The Recall Desk

Archive

October 2014 recalls

501 recalls were announced in October 2014.

What the numbers show

Critical
33
Severe
108
High
200
Moderate
147
Low
13

Of the 501 recalls this month scored against our rubric, 7% are Critical, 22% are Severe.

301–400 of 501

  • HighNHTSA·14V639000·2014-10-10

    Acura Recalls MDX and RLX Models for Seat Belt Malfunction

    Honda is recalling 2014-2015 Acura MDX and 2014 RLX vehicles because seat belts may not extend or retract in low temperatures, increasing crash injury risk.

    Product
    ACURA — ACURA MDX, RLX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14E068000·2014-10-10

    Eaton Fuller 365mm Clutch Recall for Disengagement Failure

    Eaton is recalling 574 Fuller 365mm clutches manufactured in 2014 due to a defective bearing that may prevent disengagement, increasing crash risk.

    Product
    POWER TRAIN:CLUTCH ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V637000·2014-10-10

    Goshen Buses Recalled for Wheelchair Lift Platform Cracking Risk

    Goshen Coach is recalling certain buses because wheelchair lift platform side plates may crack, posing an injury risk to operators.

    Product
    GOSHEN — GOSHEN GCII, SENTINEL, SENTRY, PACER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V640000·2014-10-10

    Keystone Recalls 2015 Dutchmen Rubicon Trailers Due to Fuel Line Defect

    Keystone RV Company is recalling 2015 Dutchmen Rubicon trailers because an incorrectly installed fuel line clamp may cause the line to disconnect, potentially leading to a fuel leak and fire.

    Product
    DUTCHMEN — DUTCHMEN RUBICON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15704·2014-10-09

    Rejuvenation Recalls Hanging Lamps Due to Risk of Falling Injury

    Rejuvenation is recalling about 85 Haleigh Wire Dome Pendant lamps because the cord system can fail, causing the lamp to fall and pose a risk of injury.

    Product
    Hanging lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·15703·2014-10-09

    Fluid Handling Recalls Low Water Cut-Off Control Units for Fire Hazard

    Fluid Handling is recalling McDonnell & Miller low water cut-off control units for hot water or steam boilers due to fire and explosion hazards.

    Product
    McDonnell & Miller Low Water Cut-Off control units for hot water or steam boilers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V645000·2014-10-09

    GM Recalls 2015 Chevrolet Colorado and GMC Canyon for Air Bag Wiring

    General Motors is recalling 2015 Chevrolet Colorado and GMC Canyon vehicles because incorrect driver air bag wiring may disrupt deployment timing, increasing injury risk in crashes.

    Product
    CHEVROLET — CHEVROLET, GMC COLORADO, CANYON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1613-2014·2014-10-08

    Black Ant capsules recalled for undeclared sildenafil

    Eugene Oregon, Inc. is recalling Black Ant capsules because FDA testing found undeclared sildenafil. The product was marketed without an approved NDA or ANDA.

    Product
    Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang Pharmaceutical Co., Ltd.
    Category
    Drug
    Distribution
    11 states
  • CriticalFDA (Food)·F-2539-2014·2014-10-08

    TJ's Place Recalls Basil Pesto Pasta Due to Listeria Risk

    TJ's Place is recalling 8 oz. Basil Pesto Pasta tubs because they may be contaminated with Listeria monocytogenes.

    Product
    Basil Pesto Pasta packaged in a non-flex plastic tub, net wt 8 oz. A green sticker is placed on the lid of the package which contains the lot code. Product is refrigerated
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Drugs)·D-1614-2014·2014-10-08

    MOJO RISEN Recalled for Undeclared Sildenafil and Lack of Approval

    Eugene Oregon, Inc. is recalling MOJO RISEN because FDA testing found undeclared sildenafil and the product was marketed without an approved NDA or ANDA.

    Product
    MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Springville, UT 84663
    Category
    Drug
    Distribution
    11 states
  • CriticalFDA (Drugs)·D1612-2014·2014-10-08

    African Black Ant capsules recalled for undeclared sildenafil

    Eugene Oregon, Inc. is recalling African Black Ant capsules because FDA laboratory analyses found undeclared sildenafil. The product was marketed without an approved NDA/ANDA.

    Product
    AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei Bioengineering Company, No. 158, Renmin Road, Xining City.
    Category
    Drug
    Distribution
    11 states
  • CriticalFDA (Drugs)·D-1610-2014·2014-10-08

    Baxter Recalls Dianeal Low Calcium Peritoneal Dialysis Solution Bags

    Baxter Healthcare is recalling 50,530 bags of Dianeal Low Calcium peritoneal dialysis solution due to the presence of particulate matter found during manufacturing.

    Product
    DIANEAL LOW CALCIUM WITH DEXTROSE — DIANEAL LOW CALCIUM WITH DEXTROSE (SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2534-2014·2014-10-08

    Boskovich Farms Recalls Diced Roma Tomatoes Due to Salmonella Risk

    Boskovich Farms is recalling diced Roma tomatoes sold in 24-ounce bags because they may be contaminated with Salmonella.

    Product
    2/24 ounce clear plastic bags of 3/8 inch diced Roma tomatoes. These bags are in a cardboard carton. The bags and carton have a yellow label that reads in part: Boskovich Farms, Inc Costco Deli Dept. 63 ***QUINOA SALAD KIT Item # 624843 CONTENTS: (2) QUINIA MIX *** (2) Diced R
    Category
    Food
    Distribution
    1 state
  • SevereCPSC·15003·2014-10-08

    Fiskars 32-Inch Bypass Lopper Shears Recalled for Laceration Hazard

    Fiskars is recalling 32-inch bypass lopper shears sold at Home Depot because the handles can break, posing a risk of serious injury and laceration.

    Product
    Fiskars® 32-Inch Bypass Lopper Shears
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0002-2015·2014-10-08

    Hospira Recalls Marcaine Injection Vials Due to Visible Metal Particles

    Hospira is recalling 40,730 vials of Marcaine (bupivacaine hydrochloride) injection because of a confirmed complaint of visible metal particles in the solution.

    Product
    MARCAINE — MARCAINE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2535-2014·2014-10-08

    Boskovich Farms Recalls Diced Roma Tomatoes Due to Salmonella Risk

    Boskovich Farms is recalling diced Roma tomatoes because they may be contaminated with Salmonella. The affected product was distributed in California.

    Product
    2-5 lb. clear plastic overwrapped black poly trays of 3/8" diced Roma Tomato per cardboard carton. Cardboard carton labeled: 2-5 LB. DICED TOMATOES 3/8  PACKED BY BOSKOVICH FARMS OXNARD CA, 93030 PRODUCT OF MEXICO.
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14T012000·2014-10-08

    Continental Tires Recalled for Potential Deformation and Sudden Failure

    Continental is recalling specific ProContact GX SSR MOE tires used on 2015 Mercedes-Benz C-Class vehicles due to potential deformation during curing that could cause sudden tire failure.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V634000·2014-10-08

    Chrysler Group Recalls Vehicles Due to Alternator Failure Risk

    Chrysler Group is recalling specific 2011-2014 models because the alternator may fail, causing the vehicle to stall without warning and increasing crash risk.

    Product
    CHRYSLER — CHRYSLER, DODGE, JEEP 300, CHALLENGER, CHARGER, GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V635000·2014-10-08

    Chrysler Recalls 2010-2014 Ram Trucks for Diesel Fuel Heater Fire Risk

    Chrysler is recalling 2010-2014 Ram trucks because diesel fuel heater connectors may overheat, potentially causing fuel leaks and fire.

    Product
    DODGE — DODGE, RAM RAM 5500, 4500, redundant 4500, redundant 5500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0004-2015·2014-10-08

    Baxter Recalls Dopamine Hydrochloride Bags Due to Sterility Concerns

    Baxter Healthcare is recalling 11,808 bags of Dopamine Hydrochloride and Dextrose due to a potential manufacturing defect that may compromise sterility.

    Product
    DOPAMINE HYDROCHLORIDE AND DEXTROSE — DOPAMINE HYDROCHLORIDE AND DEXTROSE (DOPAMINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1615-2014·2014-10-08

    Sagent Recalls Zoledronic Acid Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling 10,622 bags of Zoledronic Acid Injection because of a lack of assurance of sterility and leaking premix bags.

    Product
    ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0005-2015·2014-10-08

    Siemens Medical Imaging Systems Recalled for Image Loss and Labeling Errors

    Siemens is recalling five Luminos Agile Max systems due to malfunctions that cause image loss and incorrect labels, leading to repeated examinations.

    Product
    Siemens Luminos Agile Max system The Luminos Agile is intended to be used as 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, angiog
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·068-2014·2014-10-08

    Buddy's Kitchen Recalls Meat and Poultry Products for Listeria Risk

    Buddy's Kitchen is recalling approximately 62,488 pounds of meat and poultry breakfast products due to possible Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Buddy's Kitchen, Inc. — Minnesota Firm Recalls Meat and Poultry Products for Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2714-2014·2014-10-08

    Teleflex Recalls Hudson Pediatric Anesthesia Breathing Circuits Due to Cracking

    Teleflex Medical is recalling Hudson RCI Pediatric Anesthesia Breathing Circuits because they can crack prior to and during use.

    Product
    Hudson RCI¿ Pediatric Anesthesia Breathing Circuits, Single Patient Use, Rx Only, Product Usage: To administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Ypiece.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0004-2015·2014-10-08

    Siemens Uroskop Omnia Max X-Ray System Recalled for Image Loss

    Siemens is recalling two Uroskop Omnia Max systems because a malfunction causes image loss and incorrect labels, leading to repeated examinations.

    Product
    Siemens Uroskop Omnia Max system The Uroskop Omnia is 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 treat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2537-2014·2014-10-08

    Bar Harbor Jam Company Recalls Blueberry Muffin Mix for Wheat Labeling

    Bar Harbor Jam Company is recalling Maine Wild Blueberry Muffin Mix because the label does not declare wheat. The product was distributed in Maine, New Hampshire, and Massachusetts.

    Product
    BAR HARBOR JAM COMPANY Maine Wild Blueberry Muffin Mix; Net Wt. 1 lb 6 oz (624 g)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2713-2014·2014-10-08

    Siemens Symbia Intevo SPECT/CT Systems Recalled for Rubber Isolator Aging

    Siemens Medical Solutions is recalling 48 Symbia Intevo SPECT/CT systems because a rubber isolator may degrade over time, potentially leading to drive belt rupture.

    Product
    The Symbia Intevo series consists of the Intevo 16, Intevo 6 and Intevo 2. This manual also describes the Symbia Intevo Excel. The Symbia Intevo series integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. T
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-2737-2014·2014-10-08

    Zimmer Recalls Persona Knee System Female Screws Due to Stripping Risk

    Zimmer, Inc. is recalling 16,380 units of Persona The Personalized Knee System 2.5 mm Female Screws due to potential stripping of the hex driver when used in cortical bone.

    Product
    Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2733-2014·2014-10-08

    Lumenis Array LaserLink Recall for Erroneous Retinal Pattern Display

    Lumenis is recalling 16 Array LaserLink laser system accessories because they may project an incorrect pattern on the retina during treatment.

    Product
    Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser system accessory intended for use in the treatment of ocular pathology. " For the Posterior Segment, the Array" LaserLink" is indicated for use in Retinal Photocoagulation and Panretinal Photocoagulatio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2538-2014·2014-10-08

    Bar Harbor Jam Company Popover Mix Recalled for Undeclared Wheat

    Bar Harbor Jam Company is recalling Maine Old Fashioned Popover Mix because the label does not declare wheat. The product was distributed in Maine, New Hampshire, and Massachusetts.

    Product
    BAR HARBOR JAM COMPANY Maine Old Fashioned Popover Mix; Net Wt 1 lb 5 oz (624g)
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2738-2014·2014-10-08

    Baxter SPECTRUM Pump Recall Due to Service Technician Error

    Baxter Healthcare is recalling SPECTRUM Pumps because a service technician may not have followed established procedures between May 5 and June 3, 2014.

    Product
    SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2536-2014·2014-10-08

    Bar Harbor Jam Company Recalls Blueberry Pancake Mix for Wheat Mislabeling

    Bar Harbor Jam Company is recalling Maine Wild Blueberry Pancake Mix because the label fails to declare wheat, posing a risk to individuals with wheat allergies.

    Product
    BAR HARBOR JAM COMPANY Maine Wild Blueberry Pancake Mix; Net Wt. 1 lb 6 oz (624 g)
    Category
    Food
    Distribution
    3 states
  • HighNHTSA·14V632000·2014-10-08

    Chrysler Recalls 2014 Minivans and Wranglers for Tire Pressure Software Error

    Chrysler is recalling 2014 Town and Country, Grand Caravan, and Jeep Wrangler vehicles because a software error may prevent the tire pressure monitoring system from detecting low air pressure.

    Product
    DODGE — DODGE, JEEP, CHRYSLER GRAND CARAVAN, WRANGLER, TOWN AND COUNTRY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0001-2015·2014-10-08

    Invivo Recalls Philips MRI Patient Monitoring Systems Due to Metal Debris

    Invivo is recalling 10 Philips MRI Patient Monitoring Systems because metal debris found during production could cause power failures and loss of patient monitoring.

    Product
    Philips Expression MR200 MRI Patient Monitoring System Model 866120
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2731-2014·2014-10-08

    Intuitive Surgical Recalls da Vinci Xi Patient Side Carts Due to Sensor Failure

    Intuitive Surgical is recalling 75 da Vinci Xi Patient Side Carts because a motor sensor failure can occur after a mid-procedure restart.

    Product
    ASSEMBLY, PATIENT SIDE CART, PS4000 used with the da Vinci Xi Surgical System. Product Usage: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Ins
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0003-2015·2014-10-08

    Siemens AXIOM Luminos dRF Max Systems Recalled for Image Loss Risk

    Siemens is recalling AXIOM Luminos dRF Max systems due to malfunctions that cause lost images and incorrect labels, potentially leading to repeated examinations.

    Product
    Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as 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 p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0001-2015·2014-10-08

    CUBICIN daptomycin injection vials recalled due to potential glass particulate matter

    The FDA is recalling CUBICIN daptomycin injection vials because there may be glass particles present in the vials.

    Product
    CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0002-2015·2014-10-08

    Siemens Ysio Max Radiographic Systems Recalled for Image Loss Risk

    Siemens is recalling Ysio Max radiographic systems because a malfunction can cause images to be lost, requiring patients to repeat examinations.

    Product
    Siemens Ysio Max system The Ysio Max is 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 ba
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2730-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Warnings

    Instrumed International is recalling reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2529-2014·2014-10-08

    Goya Pink Beans Recalled for Possible Can Seam Defect

    Goya Pink Beans are being recalled due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Pink Beans In sauce prepared with Olive Oil, Cilantro & Onion 15 oz. (425g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-2527-2014·2014-10-08

    Goya Red Kidney Beans Recalled for Possible Can Seam Defect

    Tradewind Foods de Puerto Rico Inc. is recalling Goya Red Kidney Beans due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Red Kidney Beans Habichuelas Coloradas 15.5 oz. (439 g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-2523-2014·2014-10-08

    Goya Black Beans Recalled for Possible Can Seam Defect

    Tradewind Foods is recalling Goya Black Beans due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Black Beans Frijoles Negros 15.5 oz (439g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-1616-2014·2014-10-08

    Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Splitting

    Actavis is recalling 36,538 bottles of Diclofenac Sodium and Misoprostol tablets due to complaints of split or broken tablets.

    Product
    DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2531-2014·2014-10-08

    Goya Pinto Beans Recalled for Possible Can Seam Defect

    Goya Pinto Beans In Sauce are being recalled due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Pinto Beans In Sauce prepared with Olive Oil, Cilantro &Tomato 15 oz. (425g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Food)·F-2525-2014·2014-10-08

    Goya and Jibarito Pink Beans Recalled for Can Seam Defect

    Tradewind Foods is recalling Goya and Jibarito Pink Beans due to a possible can seam defect that may compromise product integrity.

    Product
    Pink Beans sold under two brand names Goya and Jibarito (see labels description below) Goya Pink Beans Habichuelas Rosadas 15.5 oz. (439g) El Jibarito Habichuelas Rosadas 15.5 oz. (439g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Drugs)·D-1617-2014·2014-10-08

    Actavis Recalls Diclofenac Sodium and Misoprostol Tablets Due to Splitting

    Actavis is recalling 6,041 bottles of Diclofenac Sodium and Misoprostol tablets because they may be split or broken.

    Product
    DICLOFENAC SODIUM AND MISOPROSTOL — DICLOFENAC SODIUM AND MISOPROSTOL (DICLOFENAC SODIUM AND MISOPROSTOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2711-2014·2014-10-08

    Philips Ingenuity CT Scanners Recalled for Image Exposure Mislabeling

    Philips Medical Systems is recalling 79 Ingenuity CT scanners because they may mislabel the order of image exposures, potentially affecting clinical interpretation.

    Product
    The Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are 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. This device may include signal
    Category
    Medical Device
    Distribution
    11 states
  • ModerateFDA (Devices)·Z-2729-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling 15 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2721-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling 65 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2728-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Caution Statements

    Instrumed International is recalling 71 reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2530-2014·2014-10-08

    Goya Black Bean Soup Recalled for Possible Can Seam Defect

    Tradewind Foods is recalling Goya Black Bean Soup due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Black Bean Soup Prepared with Olive Oil, Bell Pepper & Onion 15 oz. (425g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2732-2014·2014-10-08

    Apollo Endosurgery Recalls LAP-BAND AP Systems Distributed Past Expiration

    Apollo Endosurgery is recalling 10 LAP-BAND AP Systems distributed past their expiration date in seven states.

    Product
    LAP-BAND AP SYSTEM AP Large with Access Port, Allergan, LAP-BAND AP SYSTEM Access Port I. Product was distributed for both the AP Large and AP Standard sizes. The LAP-BAND System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at l
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Food)·F-2524-2014·2014-10-08

    Goya Whole Green Peas Recalled for Possible Can Seam Defect

    Goya Whole Green Peas are being recalled due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Whole Green Peas Chicharos 15.5 oz (439g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2736-2014·2014-10-08

    Nanosphere Recalls Verigene BC-GN Kits Due to Processing Error Risk

    Nanosphere is recalling Verigene BC-GN Kits because a specific lot of extraction trays may cause processing errors in the device.

    Product
    Verigene BC-GN Kit (Catalog number 20-005-021); 1) 20 Verigene BC-GN Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2526-2014·2014-10-08

    Goya Chick Peas Recalled for Possible Can Seam Defect

    Tradewind Foods de Puerto Rico Inc. is recalling Goya Chick Peas Garbanzos 15.5 oz. due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Chick Peas Garbanzos 15.5 oz. (439g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2717-2014·2014-10-08

    KCI CelluTome Epidermal Harvesting System Recalled Due to Blade Shift

    KCI USA, Inc. is recalling 1,331 units of the CelluTome Epidermal Harvesting System because the blade can shift during shipping, rendering the product ineffective.

    Product
    CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2015·2014-10-08

    GE Healthcare Precision 500D X-ray Systems Recalled for Missing Screws

    GE Healthcare is recalling Precision 500D X-ray systems because missing screws may cause the overhead video monitor to detach from the tray assembly.

    Product
    GE Healthcare Precision 500D, Classical R&F System. Product Usage: The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and Pediatric examinations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2727-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling 895 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2724-2014·2014-10-08

    Instrumed Recalls Reusable Laparoscopic Instruments for Updated Safety Instructions

    Instrumed International is recalling 3,093 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2720-2014·2014-10-08

    Siemens Dimension Vista CHEM 1 CAL Recall for Magnesium Calibration Error

    Siemens is recalling Dimension Vista CHEM 1 CAL lot 3GM081 because it causes under-recovery of Magnesium in patient and QC samples.

    Product
    Siemens Dimension Vista¿ CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product for the calibration of Calcium (CA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactic Acid (LA), Magnesium (MG), Thyroxine (T4), Thyroxine Uptake (TU), Blood Urea Nitr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2532-2014·2014-10-08

    Goya Small Red Beans Recalled for Possible Can Seam Defect

    Tradewind Foods de Puerto Rico Inc. is recalling Goya Small Red Beans due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Small Red Beans Habichuelas Coloradas Pequenas 15.5 OZ (439g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2716-2014·2014-10-08

    Siemens Recalls ADVIA Centaur XP Immunoassay Systems Due to Data Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur XP Immunoassay Systems because patient demographic data may incorrectly merge with subsequent orders under rare circumstances.

    Product
    ADVIA Centaur XP Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical di
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2723-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Caution Statements

    Instrumed International is recalling 156 reusable laparoscopic instruments to add caution statements regarding voltage limits and useful life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2722-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling reusable laparoscopic instruments to add caution statements regarding voltage limits and product life.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2528-2014·2014-10-08

    Goya Pinto Beans Recalled for Possible Can Seam Defect

    Tradewind Foods de Puerto Rico Inc. is recalling Goya Pinto Beans due to a possible can seam defect that may compromise product integrity.

    Product
    Goya Pinto Beans Habichuelas Pintas 15.5 oz. (439g)
    Category
    Food
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2726-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling 122 reusable laparoscopic instruments to add caution statements regarding voltage limits and product life to the Instructions For Use.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0009-2015·2014-10-08

    Gendex eXpertDC Intraoral X-Ray Recall for Spring Link Failures

    Gendex Corp is recalling 651 eXpertDC intraoral x-ray units worldwide because spring link components in the articulated arm assembly broke during normal assembly.

    Product
    eXpertDC intraoral x-ray, models: eXpert DC, NA, 75 Inch reach; eXpert DC, NA, 65 Inch reach; eXpert DC, CN, 55 Inch reach; eXpert DC, WW, 75 Inch reach; eXpert DC, WW, 65 Inch reach; eXpert DC, WW, 55 Inch reach; OEM Arm Assembly w/o cables; Assy, Articulated Arm & Tubehead, eD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2715-2014·2014-10-08

    Siemens Recalls ADVIA Centaur Immunoassay Systems Due to Data Error

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Immunoassay Systems because patient demographic data may be incorrectly merged under rare circumstances.

    Product
    ADVIA Centaur Immunoassay System (including refurbished units), This system is intended for professional use in a laboratory environment only. Tests performed using this system are intended for in vitro diagnostic use. As with all diagnostic tests, a definitive clinical diagn
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2719-2014·2014-10-08

    St. Jude Medical Percutaneous Trial Lead Kit Manual Recall

    St. Jude Medical is recalling four units of the Percutaneous Trial Lead Kit Model 3086 because the included manual contained information for devices not approved in the US.

    Product
    Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0007-2015·2014-10-08

    Ortho-Clinical Diagnostics Recalls VITROS Phenytoin Slides Due to Potential Bias

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results, potentially affecting patient care.

    Product
    VITROS Chemistry Products PHYT (Phenytoin) Slides, REF/Product Code 829 8671, IVD. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0006-2015·2014-10-08

    Recall of ENVOY 500 AST Reagent Kits Due to Quality Control Failures

    ELITech Clinical Systems is recalling 878 ENVOY 500 AST Reagent Kits because quality control tests are failing before the products expire.

    Product
    ENVOY 500 AST Reagent Kit, reference Model/Catalog 55255, for Envoy 500. Intended Use of the Product: Envoy 500 AST Reagent is for the quantitative in vitro diagnostic determination of aspartate aminotransferase (AST) in human serum and plasma using the Envoy 500 Chemistry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2725-2014·2014-10-08

    Instrumed Reusable Laparoscopic Instruments Recalled for Updated Safety Instructions

    Instrumed International is recalling 83 reusable laparoscopic instruments to add caution statements regarding voltage limits and product useful life.

    Product
    Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manip
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2734-2014·2014-10-08

    Baro-Therapies Rejuvenator Chamber Recalled for Lack of FDA Approval

    Baro-Therapies, Inc. is recalling 10 Rejuvenator Chambers because they were distributed without an approved 510(k).

    Product
    The Rejuvenator Chamber manufactured by Baro-Therapies, Inc. Product Usage: Indicated for relief from general aches and pains brought on by changes in the weather.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2712-2014·2014-10-08

    Siemens Symbia T Series Medical Imaging Systems Recalled for Rubber Isolator Defect

    Siemens is recalling 1,039 Symbia T Series SPECT/CT systems because a rubber isolator may degrade, potentially leading to drive belt rupture.

    Product
    The Symbia T Series consists of the T16, T6, T2, and T. The Symbia T integrates state-of-the-art SPECT and high quality spiral CT to provide precise attenuation correction and anatomical mapping. The system can also be used as a complete clinical SPECT system for general purpose,
    Category
    Medical Device
    Distribution
    40 states
  • ModerateFDA (Devices)·Z-2735-2014·2014-10-08

    Nanosphere Verigene BC-GP Kit Extraction Tray Recall

    Nanosphere is recalling Verigene BC-GP Kit extraction trays because a specific lot may cause processing errors and tips to drop into the processor.

    Product
    Verigene BC-GP Kit (Catalog number 20-005-018); 1) 20 Verigene BC-GP Test Cartridges; are qualitative multiplexed in vitro diagnostic tests for simultaneous detection and identification of selected gram-positive (BC-GP) and gram-negative (BC-GN) bacteria and resistance markers.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2718-2014·2014-10-08

    St. Jude Medical Percutaneous Trial Lead Kit Manual Recall

    St. Jude Medical is recalling 2 units of Percutaneous Trial Lead Kit Model 3046 because the included manual contained information for devices not approved in the US.

    Product
    Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
    Category
    Medical Device
    Distribution
    2 states
  • SevereNHTSA·14V626000·2014-10-07

    EZ Loader Recalls 2014-2015 Adjustable Steel and Aluminum Trailers

    EZ Loader is recalling 1,357 model year 2014-2015 Adjustable Steel and Aluminum trailers because a suspension bar may break, increasing crash risk.

    Product
    EZ LOADER — EZ LOADER ADJUSTABLE ALUM TRAILER, ADJUSTABLE STEEL TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V629000·2014-10-07

    Suzuki Recalls GSX-R Motorcycles Due to Drive Chain Adjuster Defect

    Suzuki is recalling 2009-2014 GSX-R1000 and 2011-2014 GSX-R750 motorcycles because a damaged drive chain adjuster could cause the chain to come off, increasing crash risk.

    Product
    SUZUKI — SUZUKI GSX-R1000, GSX-R750
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V627000·2014-10-07

    BMW Recalls 2012-2014 Models for Brake Vacuum Pump Defect

    BMW is recalling specific 2012-2014 models because a vacuum pump may fail due to insufficient lubrication, reducing braking power and increasing crash risk.

    Product
    BMW — BMW X1 SAV, 528I, 320I, 328I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V625000·2014-10-07

    Forest River Recalls 2014-2015 Salem and Wildwood RVs for Label Errors

    Forest River is recalling 2014-2015 Salem and Wildwood recreational vehicles because incorrect weight labels may lead to tire failure and crashes.

    Product
    FOREST RIVER — FOREST RIVER SALEM, WILDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V628000·2014-10-07

    Trans Tech School Buses Recalled for Wheelchair Lift Platform Cracking

    Trans Tech is recalling 188 school buses equipped with Ricon wheelchair lifts because the platform side plates may crack, posing an injury risk to operators.

    Product
    TRANS TECH — TRANS TECH STUDENT SAFETY TRANSPORT, ROADSTAR, STUDENT TRANSPORTER AERO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·15701·2014-10-07

    KYMCO Recalls MXU 700 ATVs Due to Fuel Tank Fire and Burn Hazards

    KYMCO is recalling approximately 540 MXU 700 ATVs from model years 2013 to 2015 because fuel tank pressure buildup can cause ruptures, fires, or burns.

    Product
    All-terrain vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·067-2014·2014-10-06

    Galant Food Company Recalls Beef Piroshki Due to Processing Flaw

    Galant Food Company is recalling approximately 410 pounds of beef piroshki because the meat filling did not meet required cooking limits. No illnesses have been reported.

    Product
    Galant Food Co — California Firm Recalls Beef Products Due To Possible Processing Flaw
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·14V621000·2014-10-06

    Micro Bird Recalls School Buses with Cracking Wheelchair Lifts

    Micro Bird is recalling 2006-2014 school buses equipped with specific Ricon wheelchair lifts because the platform side plates may crack, posing an injury risk.

    Product
    MICRO BIRD — MICRO BIRD MB II SCHOOL BUS, G5 SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V622000·2014-10-06

    Micro Bird Transit Bus Recall for Wheelchair Lift Platform Cracking

    Micro Bird is recalling 2006-2014 MB II and G5 transit buses because wheelchair lift platform side plates may crack, posing an injury risk.

    Product
    MICRO BIRD — MICRO BIRD MB II TRANSIT BUS, G5 TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V623000·2014-10-06

    Spartan Emergency Vehicles Recalled for Transmission Fluid Cooler Failure

    Spartan is recalling 2006-2013 emergency vehicles because a failing transmission fluid cooler may allow engine coolant to mix with transmission fluid, increasing crash risk.

    Product
    SPARTAN — SPARTAN METROSTAR, ADVANTAGE, GLADIATOR, DIAMOND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V624000·2014-10-06

    GM Recalls 2015 Cadillac Escalade Models for Air Bag Defect

    General Motors is recalling 2015 Cadillac Escalade and Escalade ESV vehicles because a manufacturing defect may cause inconsistent passenger air bag deployment.

    Product
    CADILLAC — CADILLAC ESCALADE, ESCALADE ESV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·066-2014·2014-10-04

    Texas Firm Recalls Ground Beef Due To Possible Foreign Matter Contamination

    Sam Kane Beef Processors is recalling approximately 90,987 pounds of ground beef products due to possible contamination with extraneous materials, including metal.

    Product
    Texas Firm Recalls Ground Beef Product Due To Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·14V619000·2014-10-03

    BMW Recalls 2014 MINI Cooper Hardtop for Spare Wheel Nut Defect

    BMW is recalling 2014 MINI Cooper Hardtop vehicles because the spare wheel nut may not be self-locking. This could allow the wheel to separate from the vehicle, creating a road hazard.

    Product
    MINI — MINI COOPER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V616000·2014-10-03

    Altec Recalls 2009-2012 Novae Trailers Due to Tongue Cracking Risk

    Altec is recalling 344 Novae Sure-Trac equipment trailers from 2009-2012 because the tongue may crack and separate, increasing crash risk.

    Product
    ALTEC — ALTEC NOVAE ST81181TPL2-B-140
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·065-2014·2014-10-03

    Vigil's Beef Jerky Recalled for Lack of Federal Inspection

    Vigil's Beef Jerky Co. is recalling approximately 48 pounds of beef jerky produced without federal inspection but marked as inspected.

    Product
    Vigil's Beef Jerky — New Mexico Firm Recalls Beef Jerky Products Produced Without the Benefit of Inspection
    Category
    Food
    Distribution
    1 state

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