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.

801–875 of 875

  • SevereFDA (Food)·F-1796-2012·2012-08-01

    B & F, Inc. Recalls Frozen Oysters Due to Insanitary Conditions

    B & F, Inc. is recalling Z.Shell Sanggul and Z.Shell HS frozen oysters because they were prepared or held under insanitary conditions, posing a potential health risk.

    Product
    Frozen Oysters are packaged in 8 oz. 40 oz, and 3 lbs. The item numbers are 06413, 03777, FO/HS-OT8; 136300-20110430. The brand names are Z.Shell Sanggul and Z.Shell HS.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1784-2012·2012-08-01

    Arctic Zero Frozen Dessert Bars Recalled for Undeclared Milk

    Arctic Zero, Inc. is recalling specific frozen dessert bars because they contain undeclared milk, a major food allergen.

    Product
    Chocolate Dipped Bars, 2 Chocolate & 2 Vanilla, 2.1 fl oz bars, UPC 8 52244 00308 4
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1425-2012·2012-08-01

    Grandpa Brands Recalls Dent's Extra Strength Toothache Gum

    Grandpa Brands Co is recalling Dent's Extra Strength Toothache Gum due to superpotent benzocaine levels. Consumers should stop using the product.

    Product
    Dent's Extra Strength Toothache Gum, (benzocaine 20%), Net Wt. .035 Oz.. (1 g) box, C.S. Dent & Co., Erlanger, KY
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1805-2012·2012-08-01

    Hanmi Recalls Frozen Oysters Due to Potential Norovirus Contamination

    Hanmi Incorporated is recalling specific lots of Surasang brand frozen oysters because they may have been exposed to human fecal waste and are potentially contaminated with norovirus.

    Product
    Frozen Oyster, IQF, Surasang Brand, 1) 8 oz, packed in plastic bags, 40 bags/case, Item No.: 03777; 2) 2.5 lb, packed in plastic bags, 10 bags/case, Item No.: 06413.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1772·2012-08-01

    Eden Apple Juice Recalled Due to Arsenic Levels

    S. Bertram Inc. is recalling Eden Quality Product Pasteurized Apple Juice because laboratory tests found arsenic at 36.4 parts per billion.

    Product
    Eden Quality Product Pasteurized Apple Juice from concentrate vitamin C added in a 46 fluid ounce can. Service Size 8 fl oz. Dist. by S. Bertram Inc., Linden, NJ 07036. Concentrate from China.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2082-2012·2012-08-01

    Hill-Rom Recalls Affinity Four Birthing Beds Due to Fall Risk

    Hill-Rom is recalling 12,726 Affinity Four Birthing Beds because bed movement during labor may cause patient or caregiver falls.

    Product
    Affinity Four Birthing Bed P3700 Product Usage: The Affinity, Four Birthing Bed is intended to be used as birthing beds for women of child bearing age in an LDR (Labor, Delivery, Recovery ) or LDRP (Labor, Delivery, Recovery, Postpartum) setting within the acute care Labor a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1792-2012·2012-08-01

    Pacific American Fish Recalls Korean Oysters Due to Insanitary Conditions

    Pacific American Fish Company is recalling specific lots of Korean Oysters because they were prepared under insanitary conditions, posing a potential health risk.

    Product
    Oyster Meat Med IQF Farm, OYS101, 10/4lbs., Oyster Meat Large IQF Farm, OYS102, 10/4lbs., Oyster Meat Tiny 8oz IQF Farm, OYS105, 40/8oz.,
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1791-2012·2012-08-01

    East Bay Seafood Recalls Frozen Yellow Fin Tuna Loins for Histamine Levels

    East Bay Seafood Co., Inc. is recalling 30,360 pounds of frozen yellow fin tuna loins imported from Vietnam because testing revealed histamine levels over 50 ppm.

    Product
    Frozen Yellow Fin Tuna Loins (AAA)Co Treated Skinless Frozen. 44 lbs./carton (3-4 Loins/Case) Imported from Vietnam
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1783-2012·2012-08-01

    Arctic Zero Frozen Dessert Bars Recalled for Undeclared Milk

    Arctic Zero, Inc. is recalling specific frozen dessert bars due to undeclared milk, a major allergen.

    Product
    Chocolate Dipped Bars 2 Strawberry and 2 Orange Cream, 2.1 Fl oz bars, UPC 8 52244 00309 1
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2077-2012·2012-08-01

    Anspach Effort Recalls Sterile Bone Cutting Burrs Due to Breakage Risk

    The Anspach Effort, Inc. is recalling specific sterile bone cutting burrs because the cutter may come apart during use.

    Product
    .***ANSPACH***Sterile. REF SHD-4820DS***QTY: 1, 4.8 mm x 2mm Twist Drill with Depth Stop. Use with SHORT-HD Attachment ***RX Only Product Usage: Cutting and shaping bone including bones of the spine and cranium.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V372000·2012-08-01

    Mitsubishi Recalls 2012 i-MiEV Vehicles Due to Air Bag Sensor Incompatibility

    Mitsubishi is recalling 261 model year 2012 i-MiEV vehicles because incompatible air bag sensors may deactivate the frontal and side airbag systems, increasing injury risk in a crash.

    Product
    MITSUBISHI — MITSUBISHI I-MIEV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1779-2012·2012-08-01

    Arctic Zero Frozen Dessert Recalled for Undeclared Milk

    Arctic Zero, Inc. is recalling its frozen dessert products, including Chocolate Peanut Butter, due to undeclared milk.

    Product
    Chocolate Peanut Butter, 1pt., UPC 8 52244 00301 5
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1793-2012·2012-08-01

    Pacific American Fish Recalls Korean Oysters Due to Insanitary Conditions

    Pacific American Fish Co Inc is recalling specific lots of Korean Oysters because they were prepared under insanitary conditions, posing a potential health risk.

    Product
    Oyster Half Shell Farm, OYS107, 144ps/cs, Oyster Half Shell small Farm, OYS114, 144ps/cs,
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1787-2012·2012-08-01

    Kettle Brand Potato Chips Recalled Due to Metal Fragments in Raw Material

    Kettle Foods is recalling New York Cheddar potato chips because metal fragments were found in the lactic acid used for flavorings.

    Product
    Kettle Brand Potato Chips, New York Cheddar; 1) 24/1.5oz, item # 0712278000, UPC 0 8114 11271 2; 2) 24/2 oz item # 0703320000 UPC 0 84114 03320 8; 3) 15/5 oz item # 0710863000, UPC 0 84114 0094 1; 4) 12/8.5 oz item #'s 0710813001 and 0710813500 (different numbers for differen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2090-2012·2012-08-01

    Stryker Recalls Rejuvenate Modular Hip Stems and Necks

    Stryker is recalling Rejuvenate Modular Hip System stems and necks due to a reported rate of less than one percent for revisions associated with fretting or corrosion.

    Product
    Rejuvenate Modular Stems Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland Rejuvenate Modular Necks Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430. Stem Bodies Rejuvenate Modular consists of 6 modular stems bodies in sizes 7-12. The M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1774-2012·2012-08-01

    Cass Clay Creamery Recalls Peppermint Ice Cream for Undeclared Eggs

    Cass Clay Creamery is recalling Peppermint Bon Bon Light Ice Cream in Minnesota, Wisconsin, North Dakota, and Iowa because the products contain undeclared eggs.

    Product
    Peppermint Bon Bon Light Ice Cream under the following three brands: Hornbachers, Peppermint Bon Bon Light Ice Cream, Half Gallon (1.89 L), UPC 41130-21663, Distributed by Supervalu Inc, Eden Prairie, MN 55344. SunnyBrook, Peppermint Bon Bon Light Ice Cream, Half Gall
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2056-2012·2012-08-01

    Terumo Advanced Perfusion System 1 Recalled for Drive Motor Failure

    Terumo CVS is recalling 640 Advanced Perfusion System 1 units worldwide due to drive motor failures in the Sarns Centrifugal System.

    Product
    System 1 Base 220/240V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2040-2012·2012-08-01

    GE OEC 6800 Miniview X-ray System Recalled for Safety Issues

    GE OEC Medical Systems is recalling 1,933 OEC 6800 Miniview fluoroscopic x-ray systems due to intermittent safety issues, including navigation tracking inaccuracy and system lock-ups.

    Product
    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremit
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2055-2012·2012-08-01

    Terumo Advanced Perfusion System 1 Recalled for Drive Motor Failure

    Terumo CVS is recalling 992 Advanced Perfusion System 1 units due to drive motor failures that trigger alarms. The potential hazards depend on the specific medical application.

    Product
    System 1 Base 100/120V The Terumo¿ Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1789-2012·2012-08-01

    Kettle Brand Potato Chips Recalled Due to Metal Fragments in Raw Material

    Kettle Foods is recalling Kettle Brand Potato Chips, Cheddar Beer, because metal fragments were found in the raw lactic acid used in the flavorings.

    Product
    Kettle Brand Potato Chips, Cheddar Beer, item #0712374000, UPC 0 84114 12375 6.
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1808-2012·2012-08-01

    Hamchorom Recalls Korean Seasoned Oysters Due to Insanitary Conditions

    Hamchorom Inc. is recalling Korean Molluscan Shellfish (Seasoned Oysters) because they were prepared under insanitary conditions, posing a potential health risk.

    Product
    Korean Molluscan Shellfish (Seasoned Oysters) 250kg, 1000kg
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2067-2012·2012-08-01

    Ortho-Clinical Diagnostics Recalls VITROS 4600 Chemistry System Software

    Ortho-Clinical Diagnostics is recalling VITROS 4600 Chemistry System Software due to a defect that prevents proper quality assessment verification when reagent lots are switched.

    Product
    VITROS 4600 Chemistry System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2083-2012·2012-08-01

    Philips and Neusoft Recall NeuViz 16 CT Scanners Due to Detached Oil Accumulator

    Philips and Neusoft are recalling 15 NeuViz 16 CT scanners because a screw failure caused the oil accumulator to detach from the X-ray tube.

    Product
    NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1788-2012·2012-08-01

    Kettle Brand Potato Chips Recalled for Metal Fragments in Flavorings

    Kettle Foods is recalling Krinkle Cut Cheddar and Sour Cream potato chips because metal fragments were found in the lactic acid used in the flavorings.

    Product
    Kettle Brand Potato Chips, Krinkle Cut Cheddar and Sour Cream; 1) 6/2 oz (caddy) item # 0711770000, UPC 0 8114 11715 1; 2) 24/2 oz item # 0711714000, UPC 0 84114 11715 1; 3) 15/5 oz item # 0711718000, UPC 0 84114 11719 9; 4) 12/8.5 oz item #'s 0711726001 and 0711726500 (diff
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2066-2012·2012-08-01

    Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS System Software versions 2.6.1 and below because the software may fail to verify quality assessments when reagent lots are switched.

    Product
    VITROS 5,1 FS System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2012·2012-08-01

    Respironics Trilogy Ventilators Recalled for Faulty Power Supply Component

    Respironics is recalling 173 Trilogy 100, 200, and 202 ventilators due to a potential faulty component in the power supply.

    Product
    Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy 100 is intended for pediatric through adult patients weighing at le
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-1785-2012·2012-08-01

    Hidden Valley Salad Crispins Recalled for Potential Metal Fragment Contamination

    The Clorox Company is recalling Hidden Valley Salad Crispins Original Ranch due to potential metal fragment contamination in the buttermilk ingredient.

    Product
    Hidden Valley Salad Crispins Original Ranch; crisp mini-croutons, crunchy carrot bits and a blend of buttermilk and spices; Net Wt. 2.5 Oz. canister, 12 canisters per case; UPC 10071100 008347
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1806-2012·2012-08-01

    Hanmi Frozen Oyster Recall Due to Potential Norovirus Contamination

    Hanmi Incorporated is recalling 110 cases of frozen oysters distributed to Virginia, Maryland, and Pennsylvania due to potential norovirus contamination from fecal waste exposure.

    Product
    Frozen Oyster, Blocks, Wang Brand, 1 lb, packed in plastic bags, 24 bags/case, Item No.: 01356.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1801-2012·2012-08-01

    Meiko Foods Recalls Cooked Shrimp Balls Due to HACCP Violations

    Meiko Foods Co. Inc. is recalling 8 oz. cooked shrimp balls because they were cooked without HACCP plans to control known hazards.

    Product
    Meiko Foods Co. Inc. Cooked Shrimp Balls, 8 oz. Product labeling reads in part:" TOM VIEN COOKED SHRIMP BALLS***MEIKO FOODS CO. INC South El Monte, CA***". The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2058-2012·2012-08-01

    Westone Recalls Oto Ease Ear Lubricant Due to Microbial Contamination

    Westone Laboratories is recalling all Oto Ease ear lubricant products due to potential microbial contamination. The product is used to ease the insertion of hearing aids and earmolds.

    Product
    Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. Product Usage: The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as heari
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2073-2012·2012-08-01

    Siemens Linear Accelerators Recalled for Potential Radiation Dosing Error

    Siemens is recalling 18 ARTISTE and ONCOR linear accelerators due to a rare software issue that could cause radiation beams to be delivered twice.

    Product
    ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatme
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2068-2012·2012-08-01

    Ortho-Clinical Diagnostics Recalls VITROS 5600 Integrated System Software

    Ortho-Clinical Diagnostics is recalling VITROS 5600 Integrated System Software due to a defect that prevents proper quality verification when reagent lots are switched.

    Product
    VITROS 5600 Integrated System Software For use in the in-vitro quantitative, semi quantitative, and qualitative measurement of variety of analytes of clinical interest.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1786-2012·2012-08-01

    Kettle Brand Potato Chips Recalled Due to Metal Fragments in Raw Material

    Kettle Foods is recalling specific lots of Kettle Brand Potato Chips, Sour Cream and Onion, because metal fragments were found in the raw material used for flavorings.

    Product
    Kettle Brand Potato Chips, Sour Cream and Onion, 12/8.5oz, item # 0711387001, UPC 0 84114 11393 1
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-2074-2012·2012-08-01

    BridgePoint Medical Recalls Stingray Catheters Due to Sterility Concerns

    BridgePoint Medical is voluntarily recalling Stingray Catheters because a faulty pouch seal may have compromised sterility assurance. No adverse clinical events have been reported.

    Product
    BridgePoint Medical, Stingray Catheter, REF M - 1000, Sterilized with Ethylene Oxide Gas, Prescription Only, Manufacturer BridgePoint Medical Inc. 13355 10th Ave N, Suite 110, Plymouth, MN 55441. Stingray" Catheters are intended to facilitate the intraluminal placement of con
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1800-2012·2012-08-01

    Chonita Foods Recalls Sonoran Rice for Undeclared Soy Protein

    Namias dba Chonita Foods is recalling 22 cases of Sonoran Rice due to undeclared hydrolyzed soy protein. The product was distributed only in Arizona.

    Product
    Sonoran Rice, 14 lbs (224 oz). Chonita Foods 847 E. 18th St. Tucson, AZ 85719.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1803-2012·2012-08-01

    Meiko Pollock Fish Balls Recalled for Lack of HACCP Plan

    Meiko Foods is recalling Pollock Fish Balls because they were cooked without HACCP plans to control known hazards.

    Product
    Meiko Foods Co. Inc. Pollock Fish Balls , 2-10 lb bags. Product labeling reads in part:" MEIKO***POLLOCK FISH BALL S***MEIKO FOODS CO. INC South El Monte, CA***". The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1802-2012·2012-08-01

    Meiko Foods Recalls Tempura Due to Missing HACCP Plans

    Meiko Foods Co. Inc. is recalling 12 oz. Tempura products because they were cooked without HACCP plans to control known hazards.

    Product
    Meiko Foods Co. Inc. Tempura, 12 oz. Product labeling reads in part:" MEIKO***TEMPURA ***MEIKO FOODS CO. INC South El Monte, CA***". The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2089-2012·2012-08-01

    Stryker Recalls ABG II Modular Hip Stems for Corrosion Risk

    Stryker is recalling ABG II Modular Hip Stems to update instructions due to a reported rate of less than one percent for revisions associated with fretting and corrosion.

    Product
    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2012·2012-08-01

    GE OEC 8800 Flexview X-ray System Recalled for Safety Issues

    GE OEC Medical Systems is recalling OEC 8800 Flexview x-ray systems due to intermittent safety issues including navigation tracking inaccuracy and system lock-up.

    Product
    OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2075-2012·2012-08-01

    Hospira LifeShield Burette Set Recalled Due to Sticking Float Valve

    Hospira is recalling 4,420 LifeShield Latex-Free 100 mL Burette Sets because the float valve may stick to the burette wall and fail to open or close properly.

    Product
    Hospira LifeShield Latex-Free 100 mL Burette Set, Convertible Pin, 77 inch with 2 Prepierced Injection Sites and Option-Lok Microdrip Soluset with Calibrated Burette and Precision Drip Chamber; an Rx sterile medical device used to administer fluids; 20 individually wrapped sets p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1773·2012-08-01

    21st Century Foods Soy Tempeh Recalled for Coliforms

    21st Century Foods is recalling Soy Tempeh in 12 lb bags and 8 oz containers because testing found coliforms. The product was distributed in Connecticut and Massachusetts.

    Product
    21st Century Foods Soy Tempeh, packaged in 12 lb plastic bags and 8 oz containers
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2087-2012·2012-08-01

    Tripath PrepStain Slide Processor Recall for Leaking Cones and Incorrect Instructions

    Tripath Imaging is recalling PrepStain Slide Processors because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain Slide Processor. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all other
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1790-2012·2012-08-01

    Duane Reade Recalls Pediatric Oral Electrolyte Solution for Deficient Sodium and Potassium

    Duane Reade is recalling Pediatric Oral Electrolyte Solution in Fruit Punch flavor due to deficient sodium and potassium content. The product was distributed in New York and New Jersey.

    Product
    Pediatric electrolyte, Fruit Punch flavor---oral electrolyte solution---helps replace fluids & electrolytes---8 FL OZ (236 mL)---UPC Code: 31191129235 Distributed by Duane Reade/(866)375-6925---440 Ninth Ave., NY, NY 10001---Item #51070-8-4-
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-2080-2012·2012-08-01

    Beekley Bella Blanket Mammography Coverlet Recalled for Imaging Artifacts

    Beekley Corporation is recalling Bella Blanket Protective Coverlets used in mammography because they can cause imaging artifacts on results.

    Product
    Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the product is to remove the cold by placing this sheet between the patients breast and the imaging receptor plate.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2076-2012·2012-08-01

    CareFusion Alaris PC Unit Model 8015 Recalled for Power Supply Board Error

    CareFusion 303, Inc. is recalling Alaris PC unit model 8015 devices because a power supply board component causes startup error codes and alarms.

    Product
    Alaris PC unit model 8015 Product Usage: The device is labeled for prescription use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2085-2012·2012-08-01

    Tripath PrepStain Kit 1.2 DiTi Cones Recalled for Leaking and Incorrect Instructions

    Tripath Imaging is recalling 18 PrepStain Kit 1.2 DiTi Cones because some units are leaking and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical cells and all ot
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2070-2012·2012-08-01

    Exactech Recalls Optetrak Knee Trays Due to Potential Mislabeled Components

    Exactech is recalling specific Optetrak knee replacement trays because they may be mislabeled. The recall covers 16 units distributed in the US and several international countries.

    Product
    Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2054-2012·2012-08-01

    Synthes Universal Spinal System Lamina Hooks Recalled for Incorrect Etching

    Synthes (USA) Products LLC is recalling 12 units of Universal Spinal System Lamina Hooks because they are etched with the wrong part number.

    Product
    Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook - Right 498.320 Non sterile LOT 6876785 Noncervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Limited to skeletally mature p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2078-2012·2012-08-01

    Siemens syngo.plaza Radiological Image Processing System Recalled for Malfunction

    Siemens is recalling two syngo.plaza radiological image processing systems due to a potential malfunction where images may fail to load without an error message.

    Product
    Siemens syngo.plaza. Radiological image processing system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1804-2012·2012-08-01

    Meiko Cooked Cuttlefish Ball Recalled for Lack of HACCP Plan

    Meiko Foods is recalling cooked cuttlefish balls because they were processed without a HACCP plan to control known hazards.

    Product
    Meiko Foods Co. Inc. Cooked Cuttlefish Ball, 2-10 lb bags . Product labeling reads in part:" MEIKO***Muc Vien [Vietnamese] ***MEIKO FOODS CO. INC South El Monte, CA***". The product is packaged in a plastic box liner with a knot tied at the top in a cardboard box.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2081-2012·2012-08-01

    Mallinckrodt Recalls Unsealed Handi-Fil Disposable Syringe Fill Tubes

    Mallinckrodt Inc is recalling 75 cases of Handi-Fil Disposable Syringe Fill Tubes because ten packages were reported as not sealed.

    Product
    The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approximately 10 inches in length, with a "J" shaped curve that projects upward approximately two inches. The Handi-Fil Disposable Syringe Fill Tube is used to transfer radiographic contrast media from a s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2057-2012·2012-08-01

    OrthoPediatrics PediLoc Locking Plate System Recalled for Incorrect Left-Right Labeling

    OrthoPediatrics Corp is recalling 15 PediLoc Locking Plate System devices because they are left-sided plates incorrectly labeled and etched as right-sided.

    Product
    OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2059-2012·2012-08-01

    Synthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling

    Synthes USA is recalling 20 units of 4.5mm Multiloc Screws because they were incorrectly labeled with the wrong screw size.

    Product
    4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.019.038S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 38MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1795-2012·2012-08-01

    Atlapac Trading Company Recalls California Girl Whole Boiled Oysters

    Atlapac Trading Company Inc is recalling 880 cases of California Girl Whole Boiled Oysters due to potential contamination from insanitary conditions.

    Product
    "California Girl" Whole Boiled Oysters, 24/8 oz cans.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2079-2012·2012-08-01

    Getinge 9100-Series Washer Disinfectors Recalled for Ground Fault Breaker Error

    Getinge USA Inc is voluntarily recalling 8 large capacity washer disinfectors due to a production error in the ground fault breaker.

    Product
    Getinge brand --- large capacity, floor loading jet spray, washers for mechanical washing, intermediate level, thermal disinfection and drying of moisture and temperature stable Hospital case carts, sterilization containers, material handling carts, stands and utensils. --- Model
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2053-2012·2012-08-01

    Leica M525 F50 Surgical Microscope Recalled for Illumination Malfunction

    Leica Microsystems is recalling M525 F50 surgical microscopes because a malfunction can cause reduced illumination when used with specific remote control adapters.

    Product
    Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2060-2012·2012-08-01

    Synthes Recalls 4.5mm Multiloc Screws Due to Incorrect Size Labeling

    Synthes USA is recalling two lots of 4.5mm Multiloc Screws because they were incorrectly labeled with the wrong screw size.

    Product
    4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.019.028S Manufactured or Distributed by Synthes (USA) 1101 Synthes Avenue, Monument CO 80132 4.5MM TI Multiloc Screw Length 28MM-Sterile Ref 04.019,038S. The Multiloc Screw 4.5 is used with a M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2069-2012·2012-08-01

    AGFA IMPAX CV Reporting Software Recalled for Incorrect Stenosis Display

    AGFA Corp. is recalling IMPAX CV Reporting software versions 2.03 to 2.08 because selecting 'Left stenosis' incorrectly displays 'Right stenosis' in printed reports.

    Product
    IMPAX CV Reporting The Results Management (RM)/IMPAX CV reporting component facilitates the quick, effective creating of digital structured reports for : adult catheterization and echocardiography, pediatric echocardiography, congenital heat disease, nuclear cardiology and non
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2088-2012·2012-08-01

    Tripath PrepStain Kits Recalled for Leaking Cones and Incorrect Instructions

    Tripath Imaging is recalling PrepStain kits because some 1.2 DiTi cones leak and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain PM Kit, T-AG (Catalog 490588); PrepStain PM Kit Europe (Catalog 490671); PrepStain Prep Only PM Kit, T-AG (Catalog 490954); PrepStain PM Kit XLP, T-US-II (Catalog 490424); PrepStain Prep PM Kit XLP T-US-II (Catalog 491118); PrepStain Prep Only PM Kit XLP, T-US-II (49042
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2086-2012·2012-08-01

    Tripath PrepStain Upgrade Kit Recalled for Leaking Cones and Incorrect Instructions

    Tripath Imaging is recalling PrepStain Upgrade Kits because some 1.2 DiTi Cones leak and the kits contain incorrect preventive maintenance instructions.

    Product
    PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is a liquid-based thin layer cell preparation process. The PrepStain System produces SurePath Slides that are intended for use in the screening and detection of cervical cancer, pre-cancerous lesions, atypical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2071-2012·2012-08-01

    Exactech Recalls Optetrak Tibial Trays Due to Potential Mislabeled Components

    Exactech is recalling 12 Optetrak tibial trays because they have the potential to be mislabeled. The affected trays were distributed in the US and several international countries.

    Product
    Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***. The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing prim
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Food)·F-1797-2012·2012-08-01

    Plenus Group Recalls New England Clam Chowder Due to Processing Issue

    Plenus Group Inc. is recalling 287 cases of 8-pound refrigerated New England Clam Chowder in four states because the product was under processed.

    Product
    New England Clam Chowda, pouch 8 lbs., refrigerated. For Institutional Use Only. Mfd. by Plenus Group, Inc., Lowell, MA 01852 Product Number 1023 UPC #: 7 3051691023 3
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-2084-2012·2012-08-01

    Stryker Recalls Tibial Punch Tower Assembly Due to Undersized Slot

    Stryker Howmedica Osteonics is recalling 152 units of Tibial Punch Tower Assemblies because an undersized slot may prevent keel punches from being inserted.

    Product
    Tibial Punch Tower Assembly. Non-Sterile. CAT NO. 8000-1089. Howmedica Osteonics Corp., 59 Route 17, Allendale, NJ 07401. During primary Scorpio TKA procedures, the Scorpio Tibial Punch Tower (8000-1089) is used in conjunction with Scorpio Tibial Keel Punches (3760-0305/
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1798-2012·2012-08-01

    Plenus Group Recalls New England Clam Chowda Base

    Plenus Group Inc. is recalling 13 cases of New England Clam Chowda Base due to a processing issue. The product was distributed in four New England states.

    Product
    New England Clam Chowda Base, pouch 4 lbs., refrigerated. For Institutional Use Only. Mfd. by Plenus Group, Inc., Lowell, MA 01852 Product Number 1010 UPC #: 7 3051691010 3
    Category
    Food
    Distribution
    4 states
  • LowFDA (Drugs)·D-1426-2012·2012-08-01

    Fougera Recalls Erythromycin Topical Solution Due to Plasticizer Contamination

    Fougera Pharmaceuticals is recalling 444 bottles of Erythromycin Topical Solution USP, 2%, due to potential trace contamination with Di-Octyl Phthalate.

    Product
    Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215-60 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1427-2012·2012-08-01

    Stat Rx USA Recalls Tizanidine Tablets Due to Labeling Error

    Stat Rx USA is recalling 51 bottles of Tizanidine 4 mg tablets because some labels incorrectly identified Actavis as the manufacturer.

    Product
    Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.
    Category
    Drug
    Distribution
    Distributed nationwide

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