The Recall Desk

Archive

July 2012 recalls

445 recalls were announced in July 2012.

What the numbers show

Critical
14
Severe
125
High
192
Moderate
88
Low
26

Of the 445 recalls this month scored against our rubric, 3% are Critical, 28% are Severe.

401–445 of 445

  • HighFDA (Devices)·Z-1867-2012·2012-07-04

    Siemens BCS Behring Coagulation System Recalled for Potential Test Errors

    Siemens Healthcare Diagnostics is recalling 186 BCS Behring Coagulation Systems because a specific sequence of tests may result in shortened clotting times.

    Product
    BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system for In Vitro coagulation studies
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1891-2012·2012-07-04

    Terumo Recalls Sarns Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance was found on the inner surface of some tips that can be dislodged.

    Product
    CPB CATHETER KIT- DR HENDRICKSO Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1861-2012·2012-07-04

    Stryker Rose Bed Recall Due to Loadcell Failure in Scale Function

    Stryker is recalling Rose Model FL14E beds because loadcell failures cause scale errors and disabled bed exit functions.

    Product
    Stryker Rose Bed Model (FL14E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1879-2012·2012-07-04

    Terumo Recalls Sarns Cardioplegia Cannulas Due to Foreign Substance

    Terumo CVS is recalling Sarns Antegrade Cardioplegia Cannulas because a foreign substance on the inner surface may dislodge during use.

    Product
    FX PACK Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1649-2012·2012-07-04

    Bay Valley Foods Recalls Macaroni and Cheese Due to Metal Fragments

    Bay Valley Foods is voluntarily recalling approximately 74,000 cases of boxed pasta mix products because they may contain small metal fragments.

    Product
    Meijer Macaroni & Cheese Dinner Thick"n Cheesy, NET WT 7.25 OZ (206 g), UPC 4125096335, DIST. BY MEIJER DISTRIBUTION INC. GRAND RAPIDS, MI 49544
    Category
    Food
    Distribution
    25 states
  • HighFDA (Food)·F-1670-2012·2012-07-04

    Smart Juice Organic Pomegranate Juice Recalled for Lead Contamination

    Smart Juice LLC is recalling Organic 100% Pomegranate Juice due to lead levels above allowable limits. Consumers in 12 states should stop using the product.

    Product
    Organic 100% Pomegranate Juice packed in glass bottles Smart Juice Organic Pomegranate 100% Juice 33.8 FL. Oz. 100% Juice Distributed by: Smart Juices LLC, Bethlehem, PA 18018 BBE: 09.09.2014 ORGANIC N49
    Category
    Food
    Distribution
    12 states
  • ModerateFDA (Food)·F-1669-2012·2012-07-04

    Kellogg Recalls Queso Pringles Due to Potential Metal Fragment Contamination

    Kellogg is recalling Queso Pringles in Mexico and Grenada because the flavoring ingredient may be contaminated with metal fragments.

    Product
    Queso Pringles, 40 g , and Cont. Neto Net Weight: 139 g( 4.9 oz) Queso /Cheese; Busting with more Flavor "Ahora con Man Sabor"
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1904-2012·2012-07-04

    Abbott Recalls Architect CA 19-9 Reagent Kits Due to Result Shifts

    Abbott Laboratories is recalling specific lots of ARCHITECT CA 19-9XR Reagent Kits because they are causing an upward shift in patient test results.

    Product
    ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x 100 tests); Product Usage: The ARCHITECT CA 19-9XR assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1895-2012·2012-07-04

    Zimmer Recalls Shoulder Surgery Drill Due to Labeling Error

    Zimmer, Inc. is recalling 87 units of a shoulder surgery drill because the catalog number on the packaging did not match the actual product.

    Product
    Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm; the products are medical instruments intended for use when performing surgery of the shoulder.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1391-2012·2012-07-04

    Methylprednisolone Tablets Recalled for Potential Impurity Specification Failure

    Physicians Total Care Inc. is recalling Methylprednisolone Tablets, USP, 4 mg, due to potential failure to meet Impurity C specifications.

    Product
    Methylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC # 54868-2913-03
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Food)·F-1655-2012·2012-07-04

    Broaster Fish Coating Recalled for Undeclared Yellow Dye No. 6

    The Broaster Company is recalling three lots of Broaster Fish Coating because they contain an undeclared color additive, Yellow Dye No. 6.

    Product
    Broaster Fish Coating, 96627, Ingredients: Corn Meal, Wheat Flour, Corn Crumbs, Salt, Spices, Paprika, Citric Acid, Onion, Sugar, Garlic, Celery Seed, Modified Con Starch, Lemon Oil, Natural and Artifical Flavors, Silicon Dioxide (Anti-Caking Agent) and FD&C yellow #5., Net…
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-1635-2012·2012-07-04

    Brinkhoff & Monoson Recalls Organic Paprika for Unapproved Colors

    Brinkhoff & Monoson is recalling Archer Farms and O Organics organic paprika because the product contains unapproved colors.

    Product
    Organic Paprika packaged under the following labels: (1) Archer Farms organic Paprika, packaged in 1.0-oz rectangle glass bottles, packed in cases-9 glass bottles/case, Distributed by: Target Corporation, Minneapolis, MN 55483; and (2) O Organic organic Paprika, packaged…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1660-2012·2012-07-04

    Mexicantown Wholesale Recalls Concha Blancas for Undeclared Yellow #6

    Mexicantown Wholesale is voluntarily recalling Concha Blancas (Vanilla) due to undeclared FD&C Yellow #6. The recall affects 180 products distributed in Michigan.

    Product
    CONCHA BLANCAS (VANILLA) QTY: 90 MEXICANTOWN BAKERY 313-894-2000
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1394-2012·2012-07-04

    Lloyd Inc Recalls Subpotent Levothroid Levothyroxine Sodium Tablets

    Lloyd Inc is recalling 19,039 bottles of Levothroid 75 mcg tablets because the drug tested below the required potency level.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, Iowa 51601
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1393-2012·2012-07-04

    Lloyd Inc Recalls Subpotent Levothroid Levothyroxine Sodium Tablets

    Lloyd Inc is recalling 19,166 bottles of Levothroid 50 mcg tablets because they failed potency testing at 9 months.

    Product
    Levothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1666-2012·2012-07-04

    Mexicantown Wholesale Recalls Tacos de Pina for Undeclared Dye

    Mexicantown Wholesale is voluntarily recalling Tacos de Pina due to undeclared FD&C Yellow #5. The recall affects 11 products distributed in Michigan.

    Product
    TACOS DE PINA QTY: 120 MEXICANTOWN BAKERY 313-894-2000
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1863-2012·2012-07-04

    Stryker Recalls Go Bed II+ Model FL 28 Ex Due to Scale Failures

    Stryker is recalling 9,440 Go Bed II+ Model FL 28 Ex hospital beds due to an abnormally high failure rate of loadcells, which can cause scale errors or disabled functions.

    Product
    Go Bed II+ Model FL 28 Ex Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1636-2012·2012-07-04

    Young Ocean Recalls Salted Pollock Roe Due to Undeclared Artificial Colors

    Young Ocean, Inc. is recalling approximately 1,920 pounds of salted pollock roe sold in Washington due to the use of undeclared artificial colors Red #5, Yellow #5, and Red #40.

    Product
    Salted/marinated Pollock roe packaged in white plastic trays with either a clear or opaque plastic lid. Product is packaged in 1.0 lb., 2.2 lb., and 5 lb. sizes and is labeled in part: "Marinated Pollock Roe***Weight: 5.0lb***Production Date: March 2012 Packed by: Young Ocean…
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-1659-2012·2012-07-04

    Mexicantown Wholesale Recalls Concha Chocolate for Undeclared Dye

    Mexicantown Wholesale is voluntarily recalling Concha Chocolate products due to the presence of undeclared FD&C Yellow #6.

    Product
    CONCHA CHOCOLATE QTY: 90 MEXICANTOWN BAKERY 313-894-2000
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1871-2012·2012-07-04

    Colgate Adult Motion Whitening Battery Toothbrush Recalled for Battery Cap Defect

    Colgate-Palmolive is recalling Adult Motion Whitening Battery Toothbrushes because the battery cap can be forcibly blown off the handle.

    Product
    Colgate Adult Motion Whitening Battery Toothbrush UPC 035000691507 Dist. by Colgate-Palmolive Co. New York, NY 10022 Made in China. For teeth cleansing.
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1640-2012·2012-07-04

    Unpasteurized Orange Juice Recalled for Lack of HACCP Plan

    Jugos Naturales del Pepino is recalling 29 gallons of unpasteurized natural orange juice because it was manufactured without a HACCP Plan.

    Product
    Jugos Naturales del Pepino, Jugo de China Natural (Natural Orange Juice), 1 Gal (128 oz), Este producto no est¿ pasteurizado (This product is not pasteurized), Carr 466 Km 4.7 Bo. Robles, San SEbastian, PR 00685
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1392-2012·2012-07-04

    Lloyd Inc Recalls Subpotent Thyro-Tab 0.050mg Bulk Tablets

    Lloyd Inc is recalling 1,924,297 bulk Thyro-Tab 0.050mg tablets because they failed potency testing at the 9-month interval. The product was distributed nationwide and to Puerto Rico.

    Product
    Thyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1862-2012·2012-07-04

    Stryker MA204 Bed Recall Due to Loadcell Failure in Scale Function

    Stryker is recalling MA204 beds because loadcells in the scale and bed exit systems are failing at an abnormally high rate.

    Product
    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1662-2012·2012-07-04

    Mexicantown Wholesale Recalls Cuernos Croissants Due to Undeclared Dye

    Mexicantown Wholesale is voluntarily recalling Cuernos (croissants) because they contain undeclared FD&C Yellow #6, a food dye that may cause allergic reactions in sensitive individuals.

    Product
    CUERNOS (CROISSANT) QTY: 90 MEXICANTOWN BAKERY 313-894-2000
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1868-2012·2012-07-04

    MedComp 8F Plastic Pro-Fuse CT Low Profile Port Recall

    Medical Components, Inc. is recalling 30 kits of the MedComp 8F Plastic Pro-Fuse CT Low Profile Port because the kits contain the wrong port model.

    Product
    MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1898-2012·2012-07-04

    Salter Labs Recalls Adult Divided Cannula Due to Connector Mismatch

    Salter Labs is recalling 242 cases of adult divided cannulas because some units labeled with male luer lock connectors actually contained female luer lock connectors.

    Product
    Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft, oxygen tube, 7 ft. CO2 tube RX only.For Single Patient Use only. Distributed by Tri-Anium Assembled in Mexico. Usage: Delivery of Anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1902-2012·2012-07-04

    Sekisui Recalls 1,600 Acetaminophen Assay Kits Due to Reagent Discoloration

    Sekisui Diagnostics is recalling 1,600 MULTIGENT Acetaminophen assay kits distributed in Illinois because discoloration of the enzyme reagent causes erratic test results.

    Product
    MULTIGENT Acetaminophen for use with Architect/Aeroset Cat. No. 2K99-20. Assay is intended for the quantitative determination of acetaminophen in human serum or plasma.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1397-2012·2012-07-04

    Teva Recalls Zeosa Oral Contraceptive Tablets Due to Impurity Concerns

    Teva Pharmaceuticals is recalling specific lots of Zeosa chewable oral contraceptive tablets because they may not meet impurity specifications.

    Product
    Zeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons…
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1903-2012·2012-07-04

    Polymer Technology Systems Recalls PTS Panels Creatinine Test Strips

    Polymer Technology Systems is recalling 1,650 vials of PTS Panels Creatinine Test Strips because they may provide inaccurate results outside the reportable range.

    Product
    PTS Panels Creatinine test strips. PTS Panels Creatinine Test Strips are intended to measure creatinine in whole blood. Creatinine measurements are used in the diagnosis and treatment of renal (kidney) diseases and in the monitoring of renal dialysis. This system is intended…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1860-2012·2012-07-04

    Stryker Recalls Go Bed II+ Units Due to Scale and Bed Exit Failures

    Stryker is recalling 8,009 Go Bed II+ Model FL28C hospital beds worldwide due to a high failure rate of loadcells that affects scale and bed exit functions.

    Product
    Go Bed II+ Model FL28C Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1637-2012·2012-07-04

    Persimmon Hill Farm Shiitake Mushroom Sauce Recalled for Temperature Violations

    Persimmon Hill Farm is recalling 120 jars of Shiitake Mushroom Sauce because the product did not meet temperature requirements during manufacturing.

    Product
    Persimmon Hill Farm, Shiitake Mushroom Sauce, packaged in 8 oz/glass jars. The firm name on the label is Persimmon Hill Farm, 367 Persimmon Hill Lane, Lame, MO 65681.
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Drugs)·D-1396-2012·2012-07-04

    Teva Recalls Mefloquine Hydrochloride Tablets Due to Weight Variations

    Teva Pharmaceuticals is recalling Mefloquine Hydrochloride 250 mg tablets because they may be underweight or overweight.

    Product
    MEFLOQUINE HYDROCHLORIDE — MEFLOQUINE HYDROCHLORIDE (MEFLOQUINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1661-2012·2012-07-04

    Mexicantown Wholesale Recalls Concha Rosa for Undeclared Yellow Dye

    Mexicantown Wholesale is voluntarily recalling Concha Rosa products distributed in Michigan due to the presence of undeclared FD&C Yellow #6.

    Product
    CONCHA ROSA QTY: 90 MEXICANTOWN BAKERY 313-894-2000
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-1398-2012·2012-07-04

    Shionogi Recalls Nisoldipine Extended Release Tablets for Dissolution Failure

    Shionogi Inc. is recalling Nisoldipine Extended Release Tablets, 17mg, because a specific lot failed USP dissolution testing requirements.

    Product
    Nisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01
    Category
    Drug
    Distribution
    1 state
  • SevereCPSC·12215·2012-07-03

    Innovage Recalls Discovery Kids Lamps Due to Fire and Burn Hazards

    Innovage is recalling Discovery Kids Animated Marine and Safari Lamps because internal wires can cause short-circuiting, sparking, and fire.

    Product
    Discovery Kids™ Animated Marine and Safari Lamps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V310000·2012-07-02

    Zero Motorcycles Recalls 2012 Models Due to Battery Short Circuit Risk

    Zero Motorcycles is recalling 254 model year 2012 motorcycles because insufficient weatherproofing may cause a battery short circuit in wet conditions, leading to sudden power loss.

    Product
    ZERO — ZERO X, XU-LSM, ZERO S, ZERO DS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V309000·2012-07-02

    Prevost Recalls 98 Buses Due to Fire Suppression System Defect

    Prevost is recalling 98 model year 2008-2010 buses because the fire suppression system may activate without a fire, causing an unplanned stop and increasing crash risk.

    Product
    PREVOST — PREVOST H3-45, XLII-45E, X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V308000·2012-07-02

    Mack Trucks Recall 2012 Models for Windshield Wiper Linkage Defect

    Mack Trucks is recalling certain 2012 Granite and Pinnacle trucks because windshield wiper linkage hardware may not be sufficiently torqued, potentially causing wipers to stop functioning.

    Product
    MACK — MACK GRANITE (GU), PINNACLE (CHU), PINNACLE (CXU)
    Category
    Vehicle
    Distribution
    Distributed nationwide

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