The Recall Desk

Archive

August 2012 recalls

875 recalls were announced in August 2012.

What the numbers show

Critical
155
Severe
348
High
251
Moderate
101
Low
20

Of the 875 recalls this month scored against our rubric, 18% are Critical, 40% are Severe.

Which agencies issued them

701–800 of 875

  • HighFDA (Devices)·Z-2104-2012·2012-08-08

    Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes

    Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.

    Product
    KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2134-2012·2012-08-08

    Stryker Recalls 210 RF Cannula Units Due to Packaging Error

    Stryker is recalling 210 RF Cannula units because 5mm and 10mm needles were mistakenly packaged in the wrong boxes. This error could lead to thermal skin lesions if the larger tip is used in cervical procedures.

    Product
    RF Cannula, 100 mm,Curved 5 MM, 20 G, REF 0406-630-115 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spina
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2098-2012·2012-08-08

    Arm and Hammer Spinbrush Pro Clean Sonic Recharge Recalled for Choking Hazard

    Church & Dwight is recalling Arm and Hammer Spinbrush Pro Clean Sonic Recharge units due to a potential small parts choking hazard when used beyond the recommended brush head life.

    Product
    Arm and Hammer Spinbrush Pro Clean Sonic Recharge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Devices)·Z-2094-2012·2012-08-08

    Arm and Hammer Spinbrush Pro Clean Sonic Toothbrush Recall for Choking Hazard

    Church & Dwight is recalling Arm and Hammer Spinbrush Pro Clean Sonic toothbrushes due to a small parts choking hazard if brush heads are used beyond their recommended life.

    Product
    Arm and Hammer Spinbrush Pro Clean Sonic Color Wear Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Devices)·Z-2121-2012·2012-08-08

    Perkin Elmer Genetic Screening Processor Recalled for Shaker Unit Contamination

    Perkinelmer is recalling 78 Genetic Screening Processor units worldwide because shaker unit contamination causes decreased signal activity in neonatal screening assays.

    Product
    Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Product Usage: The GSP instrument is a fully automated, high throughput batch analyzer for time- resolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1828-2012·2012-08-08

    Spillson's Club Sub Sandwich Recalled for Undeclared Wheat Allergen

    Spillson's Ltd. is recalling Club Sub Sandwiches because they contain undeclared wheat. People with wheat allergies or sensitivities are at risk of serious or life-threatening reactions.

    Product
    Spillson's Ltd. Club Sub Sandwich, 7oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2095-2012·2012-08-08

    Church & Dwight Recalls Spinbrush Pro White Sonic Crest Toothbrushes

    Church & Dwight is recalling Spinbrush Pro White Sonic Crest Powered Toothbrushes due to a potential small parts choking hazard if used beyond the recommended 3-month brush head life.

    Product
    Arm and Hammer Spinbrush Pro White Sonic Crest Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Devices)·Z-0858-2012·2012-08-08

    Arm and Hammer Spinbrush Toothbrush Recalled for Choking Hazard

    Church & Dwight is recalling Arm and Hammer Spinbrush toothbrushes due to a potential choking hazard from small parts if used beyond the recommended brush head life.

    Product
    Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Food)·F-1831-2012·2012-08-08

    Spillson's Pizza Boat Recalled for Undeclared Wheat Allergen

    Spillson's Ltd. is recalling 4 oz. Pizza Boats because they contain undeclared wheat. People with wheat allergies or sensitivities are at risk of serious reactions.

    Product
    Spillson's Ltd. Pizza Boat, 4 oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1816-2012·2012-08-08

    Punjabi Cookies Recalled for Potential Undeclared Milk Allergen

    Chetak San Francisco LLC is recalling Crispy Just Baked Punjabi Cookies because they may not declare milk as an ingredient.

    Product
    Crispy Just Baked Punjabi Cookies sold in 800 gr clamshell packages. Manufactured by : TWI Foods, Inc., Mississauga, ON, Canada.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2132-2012·2012-08-08

    Baxter Recalls Peritoneal Dialysis Solution Due to Incorrect Inspection Instructions

    Baxter Healthcare is recalling Extraneal and DIANEAL Low Calcium peritoneal dialysis solutions because a technical service representative provided incorrect instructions for inspecting solution bags.

    Product
    Extraneal and/or DIANEAL LOW CALCIUM Peritoneal Dialysis Solution in Plastic Container, PL-146 used with Automated Peritoneal Dialysis System/Automated PD Set with Cassette; Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. The HomeChoice dialysis system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2123-2012·2012-08-08

    Integra Advansys Medial Lisfranc Plate Recalled for Surgical Technique Risk

    Integra LifeSciences is recalling Advansys Medial Lisfranc Plates because an incorrect surgical technique may cause potential rupture of the tibialis anterior tendon.

    Product
    Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthr
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Food)·F-1833-2012·2012-08-08

    Spillson's Double Cheeseburger Sandwich Recalled for Undeclared Soy Lecithin

    Spillson's, Ltd. is recalling Double Cheeseburger Sandwiches because they contain undeclared soy lecithin. The source text notes a risk of serious reaction for people with wheat allergies.

    Product
    Spillson's Ltd. Double Cheeseburger Sandwich.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1821-2012·2012-08-08

    Spillson's Ham Sandwiches Recalled for Undeclared Wheat and Soy Allergens

    Spillson's Ltd. is recalling 42 units of 7-ounce ham sandwiches due to undeclared wheat and soy ingredients. Consumers with allergies to wheat or soy should not consume the product.

    Product
    Spillson's Ltd. Ham Sandwich Nt. Wt. 7 oz
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1839-2012·2012-08-08

    JFC International Recalls Oyster Products Due to Insanitary Conditions

    JFC International Inc. is recalling several oyster products because they were prepared or held under insanitary conditions, potentially rendering them injurious to health.

    Product
    Tablemark Kaki (Oyster) Fry, 2/12/6.34 oz.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1823-2012·2012-08-08

    Spillson's Greek Pita Sandwich Recalled for Undeclared Wheat

    Spillson's, Ltd. is recalling Greek Pita Sandwiches due to undeclared wheat in the flour ingredient. People with wheat allergies or sensitivities are at risk of serious reactions.

    Product
    Spillson's Ltd.Greek Pita Sandwich Nt. Wt. 7oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2125-2012·2012-08-08

    GE OEC Medical Systems Recalls OEC 9800 Plus Digital Imaging Systems

    GE OEC Medical Systems is recalling OEC 9800 Plus Digital imaging systems due to a hard disk drive issue. The recall covers 82 units distributed worldwide.

    Product
    OEC 9800 Plus Digital; MDL number A349855. Product Usage: Is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2102-2012·2012-08-08

    Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes

    Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.

    Product
    KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2133-2012·2012-08-08

    Abbott i-Stat EG7 Cartridges Recalled for Inaccurate PCO2 Results

    Abbott Point of Care is recalling 52,750 i-Stat EG7 cartridges because they may produce falsely low PCO2 readings if stored at room temperature for four weeks or longer.

    Product
    I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ. The i-Stat EG7 cartridge is intended to be used for quantitatively measure sodium, potassium, ionized calcium, oxygen, carbon dioxide, partial pressure in arterial, venous, or capillary whole blood.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2106-2012·2012-08-08

    Intuitive Surgical Recalls Instrument Arm Drapes Due to Adaptor Engagement Issues

    Intuitive Surgical is recalling specific lots of Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument during surgery.

    Product
    ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2128-2012·2012-08-08

    ICU Medical Recalls High Pressure Stopcocks Due to Molding Defect

    ICU Medical is recalling 4,625 High Pressure Stopcocks because a molding defect may cause side ports to become totally occluded.

    Product
    High Pressure Stopcock (3-Way, Luer Lock, Off). Product Usage: For IV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2096-2012·2012-08-08

    Arm and Hammer Spinbrush Pro White Sonic Toothbrush Recalled for Choking Hazard

    Church & Dwight is recalling Arm and Hammer Spinbrush Pro White Sonic Toothbrushes due to a potential choking hazard from small parts if used beyond the recommended 3-month brush head life.

    Product
    Arm and Hammer Spinbrush Pro White Sonic Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Food)·F-1825-2012·2012-08-08

    Spillson's Ham & Swiss Pita Sandwich Recalled for Undeclared Wheat

    Spillson's Ltd. is recalling 58 units of Ham & Swiss Pita Sandwiches due to undeclared wheat, posing a risk to people with wheat allergies.

    Product
    Spillson's Ltd. Ham & Swiss Pita Sandwich, 7 oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2105-2012·2012-08-08

    Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes

    Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.

    Product
    KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1834-2012·2012-08-08

    Spillson's Breakfast Muffin Sandwich Recalled for Undeclared Wheat and Soy

    Spillson's Ltd. is recalling Breakfast Muffin Sandwiches containing undeclared wheat and soy lecithin. People with allergies to these ingredients are at risk of serious reactions.

    Product
    Spillson's Ltd. Breakfast Muffin Sandwich, 6 oz Ham
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1832-2012·2012-08-08

    Spillson's Cheeseburger Sandwich Recalled for Undeclared Soy Lecithin

    Spillson's Ltd. is recalling Cheeseburger Sandwiches containing undeclared soy lecithin. The agency notes a risk of serious reaction for people with wheat allergies.

    Product
    Spillson's Ltd. Cheeseburger Sandwich.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1841-2012·2012-08-08

    Cafe Moto Almond Truffle Coffee Recalled for Undeclared Milk

    Cafe Moto is recalling Almond Truffle Flavored Coffee because the flavoring contains whey, a milk derivative, which is not declared on the label.

    Product
    Flavored coffee. Cafe Moto Almond Truffle Flavored Coffee, 16 oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2135-2012·2012-08-08

    Stryker Recalls RF Cannulas Due to Packaging Error

    Stryker is recalling 226 units of RF Cannulas because 5mm and 10mm needles were incorrectly packaged in each other's boxes, posing a risk of thermal skin lesions.

    Product
    RF Cannula, 100 mm,Curved 10 MM, 20 G, REF 0406-630-125 RX only, Disposable ( 10/pk) Product Usage: The Stryker RF Cannulae, in combination with the Stryker RF Generator/Multi- Gen and electrodes, are intended for coagulation of soft tissue in orthopedic, arthroscopic, spin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2126-2012·2012-08-08

    GE OEC Medical Systems Recalls Mobile C-Arm Devices for Hard Disk Drive Issue

    GE OEC Medical Systems is recalling OEC MiniView 6800 Mobile C-Arms due to a hard disk drive issue. The recall covers 82 units distributed worldwide.

    Product
    OEC MiniView 6800 Mobile; MDL number A349855. Product Usage: The mini 6800 digital mobile c arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical, orthopedic, and extremity imaging. The device is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2093-2012·2012-08-08

    Arm and Hammer Spinbrush Pro Clean Sonic Toothbrush Recall for Choking Hazard

    Church & Dwight is recalling 1.744 million Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrushes due to a potential small parts choking hazard.

    Product
    Arm and Hammer Spinbrush Pro Clean Sonic Powered Toothbrush Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Food)·F-1829-2012·2012-08-08

    Spillson's Roast Beef Sandwich Recalled for Undeclared Wheat and Soy

    Spillson's Ltd. is recalling Roast Beef Sandwiches containing undeclared wheat and soy lecithin. Individuals with allergies to these ingredients are at risk of serious reactions.

    Product
    Spillson's Ltd. Roast Beef Sandwich 97% Fat Free, 7oz.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2108-2012·2012-08-08

    Maquet Magnus Carbon-Fibre Operating Table Top Recall for Brake Defect

    Maquet is recalling specific Magnus carbon-fibre operating table tops due to a potential issue with motor brakes for the longitudinal shift and tilt drives.

    Product
    Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS table top (1180-16XX) serves to support and position patients for surgical procedures (e.g. cardiovascular surgery) and interventional examination immediately befo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2131-2012·2012-08-08

    ICU Medical Flush Kits Recalled for Stopcock Molding Defect

    ICU Medical is recalling Flush Kits with 3 Way Off Stopcocks due to a molding defect that may occlude side ports.

    Product
    Flush Kit w 3 Way Off Stopcock Product Usage: Flush Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2130-2012·2012-08-08

    ICU Medical Recalls 94-inch IV Administration Sets Due to Molding Defect

    ICU Medical is recalling specific lots of 94-inch IV administration sets because a molding defect may cause side ports to become occluded.

    Product
    94" (239cm) 20 Drop Admin Set w/High Pressure 4-Way (300 psi) Stopcock, Rotating Luer, Non-DEHP Tubing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0859-2012·2012-08-08

    Arm and Hammer Spinbrush Recall for Choking Hazard

    Church & Dwight is recalling Spinbrush Pro Whitening toothbrushes due to a potential small parts choking hazard if used beyond the recommended 3-month brush head life.

    Product
    Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Devices)·Z-2097-2012·2012-08-08

    Arm and Hammer Spinbrush Pro Clean Sonic Tray Recalled for Choking Hazard

    Church & Dwight is recalling Arm and Hammer Spinbrush Pro Clean Sonic Trays due to a potential small parts choking hazard if used beyond the recommended 3-month brush head life.

    Product
    Arm and Hammer Spinbrush Pro Clean Sonic Tray BJS Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Food)·F-1815-2012·2012-08-08

    Dr. Mercola Miracle Whey Protein Powder Recalled for Undeclared Soy Lecithin

    Defense Nutrition is recalling Dr. Mercola Miracle Whey Protein Powder because it contains undeclared soy lecithin, a potential allergen.

    Product
    Dr. Mercola Miracle Whey Protein Powder, dietary supplement, packaged in 1-lb. bottles and packed 6/1 lb-bottles per case. Distributed by Mercola Health Resources, LLC, Aurora, IL.
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-0857-2012·2012-08-08

    Arm and Hammer Spinbrush Toothbrush Recalled for Choking Hazard

    Church & Dwight is recalling 22.783 million Arm and Hammer Spinbrush toothbrushes worldwide due to a potential choking hazard from small parts.

    Product
    Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Devices)·Z-2099-2012·2012-08-08

    Arm and Hammer Spinbrush ProClean Sonic Recharge Recalled for Choking Hazard

    Church & Dwight is recalling Arm and Hammer Spinbrush ProClean Sonic Recharge units due to a potential choking hazard from small parts if used beyond the recommended brush head life.

    Product
    Arm and Hammer Spinbrush ProClean Sonic Recharge Color Wear Made in China. Manufactured for Church and Dwight Co., Inc. Princeton, NJ 08543 USA. For dental health; plaque removal.
    Category
    Consumer Product
    Distribution
    0 states
  • HighFDA (Food)·F-1822-2012·2012-08-08

    Spillson's Meatball Sub Sandwich Recalled for Undeclared Wheat

    Spillson's Ltd. is recalling Meatball Sub Sandwiches because the flour ingredient contains undeclared wheat. People with wheat allergies or sensitivities are at risk of serious or life-threatening reactions.

    Product
    Spillson's Ltd. Meatball Sub Sandwich Nt. Wt. 10 oz
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1438-2012·2012-08-08

    West-Ward Recalls Fosphenytoin Sodium Injection Due to Particulate Matter

    West-Ward Pharmaceutical Corp. is recalling specific lots of Fosphenytoin Sodium Injection because particles were found in stability and retain samples.

    Product
    FOSPHENYTOIN SODIUM — FOSPHENYTOIN SODIUM (FOSPHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Food)·F-1817-2012·2012-08-08

    Aloha Maid Natural Coconut Water with Pineapple Recalled for Off-Smell and Taste

    Itoen (USA) Inc. is recalling Aloha Maid Natural Coconut Water with Pineapple cans in Hawaii due to off-smell and off-taste.

    Product
    Aloha Maid Natural brand Coconut Water with Pineapple in 11.5 fl oz (340mL) Can; UPC Code: 8-35146-00818-3; 24 cans per case (4 packs X 6 cans each) Product is processed and packaged by ITO EN (USA) INC., Honolulu, Hi
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2120-2012·2012-08-08

    Exactech Recalls Orthopedic Devices Due to Incorrect Shelf Life Labeling

    Exactech is recalling specific orthopedic implants because the labeling incorrectly states a ten-year shelf life, while the packaging is only qualified for five years.

    Product
    Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine intervertebral body fusion procedures at one level (C3-C7).
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-1439-2012·2012-08-08

    Apotex Recalls Dorzolamide HCI/Timolol Maleate Ophthalmic Solution Due to Particulates

    Apotex Inc. is recalling specific lots of Dorzolamide HCI/Timolol Maleate Ophthalmic Solution because they may contain small particulates.

    Product
    Dorzolamide HCI/Timolol Maleate Ophthalmic Solution 22.3mg/6.8mg per mL, 10mL bottle, For Topical Application in the Eye, Sterile Ophthalmic Solution, Rx Only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2111-2012·2012-08-08

    Beekley O-Spots Floral Skin Markers Recalled for Separation Defect

    Beekley Corporation is recalling 267,332 units of O-Spots Floral Skin Markers because the digital skin marker may separate from the backing material.

    Product
    Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2118-2012·2012-08-08

    Exactech Recalls Shoulder and Spine Devices Due to Labeling Error

    Exactech is recalling Equinoxe and Octane-C devices because labeling incorrectly states a ten-year shelf life for parts qualified for five years.

    Product
    Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-1437-2012·2012-08-08

    West-Ward Recalls Fosphenytoin Sodium Injection Due to Particulate Matter

    West-Ward Pharmaceutical Corp. is recalling specific lots of Fosphenytoin Sodium Injection because particles were found in stability and retain samples.

    Product
    FOSPHENYTOIN SODIUM — FOSPHENYTOIN SODIUM (FOSPHENYTOIN SODIUM)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2119-2012·2012-08-08

    Exactech Recalls Equinoxe Shoulder Arthroplasty Devices Due to Labeling Error

    Exactech is recalling Equinoxe shoulder arthroplasty devices because the labeling incorrectly states a ten-year shelf life, while the packaging is only qualified for five years.

    Product
    Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Devices)·Z-2100-2012·2012-08-08

    Advanced Sterilization Products Recalls STERRAD Biological Indicators Due to Shelf-Life Data Gaps

    Advanced Sterilization Products is recalling specific lots of STERRAD CYCLESURE 24 Biological Indicators because the company lacks adequate data to support the product's full labeled shelf-life.

    Product
    STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitorin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2107-2012·2012-08-08

    Smiths Medical Medfusion 4000 Syringe Infusion Pump Software Recall

    Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps due to a software anomaly that causes device history log corruption and triggers a Watchdog Fail-Safe alarm.

    Product
    Smiths Medical, Medfusion¿ Syringe Infusion Pump, Model 4000, Software Version V1.0 & V1.1, Reorder Numbers 4000-0100-50, 4000-0100-95, 4000-0101-50, 4000-0101-51, and 4000-0101-78. Designed for use in care areas for the administration of fluids requiring precisely controlled
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2122-2012·2012-08-08

    Steris Reliance 130 Cart Washer Recall for Door Safety Feature Installation

    Steris is recalling 367 Reliance 130 and 130L Cart Washers to install a door close confirmation button and door open delay to ensure proper operation.

    Product
    The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanical washer intended for use in the washing, low-level disinfecting, and drying of carts, utensils, beds and other miscellaneous reusable items used in the care of patients at healthcare facilities / Crate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2109-2012·2012-08-08

    Beekley S-Spots Floral Skin Markers Recalled for Separation Defect

    Beekley Corporation is recalling 36,518 units of S-Spots Floral Skin Markers because the digital skin marker may separate from the backing material.

    Product
    Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1811-2012·2012-08-08

    Nestle Nesquik Chocolate Powder Recalled for Metal Fragment Contamination

    Nestle USA is recalling specific batches of Nesquik Chocolate Flavor beverage powder due to potential contamination with metal fragments.

    Product
    Nestle Nesquik Chocolate Flavor, chocolate beverage powder, New Wt 48.7 OZ. Product labeling reads in part:"***Nestle Nesquick Chocolate FLAVOR*** NET WT***48.7OZ***DISTRIBUTED BY***NESTLE USA, INC., GLENDALE, CA 91203 USA***".
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2116-2012·2012-08-08

    Exactech Recalls Equinoxe Shoulder Arthroplasty Devices Due to Labeling Error

    Exactech is recalling Equinoxe shoulder arthroplasty devices and related components because the labeling incorrectly states a ten-year shelf life instead of the qualified five-year shelf life.

    Product
    Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-1431-2012·2012-08-08

    Mallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution Due to Expired Flavoring

    Mallinckrodt Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Oral Solution because expired flavoring was used during manufacturing.

    Product
    Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2101-2012·2012-08-08

    Intuitive Surgical Recalls Instrument Arm Drapes Due to Adaptor Engagement Issues

    Intuitive Surgical is recalling specific lots of Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument during surgical procedures.

    Product
    INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2114-2012·2012-08-08

    Aesculap SIBD Trial Implants Recalled for Incorrect Part Number Etching

    Aesculap Implant Systems LLC is recalling 5 SIBD trial implants because the part numbers etched on the instruments may be incorrect, potentially causing selection errors.

    Product
    Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2127-2012·2012-08-08

    GE OEC Medical Systems Recalls UroView 2800 Imaging Devices

    GE OEC Medical Systems is recalling UroView 2800 and other imaging devices due to hard disk drive issues. The recall covers 82 units distributed worldwide.

    Product
    UroView 2800; MDL number A349855. Product Usage: Designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical application may include but are not limited to urologic and endoscopic procedures. The
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1436-2012·2012-08-08

    Watson Recalls Caziant Tablets Due to High Impurity Levels

    Watson Laboratories is recalling Caziant tablets because high levels of impurities were detected. Consumers should stop using the product and contact their healthcare provider.

    Product
    Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Wa
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1813-2012·2012-08-08

    Defense Nutrition Warrior Whey Powder Recalled for Undeclared Soy Lecithin

    Defense Nutrition is recalling Warrior Whey Natural Powder because it contains undeclared soy lecithin, a common allergen.

    Product
    Defense Nutrition Warrior Whey Natural Powder, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case.
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2129-2012·2012-08-08

    ICU Medical Recalls Cardiac Catheterization Waste Management Systems

    ICU Medical is recalling Cardiac Catheterization Waste Management Systems due to a molding defect in a high pressure stopcock that could cause side ports to become occluded.

    Product
    Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2112-2012·2012-08-08

    Beekley Altus Floral Skin Markers Recalled for Separation Defect

    Beekley Corporation is recalling 6,420 units of Altus Floral Skin Markers because the marker may separate from the backing material.

    Product
    Beekley Altus Floral Skin Markers -Order Number: 754 Product Usage: designed for Digital Mammography-Disposable skin markers for marking areas of concern or pain
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2103-2012·2012-08-08

    Intuitive Surgical Recalls Specific Lots of da Vinci Instrument Arm Drapes

    Intuitive Surgical is recalling specific lots of da Vinci Instrument Arm Drapes because the sterile adaptor may have difficulty engaging an instrument.

    Product
    KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intended use of the Instrument arm drape is to protect equipment from contamination and to maintain a sterile field during surgical procedures using the da Vinci Surgical Systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1814-2012·2012-08-08

    Defense Nutrition Organic Warrior Whey Powder Recalled for Undeclared Soy

    Defense Nutrition is recalling Organic Warrior Whey Powder, Plain, because it contains undeclared soy lecithin. The product was distributed in 23 states and Canada.

    Product
    Defense Nutrition Organic Warrior Whey Powder, Plain, dietary supplement, packaged in 14-oz. bottles and packed 6/14-oz bottles per case. Distributed by Defense Nutrition, Woodland Hills, CA.
    Category
    Food
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-2110-2012·2012-08-08

    Beekley A-Spots Floral Skin Markers Recalled for Separation Defect

    Beekley Corporation is recalling 32,640 units of A-Spots Floral Skin Markers because the digital skin marker may separate from the backing material.

    Product
    Beekley A-Spots Floral Skin Markers -Order Number: 751 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2117-2012·2012-08-08

    Exactech Recalls Shoulder Arthroplasty Devices Due to Labeling Error

    Exactech is recalling Equinoxe shoulder arthroplasty devices because labeling incorrectly states a ten-year shelf life instead of the qualified five-year limit.

    Product
    Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Drugs)·D-1432-2012·2012-08-08

    Cadence Pharmaceuticals Recalls OFIRMEV Acetaminophen Injection Due to Particulate Matter

    Cadence Pharmaceuticals is recalling OFIRMEV (acetaminophen) injection vials due to the visible presence of particulate matter.

    Product
    OFIRMEV (acetaminophen) injection, 1000 mg/100 mL (10 mg/mL), 24-count Single Use 100 mL Vials per carton, Rx only, Manufactured for: Cadence Pharmaceuticals, Inc., San Diego, CA 92130, NDC 43825-102-01, UPC 3 43825 10201 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2115-2012·2012-08-08

    Exactech Recalls Shoulder Arthroplasty Devices Due to Labeling Error

    Exactech is recalling Equinoxe shoulder arthroplasty devices because the labeling incorrectly states a ten-year shelf life instead of the qualified five-year shelf life.

    Product
    Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    27 states
  • LowFDA (Drugs)·D-1430-2012·2012-08-08

    Mallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution for Low Potency

    Mallinckrodt Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Oral Solution because the hydrocodone ingredient was found to be subpotent.

    Product
    Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1441-2012·2012-08-08

    Axcentria Recalls Infants' Mapap Due to Incorrect Expiration Date Labeling

    Axcentria Pharmaceuticals LLC is recalling 13,128 bottles of Infants' Mapap in Michigan because the outer packaging displays an incorrect expiration date.

    Product
    Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30,
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-2124-2012·2012-08-08

    Iris Diagnostics Recalls Urine Chemistry Control Material Due to Inaccurate Results

    Iris Diagnostics is recalling IRISpec CA/CB urine chemistry control material because nitrite results were incorrectly negative.

    Product
    IRISpec" CA/CB two-part urine chemistry control twin set, Iris Diagnostics part number 800-0074. Intended Use: IRISpec CA/CB is an assayed QC material for monitoring of the urine chemistry analytes and devices as listed on the package insert. For in vitro diagnostic (IVD) us
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V385000·2012-08-07

    CTW Recalls 2011-2012 Boat Trailers Due to Wheel Torque Defect

    California Trailer Works is recalling 2011-2012 boat trailers because wheels may not be tightened to proper torque, risking wheel separation.

    Product
    CTW — CTW TIGE Z-3, TIGE RZR, MOOMBA LSV, MASTERCRAFT 280V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V387000·2012-08-06

    Collins Recalls 2012 School Buses Due to Brake Line Interference

    Collins is recalling 282 model year 2012 school buses because a brake line may interfere with a body mount, risking brake failure.

    Product
    CORBEIL — CORBEIL, COLLINS, MID-BUS SL, DE, DH, SH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V386000·2012-08-06

    Collins Recalls 2012 School Buses Due to Body Mount Bolt Torque Issues

    Collins Bus Corporation is recalling 641 model year 2012 school buses because some body mount bolts may not have been torqued to specification, potentially reducing vehicle integrity in a crash.

    Product
    COLLINS — COLLINS, MID-BUS, CORBEIL SL, SH, DE, DH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V380000·2012-08-06

    Mercedes-Benz Recalls 2011 G55 and G550 Due to Airbag Molding Strip Hazard

    Mercedes-Benz is recalling 2011 G55 and G550 vehicles because the front passenger airbag molding strip may become loose and act as a projectile during deployment, increasing injury risk.

    Product
    MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ G55, G550
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V383000·2012-08-03

    Altec Wood Chippers Recalled for Frame Cracks and Injury Risk

    Altec Environmental Products is recalling specific wood chippers because cracks in the frame could lead to personal injury or property damage.

    Product
    ALTEC — ALTEC DC1317HP, DC1317, DC1217
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V393000·2012-08-03

    Jayco Recalls 2012-2013 Jay Flight Swift SLX Trailers Due to Axle Bearing Defect

    Jayco is recalling certain 2012-2013 Jay Flight Swift SLX travel trailers because oversized axle bearings may overheat and wear, potentially leading to axle failure and a crash.

    Product
    JAYCO — JAYCO JAY FLIGHT SWIFT SLX, JAY FLIGHT SWIFT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V381000·2012-08-03

    Boatwheels Recalls 2011 Trailers Due to Brake Actuator Defect

    Alumina, Inc. is recalling 2011 Boatwheels PB36-RS2100 and PB27-TH1200 trailers because defective brake actuator pumps may fail, increasing crash risk.

    Product
    BOATWHEELS — BOATWHEELS PB36-RS2100, PB27-TH1200
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V384000·2012-08-03

    Glaval Transit Bus Recall for Roof Hatch Opening Force Defect

    Glaval Bus is recalling 2011-2012 models because roof escape hatches may require excessive force to open, potentially hindering emergency exits.

    Product
    GLAVAL BUS — GLAVAL BUS, GLAVAL ENTOURAGE, PRIMETIME, SPORT, UNIVERSAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V375000·2012-08-02

    Vermeer Recalls 2009-2012 Brush Chipper Trailers Due to Axle Bolt Loosening

    Vermeer is recalling 3,450 single axle brush chipper trailers because axle mounting bolts could loosen, leading to axle separation and an increased risk of a crash.

    Product
    VERMEER — VERMEER BC1200XL, BC1000XL, BC1500, BC1800XL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V373000·2012-08-02

    Toyota Recalls RAV4 and Lexus HS 250h for Rear Suspension Defect

    Toyota is recalling 2006-2011 RAV4 and 2010 Lexus HS 250h vehicles because rear tie rods may fail, causing loss of vehicle control.

    Product
    TOYOTA — TOYOTA, LEXUS RAV4, HS 250 HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12241·2012-08-02

    Patio Bistro Sets Recalled by CPSC Due to Chair Fall Hazard

    CPSC recalls patio bistro sets sold at Lowe's because chairs may not lock fully, posing a fall hazard. Thirteen injury reports were received.

    Product
    Patio Bistro Sets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1799-2012·2012-08-01

    Wellements Recalls Baby Move Prune Concentrate Due to Salmonella Risk

    Wellements is recalling Baby Move Prune Concentrate because a supplier ingredient may be contaminated with Salmonella.

    Product
    Wellements Baby Move Prune Concentrate with Prebiotics, 4oz., 12 units per case, SKU# 141161, UPC 729609019878.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2038-2012·2012-08-01

    GE OEC 9800 C-arm Systems Recalled for Power Supply Defect

    GE OEC Medical Systems is recalling 8,214 OEC 9800 C-arm systems worldwide because the vertical lift column power supply is defective and subject to early life failure.

    Product
    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional pro
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-1775-2012·2012-08-01

    Arctic Zero Frozen Dessert Recalled for Undeclared Milk

    Arctic Zero, Inc. is recalling its frozen dessert products due to undeclared milk, a major food allergen.

    Product
    Chocolate, 1pt., UPC 8 52244 00300 8
    Category
    Food
    Distribution
    Distributed nationwide

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