CT Systems Recalled for Unexpected Couch Descent

    Philips Medical Systems is recalling 153 Brilliance iCT computed tomography systems because the patient couch may unexpectedly descend during an exam.

    Product
    Brilliance iCT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1688-2015·2015-06-03

    Terumo Advanced Perfusion System 1 Base Recalled for Power Loss

    Terumo is recalling 1,713 Advanced Perfusion System 1 bases worldwide to address power loss issues. The recall involves design changes and switch protectors.

    Product
    Base for Terumo Advanced Perfusion System 1, 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualif
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1652-2015·2015-06-03

    Philips Brilliance CT 16 Water Computed Tomography Systems Recalled for Couch Descent

    Philips Medical Systems is recalling 153 Brilliance CT 16 Water systems because the patient couch may unexpectedly descend during an exam.

    Product
    Brilliance CT 16 Water. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1609-2015·2015-06-03

    CareFusion AVEA Ventilator Recalled for Pressure Transducer Failure

    CareFusion is recalling AVEA ventilators because a pressure transducer failure can stop ventilation. Nonbreathing patients may require manual ventilation or a different device.

    Product
    CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1649-2015·2015-06-03

    Philips Brilliance CT 64 Systems Recalled for Unexpected Couch Descent

    Philips is recalling 153 Brilliance CT 64 systems because the patient couch may unexpectedly descend during an exam.

    Product
    Brilliance CT 64. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1657-2015·2015-06-03

    Philips Ingenuity CT Recall for Unexpected Patient Couch Descent

    Philips is recalling 153 Ingenuity CT systems in China because the patient couch unexpectedly descended to its lowest point during an exam.

    Product
    Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1691-2015·2015-06-03

    Biosense Webster Recalls SMARTABLATE RF Generator Systems Due to Unintended Energy Delivery

    Biosense Webster is recalling 115 SMARTABLATE RF Generator Systems because two complaints reported the device inadvertently delivered RF energy during procedures.

    Product
    SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1681-2015·2015-06-03

    Medtronic Recalls SynchroMed II Implantable Pumps Due to Alarm Failure

    Medtronic is recalling specific SynchroMed II implantable drug pumps because the audible alarm may stop working, potentially preventing patients from detecting issues.

    Product
    Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1654-2015·2015-06-03

    Philips Brilliance CT 10 Air Recalled for Unexpected Couch Descent

    Philips Medical Systems is recalling 153 Brilliance CT 10 Air systems in China because the patient couch may unexpectedly descend during an exam.

    Product
    Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1648-2015·2015-06-03

    Philips Brilliance CT Big Bore Oncology Recalled for Unexpected Couch Descent

    Philips Medical Systems is recalling 153 Brilliance CT Big Bore Oncology systems because the patient couch may unexpectedly descend during an exam.

    Product
    Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1677-2015·2015-06-03

    Alere i Influenza A & B kits recalled for false negative risk

    Alere Scarborough, Inc. is recalling specific lots of Alere i Influenza A & B kits due to a high invalid rate and increased risk of false negative results.

    Product
    Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Alere i Instrument, is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of inf
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2015·2015-06-03

    Philips MX8000 CT Scanner Recall Due to Unexpected Couch Descent

    Philips is recalling 153 MX8000 CT scanners because the patient couch may descend unexpectedly during an exam.

    Product
    MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1680-2015·2015-06-03

    GE Healthcare Recalls D-Fend Water Traps Due to Occlusion Risk

    GE Healthcare is recalling D-Fend and D-Fend+ water traps because they may occlude, causing a loss of respiratory gas monitoring.

    Product
    D-fend, (p/n 876446-HEL), and D-fend+ (p/n 881319-HEL) water trap. Used with Compact Airway Modules E/M-C(Ai)O(V)(X) and Cardiocap/5 monitors. Product Usage: Water traps are intended to protect the GE monitor from humidity, secretions and bacterial contamination when monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1678-2015·2015-06-03

    Halyard KimVent Closed Suction System Recalled for Potential Valve Defect

    Halyard Health is recalling specific KimVent Turbo-Cleaning Closed Suction Systems for adults because a defective internal valve may allow air to leak from the ventilator circuit.

    Product
    KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2015·2015-06-03

    Stryker EliteCore Biopsy Device Recalled for Cannula Overthrow Risk

    Stryker is recalling EliteCore Full Core Biopsy Devices because the cannula may extend past its intended length.

    Product
    EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1675-2015·2015-06-03

    Mindray Recalls Panorama Patient Monitoring Network Due to Software Anomaly

    Mindray is recalling four Panorama Patient Monitoring Network units due to a software anomaly that prevents arrhythmia alarms from displaying on the Panorama system after a restart.

    Product
    Panorama Patient Monitoring Network, Multi- Parameter Patient Monitor (with Arrhythmia Detection and Alarm. Part number 0998-00-0708-01. The Panorama Network includes the Panorama Telemetry System, which acquires and monitors physiological data for ambulating patients withi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2015·2015-06-03

    Codman 3000 Series Refill Set Recalled for Leaking Needles

    Codman & Shurtleff, Inc. is recalling 5,463 units of the CODMAN 3000 Series Refill Set because the needles may leak from the hub connection.

    Product
    CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump CATALOG NO. : AP-07014 Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calib
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1686-2015·2015-06-03

    Medrad Stellant CT Injector System Recalled for Under-Volume Hazard

    Medrad Inc dba Bayer R&I is recalling 133 Stellant CT Injector Systems with Certegra Workstations due to a configuration error that may cause under-infusion of contrast media.

    Product
    MEDRAD¿ Stellant CT Injector System with Certegra Workstation; intended for the specific purpose of injecting intravenous contrast media into humans for diagnostic studies in computed tomography (CT) applications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2327-2015·2015-06-03

    Santa Barbara Smokehouse Recalls Smoked Salmon Due to Listeria Risk

    The Santa Barbara Smokehouse is recalling specific lots of smoked salmon due to potential Listeria monocytogenes contamination.

    Product
    Coastal Harbor Beechwood Smoked Salmon Pastrami Sliced Side Coastal Harbor by the Santa Barbara Smokehouse Keep Refrigerated at 38 or Below The product is ROP and is either kept refrigerated or frozen.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1687-2015·2015-06-03

    Terumo Advanced Perfusion System 1 Recalled for Power Loss Risk

    Terumo is recalling 1,713 Advanced Perfusion System 1 units worldwide due to a risk of losing system power during critical medical procedures.

    Product
    100/120V AC, Advanced Perfusion System Platform (APS) The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualif
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2015·2015-06-03

    OptiMedica Catalys Precision Laser System Software Recall for Incorrect Parameters

    OptiMedica is recalling Catalys Precision Laser Systems with software version 3.00.05 because a software anomaly may provide incorrect cataract surgery parameters.

    Product
    Catalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; software version 3.00.05 The OptiMedica Catalys Precision Laser System is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1674-2015·2015-06-03

    DePuy Spine Recalls EXPEDIUM Offset Conical Lock Nut Devices

    DePuy Spine, Inc. is recalling 183 EXPEDIUM Offset Conical Lock Nut 8mm devices because they do not mate as intended.

    Product
    EXPEDIUM Spine System/Synapse System; MODEL: EXPEDIUM Offset Conical Lock Nut 8mm, CATALOG NO. : 1754-91-150, UDI NUMBER (if applicable): GTIN: 10705034032467
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-2334-2015·2015-06-03

    James Gang BBQ Bull Breath Chili Seasoning Recalled for Undeclared Wheat

    Regency Group, Inc. is recalling 200 lbs of James Gang BBQ Bull Breath Chili Seasoning because it contains gluten (wheat) but the label does not declare it.

    Product
    James Gang BBQ Bull Breath Chili Seasoning, stock code 11523, packaged in 50 lbs. container. No UPC.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-2331-2015·2015-06-03

    Fajita Seasoning Recalled for Undeclared Wheat Allergen

    Regency Group, Inc. is recalling Fajita Seasoning because it is contaminated with gluten (wheat) and the label does not declare wheat.

    Product
    Fajita Seasoning, stock code 03232, packaged in 1 lb., 1.5 lbs., 5 lbs., 7 lbs., 10 lbs., 20 lbs., or 50 lbs. container. The 1 lb. container has the UPC 0 23605 03232 0.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1689-2015·2015-06-03

    Maquet Quadrox-iD Adult Diffusion Membrane Oxygenator Recalled for Blood Leakage Risk

    Maquet Cardiovascular is recalling Quadrox-iD Adult Diffusion Membrane Oxygenators due to a potential issue that could result in blood leakage from the gas outlet port.

    Product
    Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2335-2015·2015-06-03

    Metro Market Lemon Pepper Rub Recalled for Undeclared Wheat Allergen

    The Regency Group, Inc. is recalling Metro Market Lemon Pepper Rub due to contamination with gluten (wheat) that is not declared on the label.

    Product
    Metro Market Lemon Pepper Rub, stock code 11525, packaged in 25 lbs. container. No UPC.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-2329-2015·2015-06-03

    Regency Group Recalls Ground Oregano Due to Gluten Contamination

    The Regency Group is recalling 552.50 lbs of Mediterranean ground oregano because it is contaminated with gluten, a wheat allergen.

    Product
    Oregano, Mediterranean ground, stock code 03355, packaged in 0.2 lb., .75 lb., 0.8 lb., 1 lb., 4 lbs., 10 lbs., 15 lbs., 25 lbs., or 50 lbs. container. The UPC for 50 lbs. container is 0 23605 03355 6.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1672-2015·2015-06-03

    DePuy LCS COMPLETE RPS Femoral Implants Recalled for Patello-femoral Pain Risk

    DePuy Orthopaedics is recalling 19,059 LCS COMPLETE RPS Femoral Implants because they are associated with higher revision rates and potential patello-femoral pain when the native patella is not resurfaced.

    Product
    LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2333-2015·2015-06-03

    Fresca Tomato Spice with Beet Recalled for Undeclared Wheat Allergen

    Regency Group is recalling Fresca Tomato Spice with Beet due to gluten contamination and failure to declare wheat on the label.

    Product
    Fresca Tomato Spice with Beet, stock code 12487, packaged in 26 lbs. container. No UPC.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1679-2015·2015-06-03

    RaySearch RayStation Software Recalled for Dose Calculation Errors

    RaySearch Laboratories AB is recalling RayStation software versions 2.5 through 4.0 due to dose calculation issues in specific VMAT plans.

    Product
    RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distri
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2332-2015·2015-06-03

    Regency Group Recalls French Fry Seasoning for Undeclared Wheat Allergen

    Regency Group is recalling 200 lbs of French Fry Seasoning because it contains gluten (wheat) but the label does not declare wheat.

    Product
    French Fry Seasoning, stock code 03223, packaged in 50 lbs. container. The UPC is 0 23605 03223 8
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-2337-2015·2015-06-03

    Regency Group Recalls Taco Seasoning No Salt Due to Gluten Contamination

    Regency Group, Inc. is recalling Taco Seasoning No Salt because it is contaminated with gluten (wheat) and the label does not declare wheat.

    Product
    Taco Seasoning No Salt, stock code 03455, packaged in 1 lb., 2 lbs., 3 lbs., or 5 lbs., container. The UPC is 0 23605 03455 3
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1653-2015·2015-06-03

    Philips Brilliance CT 16 Air Recalled for Unexpected Couch Descent

    Philips is recalling 153 Brilliance CT 16 Air systems because the patient couch may unexpectedly descend to its lowest point during an exam.

    Product
    Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2338-2015·2015-06-03

    Taco Seasoning Suprema Recalled for Undeclared Wheat Allergen

    Regency Group is recalling Taco Seasoning Suprema because it contains gluten (wheat) but the label does not declare wheat.

    Product
    Taco Seasoning Suprema, stock code 03456, packaged in 1 lb., 5 lbs., 25 lbs., or 50 lbs container. The UPC is 0 23605 03456 0
    Category
    Food
    Distribution
    8 states
  • HighFDA (Food)·F-2339-2015·2015-06-03

    Turtle Island Roast Beef Spice Blend Recalled for Undeclared Wheat Allergen

    Regency Group, Inc. is recalling Turtle Island Roast Beef Spice Blend because it is contaminated with gluten and the label does not declare wheat.

    Product
    Turtle Island Roast Beef Spice Blend, stock code 12690, packaged in 25 lbs.container. No UPC
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-1644-2015·2015-06-03

    Siemens SOMATOM Emotion 6 CT Scanner Software Recall

    Siemens Medical Solutions is recalling 75 SOMATOM Emotion 6 CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.

    Product
    SOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1663-2015·2015-06-03

    Siemens Liquid Waste Bottle Kit Recalled for Defective Bottle Openings

    Siemens is recalling Liquid Waste Bottle Kits for Immulite 2000 systems because some bottle openings are undersized or deformed, preventing caps from closing securely.

    Product
    Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1659-2015·2015-06-03

    Siemens Recalls Liquid Waste Bottles for Immulite 2000 Systems

    Siemens Medical Solutions Diagnostics is recalling 231 Liquid Waste Bottles for Immulite 2000 systems due to a quality issue where the opening may be undersized or deformed, preventing the cap from closing securely.

    Product
    Liquid Waste Bottle, Catalog#10291587. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1085-2015·2015-06-03

    Boehringer Ingelheim Roxane Recalls Subpotent Acarbose Tablets

    Boehringer Ingelheim Roxane Inc is recalling Acarbose 50 mg tablets because potency was below specification at a 9-month stability time point.

    Product
    ACARBOSE — ACARBOSE (ACARBOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1660-2015·2015-06-03

    Siemens Immulite 2000 Accessory Kit Recall for Undersized Bottle Openings

    Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Accessory Kits because bottle openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1669-2015·2015-06-03

    Siemens Luminos Agile Max Imaging System Software Recall

    Siemens is recalling 133 Luminos Agile Max imaging systems due to a software defect that causes image loss and connection issues.

    Product
    SIEMENS Luminos Agile Max; a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. Luminos Agile is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1682-2015·2015-06-03

    Philips Ingenuity TF PET/MRI Recalled for Incorrect Chemical Shift Imaging Data

    Philips Medical Systems is recalling 10 Ingenuity TF PET/MRI systems because the spectroscopy voxel map did not align with anatomical images, resulting in incorrect orientation of Chemical Shift Imaging data.

    Product
    Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI), 882380, Philips Medical Systems. The device is a diagnostic imaging system for fixed installations that combines Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI).
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1645-2015·2015-06-03

    Siemens SOMATOM Emotion 16 CT Scanner Software Recall

    Siemens is recalling 75 SOMATOM Emotion 16 CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.

    Product
    SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1646-2015·2015-06-03

    Siemens SOMATOM Perspective CT Scanner Software Recall

    Siemens is recalling 75 SOMATOM Perspective CT scanners due to software bugs that may cause system crashes, image freezes, or database locks, potentially requiring patients to be rescanned.

    Product
    SOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1668-2015·2015-06-03

    Siemens Axiom Luminos dRF Max Recall for Software Data Loss

    Siemens is recalling 133 Axiom Luminos dRF Max imaging systems due to a software defect that can cause acquired images to be deleted, requiring studies to be repeated.

    Product
    SIEMENS Axiom Luminos dRF Max, a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1658-2015·2015-06-03

    Siemens Immulite 2000 Water Bottle Recall for Quality Defects

    Siemens Medical Solutions Diagnostics is recalling 186 Immulite 2000 water bottles because the openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2322-2015·2015-06-03

    Gromex Ground Shrimp Recalled for Undeclared Dyes

    Gromex Inc. is recalling 100 lbs of Ground Shrimp found to contain undeclared and unallowed dyes.

    Product
    Gromex Camaron Molido (Ground Shrimp), Net Wt. 2 oz., packaged in a clear bag, Mexican Products, Importers & Distributors, UPC 690912620108
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1670-2015·2015-06-03

    Siemens Uroskop Omnia Max X-Ray System Software Data Loss Recall

    Siemens is recalling 133 Uroskop Omnia Max X-ray systems due to software defects that cause image deletion and connection issues.

    Product
    SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1666-2015·2015-06-03

    United Surgical Associates Recalls Keo Wrist Braces for Missing Latex Label

    United Surgical Associates is recalling 756 Keo elastic wrist braces because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.

    Product
    Keo Brace, elastic wrist brace for carpal tunnel. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1664-2015·2015-06-03

    United Surgical Associates Recalls Elastic Ankle Supports for Missing Latex Label

    United Surgical Associates is recalling 1,278 Elastic Ankle Supports because they lack a caution label regarding latex content, posing a risk of allergic skin reactions.

    Product
    Elastic Ankle Support. A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1110-2015·2015-06-03

    Blenheim Pharmacal Recalls Clarithromycin Tablets Due to cGMP Deviations

    Blenheim Pharmacal is recalling 50 bottles of Clarithromycin Tablets 500 mg in Indiana due to cGMP deviations and inadequate complaint investigation.

    Product
    Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-522-20, MFG: 64679-904-02
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1667-2015·2015-06-03

    Siemens Ysio Max Radiographic System Recalled for Software Data Loss

    Siemens is recalling 133 Ysio Max radiographic systems because a software defect can delete acquired images and studies, requiring patients to repeat exposures.

    Product
    SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1662-2015·2015-06-03

    Siemens Immulite 2000 Water Feed Kit Recall for Defective Bottle Assemblies

    Siemens Medical Solutions Diagnostics is recalling Immulite 2000 Water Feed Kits because bottle openings may be undersized or deformed, preventing caps from closing securely.

    Product
    Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use serum, plasma, or urine samples for in vitro diagnostic testing.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1109-2015·2015-06-03

    Blenheim Pharmacal Recalls Captopril Tablets Due to cGMP Deviations

    Blenheim Pharmacal is recalling 166 bottles of Captopril 50 mg tablets distributed in Indiana due to cGMP deviations and inadequate complaint investigations.

    Product
    Captopril Tablets, USP, 50 mg, 30 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Packaged By: Blenheim Pharmacal Inc. North Blenheim, NY 12131, NDC 10544-175-30, MFG: 64679-904-02
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-1676-2015·2015-06-03

    Biocare Medical Recalls D2-40 Lymphatic Marker Due to Incorrect Instructions

    Biocare Medical is recalling 19 units of D2-40 Lymphatic Marker because incorrect Instructions for Use were shipped with the product.

    Product
    D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1087-2015·2015-06-03

    Teva Recalls QVAR Inhalers Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling QVAR inhalers because stability testing revealed out-of-specification impurity results.

    Product
    QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-2323-2015·2015-06-03

    Ubervita Recalls W700 Lose Weight Supplement Due to Packaging Error

    Ubervita LLC is recalling less than 30 units of W700 Lose Weight Fast W700 Thermogenic Hyper-Metabolizer dietary supplements sold at Walmart due to a packaging error.

    Product
    UBERVITA LOSE WEIGHT FAST W700 THERMOGENIC HYPER-METABOLIZER DIETARY SUPPLEMENT. The product has an outer box which contains a labeled bottle. This is a bright red box with gold and chrome foil. Bottle inside is black and red in color. UPC 7 00115 35277 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1685-2015·2015-06-03

    Volk Optical Recalls 25D BIO Lenses Due to Incorrect Lot Number

    Volk Optical Inc. is recalling six 25D Large Clear BIO Lenses because the incorrect lot number was engraved on the anodized aluminum ring.

    Product
    Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope.
    Category
    Medical Device
    Distribution
    2 states
  • SevereNHTSA·15V339000·2015-06-02

    Ford Recalls 2015 Mustangs for Fuel Leak and Fire Risk

    Ford is recalling 2015 Mustangs with 2.3L engines because heat can degrade fuel lines, causing leaks and fire risks.

    Product
    FORD — FORD MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V337000·2015-06-02

    Mitsubishi Recalls Eclipse Vehicles Due to ABS Valve Seizure Risk

    Mitsubishi is recalling 2006-2009 Eclipse and 2007-2009 Eclipse Spyder vehicles because corrosion in the ABS unit may cause valves to seize, reducing braking ability.

    Product
    MITSUBISHI — MITSUBISHI ECLIPSE SPYDER, ECLIPSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V336000·2015-06-02

    Airstream Interstate Motorhomes Recalled for Screen Door Exit Hazard

    Airstream is recalling 2015-2016 Interstate NCV3 B motorhomes because the screen door may prevent occupants from opening the sliding door to exit in an emergency.

    Product
    AIRSTREAM — AIRSTREAM INTERSTATE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V338000·2015-06-02

    Mitsubishi, Chrysler, and Dodge Recall Vehicles for Sun Visor Airbag Hazard

    Mitsubishi, Chrysler, and Dodge are recalling specific 2000-2005 vehicles because the passenger sun visor may detach during airbag deployment, increasing injury risk.

    Product
    CHRYSLER — CHRYSLER, DODGE, MITSUBISHI SEBRING, STRATUS, ECLIPSE, ECLIPSE SPYDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15154·2015-06-02

    ORTOVOX S1+ Avalanche Transceiver Recalled for Signal Failure Risk

    CPSC recalls about 3,000 ORTOVOX S1+ avalanche transceivers because they may fail to transmit a signal during emergencies. Consumers should stop using them and return them for repair.

    Product
    ORTOVOX S1+ Avalanche Transceiver
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V340000·2015-06-02

    Ford Recalls 2011-2013 Vehicles for Electric Power Steering Defect

    Ford is recalling specific 2011-2013 Ford, Lincoln, and Mercury vehicles because the electric power steering assist system may shut down, increasing crash risk.

    Product
    LINCOLN — LINCOLN, FORD, MERCURY MKZ, FUSION, MILAN, TAURUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V330000·2015-06-01

    Oshkosh Recalls S-Series Concrete Mixers Due to Engine Fire Risk

    Oshkosh is recalling 2012-2014 S-Series Front Discharge Concrete Mixers because excessive engine pressure may cause oil to leak onto hot surfaces, increasing fire risk.

    Product
    OSHKOSH — OSHKOSH S-SERIES
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V331000·2015-06-01

    Van Hool Recalls Coaches Due to Front Steering Knuckle Breakage Risk

    Van Hool is recalling specific 2014-2015 coaches because the front steering knuckle carrier may break, potentially causing the wheel to separate and increasing crash risk.

    Product
    VAN HOOL — VAN HOOL TX40, TX45, C2045, CX45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V335000·2015-06-01

    Porsche Recalls 2015 918 Spyder Vehicles Due to Fire Risk

    Porsche is recalling 223 model year 2015 918 Spyder vehicles because a wiring harness may chafe and cause an electrical short, increasing the risk of a fire.

    Product
    PORSCHE — PORSCHE 918 SPYDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V333000·2015-06-01

    New Flyer Transit Bus Recall for Door Software Defect

    New Flyer is recalling specific transit buses because a software defect may cause rear doors to open while the bus is moving.

    Product
    NEW FLYER — NEW FLYER XDE35, XN40, XN60, C40LFR
    Category
    Vehicle
    Distribution
    Distributed nationwide

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