The Recall Desk

Archive

February 2014 recalls

473 recalls were announced in February 2014.

What the numbers show

Critical
14
Severe
98
High
222
Moderate
120
Low
19

Of the 473 recalls this month scored against our rubric, 3% are Critical, 21% are Severe.

Which agencies issued them

301–400 of 473

  • LowFDA (Drugs)·D-1071-2014·2014-02-12

    Timolol Maleate Eye Drops Recalled Due to Exterior Residue

    PACK Pharmaceuticals is recalling Timolol Maleate Sterile Ophthalmic Solution due to white solid residue found on the exterior of the bottles.

    Product
    Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-10). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1072-2014·2014-02-12

    Timolol Maleate Eye Drops Recalled for Exterior Bottle Residue

    PACK Pharmaceuticals is recalling Timolol Maleate eye drops due to white solid residue found on the exterior of the bottles.

    Product
    Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50). The products are packaged in Low Density Polyethylene (LDPE) Blow Fill Seal containers equipped with a dropper tip. The filled bottles are individually packaged into fiberboard cartons.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1065-2014·2014-02-12

    Forest Pharmaceuticals Recalls Namenda XR Sample Packs for Dissolution Failures

    Forest Pharmaceuticals is recalling Namenda XR sample packs because they failed stability dissolution testing. The affected lots were distributed nationwide and in Puerto Rico.

    Product
    Namenda XR (memantine HCl), sample pack, 28 mg, extended release capsules, packaged in 5-count sample packs, Rx only, Forest Pharmaceuticals Inc., St. Louis, MO 63045 NDC 0456-3428-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V070000·2014-02-11

    Monroe Truck Equipment Recalls Sure Power Battery Equalizers and Converters

    Monroe Truck Equipment is recalling specific Chevrolet and Ford vehicles equipped with Sure Power battery equalizers or DC-DC converters due to a fire risk caused by a defective potting compound.

    Product
    CHEVROLET — CHEVROLET, FORD TAHOE, F-350, C7500NA, F-450 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V055000·2014-02-11

    Freedom Motors Recalls Wheelchair-Accessible Vans Due to Rear Axle Cracks

    Freedom Motors is recalling certain 2008-2010 Dodge, Chrysler, and 2009 Volkswagen wheelchair-accessible vans because the rear axle may crack and fail, increasing crash risk.

    Product
    DODGE — DODGE, VOLKSWAGEN, CHRYSLER GRAND CARAVAN, ROUTAN, TOWN AND COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·014-2014·2014-02-11

    Utah Firm Recalls Beef Jerky for Undeclared Soy Allergen

    Prime Snax Inc. is recalling approximately 90,000 pounds of beef jerky products because they contain soy lecithin, a known allergen not declared on the label.

    Product
    Prime Snax Inc. — Utah Firm Recalls Various Beef Jerky Products Due to Misbranding and Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V066000·2014-02-10

    Elkhart Transit Bus Recall for Alternator Harness Pinch Hazard

    Elkhart Coach is recalling 2010-2013 ECI and ECII transit buses because a pinched alternator harness could cause vehicle stalling or a fire.

    Product
    ELKHART — ELKHART ECI, ECII
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V046000·2014-02-10

    Mitsubishi Fuso Trucks Recalled for Transmission Debris Contamination

    Mitsubishi Fuso is recalling 2012-2014 trucks because debris in the transmission fluid may cause the vehicle to stall, increasing crash risk.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO FEC52, FEC92, FGB72, FEC72
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V049000·2014-02-10

    EZ Loader Recalls 2013-2014 Boat Trailers Due to Wheel Cracking

    EZ Loader is recalling 2013-2014 boat trailers because specific trailer wheels may crack and separate, potentially causing a crash.

    Product
    EZ LOADER — EZ LOADER BOAT TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V048000·2014-02-10

    Elkhart ECII Transit Bus Recall for Electrical Fire Risk

    Elkhart Coach is recalling 2009-2010 ECII transit buses due to a defect in electric door actuators that may cause circuit boards to overheat and start a fire.

    Product
    ELKHART — ELKHART ECII
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V047000·2014-02-10

    GM Recalls Vehicles for Ignition Switch Airbag Deployment Risk

    General Motors is recalling approximately 2.19 million vehicles because a defective ignition switch may turn off the engine, preventing airbags from deploying in a crash.

    Product
    CHEVROLET — CHEVROLET, SATURN, PONTIAC HHR, SKY, SOLSTICE, G5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V057000·2014-02-10

    Midway Recalls 2010 Pinnacle Buses Due to Door Circuit Fire Risk

    Midway Specialty Vehicles is recalling 21 model year 2010 Pinnacle buses because voltage spikes may damage door actuators, increasing the risk of a fire.

    Product
    MIDWAY — MIDWAY PINNACLE BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V044000·2014-02-10

    Yamaha Recalls YZFR1 and XTZ12 Motorcycles for Headlight Socket Defect

    Yamaha is recalling 2009-2013 YZFR1 and 2012-2013 XTZ12 motorcycles because headlight sockets may overheat and melt, causing headlight failure and increasing crash risk.

    Product
    YAMAHA — YAMAHA YZFR1, XTZ12
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14C001000·2014-02-10

    Graco Recalls Child Seats Due to Stuck Harness Buckle Defect

    Graco is recalling approximately 4.2 million toddler and booster seats because the harness buckle may get stuck, making it difficult to remove a child in an emergency.

    Product
    CHILD SEAT:HARNESS/CROTCH BUCKLE recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·012-2014·2014-02-08

    Wyoming Firm Recalls Beef Jerky Due to Processing Deviation

    Wyoming Authentic Products LLC is recalling 365 pounds of beef jerky sold in four states and online due to a processing deviation.

    Product
    Wyoming Authentic Products LLC — Wyoming Firm Recalls Beef Jerky Products Due to a Processing Deviation
    Category
    Food
    Distribution
    4 states
  • HighNHTSA·14V051000·2014-02-07

    Toyota Recalls 2014 Highlanders for Third-Row Seat Belt Anchor Defect

    Toyota is recalling 2014 Highlanders because the third-row middle seat belt may not be properly secured to the vehicle floor, increasing injury risk in a crash.

    Product
    TOYOTA — TOYOTA HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V045000·2014-02-07

    Starcraft Launch Travel Trailer Recall for Incorrect Tire Labeling

    Starcraft is recalling 2014 Launch travel trailers with incorrect tire size labels. The error may lead to improper tire installation and increased crash risk.

    Product
    STARCRAFT — STARCRAFT LAUNCH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V041000·2014-02-06

    Marathon Recalls Prevost Motorcoaches Due to Battery Fire Risk

    Marathon Coach is recalling 450 Prevost H3 and XL motorcoaches because battery components may conduct electricity and cause fires.

    Product
    PREVOST — PREVOST H3, XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V040000·2014-02-06

    Ford F-550 Transit Bus CNG Tank Bracket Recall

    Almared is recalling 2011-2012 Ford F-550 buses converted to CNG because fuel tank brackets may break, risking a crash or fire.

    Product
    FORD — FORD F-550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14102·2014-02-06

    BebeLove Recalls Baby Walkers Due to Fall and Entrapment Hazards

    BebeLove is recalling about 3,600 baby walkers due to fall and entrapment hazards. Consumers should stop using them immediately and contact the company for a free repair kit.

    Product
    BebeLove™ Baby Walkers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1046-2014·2014-02-05

    MaXtremeZEN Capsules Recalled for Containing Unapproved Drug Ingredients

    SS Wholesale Inc. is recalling MaXtremeZEN capsules because FDA analysis found undeclared desmethyl carbondenafil and dapoxetine, making the product an unapproved new drug.

    Product
    MaXtremeZEN capsules, 1 capsule per blister pack, Distributed by: P&A Enterprise, Buena Park, CA 90621, UPC 6 10079 52468 2.
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1047-2014·2014-02-05

    eXtenZone capsules recalled for containing unapproved drug ingredients

    SS Wholesale Inc. is recalling eXtenZone capsules because FDA analysis found undeclared desmethyl carbondenafil and dapoxetine, making the product an unapproved new drug.

    Product
    eXtenZone capsules, 1 capsule per blister pack, Distributed by: P.M.C. Company, Buena Park, CA 90621, UPC 6 89076 49126 6.
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1049-2014·2014-02-05

    Alexion Recalls Soliris Vials Due to Visible Particulate Matter

    Alexion Pharmaceuticals is recalling 21,661 vials of Soliris (eculizumab) because they failed an appearance test for visible particles.

    Product
    SOLIRIS — SOLIRIS (ECULIZUMAB)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1445-2014·2014-02-05

    Monarch Breakfast Syrup Recalled for Undeclared Peanut Allergen

    The C F Sauer Company is recalling Monarch Breakfast Syrup in 1.5 oz cups due to undeclared peanuts. The product was distributed in Florida, Maryland, South Carolina, and Tennessee.

    Product
    Monarch Breakfast Syrup, in 1.5 oz. portion control cups, Distributed by US Foods, Inc., Rosemont, IL 60018.
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Drugs)·D-1045-2014·2014-02-05

    FDA Recalls Rhino 5 Capsules Containing Unapproved Drug Ingredients

    FDA is recalling Rhino 5 capsules marketed as a dietary supplement because they contain undeclared desmethyl carbondenafil and dapoxetine, making them unapproved new drugs.

    Product
    Rhino 5 capsules(Spanish & English Labeling), 1 capsule per blister pack, Distributed by P&A Enterprise, Buena Park, CA 90621, English UPC 6 10708 10730 9, Spanish UPC 6 10708 10729 3.
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1052-2014·2014-02-05

    NuVision Pharmacy Recalls Sermorelin/GHRP-6 Vials Due to Sterility Concerns

    NuVision Pharmacy is recalling 122 vials of Sermorelin/GHRP-6 due to lack of sterility assurance identified during an FDA inspection.

    Product
    Sermorelin/GHRP-6, 3 mg/3 mg, 5 mL vial, Stock # 21740, Compounded by NuVision Pharmacy, Dallas, TX 75244
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1050-2014·2014-02-05

    FDA Recalls Hydravax Weight Loss Supplement for Undeclared Prescription Drug

    IQ Formulations is recalling Hydravax High Potency Diuretic Weight Loss Solution because it contains an undeclared prescription diuretic, Triamterene.

    Product
    Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabolicnutrition.com
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0837-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature and Shock Risks

    DeRoyal Industries is recalling 48 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature and have caused electric shocks.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee Blanket w/ Straps NS, REF T654NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1038-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling Rohto eye drops because of concerns about the quality assurance of sterility controls.

    Product
    ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01086 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1039-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling several Rohto eye drop products due to concerns about the quality assurance of sterility controls.

    Product
    ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01096 1, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0862-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 369 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Catheter and Accessories Product Code: 82-8805 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrosp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1454-2014·2014-02-05

    Health Wright B-Complex Supplement Recalled for Chloramphenicol Contamination

    Health Wright Products Inc. is recalling B-Complex with Enzymes supplements contaminated with Chloramphenicol. The affected product was distributed to five US states and Mexico.

    Product
    B-Complex with Enzymes, Vitamin/Enzyme Supplement. Packaged 60 vegetable capsules per bottle. They are sold under brand Enzyme Research Products.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1457-2014·2014-02-05

    Health Wright Recalls Zinc Plus Supplements Contaminated with Chloramphenicol

    Health Wright Products Inc is recalling Zinc Plus dietary supplements because they were made from an ingredient contaminated with Chloramphenicol.

    Product
    Zinc Plus, Mineral/Enzyme supplement, 90 vegetable capsules per bottle. They are sold under brand Enzyme Research Products.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1035-2014·2014-02-05

    Hospira Recalls Aminosyn 3.5% Bags Due to Sterility Concerns

    Hospira Inc. is recalling 15,258 bags of Aminosyn 3.5% M Sulfite-Free due to a lack of assurance of sterility and potential leakage from the administrative port.

    Product
    Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1453-2014·2014-02-05

    Health Wright Digestive Enzyme Supplement Recalled for Chloramphenicol Contamination

    Health Wright Products Inc is recalling Digestive Enzyme Supplements contaminated with Chloramphenicol. The products were distributed to California, Florida, Oregon, Utah, and Mexico.

    Product
    Digestive, Enzyme Supplement, packaged 90 capsules per bottle, 135 capsules per bottle, or 270 capsules per bottle. They are sold under brand Enzyme Research Products or Empower Life.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1459-2014·2014-02-05

    Health Wright Enzyme Formula Recalled for Chloramphenicol Contamination

    Health Wright Products Inc. is recalling Enzyme Formula dietary supplements because they were made from ingredients contaminated with Chloramphenicol.

    Product
    Enzyme Formula, dietary supplement, 100 capsules or 250 capsules per bottles, sold unlabeled to Rich Distributing.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1461-2014·2014-02-05

    YOR Digest Ultra Recalled Due to Chloramphenicol Contamination

    Health Wright Products Inc. is recalling YOR Digest Ultra dietary supplements because they were made with ingredients contaminated with Chloramphenicol.

    Product
    Digest Ultra, dietary supplement, packaged 56 capsules per bottle or distributed in bulk, sold under brand YOR. Product distributed OUTSIDE the US has Spanish label.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1460-2014·2014-02-05

    Health Wright Recalls XymoZyme Dietary Supplements Due to Chloramphenicol Contamination

    Health Wright Products Inc is recalling XymoZyme dietary supplements because the ingredients were contaminated with Chloramphenicol. The affected products were distributed to California, Florida, Oregon, Utah, and Mexico.

    Product
    XymoZyme, dietary supplement, packaged 60 capsules per bottte, 120 capsules per bottle, sold under brand ZYMOGEN.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1037-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling Rohto eye drops because of concerns about sterility controls. The recall covers nationwide distribution and Puerto Rico.

    Product
    ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 10909 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1051-2014·2014-02-05

    NuVision Pharmacy Recalls HCG Vials Due to Sterility Assurance Concerns

    NuVision Pharmacy is recalling 285 vials of HCG (Lyophilized) nationwide due to a lack of sterility assurance identified during an FDA inspection.

    Product
    HCG (Lyophilized) Stock # 21714, 5000 IUnits-5 mL vial, Compounded by NuVision Pharmacy Dallas, TX 75244
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1455-2014·2014-02-05

    Health Wright B-Complex Plus Recalled Due to Chloramphenicol Contamination

    Health Wright Products Inc is recalling B-Complex Plus dietary supplements because they were made from an ingredient contaminated with Chloramphenicol.

    Product
    B-Complex Plus. They are sold under brand Enzyme Research Products
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0859-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 895 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

    Product
    Codman Certas Programmable Valve In Line Valve with Catheter and Accessories Product Code: 82-8801 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0838-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 2 units of the Aquarius Hot/Cold Therapy Combo Unit due to temperature monitoring failures and electric shock reports.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Shoulder Blanket w/ Straps NS, REF T655NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1040-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling several Rohto eye drop products due to concerns about the quality assurance of sterility controls.

    Product
    ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent, Lubricant, Redness Reliever Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01099 2, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0839-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 25 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Foot/Ankle Blanket NS, REF T656NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1458-2014·2014-02-05

    Digestaze dietary supplement recalled due to Chloramphenicol contamination

    Health Wright Products Inc is recalling Digestaze dietary supplements because they were made from an ingredient contaminated with Chloramphenicol.

    Product
    Digestaze, dietary supplement, 90 vegetable capsules per bottle. They are sold under brand DESBIO
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0836-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 409 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blnkt NS, REF T653NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0860-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 431 Codman Certas Programmable Valves because they may not operate properly. These implantable devices are used to manage hydrocephalus.

    Product
    Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal Catheter and Accessories Product Code: 82-8803 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0835-2014·2014-02-05

    DeRoyal Aquarius Hot/Cold Therapy Unit Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 121 Aquarius Hot/Cold Therapy Combo Units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    DeRoyal (R) Aquarius Hot/Cold Therapy Combo Unit, w/ Knee/Shoulder Blanket NS, REF T652NS, Rx only, Manufacturer DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1036-2014·2014-02-05

    Hospira Recalls Heparin Sodium Bags Due to Sterility Concerns

    Hospira is recalling 27,780 bags of Heparin Sodium 2000 USP Units per 1000 mL due to a lack of assurance of sterility and potential leakage from the administrative port.

    Product
    HEPARIN SODIUM — HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1041-2014·2014-02-05

    Mentholatum Recalls Rohto Eye Drops Due to Sterility Concerns

    The Mentholatum Company is recalling several Rohto eye drop products due to concerns about the quality assurance of sterility controls.

    Product
    ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL). UPC 3 10742 01074 9, Manufactured by Rohto-Mentholatum (Vietnam) Co., Ltd. for The Mentholatum Company, Orchard Park, NY 14127. Made in Vietnam.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0834-2014·2014-02-05

    DeRoyal Aquarius Temperature Therapy Units Recalled for Temperature Control Failure

    DeRoyal Industries is recalling 738 Aquarius Temperature Therapy units because they fail to monitor water temperature, posing a risk of temperature injuries and electric shock.

    Product
    Aquarius (TM) TEMPERATURE THERAPY, REF T650, Rx Only, Manufactured for DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, Made in China. Physical Therapy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1435-2014·2014-02-05

    Lambs Farm Banana Nut Bread Recalled for Undeclared Soy Allergen

    The Lambs Farm, Inc. is recalling Banana Nut Bread loaves sold in Bread Trio gift boxes because the labels do not declare soy allergens.

    Product
    Banana Nut Bread loaf sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 8 oz. This product was only sold as a part of the Bread Trio gift box.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0849-2014·2014-02-05

    Stryker Recalls Sterile Teflon Tubes Due to Potential Seal Compromise

    Stryker is recalling 34 units of sterile Teflon tubes used in orthopedic nailing systems because laboratory testing indicated the sterile barrier seal may be compromised.

    Product
    Teflon Tube, sterile T2 Humerus System Stryker Trauma GmbH Prof Kuntscher Str 1-5 24232 Sconkidrchen, Germany distributed in the USA by: Stryker Howmedica Osteonics Corp.: Mahwah, NJ 07430 USA 510 K042396 Used in several T2 systems intended to support the exchange of
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0833-2014·2014-02-05

    Symmetry and CODMAN QUAD-LOCK Sterilization Containers Recalled for Sterile Barrier Failure

    Symmetry Medical/SSI is recalling QUAD-LOCK Sterilization Containers because they may not maintain an effective sterile barrier. The recall covers 2,991 units distributed worldwide.

    Product
    Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization container systems manufactured and distributed under the following names: Small Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container Small Perforated Bottom, REF 50-8731, 270mm x 270mm x 100m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0885-2014·2014-02-05

    Synergetics Recalls 25ga Endo Illuminator Due to Faulty Seals

    Synergetics Inc is recalling 96 units of 25ga Endo Illuminator devices because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02.25 Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0875-2014·2014-02-05

    Synergetics Chandelier Infusion Cannula Recalled for Faulty Seals

    Synergetics Inc. is recalling Chandelier Infusion Cannulas due to faulty seals on the outer pouch, which could result in seal failure.

    Product
    Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile / EO, 56.30.P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0852-2014·2014-02-05

    ACUTE Innovations RibLoc U plus System Recalled for Malfunction Risk

    ACUTE Innovations is recalling 176 units of the RibLoc U plus system because the implants may malfunction during surgical installation.

    Product
    The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. The plates are manufactured from titanium and the screws are manufact
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0774-2014·2014-02-05

    Carestream DRX Evolution System Recalled for Unintended X-Ray Exposure

    Carestream Health Inc. is recalling four DRX Evolution System units because they allowed x-ray exposures without an image receptor, resulting in two exposures before an image was captured.

    Product
    Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are permanently installed diagnostic x-ray systems compo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2014·2014-02-05

    GE Healthcare Recalls CARESCAPE Patient Monitors Due to Safety Issues

    GE Healthcare is recalling CARESCAPE B650 and B850 monitors due to 25 reported safety issues involving alarms and connectivity.

    Product
    GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended fo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0894-2014·2014-02-05

    Synergetics Recalls 23ga Wide Field Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 568 units of 23ga Wide Field Endo Illuminators because faulty seals on the outer pouch could result in seal failure.

    Product
    23ga Wide Field Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.21.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0888-2014·2014-02-05

    Synergetics Recalls Corona Shielded Wide Field Endo Illuminator Due to Seal Failure

    Synergetics Inc. is recalling specific lots of Corona Shielded Wide Field Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    "The Corona" Shielded Wide Field Endo Illuminator, Synergetics, inc. 20ga, length 7.0 ft, sterile / EO, 56.12. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2014·2014-02-05

    Medtronic Set Screw Retaining Driver Recalled Due to Component Sizing Issue

    Medtronic is recalling seven Set Screw Retaining Drivers because oversized retaining tabs may prevent proper mating with set screws.

    Product
    SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Danek, USA, Inc. Screwdriver - orthopedic manual surgical instrument.
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0831-2014·2014-02-05

    Philips Brilliance iCT Systems Recalled for Potential Image Artifacts

    Philips Medical Systems is recalling Brilliance iCT and iCT SP systems because an artifact resembling a thrombus may appear on images.

    Product
    Brilliance iCT and Brilliance iCT SP These systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. May include signal analysis and display equipment, patient and equipment su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0844-2014·2014-02-05

    Carestream Recalls Kodak DirectView DR 7500 Dual Detector Systems

    Carestream Health is recalling 164 Kodak DirectView DR 7500 Dual Detector Systems due to a possible patient image display error.

    Product
    KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream Health, Inc. Made in U.S.A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2014·2014-02-05

    Synergetics Recalls 25ga Wide Field Corona Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling 96 units of 25ga Wide Field Corona Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    25ga Wide Field Corona Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.12.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0897-2014·2014-02-05

    Synergetics 25ga Mid-Field Endo Illuminator Recalled for Seal Failure

    Synergetics Inc is recalling 25ga Mid-Field Endo Illuminators because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    25ga Mid-Field Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.22.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0861-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff is recalling 1,481 Codman Certas Programmable Valves because they may not operate properly, potentially affecting hydrocephalus management.

    Product
    Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the m
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0864-2014·2014-02-05

    Codman Certas Programmable Valves Recalled for Potential Malfunction

    Codman & Shurtleff, Inc. is recalling 746 Codman Certas Programmable Valves because they may not operate properly. The devices are used to manage hydrocephalus.

    Product
    Codman Certas Programmable Valve In Line Valve with SiphonGuard Device, Unitized Bactiseal Catheter and Accessories Product Code: 82-8807 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and dra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0873-2014·2014-02-05

    Synergetics Recalls 23ga Chow Illuminated Pick Due to Faulty Seals

    Synergetics Inc. is recalling 38 units of 23ga Chow Illuminated Picks due to faulty seals that could compromise sterility.

    Product
    23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 56.07.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0880-2014·2014-02-05

    Synergetics Recalls 25ga Awh Vivid Chandelier Due to Faulty Seals

    Synergetics is recalling 108 units of 25ga Awh Vivid Chandeliers because faulty seals on the outer pouch could fail, potentially compromising the sterile status of the ophthalmic devices.

    Product
    25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0877-2014·2014-02-05

    Synergetics Recalls 25ga Awh Chandelier Due to Faulty Sterile Seals

    Synergetics Inc. is recalling 36 units of 25ga Awh Chandeliers because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.

    Product
    25ga Awh Chandelier, Synergetics, inc., length 8.0 ft, sterile / EO, 56.50.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2014·2014-02-05

    Synergetics Recalls 25ga Aspirating Endo Illuminator Due to Seal Failure

    Synergetics is recalling 25ga Aspirating Endo Illuminators because faulty seals on the outer pouch could fail, compromising the sterile status of the ophthalmic devices.

    Product
    25ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 56.24.25P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0856-2014·2014-02-05

    Sorin S5/C5 Heart-Lung Machine Recalled for Pump Control Failures

    Sorin Group is recalling S5/C5 Heart-lung machines and CP5 centrifugal pump systems due to pump speed control knob failures that result in no response.

    Product
    S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0874-2014·2014-02-05

    Synergetics Recalls Stiff 25ga Chow Illuminated Pick Due to Seal Failure

    Synergetics Inc. is recalling 44 units of Stiff 25ga Chow Illuminated Picks because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    Stiff 25ga Chow Illuminated Pick (Dull), Synergetics, inc., length 8.0 ft, sterile / EO, 56.07.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0882-2014·2014-02-05

    Synergetics Recalls 72 Sterile Ophthalmic Laser Probes Due to Seal Failure

    Synergetics is recalling 72 sterile ophthalmic laser probes because faulty seals on the outer pouch could fail, potentially compromising sterility.

    Product
    23ga Straight Fixed Extended Illuminated Laser Probe, Synergetics, length 7.5 ft, sterile / EO, 55.62.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0845-2014·2014-02-05

    Philips Healthcare Recalls InnerCool RTx Endovascular Systems Due to Temperature Reading Errors

    Philips Healthcare is recalling 50 InnerCool RTx Endovascular Systems because the main control board may display inaccurate low patient temperature readings and trigger false alarms.

    Product
    InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever redu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14V039000·2014-02-05

    Nomad Recalls 2013 Dispatch Trailers Due to Door Lock Jamming Risk

    Nomad is recalling 2013 Dispatch 14A, 20SS0, and 16AS0 trailers because a door lock defect could jam the deadbolt, trapping occupants inside.

    Product
    NOMAD — NOMAD DISPATCH 20SS0, DISPATCH 14A, DISPATCH 16AS0
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1434-2014·2014-02-05

    Lambs Farm Raspberry Swirl Bread Recalled for Undeclared Soy Allergen

    The Lambs Farm, Inc. is recalling Raspberry Swirl Bread loaves sold in Bread Trio gift boxes because the labels do not declare soy allergens.

    Product
    Raspberry Swirl Bread loaf sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 8 oz. This product was only sold as a part of the Bread Trio gift box.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·14V038000·2014-02-05

    Four Wheel & Six-Pac Truck Campers Recalled for Door Lock Defect

    Four Wheel & Six-Pac is recalling 2006-2013 truck campers because a door lock defect could jam the deadbolt, potentially trapping occupants inside.

    Product
    FOUR WHEEL & SIX-PAC — FOUR WHEEL & SIX-PAC TRUCK CAMPERS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1444-2014·2014-02-05

    Condies Foods Recalls Shredded Lettuce Due to Plastic Contamination

    Condies Foods is recalling fine and 1/4 shred lettuce after a piece of hard plastic was found in a bag. The plastic originated from a quality control instrument.

    Product
    Condies Food fine shred lettuce, and 1/4 shred lettuce; 5 lbs bags, 4 bags per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1443-2014·2014-02-05

    Target Simply Balanced Herb Mixed Freeze Dried Vegetables Recalled for Undeclared Soy

    American Importing Co. is recalling Target Simply Balanced Herb Mixed Freeze Dried Vegetables due to a potential for undeclared soy.

    Product
    Simply balanced, herb mixed freeze dried vegetables all natural, Ingredients: Super sweet corn, edamame, peas, carrots, (carrots, sugar, dextrose, tapioca starch), Italian seasoning (Garlic, tomato (tomato, salt), crushed red pepper, basil, oregano), coconut oil, sea salt. May c
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1436-2014·2014-02-05

    Lambs Farm Blueberry Bread Recalled for Undeclared Soy Allergen

    The Lambs Farm, Inc. is recalling Blueberry Bread loaves sold in Bread Trio gift boxes because the labels do not declare soy allergens.

    Product
    Blueberry Bread loaf sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 8 oz. This product was only sold as a part of the Bread Trio gift box.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F1462-2014·2014-02-05

    NatureBox Salsa Spiced Nut Mix Recalled for Missing Wheat Allergen Labeling

    NatureBox is recalling 8,672 bags of Salsa Spiced Nut Mix because the ingredient list failed to disclose unbleached wheat flour and bulgur wheat.

    Product
    NatureBox Salsa Spiced Nut Mix; Net. WT: 4 oz. (113 g), Stand up Pouch, Vegan Ingredients: Almonds, Corn chips with flax (yellow corn masa, flax seed, soybean oil, salt), Cashews, seasoning ( tomato powder, salt, sugar, onion powder, garlic powder, spices, cilantro, lime juice
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1431-2014·2014-02-05

    Lambs Farm Lemon Butter Cookies Recalled for Undeclared Milk and Wheat Allergens

    The Lambs Farm, Inc. is recalling Lemon Butter Cookies because the labels fail to declare milk and wheat allergens.

    Product
    Lemon Butter Cookies sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 10 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1429-2014·2014-02-05

    Lambs Farm Double Chocolate Butter Cookies Recalled for Allergen Mislabeling

    The Lambs Farm, Inc. is recalling Double Chocolate Butter Cookies because the labels do not declare milk and wheat allergens.

    Product
    Double Chocolate Butter Cookies sold under the Lambs Farm brand and packaged in a plastic bag with a net weight of 10 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1456-2014·2014-02-05

    Health Wright Recalls Glucosamine Supplements Contaminated with Chloramphenicol

    Health Wright Products Inc. is recalling specific lots of Glucosamine, Chondroitin, MSM Plus dietary supplements because they were made with an ingredient contaminated with Chloramphenicol.

    Product
    Glucosamine, Chondroitin, MSM Plus, dietary supplement, 60 capsules per bottle. They are sold under brand Enzyme Research Products or Empower Life Vital Joints brand.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Drugs)·D-1048-2014·2014-02-05

    Humco Recalls Mercuroclear Antiseptic Anesthetic Due to Microbial Contamination

    Humco Holding Group is recalling Mercuroclear Antiseptic Anesthetic First Aid products due to contamination with Burkholderia sp. bacteria.

    Product
    Mercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Aqueous solution. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External ana
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1432-2014·2014-02-05

    Lambs Farm Snowball Cookies Recalled for Undeclared Allergens

    The Lambs Farm, Inc. is recalling Snowball Cookies because the labels fail to declare milk, soy, and wheat allergens.

    Product
    Snowball Cookies sold under the Lambs Farm brand and packaged in a white metal tin with a net weight of 1 lb.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0876-2014·2014-02-05

    Synergetics Recalls 23ga Chandelier Infusion Cannulas Due to Seal Failure

    Synergetics Inc is recalling 240 units of 23ga Chandelier Infusion Cannulas because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile / EO, 56.30.23P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0895-2014·2014-02-05

    Synergetics Recalls Stiff 25ga Wide Field Endo Illuminator Due to Seal Failure

    Synergetics Inc is recalling specific lots of Stiff 25ga Wide Field Endo Illuminators because faulty seals on the outer pouch could fail, compromising sterility.

    Product
    Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, sterile / EO, 56.21.25PS. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0826-2014·2014-02-05

    Navilyst Medical Recalls Port Kits Due to Sterilization Barrier Breach

    Navilyst Medical is recalling 920 Port Kits with Access Infusion Sets due to a possible breach of the sterilization barrier. The devices were distributed nationwide.

    Product
    Port Kit with Access Infusion Set under the following labels: 1) 8F/SL/Plastic Port/F, Product Number H965450140, Catalog Number 45-014; 2) 8F/SL/Titanium Ports/NF, Product Number H965450170, Catalog Number 45-017; 3) 6F/SL/Plastic Port/F, Product Number H965450200, Catalog Num
    Category
    Medical Device
    Distribution
    Distributed nationwide

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