The Recall Desk

Archive

September 2012 recalls

607 recalls were announced in September 2012.

What the numbers show

Critical
135
Severe
154
High
210
Moderate
83
Low
25

Of the 607 recalls this month scored against our rubric, 22% are Critical, 25% are Severe.

501–600 of 607

  • HighFDA (Food)·F-2044-2012·2012-09-05

    Cass Clay Creamery Recalls Ice Cream for Undeclared Soy

    Cass Clay Creamery is voluntarily recalling specific ice cream products because they may contain undeclared soy lecithin.

    Product
    Dan's, LIGHT BUTTER PECAN, half gallon *(1.89 L), 0 70422 24210 4 Hornbachers, LIGHT BUTTER PECAN, half gallon (1.89 L), 0 41130 21661 9 Sunnybrook, LIGHT BUTTER PECAN, half gallon (1.89 L), 0 70422 24908 0
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2286-2012·2012-09-05

    Medline Extended PTFE Needle Recall for Sterility Concerns

    Unimed Surgical Products is recalling Medline Extended PTFE Needles due to sterility concerns. The recall affects 1,440 units distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm) Length***Reorder: ES0016***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of Medline
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2279-2012·2012-09-05

    Mindray Recalls V Series Patient Monitors Due to Software Anomalies

    Mindray is recalling 979 V Series Patient Monitors worldwide due to two identified software anomalies. No injuries have been reported.

    Product
    V Series Patient Monitors; Mindray DS USA, Inc. Product Usage: The V Series Monitor is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The indications for Use for the V Series include the monitoring of the following human ph
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2287-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to concerns regarding sterility. The affected products are intended for cutting and coagulation of soft tissue.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0" (10.16cm) Length***Reorder: ES0016A***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2296-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units were distributed nationwide in the US.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2093-2012·2012-09-05

    Shin Shin Foods Recalls Strawberry Yogurt Parfait for Undeclared Coconut

    Shin Shin Foods is recalling Strawberry Yogurt Parfait because it contains coconut, which is not declared on the label.

    Product
    Yogurt Parfait Strawberry, Net weight 9 oz. (225 g), UPC 0 20728 70004 4. Product contains yogurt and strawberry filling and one cup of granola, packaged in a clear container, and granola is in the inner container. The product is labeled in part: '***YOGURT PARFAIT STRAWBERRY
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2304-2012·2012-09-05

    Sendx Medical Recalls ABL80 FLEX Blood Gas Analyzers for Glucose Errors

    Sendx Medical Inc is recalling ABL80 FLEX and ABL80 FLEX CO-OX analyzers because glucose measurements may be inaccurate and not reflect patient clinical conditions.

    Product
    ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood gase
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2019-2012·2012-09-05

    Rita's Fine Food Recalls Ham and Cheese Sandwiches for Undeclared Milk

    Rita's Fine Food is recalling specific ham and cheese sandwiches sold in California because they contain undeclared milk.

    Product
    6" Ham & Cheese Sandwich, 8" Ham & Cheese Sandwich, and Ham & Cheese Triangle Sandwich
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2018-2012·2012-09-05

    Rita's Fine Food Club Sandwiches Recalled for Undeclared Milk

    Rita's Fine Food is recalling specific club sandwiches sold in California because they contain undeclared milk in the cheese.

    Product
    6" Club Sandwich, 8" Club Sandwich, Club Sandwich Triangle, and Wide Wedge Club Sandwich
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2049-2012·2012-09-05

    Cass Clay Ice Cream Recalled for Undeclared Soy Allergen

    Cass Clay Creamery is voluntarily recalling specific ice cream products because they may contain undeclared soy lecithin.

    Product
    Cass Clay, TIN ROOF SUNDAE 3 Gallon (11.34 L) Cass Clay, TIN ROOF SUNDAE, one gallon (3.78 L), 0 70422 03474 7
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2290-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Needles Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical needles due to concerns about sterility. The affected lot is distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm (1.81) Length***Reorder: ESE1651***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2303-2012·2012-09-05

    Philips SureSigns VSi and VS2+ Patient Monitors Recalled for Mounting Defect

    Philips is recalling SureSigns VSi and VS2+ patient monitors because they may not be properly secured to wall mounts and could fall.

    Product
    Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2069-2012·2012-09-05

    Fresh Ideas Soup Vegetable Mix Recalled for Listeria Contamination

    Fresh Ideas Inc. is recalling soup vegetable mixes containing recalled Gill's Onions due to Listeria monocytogenes contamination.

    Product
    Small Soup Vegetable Mix:-(Item #CC4) Spanish Onions {1/4" dice), Carrots, Celery Medium Soup Mix Vegetables (Item #CC5) Spanish Onions (1/2" dice), Carrots. Celery 5 lb poly bags Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00254
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-2111-2012·2012-09-05

    Naturally Fresh Pecan Salad Toppings Recalled for Undeclared Almond Allergen

    Naturally Fresh Inc. is recalling Roasted & Glazed Pecan Pieces because they contain undeclared almonds. Consumers with nut allergies should not eat the product.

    Product
    Naturally Fresh Salad Toppings, Roasted & Glazed Pecan Pieces, Net weight 3.5 oz, Distributed by: Naturally Fresh, Atlanta, GA
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-2059-2012·2012-09-05

    Cass-Clay Ice Cream Recalled for Undeclared Brazil Nuts

    Cass-Clay Creamery is voluntarily recalling Light Maple Nut ice cream because it may contain undeclared Brazil nuts.

    Product
    CASS-CLAY, Ice cream, LIGHT MAPLE NUT, One Gallon (3.78L), 0 70422 23404 8
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·12V432000·2012-09-05

    Honda Recalls 2012 Ridgeline Vehicles Due to Airbag Indicator Defect

    Honda is recalling specific 2012 Ridgeline vehicles because an incorrect passenger airbag status indicator may be installed. This could prevent drivers from knowing the front passenger airbag is off.

    Product
    HONDA — HONDA RIDGELINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2045-2012·2012-09-05

    Cass Clay Creamery Recalls Ice Cream for Undeclared Soy

    Cass Clay Creamery is voluntarily recalling specific chocolate chip ice cream products because they may contain undeclared soy lecithin.

    Product
    SunnyBrook, Chocolate Chip one gallon and one quart ( (4.73 L), 0 70422 02905 7 SunnyBrook, CHOCOLATE CHIP half gallon ( (1.89 L), 0 70422 04905 5 Cass Clay, CHOCOLATE CHIP 3 Gallon (11.34 L)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2035-2012·2012-09-05

    Cass-Clay Creamery Recalls Ice Cream for Undeclared Brazil Nuts

    Cass-Clay Creamery is voluntarily recalling specific ice cream products because they may contain undeclared Brazil nuts.

    Product
    CASS-CLAY, Ice Cream, Artificially Flavored MAPLE NUT, One Gallon (3.78 L), 0 70422 03404 4 HORNBACHERS, MAPLE NUT, Ice Cream, HALF GALLON(1.89 L), 0 41130 21666 4 COLUMBIA VALLEY FARMS, MAPLE NUT, 62438, 3 GALLON(11.34L), 0 41493 62438 0
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2056-2012·2012-09-05

    Cass-Clay Creamery Recalls Ice Cream for Undeclared Peanuts

    Cass-Clay Creamery is voluntarily recalling specific ice cream products because they may contain undeclared peanuts, posing a risk to consumers with peanut allergies.

    Product
    Hornbachers, Peanut Butter Fudge, Half Gallon, (1.89L), 0 41130-21659 6.
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2050-2012·2012-09-05

    Cass Clay Bison Crunch Ice Cream Recalled for Undeclared Soy

    Cass Clay Creamery is voluntarily recalling Bison Crunch ice cream products because they may contain undeclared soy lecithin.

    Product
    Cass Clay, BISON CRUNCH, half gallon (1.89 L) 0 70422 04033 5 Cass Clay, BISON CRUNCH, 3 Gallon (11.34 L)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2047-2012·2012-09-05

    Cass Clay Ice Cream Recalled for Undeclared Soy

    Cass Clay Creamery is voluntarily recalling specific ice cream products because they may contain undeclared soy lecithin.

    Product
    Cass Clay, LIGHT BROWNIE FDG, one gallon ( 3.78 L) 0 70422 23485 7 Cass Clay, LIGHT BROWNIE FUDGE, half gallon (1.89 L) 0 70422 24085 8
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2289-2012·2012-09-05

    Medline PTFE Coated Needle Recall Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline Standard PTFE Coated Needles due to sterility concerns. The affected lots are distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2295-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.

    Product
    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2293-2012·2012-09-05

    Medline Electrosurgical Electrodes Recalled for Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2060-2012·2012-09-05

    Cass Clay Creamery Recalls Sunnybrook Light Cookies 'N Cream Ice Cream

    Cass Clay Creamery is voluntarily recalling Sunnybrook Light Cookies 'N Cream ice cream because it may contain undeclared soy lecithin.

    Product
    SUNNYBROOK, LIGHT COOKIES 'N CREAM, half gallon (1.89 L), 0 70422 24943 1
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2051-2012·2012-09-05

    Cass Clay Light Candy Bar Ice Cream Recalled for Undeclared Soy

    Cass Clay Creamery is voluntarily recalling Light Candy Bar ice cream because it may contain undeclared soy lecithin.

    Product
    Cass Clay, LIGHT CANDY BAR, half gallon (1.89 L ) 0 70422 24032 2
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2052-2012·2012-09-05

    Cass Clay Ice Cream Recalled for Undeclared Soy Lecithin

    Cass Clay Creamery is voluntarily recalling specific ice cream products because they may contain undeclared soy lecithin, a common allergen.

    Product
    Cass Clay, LIGHT MUDDY SNEAKERS, half gallon (1.89 L) 0 70422 24072 8
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-2291-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling specific lots of Medline electrosurgical electrodes due to concerns regarding sterility.

    Product
    Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with Extended Insulation 2.75 (6.99cm) Length***Reorder: ES0013M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2266-2012·2012-09-05

    Toshiba CT Systems Recalled for Potential Table Position Errors

    Toshiba American Medical Systems is recalling 757 CT systems because a table control board defect may cause patients to be scanned at incorrect positions.

    Product
    Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2253-2012·2012-09-05

    I-Flow Recalls ON-Q Pumps Due to Bolus Button Malfunction

    I-Flow Corporation is recalling ON-Q pumps with ONDEMAND because the bolus button may fail to lock, causing patients to receive medication at higher-than-expected rates.

    Product
    ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100, 10
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2055-2012·2012-09-05

    Cass-Clay Creamery Recalls Ice Cream for Undeclared Wheat

    Cass-Clay Creamery is voluntarily recalling Schroeder Chocolate Chip Cookie Dough ice cream because it may contain undeclared wheat.

    Product
    Schroeder, Ice Cream, Chocolate Chip Cookie Dough, half gallon (1.89 L), 0 72340 00183 2
    Category
    Food
    Distribution
    5 states
  • HighFDA (Drugs)·D-1666-2012·2012-09-05

    GlaxoSmithKline Recalls Ventolin Inhalers Due to Low Albuterol Content

    GlaxoSmithKline is recalling 1.4 million Ventolin inhalers because the albuterol content may be below specification, potentially failing to deliver the proper metered dose.

    Product
    VENTOLIN — VENTOLIN (ALBUTEROL SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2263-2012·2012-09-05

    Cisco HealthPresence Software Recall for Vital Signs Display Errors

    Cisco Systems is recalling HealthPresence software version 2.1 because subsequent vital signs readings may not update correctly in the OnePlace tab, potentially leading to incorrect interpretations.

    Product
    Cisco brand HealthPresence, version 2.1; Model/Catalog Number: CHP-ENTPRSYR2.I-K9; Product is manufactured and distributed by Cisco Systems, Inc. San Jose, CA Cisco HealthPresence, version 2 is intended for remote consultation of patients with a healthcare provider. Cisco Heal
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2267-2012·2012-09-05

    Metrex Recalls CaviCide Disinfectant Due to Reported Health Reactions

    Metrex Research is recalling CaviCide disinfectant with Spring Fresh Fragrance because it caused health reactions like headaches and nausea in some users.

    Product
    CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate brands: EnviroCide, part number: 13-3325. Private labeled products of Cavicide: Backscratchers Cavicide, part number: 13-4800. MaxiSpray Plus, part numbers: 13-7400 and 13-7405. pdCARE Surface Di
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2265-2012·2012-09-05

    Canon Solid State X-ray Imager Recall Due to Loose Screws

    Canon is recalling 468 Solid State X-ray Imagers because screws holding the 55REF circuit board are loosening and roaming inside the sealed sensor.

    Product
    Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiography, Models CXDI-55C, CXDI-55G and CXDI-70C. These devices are intended to replace radiographic film/screen systems in all general purpose diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2288-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling specific lots of Medline electrosurgical electrodes due to concerns regarding sterility.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with Extended Insulation 4.0" (10.16cm) Length***Reorder: ES0016AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2292-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to concerns about sterility. The recall affects 1,920 units distributed nationwide.

    Product
    Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5 (16.51cm) Length***Reorder: ES0014***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2294-2012·2012-09-05

    Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns

    Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected lot is 052709-01.

    Product
    Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball 5.0 (12.70cm) Length***Reorder: ES0009***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·12E034000·2012-09-05

    Automotive Innovations Recalls Electronic Gas/Brake Systems Lacking Backup Diagnostics

    Automotive Innovations is recalling Electronic Gas/Brake systems installed as adaptive equipment on motor vehicles. The systems lack adequate backup brake diagnostics, potentially allowing drivers to operate vehicles with malfunctioning backup brakes.

    Product
    EQUIPMENT ADAPTIVE/MOBILITY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2039-2012·2012-09-05

    Cass Clay Creamery Recalls Ice Cream for Labeling Errors

    Cass Clay Creamery is voluntarily recalling 23,852 containers of light French vanilla ice cream due to non-compliant egg labeling and undeclared Yellow 5 color.

    Product
    HORNBACHERS, LIGHT FRENCH VANILLA, HALF GALLON (1.89L), 0 41130 21662 6 (Missing Egg from Contains statement) SUNNYBROOK, LIGHT FRENCH VANILLA, HALF GALLON (1.89 L), 0 70422 24917 2 . (MISSING YELLOW 5 FROM LABEL) DAN'S, LIGHT FRENCH VANILLA, HALF GALLON(1.89 L), 0 70422
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2038-2012·2012-09-05

    Cass-Clay Creamery Recalls Ice Cream for Undeclared Soy and Wheat

    Cass-Clay Creamery is voluntarily recalling specific ice cream products because they may contain undeclared soy lecithin and wheat.

    Product
    CASS-CLAY: LIGHT DUSTY ROAD, ONE GALLON (3.78 L), 0 70422 23480 2. LIGHT ICE CREAM, DUSTY ROAD, HALF GALLON (1.89L), 0 70422 24080 3
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2054-2012·2012-09-05

    Cass Clay Ice Cream Recalled for Undeclared Soy Lecithin

    Cass Clay Creamery is voluntarily recalling Winter Wonder ice cream products because they may contain undeclared soy lecithin.

    Product
    Cass Clay, WINTER WONDER, half gallon (1.89 L) , 0 70422 00100 8 Cass Clay, Winter Wonder, 3 Gallon (11.334 L)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2061-2012·2012-09-05

    Cass-Clay Ice Cream Recalled for Undeclared Soy Lecithin

    Cass-Clay Creamery is voluntarily recalling specific ice cream products because they may contain undeclared soy lecithin, a common allergen.

    Product
    Cass-Clay, COOKIES 'N VANILLA 3 Gallon (11.34 L)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2057-2012·2012-09-05

    Cass-Clay Creamery Recalls Swiss Chip Ice Cream for Undeclared Soy

    Cass-Clay Creamery is voluntarily recalling Swiss Chip ice cream because it may contain undeclared soy lecithin. The recall affects 81 containers distributed in five states.

    Product
    Cass-Clay , Swiss Chip, 3 Gallon(11.34 L).
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2053-2012·2012-09-05

    Cass Clay Ice Cream Recalled for Undeclared Soy Allergen

    Cass Clay Creamery is voluntarily recalling specific ice cream products because they may contain undeclared soy lecithin.

    Product
    Cass Clay, PEPPERMINT CANDY, half gallon (1.89 L), 0 70422 00100 8 Cass Clay, Peppermint Stic, 3 Gallon (11.34 L).
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2048-2012·2012-09-05

    Cass Clay Ice Cream Recalled for Undeclared Soy Lecithin

    Cass Clay Creamery is voluntarily recalling specific CHOCOLATE MONSTER ice cream products because they may contain undeclared soy lecithin.

    Product
    Cass Clay CHOCOLATE MONSTER, half gallon (1.89 L) 0 70422 00032 2 Cass Clay CHOCOLATE MONSTER, 3 Gallon (11.34 L) Soy (Lecithin) N/A
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2036-2012·2012-09-05

    Cass-Clay Ice Cream Recalled for Undeclared Soy and Peanut Allergens

    Cass-Clay Creamery is voluntarily recalling Double Chocolate Fudge Premium Light Ice Cream because it may contain undeclared soy lecithin and peanut oil.

    Product
    CASS-CLAY, DOUBLE CHOCOLATE FUDGE, Premium Light Ice Cream, HALF GALLON (1.89L), 0 70422 24061 2
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2046-2012·2012-09-05

    Cass-Clay Creamery Recalls Ice Cream for Undeclared Soy

    Cass-Clay Creamery is voluntarily recalling specific ice cream products because they may contain undeclared soy lecithin.

    Product
    Cass-Clay, UND CHAMPION CHIP, half gallon (1.89 L) 0 70422 04062 5 Cass-Clay, UND CHAMPION CHIP 3 Gallon (11.34 L)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-2021-2012·2012-09-05

    Rita's Fine Food Recalls Roast Beef Sandwiches for Undeclared Milk

    Rita's Fine Food, Inc. Dba Da Vinci's is recalling four types of roast beef sandwiches sold in California due to undeclared milk in the cheese.

    Product
    8" Roast Beef Sandwich, 6" Roast Beef Sandwich, Roast Beef Triangle Sandwich, and Wide Wedge Roast Beef Sandwich
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2037-2012·2012-09-05

    Cass Clay Ice Cream Recalled for Undeclared Soy Lecithin

    Cass Clay Creamery is voluntarily recalling specific Cookies 'N Cream ice cream products because they may contain undeclared soy lecithin.

    Product
    Cass Clay, COOKIES 'N CREAM, 1 gallon ( 3.78 L), 0 70422 45034 9 Cass Clay, COOKIES 'N CREAM, half gallon (1.89 L), 0 70422 04010 6
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2251-2012·2012-09-05

    GE OEC Surgical Navigation Systems Recalled for Unvalidated Headset Configuration

    GE OEC Medical Systems is recalling 768 surgical navigation systems because the Inverted Headset Placement is not a validated configuration.

    Product
    OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1668-2012·2012-09-05

    Mercaptopurine Tablets Recalled for Failed Dissolution Test Requirements

    American Health Packaging is recalling 694 cartons of Mercaptopurine Tablets, USP, 50 mg, because the lot failed USP dissolution test requirements.

    Product
    Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511; Carton labeling Dist by: Par Pharmaceutical Companies, Inc., Spring Valley, NY
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1660-2012·2012-09-05

    Galderma Recalls Subpotent Capex Shampoo Due to Low Fluocinolone Acetonide Levels

    Galderma is recalling 17,160 bottles of Capex Shampoo because the fluocinolone acetonide content is subpotent. The product was distributed nationwide and in Puerto Rico.

    Product
    Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1664-2012·2012-09-05

    Eco-Dent Mouth Rinse Recalled for Bacterial Contamination

    Capco Custom Packaging is recalling Eco-Dent Sparkling Clean Mint mouth rinse due to contamination with Sphingomonas paucimobilis bacteria.

    Product
    Eco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1671-2012·2012-09-05

    Oasis Age Essential Mouthwash Recalled for Microbial Contamination

    Natural Essentials Inc is recalling specific lots of Oasis Age Essential Mouthwash due to contamination with Burkholderia cepacia.

    Product
    Oasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2284-2012·2012-09-05

    Steris Recalls QKC1692E Quick Connect Devices Due to Labeling Errors

    Steris Corporation is recalling 64 QKC1692E Quick Connect devices because seven endoscope models were not validated for use with the device, requiring label corrections.

    Product
    QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2105-2012·2012-09-05

    Blount Seafood Recalls Wegman's Tomato Basil Soup Due to Foreign Plastic

    Blount Seafood Corporation is recalling Wegman's Tomato Basil with Orzo Soup because foreign plastic material was found in the retail units.

    Product
    Wegman's Tomato Basil with Orzo Soup 16 oz retail cup Product Code: 85653
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2283-2012·2012-09-05

    Siemens Stratus CS Acute Care D-dimer Calibrator Recall

    Siemens is recalling specific lots of D-dimer Calibrators that may cause instrument calibration errors.

    Product
    Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 The Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDMR CalPak), Catalog No. CDDMR-C is an in-vitro diagnostic product intended to be used for the calibration of the Stratus(R)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2109-2012·2012-09-05

    Nha Trang Seafoods Recalls Frozen T&T Pangasius Fish Due to Nitrofuran Residue

    Nha Trang Seafoods, Inc. is recalling 2,529 cartons of frozen T&T Pangasius fish because nitrofuran residue was detected. The product was distributed to one consignee in California.

    Product
    Frozen Pangasius Fish, brand name T&T, in the following sizes: a. IQF 15 lbs bulk carton: 3/5 oz, 5/7 oz, 7/9 oz, 9/11 oz b. 11lbs x 2 per carton: 8/10 oz and 10 oz/up c. 2lbs x 5 per carton: 2/3 oz d. 15lbs carton: 2/3 oz Product labeling reads in part:" T&T SWAI ROSE
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2041-2012·2012-09-05

    Cass-Clay Bubble Gum Ice Cream Recalled for Undeclared Dyes

    Cass-Clay Creamery is voluntarily recalling 3-gallon containers of Bubble Gum ice cream because they may contain undeclared food dyes Red 40, Blue 1, and Blue 2.

    Product
    CASS-CLAY, BUBBLE GUM, 3 GALLON (11.34 L).
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-2302-2012·2012-09-05

    Encore Medical Recalls 3DKnee e+ Tibial Inserts Due to Expired Labeling

    Encore Medical is recalling 7 units of 3DKnee e+ Tibial Inserts because shelf life labeling was incorrect and the components were expired.

    Product
    3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This inse
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-2104-2012·2012-09-05

    Jakes Spice Drop Recalled for Undeclared Food Dyes

    Four Brothers Packaging is recalling Jakes Spice Drop packages due to undeclared food dyes found by New York State.

    Product
    Jakes Spice Drop, Jake's Jelly Spice Drops 3oz, 4.5oz, 5oz, 6oz and 7oz packages Distributed by Jake's Liberty Packaging Oak Park, MI 48237 248-747-2223
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2282-2012·2012-09-05

    Toshiba Whole Body X-ray Scanner Recalled for Incorrect Data Display

    Toshiba is recalling 24 whole body X-ray scanners because incorrect couch positions and scan times may be displayed on reconstructed images.

    Product
    Whole Body X--ray Scanner This device is indicated as a whole body volume CT system. The system produces volumes of up to 320 axial slices in a single rotation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2275-2012·2012-09-05

    Siemens syngo.plaza Radiological Image Processing System Recalled for Miscalculation

    Siemens Medical Solutions is recalling 14 syngo.plaza systems due to a potential miscalculation in images with pixel depth values greater than 12 bits.

    Product
    syngo.plaza, Model number 10592457. Intended use: radiological image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2271-2012·2012-09-05

    Biomet 3i Recalls Low Profile Abutments Due to Labeling Errors

    Biomet 3i is recalling Low Profile Abutments because some packages labeled as Hexed Castable Cylinders may contain Non-Hexed Castable Cylinders.

    Product
    Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is labeled in part: "***REF LPCCC1***Low profile Abutment Hexed Castable Cylinder***Cylinder; Cylindre; Zylinder; Cilindro; Cilindro; Cilindro***RX only***NON STERILE***Caution: Law prohibits dispensing wit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2278-2012·2012-09-05

    Toshiba MRI Systems Recalled for Sequence Queue Status Display Error

    Toshiba American Medical Systems is recalling 54 EXCELART MRI systems because the status display in the sequence queue window may fail to update from 'Current' to 'Done'.

    Product
    EXCELART Vantage, Atlas, and Titan MRI Systems, MRT-1503 and MRT-1504. Imaging of the Whole Body, Fluid Visualization, 2D/3D Imaging, MR Angiography/MR Vascular Imaging, Blood Oxygenation Level Dependent Imaging, Perfusion I Diffusion Imaging, and Proton Spectroscopy.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2270-2012·2012-09-05

    Sunquest Laboratory Software Recall for Microbiology Data Entry Errors

    Sunquest Information Systems is recalling Sunquest Laboratory software versions 6.4 and later due to potential errors in specimen data entry.

    Product
    Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2264-2012·2012-09-05

    Siemens syngo Imaging XS Software Recall for Miscalculation Defect

    Siemens Medical Solutions is recalling 52 syngo Imaging XS systems due to potential miscalculation of grey scale values in specific image processing functions.

    Product
    syngo Imaging XS. Radiological image processing system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2300-2012·2012-09-05

    SRI Surgical Recalls Disposable Accessory Packs Due to Labeling Error

    SRI Surgical is recalling 802,135 disposable accessory packs distributed nationwide because they did not meet specifications due to a labeling error.

    Product
    Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly known as convenience kits and custom procedure trays) are an assembly of medical devices packaged together according to the customer specifications, which are then wrapped in a ste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2273-2012·2012-09-05

    Alphatec Recalls Trestle Luxe Anterior Cervical Plating System Components

    Alphatec Spine is recalling 38 units of the Trestle Luxe Anterior Cervical Plating System because the Slide Alignment Tool does not fit the plate screws.

    Product
    TRESTLE LUXE¿ Anterior Cervical Plating System, Product code KWQ. 510(k) K102820. The TRESTLE LUXE Anterior Cervical Plating System is a temporary device used to stabilize the cervical spine during bone fusion development. Device implants include a range of plate sizes and bon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2017-2012·2012-09-05

    SunFresh Natural Fruit & Nut Recalled for Missing Ingredient Labels

    SunFresh Natural is recalling 6-ounce Fruit & Nut packages because the labels fail to list sulfites and FD&C Yellow #6.

    Product
    SunFresh Natural Fruit & Nut, Distributed by: Sunfresh Natural, LLC. Passaic, NJ 07055. Please visit us at: www.sunfreshnatural.com. 6 ounce and 10 ounce packages (Net wt.).
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-2043-2012·2012-09-05

    Cass Clay Ice Cream Recalled for Undeclared Yellow #5 Dye

    Cass Clay Creamery is voluntarily recalling New York Cherry Ice Cream because it may contain undeclared Yellow #5 dye.

    Product
    CASS CLAY, NEW YORK CHERRY ICE CREAM, 3 GALLON (11.34 L).
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Food)·F-2062-2012·2012-09-05

    Hornbacher's French Vanilla Ice Cream Recalled for Missing Egg Labeling

    Cass Clay Creamery is voluntarily recalling Hornbacher's French Vanilla Ice Cream because the packaging fails to list egg as an ingredient, violating FALCPA requirements.

    Product
    HORNBACHERS, FRENCH VANILLA ICE CREAM, Half-gallon (1.89 L), 0 41130 21658 9 (Missing Egg in the Contains statement)
    Category
    Food
    Distribution
    5 states
  • LowFDA (Devices)·Z-2269-2012·2012-09-05

    Baxter Mini-Infuser Model 300XL Infusion Pump Recalled for Battery Contact Defect

    Baxter Healthcare is recalling 19,380 Mini-Infuser Model 300XL infusion pumps because a battery contact defect may prevent the device from operating.

    Product
    Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syringe infusion pump with an active time scale and rate selector switch; product codes 2M8171 and 2M8171R. Product Usage: These product codes includes refurbished units. Intended for the controlled
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1667-2012·2012-09-05

    Apotex Recalls Azelastine Hydrochloride Nasal Solution Due to CGMP Deviations

    Apotex Corp. is recalling Azelastine Hydrochloride Nasal Solution because tubing used for filling may interact with the nasal formulation.

    Product
    AZELASTINE HYDROCHLORIDE — AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1669-2012·2012-09-05

    VistaPharm Recalls Metoclopramide Oral Solution Due to Labeling Error

    VistaPharm is recalling 73,800 cups of Metoclopramide Oral Solution because the shipper label incorrectly displayed '5 mL x 50' instead of '10 mL x 50'.

    Product
    METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2276-2012·2012-09-05

    Advanced Sterilization Products Recalls CIDEX OPA Solution Due to Missing Labels

    Advanced Sterilization Products is recalling CIDEX OPA Solution bottles manufactured between May 2011 and April 2012 because some are missing labels.

    Product
    CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2268-2012·2012-09-05

    Baxter Mini-Infuser 150XL Infusion Pump Recalled for Battery Contact Defect

    Baxter Healthcare is recalling Mini-Infuser Model 150XL infusion pumps because a battery contact defect may prevent the device from operating.

    Product
    Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated syringe infusion pump; Product Usage: These product codes includes refurbished units. Intended for the controlled rate delivery of small volume parental fluids as prescribed by a physician. Usage:
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2285-2012·2012-09-05

    Phadia Varelisa Cardiolipin IgM Test Kits Recalled for Elevated Results

    Phadia US Inc is recalling Varelisa Cardiolipin IgM test kits because a material change combined with a prior instruction to omit a pre-wash step caused elevated assay results.

    Product
    PHADIA Varelisa Cardiolipin IgM Cardiolipin autoantibody immunological test system (IgM class antibodies)
    Category
    Medical Device
    Distribution
    Distributed nationwide

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