The Recall Desk

Archive

March 2015 recalls

559 recalls were announced in March 2015.

What the numbers show

Critical
102
Severe
148
High
245
Moderate
50
Low
14

Of the 559 recalls this month scored against our rubric, 18% are Critical, 26% are Severe.

201–300 of 559

  • HighNHTSA·15V150000·2015-03-16

    Altec Recalls 2014 Aerial Devices Due to Counterbalance Valve Defect

    Altec is recalling 2014 Aerial Devices because a counterbalance valve may crack, causing hydraulic leaks and unintended boom movement that increases injury risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·045-2015·2015-03-14

    Gourmet Kitchen Recalls Beef and Chicken Products for Undeclared Peanuts

    Gourmet Kitchen Inc. is recalling approximately 16,722 pounds of beef and chicken appetizers due to misbranding and an undeclared peanut allergen.

    Product
    Gourmet Kitchen Inc — Gourmet Kitchen Inc. Recalls Various Beef and Chicken Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • HighUSDA FSIS·046-2015·2015-03-14

    Bear Creek Smokehouse Recalls Beef Products Due to Undeclared Soy Allergen

    Bear Creek Smokehouse is recalling approximately 3,700 pounds of beef products because they contain soy, a known allergen not declared on the label.

    Product
    Bear Creek Smokehouse — Bear Creek Smokehouse Recalls Beef Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·15V147000·2015-03-13

    BMW Recalls 2014-2015 X5 Models for Air Bag Connection Defect

    BMW is recalling certain 2014-2015 X5 vehicles because the Head Protection System air bag may not be securely connected to the inflator, increasing injury risk in a crash.

    Product
    BMW — BMW X5
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V144000·2015-03-13

    Toyota Recalls 2014-2015 Camry, Highlander, and RAV4 for Steering Defect

    Toyota is recalling specific 2014-2015 Camry, Highlander, and RAV4 vehicles because a manufacturing defect in the electric power steering system may cause it to fail, increasing crash risk.

    Product
    TOYOTA — TOYOTA HIGHLANDER, CAMRY, RAV4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V146000·2015-03-13

    GM Recalls 2015 Buick Encore and Chevrolet Trax for Steering Defect

    General Motors is recalling 2015 Buick Encore and Chevrolet Trax vehicles because steering column wear may cause sudden loss of power steering assist, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, BUICK TRAX, ENCORE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·044-2015·2015-03-13

    Grand Papa's Recalls Fried Pork Skin Products Produced Without Inspection

    Grand Papa's Inc. is recalling approximately 644 pounds of fried pork skin products produced without federal inspection. The products were shipped to a retail location in Michigan.

    Product
    Grandpapa's Inc. — Grand Papa's Inc. Recalls Fried Pork Skin Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·15V148000·2015-03-13

    BMW Recalls 2015 Convertibles Due to Air Bag Timing Error

    BMW is recalling 2015 428i and 435i Convertibles because a programming error may cause the driver's front air bag to deploy at the wrong time, increasing injury risk in a crash.

    Product
    BMW — BMW 428I, 435I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V145000·2015-03-13

    GM Recalls 2011-2013 Chevrolet Volt for Carbon Monoxide Risk

    General Motors is recalling 2011-2013 Chevrolet Volt vehicles because the engine may start automatically if the electrical system is left on, posing a carbon monoxide risk in enclosed spaces.

    Product
    CHEVROLET — CHEVROLET VOLT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·042-2015·2015-03-12

    Bon Appetizers Recalls Chicken Products Due to Undeclared Peanut Allergen

    Bon Appetizers, LLC is recalling approximately 10,429 pounds of chicken products because they contain peanut, a known allergen, which is not declared on the label.

    Product
    Cuisine Innovations Unlimited, LLC — Bon Appetizers, LLC Recalls Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·043-2015·2015-03-12

    L & L Foods Recalls Bacon Bits for Undeclared Soy Allergen

    L & L Foods is recalling 30,665 pounds of bacon bits because the product contains soy lecithin, an allergen not listed on the label.

    Product
    Hearthside Food Solutions, LLC d/b/a Maker's Pride — L & L Foods Recalls Bacon Bits Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1376-2015·2015-03-11

    Jardine's Four Banditos Sampler Recalled for Undeclared Peanuts

    Jardine Foods Inc is recalling 300 units of Four Banditos Sampler because ingredients contained undeclared peanuts.

    Product
    Jardine's FOUR BANDITOS SAMPLER in cardboard box with black and red graphics
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1369-2015·2015-03-11

    Stone Mountain Pecan Co. Recalls Pecanettes Due to Salmonella

    Stone Mountain Pecan Co. is recalling 540 packages of Pecanettes because the product tested positive for Salmonella. The affected packages were distributed in Georgia.

    Product
    Pecanettes, Net Wt 8oz (226.80 Grams), Shelled and Packed by: Stone Mountain Pecan Co., 1781 Hwy 78, Monroe, GA 30656.
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-1371-2015·2015-03-11

    Jardine Mesquite Barbecue Sauce Recalled for Undeclared Peanuts

    Jardine Foods Inc is recalling 3,576 units of Mesquite Barbecue Sauce because ingredients contained undeclared peanuts.

    Product
    D.L. Jardine's MESQUITE BARBECUE SAUCE NET WT. 18 OZ. (510g) Distributed in Australia and New Zealand by Texan Imports Pty Ltd 19 Emperor Palace Kenthurst NSW 2156 Australia
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1381-2015·2015-03-11

    S&S Food Import Recalls Dried Roach Fish for Botulism Risk

    S&S Food Import Corp. is recalling uneviscerated dried roach fish due to potential Clostridium botulinum contamination. The product was distributed in six states.

    Product
    Roach dry eviscerated salted Fish (Rutilus rutilus), Weight 0.365 Kg. Product is held in plastic packaging & shipped in 5 Kg (11 lb) boxes. Imported by: B&I Overseas Trading Inc, Van Nuys, California 91406. Distributed By: S and S Food Import Corp. 5337 Preston Court, Brookly
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1373-2015·2015-03-11

    Shotgun Willie's Texas Chili Seasoning Recalled for Undeclared Peanuts

    Jardine Foods Inc is recalling Shotgun Willie's Texas Chili Seasoning because it contains undeclared peanuts.

    Product
    SHOTGUN WILLIE'S TEXAS CHILI SEASONING MAKES 1 1/2 QUARTS NET WT. 3.1 Oz (88g)
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1377-2015·2015-03-11

    Ground Cumin Seed Recalled for Undeclared Peanut Protein

    Morris J. Golombeck, Inc. is recalling 115,000 lbs of ground cumin seed because it may contain undeclared peanut protein.

    Product
    GROUND CUMIN SEED, 50 LBS NET, ETO STERILE TREATED
    Category
    Food
    Distribution
    16 states
  • CriticalFDA (Food)·F-1370-2015·2015-03-11

    Whole Foods Market Recalls Raw Macadamia Nuts for Salmonella

    Whole Foods Market is recalling specific lots of Raw Macadamia Nuts because they tested positive for Salmonella. The product was distributed in six southeastern states.

    Product
    Whole Foods Market Raw Macadamia Nuts packaged in 5.6 oz. clear plastic container with clear plastic lid; UPC: 7-23055-21415-3; 24 units per case
    Category
    Food
    Distribution
    6 states
  • CriticalFDA (Food)·F-1375-2015·2015-03-11

    Jardine Foods Recalls Texas Chili Kit for Undeclared Peanuts

    Jardine Foods Inc is recalling D.L. Jardine's Texas Chili Bag O'Fixins Kit because ingredients contained undeclared peanuts.

    Product
    D.L. Jardine's Texas Chili Bag O'Fixins Kit Net Wt. 4 Oz (113g)
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1372-2015·2015-03-11

    Jardine Foods Recalls Killer Barbecue Sauce for Undeclared Peanuts

    Jardine Foods Inc is recalling 1,896 units of D.L. Jardine's Killer Barbecue Sauce because ingredients contained undeclared peanuts.

    Product
    D.L. Jardine's KILLER BARBECUE SAUCE NET WT. 18 OZ. (510g) Distributed in Australia and New Zealand by Texan Imports Pty Ltd 19 Emperor Palace Kenthurst NSW 2156 Australia
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0406-2015·2015-03-11

    Actavis Recalls Vancomycin Hydrochloride Capsules Due to Subpotent Drug

    Actavis Inc. is voluntarily recalling 29,405 cartons of Vancomycin Hydrochloride Capsules, USP, 250 mg, because the drug was found to be subpotent.

    Product
    Vancomycin Hydrochloride Capsules, USP, 250 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3561-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V139000·2015-03-11

    Mack Pinnacle Trucks Recall Fifth Wheel Latch Defect

    Mack is recalling 2012-2015 Pinnacle trucks because the fifth wheel latch switch may be pushed accidentally, causing the trailer to disconnect.

    Product
    MACK — MACK PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1385-2015·2015-03-11

    Sole Grano Recalls Fairway Organic Cranberry Granola for Undeclared Allergens

    Sole Grano LLC is recalling Fairway Organic Cranberry Low Fat Granola because it may contain undeclared almond and wheat allergens.

    Product
    Fairway - Like No Other Market Organic Cranberry Low Fat Granola Net Wt. 12 oz. (340 g) Manufactured for Fairway Group Holdings Group, New York, NY 10027
    Category
    Food
    Distribution
    3 states
  • SevereNHTSA·15V141000·2015-03-11

    BMW Recalls Motorcycles Due to Rear Wheel Mounting Flange Crack Risk

    BMW is recalling specific 2005-2011 motorcycles because the rear wheel mounting flange may crack if bolts are over-tightened, potentially causing the wheel to detach.

    Product
    BMW — BMW R 1200 ST, HP2 ENDURO, K 1300 S, R 1200 GS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15E021000·2015-03-11

    Bendix Recalls TR-3 Inversion Air Brake Valves for Fire Risk

    Bendix is recalling specific TR-3 Inversion Air Brake Valves because incorrect dimensions may cause brakes to drag and overheat, increasing the risk of a wheel end fire.

    Product
    SERVICE BRAKES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V140000·2015-03-11

    Kalmar Recalls 2014-2015 Ottawa T2 Tractors Due to Fire Risk

    Kalmar is recalling 311 model year 2014-2015 Ottawa T2 terminal tractors because a battery cable may detach, causing the engine harness to melt and increasing the risk of a fire.

    Product
    KALMAR — KALMAR OTTAWA T2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0398-2015·2015-03-11

    Sagent Pharmaceuticals Recalls Atracurium Besylate Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling Atracurium Besylate Injection vials because FDA observations regarding aseptic and GMP practices at the manufacturing site may have impacted product sterility.

    Product
    Atracurium Besylate Injection, USP, 50 mg per 5 mL (10 mg per mL), Rx Only, 5 mL Single-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-659-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1209-2015·2015-03-11

    Boston Scientific Recalls IntellaTip MiFi Radiofrequency Ablation Catheters

    Boston Scientific is recalling 14 IntellaTip MiFi radiofrequency ablation catheters due to reports of char formation on the distal tip electrodes.

    Product
    IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number : M004EPM9620N40; Catalog number: EPM9620N4. The IntellaTip MiFi Open-Ir
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1240-2015·2015-03-11

    Richard Wolf I-Cart Medical Video Equipment Recall for Overheating Transformers

    Richard Wolf Medical Instruments Corp. is recalling 83 I-Cart units because transformers may overheat, causing smoke and black plastic material to leak from the chassis.

    Product
    The I-Cart is used to store, transport, and power video equipment used in medical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0399-2015·2015-03-11

    Sagent Pharmaceuticals Recalls Atracurium Besylate Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling Atracurium Besylate Injection vials because FDA observations suggest potential impacts on product sterility.

    Product
    Atracurium Besylate Injection, USP, 100 mg per 10 mL (10 mg per mL), Rx Only, 10 mL Multi-Dose Vial, For Intravenous Injection, Mfd. for: Sagent Pharmaceuticals, Schaumberg, IL 60195, NDC 25021-672-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1374-2015·2015-03-11

    Jardine Foods Recalls Texas Chili Works for Undeclared Peanuts

    Jardine Foods Inc is recalling D.L. Jardine's Texas Chili Works due to undeclared peanuts in the ingredients.

    Product
    D.L. Jardine's Texas Chili Works "THE WHOLE KIT N KABOODLE" NET WT. 3 Oz (85g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1244-2015·2015-03-11

    Elekta Focal Sim radiation therapy system recalled for image statistics error

    Elekta, Inc. is recalling 907 Focal Sim radiation therapy treatment planning systems because the Monaco Image Statistics Tool may produce incorrect CT to ED values.

    Product
    Focal Sim radiation therapy treatment planning system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1221-2015·2015-03-11

    Halyard Health Recalls KimVent Closed Suction Systems Due to Air Leak Defect

    Halyard Health is recalling KimVent Closed Suction Systems for Adults because a hole or crack may cause air to leak. The recall affects 5 cases distributed to specific US states and Japan.

    Product
    KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Food)·F-1382-2015·2015-03-11

    Izzio Artisan Bakery Recalls Undercooked Lemon Poppy Muffins

    Izzio Artisan Bakery is voluntarily recalling a specific lot of Lemon Poppy Muffins because the product is undercooked and may contain undercooked egg.

    Product
    Izzio Artisan Bakery Rev Lem/Poppy Muffins 3.5oz packaged individually and put into cardboard case with 90 muffins per case
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1120-2015·2015-03-11

    Philips Allura Xper X-Ray Angiographic Software Recall

    Philips Medical Systems is recalling Allura Xper X-Ray Angiographic systems due to a software error that may prevent the five-minute fluoroscopy audible signal from sounding.

    Product
    Philips Medical System Allura Xper X-Ray Angiographic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2015·2015-03-11

    Zipline Medical Recalls Zip 8i Surgical Skin Closure Devices

    Zipline Medical is recalling Zip 8i Surgical Skin Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product number PS2080 Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2015·2015-03-11

    Zipline Medical Recalls Zip 8M Wound Closure Devices Due to Sterility Concerns

    Zipline Medical is recalling Zip 8M Wound Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recalled for High Bias in Results

    Siemens is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL show high bias. The recall covers 11,980 kits distributed worldwide.

    Product
    ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SMN:10315522.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2015·2015-03-11

    Maquet Servo-I Ventilator CO2 Analyzer Recalled for Calibration Defect

    Maquet is recalling 486 Servo-I ventilator CO2 analyzers worldwide due to a calibration problem caused by an internal circuit board defect.

    Product
    Servo-I ventilator system CO2 analyzer. Part number 65 23 588.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1383-2015·2015-03-11

    LaRosa's Creamy Garlic Dressing Recalled for Undeclared Allergens

    T. Marzetti Company is recalling LaRosa's Creamy Garlic Dressing packets because ingredient labels were switched, resulting in undeclared milk, egg, and sulfites.

    Product
    LaRosa's Creamy Garlic Dressing, 1.5oz plastic packet. Labeled in part, "INGREDIENTS: Soybean Oil, Water, Vinegar, Red Wine (preserved with Sulfites)***Packed for LaRosa's Inc, Cincinnati, OH 45238" UPC 0 70200 80109
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1379-2015·2015-03-11

    MegaMex Recalls Herdez Chilpotle Peppers for Undeclared Wheat Allergen

    MegaMex Foods is recalling Herdez Chilpotle Peppers due to an undeclared wheat allergen. The recall covers 58,749 cases distributed nationwide.

    Product
    Herdez Chilpotle Peppers, 7oz., Item No. 52738, UPC 072878285131
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1384-2015·2015-03-11

    LaRosa's Italian Dressing Recalled for Undeclared Allergens

    T. Marzetti Company is recalling LaRosa's Italian Dressing packets because the ingredient labels were switched, potentially leaving undeclared milk, egg, or sulfite allergens.

    Product
    LaRosa's Italian Dressing, 1.5oz plastic packet. Labeled in part, "INGREDIENTS: Soybean Oil, Water, Cultured ?Buttermilk, Distilled Vinegar, Romano Cheese, Part Skim Milk***Egg Yolk***Whey Protein Concentrate***CONTAINS: MILK EGGS***Packed for LaRosa's Inc, Cincinnati, OH 45238"
    Category
    Food
    Distribution
    3 states
  • HighFDA (Drugs)·D-0396-2015·2015-03-11

    Actavis Recalls Subpotent Vancomycin Hydrochloride Capsules Nationwide

    Actavis Inc. is voluntarily recalling 51,472 cartons of Vancomycin Hydrochloride Capsules, USP, 125 mg, because the drug is subpotent.

    Product
    Vancomycin Hydrochloride Capsules, USP, 125 mg, 2 x 10 count blister pack, Rx Only, Manufactured for Watson Pharma Inc., Parsippany, NJ 07054, by Patheon Pharmaceuticals Inc., Cincinnati, OH. NDC 0591-3560-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1220-2015·2015-03-11

    Halyard Health Recalls KimVent Closed Suction Systems Due to Defects

    Halyard Health is recalling KimVent Closed Suction Systems for Adults because a hole or crack was found that may cause air to leak.

    Product
    KimVent Closed Suction System for Adults, Double Swivel Elbow, 12 Fr., Sterile, Distributed by Kimberly Clark Global Systems, LLC.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1210-2015·2015-03-11

    Xoran MiniCAT X-ray devices recalled for imaging and dose defects

    Xoran Technologies is recalling 432 MiniCAT X-ray imaging devices nationwide due to out-of-tolerance kVp, unexposed frames, and out-of-tolerance dose.

    Product
    Xoran MiniCAT X-ray imaging device
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2015·2015-03-11

    Elekta Monaco Radiation Therapy System Recalled for Incorrect CT to ED Conversion

    Elekta, Inc. is recalling Monaco radiation therapy treatment planning systems because the Image Statistics Tool may incorrectly convert CT to ED values.

    Product
    Monaco radiation therapy treatment planning system. The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon and electron treatment plans and displays, on-screen and in hard-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2015·2015-03-11

    iCAD Recalls DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2

    iCAD, Inc. is recalling DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2 because a device malfunction may cause biopsy needles to miss targets, potentially leading to incorrect diagnoses.

    Product
    DynaLOC Breast Interventional Planning Software Versions 3.1 and 3.2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2015·2015-03-11

    Halyard Health Recalls KimVent Wet Pak Closed Suction Systems

    Halyard Health is recalling KimVent Wet Pak closed suction systems because a defect may cause air leaks.

    Product
    KimVent Wet Pak, Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1236-2015·2015-03-11

    Zipline Medical Recalls Zip 16 Surgical Skin Closure Devices

    Zipline Medical is recalling Zip 16 Surgical Skin Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1242-2015·2015-03-11

    Biosense Webster Recalls LASSO NAV Duo Loop eco Catheters

    Biosense Webster is recalling LASSO NAV Duo Loop eco Catheters due to reports of difficulty retracting and damage to the spine cover.

    Product
    LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiological mapping of the cardiac structures of the heart, i.e. recording or stimulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2015·2015-03-11

    Ikaria INOmax DSIR Nitric Oxide Delivery System Recalled for Alarm Defect

    INO Therapeutics is recalling 45 INOmax DSIR units because a specific software and display combination may trigger false alarms, interrupting nitric oxide therapy.

    Product
    Ikaria, INOmax DSIR (Delivery System), Model 10007. Nitric oxide delivery system for use with ventilators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·15096·2015-03-11

    Kroger Recalls Kids Korner Zipper Hooded Sweatshirts Due to Choking Hazard

    Kroger is recalling approximately 140,000 Kids Korner children's zipper hooded sweatshirts because the zipper pull can detach, posing a choking hazard to young children.

    Product
    Children's zipper hooded sweatshirts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15094·2015-03-11

    SCARPA Recalls F1 EVO Ski Boots Due to Fall Hazard

    SCARPA is recalling F1 EVO ski boots because the Tronic system may fail to release from bindings, posing a fall hazard.

    Product
    F1 EVO Ski Boots with Tronic system component
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15095·2015-03-11

    Urban Outfitters Recalls Cheeky Teacups Due to Fire Hazard

    Urban Outfitters is recalling four styles of Cheeky Teacups because gold paint accents can spark in the microwave, posing a fire hazard.

    Product
    Cheeky Teacups
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1245-2015·2015-03-11

    Baxter AMIA v1.0 APD System Recall for Labeling Warning

    Baxter Healthcare is recalling 55 AMIA v1.0 APD Systems to add a warning about the risk of unintended increased intraperitoneal volume for vulnerable patients.

    Product
    AMIA v1.0 APD System. For Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1232-2015·2015-03-11

    Remel Recalls Oxoid Legionella BCYE Growth Supplement Due to False Negatives

    Remel Inc is recalling Oxoid Legionella BCYE Growth Supplement SR0110A because it may fail to recover Legionella pneumophila, leading to false negative test results.

    Product
    Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ml vials. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England and Oxoid Ltd., Basingstoke, Hants, England.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1216-2015·2015-03-11

    Arjo RotoRest Delta Therapy System Recalled for Unapproved Medical Claims

    Arjo Hospital Equipment AB is recalling 271 RotoRest Delta Advanced Therapy Systems because their labeling contains unapproved medical claims.

    Product
    RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic Therapy System offers kinetic therapy for the most aggressive treatment of pulmonary complications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1241-2015·2015-03-11

    Stryker Recalls V40 Femoral Heads Due to Assembly Issues

    Stryker Howmedica Osteonics is recalling nine V40 femoral heads because they could not be assembled with their corresponding stem trunnions.

    Product
    LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1217-2015·2015-03-11

    Arjo Rotoprone Therapy System Recalled for Unapproved Medical Claims

    Arjo Hospital Equipment AB is recalling 226 Rotoprone Therapy Systems because their labeling and instructions for use contain unapproved medical claims.

    Product
    Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1227-2015·2015-03-11

    Baxter Recalls Syringe Tip Caps for Missing Latex Symbol

    Baxter is recalling Self-Righting Syringe Tip Caps because the latex symbol is missing from the labels.

    Product
    Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1226-2015·2015-03-11

    Intuitive Surgical Recalls Vacuum Source Tubing Sets for Sterility Concerns

    Intuitive Surgical is recalling 706 Vacuum Source Tubing Sets for the EndoWrist Stabilizer because shipping damage may have compromised the sterile packaging.

    Product
    Vacuum Source Tubing Set for the EndoWrist Stabilizer for da Vinci S (IS2000) and Si (IS3000); Part number 420187-05. The Intuitive Surgical EndoWrist Stabilizer Instrument is intended to be used with the fourth arm of the da Vinci S Surgical System. The Intuitive Surgical En
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1233-2015·2015-03-11

    Arrow FiberOptix Intra-Aortic Balloon Catheter Kit Recalled for Labeling Error

    Arrow International Inc. is recalling 165 units of FiberOptix Intra-Aortic Balloon Catheter Kits because the outer package label incorrectly identifies the product size.

    Product
    ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood suppl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1218-2015·2015-03-11

    Arjo TriaDyne Proventa Critical Care Therapy System Recalled for Unapproved Claims

    Arjo Hospital Equipment AB is recalling 567 TriaDyne Proventa Critical Care Therapy Systems because their labeling and instructions for use contain unapproved medical claims.

    Product
    TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1229-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recall for High Bias in Results

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems Progesterone Kits because results above 30 ng/mL may show high bias.

    Product
    ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN: 10310305.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1380-2015·2015-03-11

    Hi-Tech Pharmacal Recalls Ferrous Sulfate Elixir Due to pH Issues

    Hi-Tech Pharmacal is recalling 581 units of Ferrous Sulfate Elixir because stability testing showed out-of-specification pH results.

    Product
    FERROUS SULFATE ELIXIR 220 mg/5 mL, UPC 350838778059, NDC 50383-778-05 --- HI-TECH PHARMACAL CO, INC. AMITYVILLE, NY 11701
    Category
    Drug
    Distribution
    5 states
  • ModerateFDA (Drugs)·D-0397-2015·2015-03-11

    Qualitest Recalls Amlodipine Besylate Tablets Due to Oversized Size

    Qualitest Pharmaceuticals is recalling 2,808 bottles of Amlodipine Besylate tablets because one lot contains oversized tablets.

    Product
    AMLODIPINE BESYLATE TABLETS USP, 10 mg*, 1000 count bottles (NDC 0603-2110-32), Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1239-2015·2015-03-11

    CooperSurgical Pessary Kit Recalled for Incorrect Size Labeling

    CooperSurgical is recalling 95 units of Pessary Kit-CUBE#2 because the packaging label displays the incorrect size.

    Product
    CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0404-2015·2015-03-11

    Pfizer Recalls Oxecta Tablets Due to Failed Impurity Specifications

    Pfizer is recalling 139 bottles of Oxecta (oxycodone HCl) 7.5 mg tablets because they failed impurity and degradation specifications.

    Product
    Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1246-2015·2015-03-11

    DePuy Orthopaedics Recalls Partially Agglomerated SMARTSET GHV Bone Cement

    DePuy Orthopaedics is recalling one lot of SMARTSET GHV Gentamicin Bone Cement because it is partially agglomerated, which may cause surgical delays.

    Product
    SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl methacrylate based cement containing antibiotic. It is used for securing a metal or polymeric prosthesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0405-2015·2015-03-11

    Akorn Recalls Fluticasone Nasal Spray Due to Preservative Failure

    Akorn, Inc. is recalling Fluticasone Propionate Nasal Spray because the preservative benazalkonium chloride failed to meet stability specifications.

    Product
    Fluticasone Propionate Nasal Spray, USP, 50 mcg per spray, in amber glass bottle with net fill weight of 16 g that provides 120 actuations, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC. Amityville, NY 11701 for Akorn Inc. 1925 W. Field Court, Suite 300 Lake Forest Illinoi
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0395-2015·2015-03-11

    Actavis Recalls Dextroamphetamine Sulfate Capsules for Dissolution Failures

    Actavis Elizabeth LLC is recalling 42 bottles of Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg, because they failed dissolution specifications.

    Product
    DEXTROAMPHETAMINE SULFATE — DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1231-2015·2015-03-11

    Siemens ADVIA Centaur Progesterone Kit Recalled for High Result Bias

    Siemens is recalling ADVIA Centaur Progesterone Kits due to high bias in results above 30 ng/mL. The recall affects 1,719 kits distributed worldwide.

    Product
    ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364; SMN: 10333111.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1219-2015·2015-03-11

    Zimmer Segmental System Hip Stem Recalled for Coating Defect

    Zimmer, Inc. is recalling specific Zimmer Segmental System hip stems because the PMMA coating may be missing or not meet specifications.

    Product
    Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0403-2015·2015-03-11

    Pfizer Recalls Oxecta Tablets Due to Failed Impurity Specifications

    Pfizer is recalling 137 bottles of Oxecta (oxycodone HCl) 5 mg tablets because they failed impurity and degradation specifications.

    Product
    Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1228-2015·2015-03-11

    Medtronic CareLink Pro Software Recall for Inaccurate Basal Data Display

    Medtronic MiniMed is recalling CareLink Pro and CareLink Clinical software due to a defect that may cause inaccurate display of Temp Basal time and duration in reports.

    Product
    CareLink Pro Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physic
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0400-2015·2015-03-11

    Nanophase Technologies Recalls Z-COTE HP 1 Transparent Zinc Oxide Powder

    Nanophase Technologies is recalling 4,104 cartons of Z-COTE HP 1 Transparent Zinc Oxide powder due to illegible labels where writing is rubbing off.

    Product
    Z-COTE HP 1 TRANSPARENT ZINC OXIDE, Zinc Oxide (and) Triethoxycaprylylsilane, powder, Net: 22 kg, Packaged in double plastic liners in a single fiber carton, For manufacturing, processing, or repackaging. Nano Technologies Corporation 1319 Marquettte Drive, Romeoville, IL 60446.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-0401-2015·2015-03-11

    AvKARE Recalls Subpotent Quinapril Tablets Due to Low Dosage

    AvKARE Inc. is voluntarily recalling 214 unit dose packs of Quinapril 5 mg tablets nationwide because the medication is subpotent.

    Product
    Quinapril Tablets USP, 5 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026868815, NDC 50268-688-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0402-2015·2015-03-11

    AvKARE Recalls Subpotent Quinapril Tablets Due to Low Drug Content

    AvKARE Inc. is voluntarily recalling 431 unit dose packs of Quinapril Tablets USP, 40 mg, because the medication was found to be subpotent.

    Product
    Quinapril Tablets USP, 40 mg, Rx only, 50 tablets (5 X 10) unit dose pack, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, UPC 5026869115, NDC 50268-691-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V138000·2015-03-10

    Mercedes-Benz Recalls 2015 C300 and C400 for Fuel Pump Defect

    Mercedes-Benz is recalling 2015 C300 and C400 vehicles because the fuel delivery module may be improperly secured or have pinched wires, increasing the risk of fire or stalling.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C400, C300
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15092·2015-03-10

    efco Gas Trimmers Recalled Due to Engine Muffler Fire Hazard

    Comet USA is recalling about 2,100 efco gas trimmers because the engine muffler can break during use, posing a fire hazard. Consumers should stop using the units and return them for a free replacement.

    Product
    efco Gas Trimmers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V136000·2015-03-10

    Blue Bird Recalls School Buses Due to Improper Seat Belt Anchoring

    Blue Bird is recalling 2013-2016 All American and Vision school buses because incorrect fasteners may cause seat belts to be improperly anchored, increasing injury risk in crashes.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN, VISION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V137000·2015-03-10

    Mercedes-Benz Recalls CLS Models for Tail Light Visibility Defect

    Mercedes-Benz is recalling certain CLS 400, 550, and 63 models because LED tail lights may not illuminate on the sides, reducing rear visibility and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ CLS63, CLS550, CLS400
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V135000·2015-03-09

    Winnebago Recalls 2015 RVs Due to Door Opening Defect

    Winnebago is recalling 2015 ERA, View, and Itasca Navion vehicles because an incorrectly installed door component may make doors harder to open after a crash.

    Product
    WINNEBAGO — WINNEBAGO, ITASCA VIEW, ERA, NAVION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15E017000·2015-03-06

    Haldex Air Brake Actuators Recalled for Potential Fire Risk

    Haldex is recalling specific air brake actuators where an internal defect may cause brake drag and overheating, increasing the risk of fire.

    Product
    SERVICE BRAKES, AIR recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V130000·2015-03-06

    Forest River Recalls 2015 XLR Nitro XLT31FQSL Recreational Vehicles

    Forest River is recalling 2015 XLR Nitro XLT31FQSL recreational vehicles because the fueling station hose may be too close to a fuel-burning appliance, increasing fire risk.

    Product
    FOREST RIVER — FOREST RIVER XLR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V131000·2015-03-06

    Forest River Recalls One 2015 XLR Trailer Due to Fire Risk

    Forest River is recalling one 2015 XLR Hyperlite trailer because fuel vapors may ignite near a fuel-burning appliance. The unit is being repaired at the dealership before delivery.

    Product
    FOREST RIVER — FOREST RIVER XLR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V132000·2015-03-06

    Peterbilt Trucks Recalled for Incorrect Tire Pressure Labels

    PACCAR is recalling 2006-2016 Peterbilt trucks because tire labels may list incorrect pressure, risking tire failure and crashes.

    Product
    PETERBILT — PETERBILT 387, 365, 367, 388
    Category
    Vehicle
    Distribution
    Distributed nationwide

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