The Recall Desk

Archive

February 2013 recalls

297 recalls were announced in February 2013.

What the numbers show

Critical
10
Severe
53
High
170
Moderate
44
Low
20

Of the 297 recalls this month scored against our rubric, 3% are Critical, 18% are Severe.

Which agencies issued them

101–200 of 297

  • HighFDA (Devices)·Z-0807-2013·2013-02-20

    Remel Xpect Clostridium difficile Toxin A/B Test Recalled for False Negatives

    Remel Inc is recalling 50 units of the Xpect Clostridium difficile Toxin A/B test kit due to a potential for false negative results.

    Product
    Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests, REF 24640. Product Usage: The test kit is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal sp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0654-2013·2013-02-20

    Lockheed Martin Gyrocam Systems Recalled for Laser Safety Non-Compliance

    Lockheed Martin Gyrocam Systems are being recalled because they contain Class IIIb lasers that failed FDA performance standards and were sold without a required variance.

    Product
    Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used for law enforcement surveillance from aircraft. Models DNV, TS and DS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0805-2013·2013-02-20

    Aesculap Miethke Shunt System Recalled Due to Deflector Movement Issue

    Aesculap, Inc. is recalling 11 units of the Miethke Shunt System because the deflector may not move freely on the ventricular catheter.

    Product
    Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric Cathet, w/Stylet and RT-ANG Guide Central Nervous System Shunt and Components intended to shunt cerebrospinal fluid (CSF) from the lateral ventricles of the brain into the
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0993-2013·2013-02-20

    H-E-B Recalls Lemon Grass Chicken Deli Products Due to Salmonella Risk

    H-E-B is recalling specific Lemon Grass Chicken deli products in Texas due to potential Salmonella contamination.

    Product
    HEB Deli Lemon Grass Chicken Entree UPC 0026967100000; HEB Deli HE Bowl Lemon Grass Chicken UPC 0026967600000; HEB Deli Lemon Grass Chicken Retail Pack UPC 0026521800000; HEB Deli Lemon Grass Chicken UPC 0026705200000
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0748-2013·2013-02-20

    GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

    GE Healthcare is recalling 276 Giraffe and Panda T-Piece Resuscitation Systems because oxygen and air inlet fittings were reversed during assembly.

    Product
    GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0818-2013·2013-02-20

    Richmar Foam Electrodes Recalled for Terminal Separation Defect

    NAImco Inc dba Richmar Inc is recalling foam electrodes where the socket terminal may pull away from the lead wire. The defect poses a risk of electrical shock or injury.

    Product
    Foam electrodes with Silver-Carbon construction: P/N 202-9271, Cat No. 400-898, 2" x 2" Electrode, Foam, AG, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 202-9281, Cat No. 202-9281, 2" Round Electrode, Foam, AG, All Serial Numb
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0804-2013·2013-02-20

    Breg Recalls Sterile Polar Pads Due to Packaging Damage

    Breg Inc is recalling 44,883 units of Sterile Polar Pads manufactured between January 2010 and October 2012 because packaging damage may compromise sterility.

    Product
    BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0815-2013·2013-02-20

    Richmar Cloth Electrodes Recalled for Terminal Separation Defect

    NAImco Inc dba Richmar Inc is recalling specific cloth electrodes because the socket terminal may pull away from the lead wire. The defect could cause electrical stimulation issues.

    Product
    Cloth electrodes with Carbon construction: P/N 201-1231, Cat Nos.: 201-123, 202-454, 203-118, 203-342, 203-454, 203-493, 203-672, 400-877, and 400-877-BJC, 2" x 2" Electrode, Cloth, All Serial Numbers distributed between 11/01/2009 and 01/31/2010 P/N 201-12
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0822-2013·2013-02-20

    Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings

    Viterion TeleHealth Monitors are being recalled because they do not transmit 'HI' or 'LO' blood glucose readings from specific Bayer and Roche meters to healthcare professionals.

    Product
    Viterion TeleHealth Monitor Model Number V500; Product Codes 08832984 (US) and 02080468 (UK) - Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0824-2013·2013-02-20

    Philips SureSigns VS2+ Vital Signs Monitor Recall for Screen Lockup

    Philips Healthcare is recalling 3,248 SureSigns VS2+ monitors because the screen may lock up and stop monitoring patients.

    Product
    Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0821-2013·2013-02-20

    Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings

    Viterion TeleHealth Monitors are being recalled because they do not transmit out-of-range blood glucose readings from specific Bayer and Roche meters to healthcare professionals.

    Product
    Viterion TeleHealth Monitor Model Number V100-BGM, Product Code 81842478 (US) -- Physiological patient monitor (without arrhythmia detection or alarms) . Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0975-2013·2013-02-20

    Suadel Recalls Yellow Dough Shells for Undeclared Allergens and Dye

    Suadel Food Products is recalling Estrella yellow dough shells in Puerto Rico due to undeclared Yellow #6 and soy.

    Product
    "Estrella Food Products, Inc***Plantillas Para Pastelillos, tacos, Empanadillas, etc. (Yellow dough shells)***12 units, and 20 units***Manufactured by: Estrella Food Products, Inc., Minillas Industrial Park,Bayamon, PR 00959-1906***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0985-2013·2013-02-20

    Pamela's Baking and Pancake Mix Recalled for Potential Glass or Plastic Fragments

    Pamela's Products, Inc. is recalling 2,229 cases of Baking and Pancake Mix due to complaints that the product may contain glass or plastic fragments.

    Product
    Pamela's Baking and Pancake Mix; Gluten Free, Wheat Free 24 oz package. UPC 93709-30010 Pamela's Products, Ukiah, CA 95482
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0987-2013·2013-02-20

    Pamela's Chocolate Cake Mix Recalled for Potential Glass or Plastic Fragments

    Pamela's Products, Inc. is recalling specific batches of Chocolate Cake Mix due to complaints that the product may contain glass or plastic fragments.

    Product
    Pamela's Chocolate Cake Mix; Gluten Free, Wheat Free, Non Dairy 21 oz. package. UPC 93709-30040 Pamela's Products, Ukiah, CA 95482
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0972-2013·2013-02-20

    Cheese Mini Turnovers Recalled for Undeclared Milk Allergen

    Suadel Food Products is recalling Estrella Pastelillos de Queso because the common name 'milk' is not declared in the ingredients or 'Contains' statement.

    Product
    "Estrella Food Products, Inc***Pastelillos de Queso (Cheese Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minilla Industrial Park, Bayamon, PR 00959-1906***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0795-2013·2013-02-20

    Lumenis Recalls VersaCut Tissue Morcellator for Labeling Corrections

    Lumenis Limited is recalling VersaCut Tissue Morcellator devices to correct labeling following three reported air embolism events caused by incorrect tubing hook-up.

    Product
    The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0749-2013·2013-02-20

    GE Healthcare Recalls Infant Resuscitation Systems Due to Reversed Fittings

    GE Healthcare is recalling 276 Giraffe and Panda Bag and Mask Resuscitation Systems because oxygen and air inlet fittings were reversed during assembly.

    Product
    Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency powered resuscitator]/Panda Bag and Mask Resuscitation System provides the basic equipment required for pulmonary resuscitation of infants.
    Category
    Medical Device
    Distribution
    31 states
  • HighFDA (Devices)·Z-0819-2013·2013-02-20

    Quidel Recalls Sofia Influenza A+B FIA Kits Due to False Positives

    Quidel is voluntarily recalling specific lots of Sofia Influenza A+B FIA kits because they may produce false positive results, potentially leading to misdiagnosis.

    Product
    Quidel, Sofia Influenza A + B FIA, Kit #20218 (25-Test Kit), in vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0820-2013·2013-02-20

    Viterion TeleHealth Monitors Fail to Transmit Out-of-Range Blood Glucose Readings

    Viterion TeleHealth Monitors are being recalled because they fail to transmit out-of-range blood glucose readings from specific Bayer and Roche meters to healthcare professionals.

    Product
    Viterion TeleHealth Monitor Model Number V100, Product Codes 09377512 (US) and 04480218 (UK). Physiological patient monitor (without arrhythmia detection or alarms). Viterion V100, V100-BGM and V500 Telehealth Monitors transfer medical information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0763-2013·2013-02-20

    St. Jude Medical Recalls TorqVue FX Delivery Systems Due to Fracture Risk

    St. Jude Medical is recalling 635 TorqVue FX Delivery Systems because the core wire could fracture during use.

    Product
    St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #'s: 9-ITVFX06F45/60, 9-ITVFX07F45/60, 9-ITVFX007F45/80, 9-ITVFX08F45/60, 9-ITVFX08F45/80, 9-ITVFX09F45/80, 9-ITVFX10F45/80 9-ITVFX12F45/80, 9-ITVFX13F45/80. Cardiac surgical instrument, used
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0803-2013·2013-02-20

    Breg Cold Therapy Units Recalled for Potential Sterility Compromise

    Breg Inc is recalling Cold Therapy Combination Units with Sterile Polar Pads because packaging damage may have compromised sterility assurance.

    Product
    BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0799-2013·2013-02-20

    Fresenius Liberty Cycler Set Recalled for Leak and Contamination Risk

    Fresenius Medical Care is recalling 5,590 Liberty Cycler Sets due to a small risk of leaks that could contaminate dialysate and cause peritonitis.

    Product
    Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0814-2013·2013-02-20

    GE Healthcare Recalls Dash Port 2 Docking Stations for Communication Failure

    GE Healthcare is recalling Dash Port 2 docking stations because they may stop communicating with the monitor, causing a loss of patient monitoring.

    Product
    GE Healthcare, Dash Port 2 Docking Station. Product Usage: is a docking station (quick mount/dismount base) for a Dash patient monitor. The system is to monitor physiologic parameter data on adult, pediatric, and neonatal patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0974-2013·2013-02-20

    Suadel Empanadillas Recalled for Undeclared Wheat and Soy Allergens

    Suadel Food Products is recalling Empanadillas Sabor a Carne because wheat and soy are not declared on the label.

    Product
    "Estrella Food Products, Inc***Empanadillas Sabor a Carne(Meat flavorTurnovers)***5 units, 12 units and 24 units***Elaborado y Empacado por: Estrella Food Products, Inc., Bayamon, PR 00959-1906***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0801-2013·2013-02-20

    Remel Lyophilized Growth Supplement Recalled for Microbial Contamination

    Remel Inc is recalling 10 units of a lyophilized growth supplement for Legionella testing due to potential low-level microbial contamination.

    Product
    The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium used for isolation of Legionellae from clinical and environmental samples.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-0971-2013·2013-02-20

    Estrella Pizza Turnovers Recalled for Undeclared Wheat and Milk Allergens

    Suadel Food Products is recalling Estrella Empanadillas de Pizza due to undeclared wheat and milk. The product was distributed in Puerto Rico.

    Product
    "ESTRELLA***Empanadillas de Pizza" (Pizza turnovers)***5 units, 12 units and 24 units***Elaborado y Empacado por: Estrella Food Products, Inc., Bayamon, PR 00959-1906***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0989-2013·2013-02-20

    Mann Packing Recalls Snap Peas Containing Unapproved Pesticide Carbendazim

    Mann Packing is recalling snap peas found to contain Carbendazim, a pesticide not allowed in the US but approved in the EU.

    Product
    Stringless Sugar Snap Peas, Sunny Shores' Mann's. Net Wt 8 oz (227 g); Perishable, Preservative Free, keep refrigerated. Product of Guatemala UPC 7 16519 13004 Distributed by Mann Packing, Salinas, CA.
    Category
    Food
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0800-2013·2013-02-20

    Bacterin Recalls Expired Osteoselect Demineralized Bone Matrix Putty

    Bacterin International is recalling expired Osteoselect Demineralized Bone Matrix Putty shipped to customers in Texas, Georgia, and California.

    Product
    Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0813-2013·2013-02-20

    GE Healthcare Recalls Dash Patient Monitors Due to Ethernet Controller Issues

    GE Healthcare is recalling Dash 3000, 4000, and 5000 Patient Monitors because an intermittent Ethernet controller defect may cause network connectivity issues.

    Product
    GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-160-2013·2013-02-20

    Upsher Smith Recalls Propranolol Hydrochloride Capsules for Dissolution Failure

    Upsher Smith Laboratories is recalling 60 bottles of Propranolol Hydrochloride Extended-release Capsules, 80 mg, due to failed dissolution test requirements.

    Product
    Propranolol Hydrochloride Extended-release Capsules, USP, 80 mg, 100 Capsules, Rx only, Manufactured for Upsher Smith Laboratories, Inc Minneapolis MN 55447 --- NDC 0245-0085-11, UPC 3 0245-0085-11 9
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0809-2013·2013-02-20

    Chenica Wheelchairs Recalled for Crash Test Specification Non-Compliance

    Chenica Inc. is recalling 53 Gunnell Rehab Series wheelchairs because they may not meet WC-19 crash testing specifications.

    Product
    Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and Tilt (TNT), Rehab Recline and Mobility (RAM), Rehab Kidster (Kidster). Provide mobility to individuals limited to a seating position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0808-2013·2013-02-20

    Remel Recalls Oxoid Cefoxitin Antimicrobial Susceptibility Discs Due to Insufficient Dose

    Remel Inc is recalling 23 units of Oxoid Cefoxitin Antimicrobial Susceptibility Discs because the cartridges may contain discs with an insufficient antibiotic dose.

    Product
    Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug REF CT0119B, packaged with 50 discs per cartridge, 5 cartridges per box. The responsible firm name on the label is Oxoid Ltd., Basingstoke, Hants, UK.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0812-2013·2013-02-20

    Ultradent Chromaclone PVS Impression Material Recalled for Packaging Error

    Ultradent Products is recalling specific lots of Chromaclone PVS impression material due to incorrect packaging of regular and fast set cartridges.

    Product
    Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-164-2013·2013-02-20

    West-ward Recalls Subpotent Glycopyrrolate Tablets in Ohio

    West-ward Pharmaceutical Corp. voluntarily recalled 1,185 bottles of Glycopyrrolate Tablets, USP, 1 mg, in Ohio due to subpotent drug content.

    Product
    Glycopyrrolate Tablets, USP, 1 mg, Rx Only, 100 tablets per bottle, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ, 07724, NDC 0143-1250-01.
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-162-2013·2013-02-20

    Ranbaxy Recalls Lac-Hydrin Lotion Due to Crystallization Texture

    Ranbaxy Inc. is recalling 4,016 bottles of Lac-Hydrin Lotion, 12%, due to a gritty texture caused by crystallization.

    Product
    Lac-Hydrin (ammonium lactate) Lotion, 12%, packaged in 400 g bottles, Rx only, Ranbaxy, Jacksonville, FL 32257 USA, NDC 10631-098-14.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-0976-2013·2013-02-20

    Guava Mini Turnovers Recalled for Undeclared Red #40 Dye

    Suadel Food Products is recalling 3,672 units of Estrella Pastelillos de Guayaba sold in Puerto Rico due to undeclared Red #40 dye.

    Product
    "Estrella Food Products, Inc***Pastelillos de Guayaba (Guava Mini Turnovers)***6 units***Manufactured by: Estrella Food Products, Inc., Minillas Industrial Park,Bayamon, PR 00959-1906***".
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-163-2013·2013-02-20

    Ranbaxy Recalls Lac-Hydrin Cream Due to Crystallization

    Ranbaxy Inc. is recalling specific lots of Lac-Hydrin (ammonium lactate) Cream, 12%, due to a gritty texture caused by crystallization.

    Product
    Lac-Hydrin (ammonium lactate) Cream, 12%, packaged in a) 280 g (2 x 140 g tubes), NDC 10631-099-28; b) 385 g bottle, NDC 10631-099-38; Rx only, Ranbaxy, Jacksonville, FL 32257 USA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0811-2013·2013-02-20

    Ultradent Chromaclone PVS Impression Material Recalled for Packaging Error

    Ultradent Products is recalling specific lots of Chromaclone PVS impression material due to incorrect packaging of regular and fast set cartridges.

    Product
    Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·13V051000·2013-02-19

    Hyundai Recalls 2012 Veloster Vehicles Due to Sunroof Glass Defect

    Hyundai is recalling 2012 Veloster vehicles with panoramic sunroofs because the glass assembly may be weakened, posing a risk of breakage while driving.

    Product
    HYUNDAI — HYUNDAI VELOSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·13V055000·2013-02-15

    Prevost Recalls H3-41 and H3-45 Coaches for Steering Defect

    Prevost is recalling 6,120 H3-41 and H3-45 coaches because a steering component may fracture, causing loss of vehicle control.

    Product
    PREVOST — PREVOST H3-41, H3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·13E008000·2013-02-15

    Yakima SpareTime Bike Rack Recall Due to Mounting Bolt Failure

    Yakima is recalling SpareTime two-bike rack systems because mounting bolts may break, causing the rack to fall and create a road hazard.

    Product
    EQUIPMENT:MECHANICAL:CARRIER/RACK recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·13725·2013-02-14

    John Deere Recalls Gator Utility Vehicles Due to Fire Hazard

    John Deere is recalling about 4,700 Gator RSX850i utility vehicles because oil filters may leak, posing a fire hazard. No injuries have been reported.

    Product
    Utility Vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·13121·2013-02-14

    Cramer Recalls Folding Step Stools Due to Fall Hazard

    Cramer LLC is recalling Task*It 1-UP folding step stools because they can crack or break, posing a fall hazard to users.

    Product
    Task*It 1-UP folding step stool
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-157-2013·2013-02-13

    Bracco Recalls Isovue-370 Injection Syringes Due to Particulate Matter

    Bracco Diagnostic Inc. is recalling specific lots of Isovue-370 injection syringes because they contain particulate matter, including cellulose and polyvinyl fibers.

    Product
    Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany).
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-148-2013·2013-02-13

    Globe All Wellness Recalls Slim Xtreme Capsules Containing Unapproved Sibutramine

    Globe All Wellness is recalling Slim Xtreme Herbal Slimming Capsules because testing revealed the presence of sibutramine, an unapproved and withdrawn drug.

    Product
    SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-155-2013·2013-02-13

    Zicam Nasal Spray Recalled for Burkholderia cepacia Contamination

    Matrixx Initiatives Inc is recalling Zicam Extreme Congestion Relief nasal spray due to potential contamination with Burkholderia cepacia. The recall covers 46,752 bottles distributed nationwide.

    Product
    Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-158-2013·2013-02-13

    Bracco Recalls Isovue-300 Injection Syringes Due to Particulate Matter

    Bracco Diagnostic Inc. is recalling specific lots of Isovue-300 Injection syringes because they contain particulate matter identified as cellulose and polyvinyl fibers.

    Product
    Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0777-2013·2013-02-13

    Winco Premier Lifecare Recliner 5400 Recalled for Fire Safety Non-Compliance

    Winco Mfg. is recalling 95 Premier Lifecare Recliner 5400 units because their foam and vinyl do not meet California's TB 133 fire protection standards.

    Product
    PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-153-2013·2013-02-13

    Hospira Recalls Carboplatin Injection Vials Due to Crystallization

    Hospira Inc. is recalling 23,315 vials of Carboplatin Injection due to visible particulates identified as Carboplatin crystals.

    Product
    CARBOPLATIN — CARBOPLATIN (CARBOPLATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-154-2013·2013-02-13

    Hospira Recalls Carboplatin Injection Vials Due to Visible Crystals

    Hospira is recalling 31,326 vials of Carboplatin Injection due to visible crystals found during inspection. The product is distributed nationwide and in Puerto Rico.

    Product
    CARBOPLATIN — CARBOPLATIN (CARBOPLATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-147-2013·2013-02-13

    Mylan Recalls Lansoprazole Capsules Due to Foreign Topiramate Tablets

    Mylan Pharmaceuticals is recalling 1,894 bottles of lansoprazole 30 mg capsules because they may contain foreign topiramate 100 mg tablets.

    Product
    LANSOPRAZOLE — LANSOPRAZOLE (LANSOPRAZOLE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0968-2013·2013-02-13

    Dried Preserved Plum Recalled for Lead Contamination

    Nuera Trading Company is recalling Dried Preserved Plum packages due to lead levels exceeding safety limits found by the California Department of Public Health.

    Product
    Dried Preserved Plum packaged in clear 4.4 lb (1904 g) plastic packages. The product comes in bulk form in a brown corrugated box with 10 x 4.4 lb packages. Net weight of one case is 44 lbs.. Product information is provided on the case with product name "Dried Preserved Plum" and
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-0784-2013·2013-02-13

    Lansinoh Thera Pearl Breast Therapy Hot and Cold Packs Recalled for Overheating Risk

    Lansinoh is recalling Thera Pearl 3-in-1 Breast Therapy packs because incorrect Spanish heating instructions may cause the product to overheat.

    Product
    THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0797-2013·2013-02-13

    Custom Breast Biopsy Tray Recalled for Potential Particulate Matter

    Custom Healthcare Systems is recalling breast biopsy trays because they may contain particulate matter in the included sodium chloride.

    Product
    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0978-2013·2013-02-13

    Penzeys Vietnamese Cinnamon Recalled Due to Glass Contamination

    Penzeys is recalling Vietnamese Cinnamon Extra Fancy after a customer reported finding pieces of glass in the product.

    Product
    Vietnamese Cinnamon Extra Fancy, product code 43200, Penzeys Spices, Wauwatosa, WI 53222. to be completed
    Category
    Food
    Distribution
    4 states
  • HighFDA (Food)·F-0965-2013·2013-02-13

    Annie's Homegrown Pizza Recalled for Potential Metal Fragments

    Annie's Homegrown is recalling Rising Crust Four Cheese Pizza due to a faulty screen at the flour mill that may have allowed metal fragments into the product.

    Product
    Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. Certified Organic, 23.5 oz package. Product UPC: 0 13562-20001 6; Case UPC 1 00 13562 20001 3 Annie's, Inc. 1610 5th Street Berkeley, CA 94710
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0766-2013·2013-02-13

    Tobii P10 Battery Box Recalled for Smoke and Chemical Smell During Recharging

    Tobii Assistive Technology is recalling 483 P10 battery boxes that malfunctioned while recharging, producing smoke and a chemical smell.

    Product
    P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·13120·2013-02-13

    MJC Recalls Beamerzzz Stuffed Animals with LED Flashlights Due to Laceration Hazard

    MJC is recalling Beamerzzz stuffed animals with LED flashlights sold at Cabela's because exposed wires pose a laceration hazard. Consumers should remove the toys from children and contact the manufacturer for a replacement.

    Product
    Beamerzzz™ Stuffed Animals with LED Flashlight
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0782-2013·2013-02-13

    Synthes Spine Vectra Adjustable Drill Stop Recalled for Slip Risk

    Synthes USA is recalling 48 units of the Spine Vectra Adjustable Drill Stop because the device may slip on the drill bit, posing a risk of adverse events during surgery.

    Product
    Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the ce
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0967-2013·2013-02-13

    Annie's Homegrown Four Cheese Pizza Recalled for Potential Metal Fragments

    Annie's Homegrown is recalling Rising Crust Four Cheese Pizza due to a faulty screen at the flour mill that may have allowed metal fragments into the product.

    Product
    Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. 22.5 oz package. Product UPC: 0 13562-20007 8; Case UPC 1 00 13561 20007 5. Annie's, Inc. 1610 5th Street Berkeley, CA 94710
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0982-2013·2013-02-13

    Tristar Food Wholesale Recalls Dried Cabbage for Undeclared Sulfites

    Tristar Food Wholesale is recalling Double Swallow brand dried cabbage because it contains undeclared sulfites, a preservative that poses a risk to sensitive individuals.

    Product
    Outer Cardboard Container - China Products Fresh Dried Cabbage. Plastic Bag: Double Swallow Brand, Net Wt 0.15 Kg (529 OZ), Dehydrated Cole, Jiangmen Native Produce Import & Export Company of Guangdong China.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-0774-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects

    Zimmer, Inc. is recalling Trilogy Acetabular AB Shells because some units have porosity levels below the required specification.

    Product
    Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2013·2013-02-13

    Winco Cozy Comfort Premier Recliner 5580 Recalled for Fire Safety Non-Compliance

    Winco Mfg. is recalling 95 Cozy Comfort Premier Recliner 5580 units because the foam and vinyl chemicals do not consistently meet California TB 133 fire protection mandates.

    Product
    Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0775-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells with Porosity Defects

    Zimmer, Inc. is recalling Trilogy Acetabular Shells with holes because some units have porosity below the specified range, which may affect bone ingrowth.

    Product
    Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0769-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells for Porosity Defect

    Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity below the specified range. The recall includes 275,952 units distributed worldwide.

    Product
    Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for reha
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0778-2013·2013-02-13

    Winco Premier Care Recliners Recalled for Fire Safety Non-Compliance

    Winco Mfg. is recalling 95 Premier Care Recliners because the foam and vinyl chemicals do not consistently meet California's TB 133 fire protection mandate.

    Product
    PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0794-2013·2013-02-13

    Allergen Medical Recalls SeriScaffold Surgical Scaffold Due to Sterility Concerns

    Allergen Medical is recalling SeriScaffold Surgical Scaffold units because the outer packaging seal may be compromised, potentially compromising sterility.

    Product
    SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-0785-2013·2013-02-13

    Invacare Solara 3G Manual Wheelchair Recalled for Brake Failure Risk

    Invacare is recalling three Solara 3G custom manual wheelchairs because the wheels may rotate freely despite the hub brake being engaged.

    Product
    Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2013·2013-02-13

    Anspach Effort Recalls Bearing Sleeve Devices Due to Metal Fragment Risk

    The Anspach Effort, Inc. is recalling 8 MA-15C Bearing Sleeve devices distributed in Massachusetts. The recall addresses a risk of metal fragments remaining in the surgical site.

    Product
    Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0780-2013·2013-02-13

    Winco Medical Recliners Recalled for Fire Protection Non-Compliance

    Winco Mfg. is recalling 95 medical recliners because their foam and vinyl do not meet California fire safety standards.

    Product
    Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells for Porosity Specification Defects

    Zimmer, Inc. is recalling Trilogy Acetabular Shell Spiked units because some may have porosity levels below the required specification.

    Product
    Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0791-2013·2013-02-13

    Medacta Quadra Trial Broach size 0 recalled due to tip breakage

    Medacta USA Inc. is recalling 26 units of the Quadra Trial Broach size 0 because the tip broke during surgery.

    Product
    Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0773-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect

    Zimmer, Inc. is recalling Trilogy Acetabular Shells because some units may have porosity below the specified range, potentially affecting the device's performance.

    Product
    Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0776-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect

    Zimmer, Inc. is recalling Trilogy Acetabular AB Shells with Holes because some units may have porosity below the specified range.

    Product
    Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells for Porosity Defects

    Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity levels below the specified range. The recall includes units manufactured since March 2009 and was expanded in October 2012.

    Product
    Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing su
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0796-2013·2013-02-13

    Custom Breast Biopsy Tray Recalled for Potential Particulate Matter

    Custom Healthcare Systems is recalling 80 breast biopsy trays because they may contain particulate matter in the pharmaceuticals used for injection.

    Product
    Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0768-2013·2013-02-13

    Oxus Portable Oxygen Concentrator Li-Ion Battery Recall

    Oxus America is recalling 1,724 Li-Ion batteries for the RS-00400 Portable Oxygen Concentrator due to potential over-discharge damage to cells.

    Product
    Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0771-2013·2013-02-13

    Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects

    Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells with Uni-Hole because some units have porosity below the specified range.

    Product
    Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0781-2013·2013-02-13

    Synthes Spine Drill Bit Recalled for Potential Drill Stop Slippage

    Synthes USA is recalling 63 units of 2.5mm drill bits for the Vectra Spine System due to a potential drill stop slippage hazard.

    Product
    Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0966-2013·2013-02-13

    Annie's Homegrown Spinach and Mushroom Pizza Recalled for Metal Fragments

    Annie's Homegrown is recalling specific pizzas due to potential metal fragments from a faulty flour mill screen.

    Product
    Annie's Homegrown Rising Crust Spinach and Mushroom Pizza. Spinach, Portobello and Button mushrooms with a Garlic Parmesan cream sauce.. Certified Organic, 25.0 oz package. Product UPC: 0 13562-20005 4; Case UPC 1 00 13562 20005 1 Annie's, Inc. 1610 5th Street Berkeley
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0969-2013·2013-02-13

    Acme Recalls Canned Mandarin Oranges Due to Unidentified Chemical Contaminant

    Acme Food Sales is recalling 8,707 cases of Western Family canned mandarin oranges after consumer complaints of chemical taste and preliminary testing confirmed a contaminant.

    Product
    Canned mandarin oranges labeled in part: "WESTERN FAMILY Choice Selections Mandarin Oranges Naturally Sweet in Mandarin Orange Juice NET WT 10.5OZ (297g)***Ingredients: Mandarin Oranges, Mandarin Orange Juice. Proudly Distributed by Western Family P.O. Box 4057, Portland, OR 972
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0793-2013·2013-02-13

    OPTIGEN Food 30 Allergen Testing Kits Recalled for Potential False Negatives

    Hitachi Chemical Diagnostics is recalling 20 kits of OPTIGEN Food 30 allergen testing products due to a potential low fill volume that could cause false negative results.

    Product
    OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-145-2013·2013-02-13

    Watson Pharmaceuticals Recalls Taztia XT Due to Dissolution Failure

    Watson Pharmaceuticals is recalling Taztia XT (diltiazem HCI) capsules because stability testing revealed a failed dissolution specification.

    Product
    Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0788-2013·2013-02-13

    Exactech Recalls Hip Replacement Liners Due to Labeling Error

    Exactech is recalling 26 hip replacement liners because the device labeling was inadvertently transposed. The units were distributed in five states.

    Product
    Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-0983-2013·2013-02-13

    Imperial Nuts and Snacks Chocolate and Peanut Platter Recalled for Undeclared Dyes

    Star Snacks Co., LLC is recalling Imperial Nuts and Snacks Chocolate and Peanut Platter because it contains undeclared FD&C colors.

    Product
    Imperial Nuts and Snacks Chocolate and Peanut Platter. Packed By: Star Snacks CO., LLC, Jersey City, NJ 07305. Net Wt. 26 oz (737 g) UPC 5351946762.
    Category
    Food
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-143-2013·2013-02-13

    Actelion Recalls Three Cartons of Subpotent Ventavis Inhalation Solution

    Actelion Pharmaceuticals is recalling three cartons of Ventavis (iloprost) Inhalation Solution due to an out-of-specification assay result indicating the drug was subpotent.

    Product
    Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30.
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-149-2013·2013-02-13

    West-ward Recalls Prednisone Tablets Due to Gray Defects

    West-ward Pharmaceutical Corp. is recalling specific lots of PredniSONE Tablets, USP, 10 mg, due to the presence of gray defects in the tablets.

    Product
    PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0790-2013·2013-02-13

    Remel Recalls Oxoid Aztreonam Antimicrobial Susceptibility Test Discs

    Remel Inc is recalling Oxoid Aztreonam test discs because some may lack antibiotic impregnation, potentially affecting test accuracy.

    Product
    Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, [email protected] (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0787-2013·2013-02-13

    Exactech Recalls Novation Crown Cup Hip Liners Due to Labeling Error

    Exactech is recalling 26 units of Novation Crown Cup hip replacement liners because device labeling was inadvertently transposed.

    Product
    Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement.
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-0765-2013·2013-02-13

    Sybron Endo Lightspeed LSX Files Recalled for Incorrect Length Markings

    Ormco/Sybronendo is recalling specific lots of Lightspeed LSX endodontic files because their length markings are incorrect.

    Product
    Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root ca
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-0977-2013·2013-02-13

    Mama Tere Barley Flour Recalled for Undeclared Food Dyes

    Family Food Distributor, Inc. is recalling Mama Tere Cebada Natural Barley Flour because it contains undeclared food dyes Red #3 and Red #40.

    Product
    Mama Tere Cebada Natural Barley Flour Net Weight /Peso Neto: 12 oz (340g) Family Food Distributors Bergen Avenue Kearny, NY 07032 UPC 7412003000259
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Drugs)·D-150-2013·2013-02-13

    West-ward Recalls Carisoprodol Tablets Due to Foreign Substance Presence

    West-ward Pharmaceutical Corp. is recalling 8,585 bottles of Carisoprodol Tablets, USP, 350 mg, due to the presence of uncharacteristic black spots on the tablets.

    Product
    Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0789-2013·2013-02-13

    ConMed Linvatec Recalls PopLok Bone Punch Due to Incorrect Shaft Diameter

    ConMed Linvatec recalled one lot of PopLok bone punches because the metal shaft diameter is 4.5mm instead of the specified 3.5mm.

    Product
    ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0767-2013·2013-02-13

    Philips Easy Diagnost Eleva DRF Recalled for Image Marker Misinterpretation

    Philips Healthcare is recalling 14 Easy Diagnost Eleva DRF units because a mirror icon on images could be misinterpreted as a right lead marker in PACS systems.

    Product
    Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
    Category
    Medical Device
    Distribution
    Distributed nationwide

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