The Recall Desk

Archive

September 2012 recalls

607 recalls were announced in September 2012.

What the numbers show

Critical
135
Severe
187
High
184
Moderate
76
Low
25

Of the 607 recalls this month scored against our rubric, 22% are Critical, 31% are Severe.

Which agencies issued them

401–500 of 607

  • HighFDA (Devices)·Z-2305-2012·2012-09-12

    Siemens syngo Lab Data Manager Recall for Quality Control Defect

    Siemens Healthcare Diagnostics is recalling syngo Lab Data Manager and Process Manager software due to a defect that may prevent the system from flagging quality control violations appropriately.

    Product
    syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2124-2012·2012-09-12

    Amport Foods Recalls Pine Nuts Due to Undeclared Peanuts

    American Importing Co. is recalling specific lots of pine nuts because they may contain undeclared peanuts, posing a risk to individuals with peanut allergies.

    Product
    Nature's Harvest, pine nuts, Net WT 3 oz (85 g), Distributed by Amport Foods, 550 Kasota Ave, SE., Minneapolis, MN 55414, 3 00 71725 72753 4. Case Label Stock No. 5640 8/3 oz Nature's Harvest, Pine Nuts Best by: 12-28-12 363x1E1, 3 00 71725 72753 5. Amport Foods Bags…
    Category
    Food
    Distribution
    24 states
  • HighFDA (Food)·F-2133-2012·2012-09-12

    Humphrey Chocolate Drizzle Popcorn Recalled for Undeclared Soy Lecithin

    The Humphrey Popcorn Co is voluntarily recalling Chocolate Drizzle Popcorn because the label fails to declare soy lecithin.

    Product
    Humphrey Chocolate Drizzle, 5 oz. in a clear plastic bag, UPC Code 8108400009. Bags are packed 12 to a case.
    Category
    Food
    Distribution
    4 states
  • HighFDA (Devices)·Z-2322-2012·2012-09-12

    Siemens Recalls Mobilett Mira Mobile X-Ray Systems Due to Switch Defect

    Siemens is recalling 20 Mobilett Mira mobile X-ray systems because a switch may become trapped, causing the unit to move continuously.

    Product
    Siemens Mobilett Mira. Mobile X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2309-2012·2012-09-12

    Cook Ireland Recalls Zilver Vascular Stents Due to Sizing Error

    Cook Ireland is recalling 15 Zilver 518 Vascular Self Expanding Stents because a unit was found to be the wrong size, causing it to lodge in a sheath.

    Product
    Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2324-2012·2012-09-12

    RayStation Treatment Planning Software Recalled for Dose Calculation Error

    RaySearch Laboratories AB is recalling RayStation software versions 2.5.0.144 and 2.5.1.89 due to a dose calculation normalization issue. No patient mistreatment has occurred.

    Product
    Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·12V444000·2012-09-12

    NABI Recalls 2010 Transit Buses Due to Emergency Window Handle Defect

    North American Bus Industries is recalling 2010 NABI 416 and 40LFW transit buses because emergency window release handles may fail, potentially delaying passenger exit.

    Product
    NABI — NABI 416, 40LFW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2310-2012·2012-09-12

    Exactech Recalls Optetrak Logic Tibial Inserts Due to Dimensional Defects

    Exactech is recalling 193 Optetrak Logic Posterior Stabilized Tibial Inserts because they were found to be out of dimensional specification.

    Product
    OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and Tibial Components***REF 02-012-35-6011. There are three product sizes being recalled, 11mm, 13mm, 15mm. All other information is the same. The Optetrak…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2118-2012·2012-09-12

    Bissinger's Campfire S'Mores Salt Caramels Recalled for Gluten Mislabeling

    Karl Bissinger Inc is recalling Bissinger's Campfire S'Mores Salt Caramels because the product is labeled as gluten-free but contains wheat.

    Product
    Bissinger's Campfire S'Mores Salt Caramels, packaged in 1.8-oz. boxes, 5 pieces per box, 12 boxes per display case, UPC 846107012788. The firm name on the label is Bissinger's Handcrafted Chocolatier, St. Louis, MO.
    Category
    Food
    Distribution
    16 states
  • HighFDA (Food)·F-2125-2012·2012-09-12

    Jaffe Bros. Pine Nuts Recalled for Undeclared Peanut Allergen

    Jaffe Bros. is recalling raw, shelled pine nuts because they were packaged on equipment that also processes peanuts, posing a risk to individuals with peanut allergies.

    Product
    Jaffe Bros. brand, Pine nuts, raw and shelled. Packaged in plastic bag. Labeling reads in part:"Jaffe Bros.***Organically Grown Raw, Shelled Pine Nuts This product was packaged on shared equipment that also processes Peanuts***Distributed by Jaffe Bros., Inc. P.O.Box 636 Valley…
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2306-2012·2012-09-12

    Princeton Biomeditech Recalls Orasure QuickFlu Rapid A+B Test Kits

    Princeton Biomeditech is recalling Orasure QuickFlu Rapid A+B Test kits due to reports of dual positive results for Flu A and Flu B.

    Product
    Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2123-2012·2012-09-12

    Apio Recalls Broccoli, Cauliflower, and Peas Due to Plastic Contamination

    Apio Inc. is recalling specific lots of broccoli, cauliflower, and peas because they may contain small plastic shavings from a production line.

    Product
    Eat Smart Broccoli & Cauliflower, 9x12oz. Item # 10068. Code Dates: B07208, B08208.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2326-2012·2012-09-12

    Breg Polar Dressing Recalled for Thickness and Durability Defects

    Breg Inc. is recalling Polar Dressing units that are thinner than specified, making them less durable and prone to tearing.

    Product
    Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold therapy pads to provide insulation barrier between the pad and patient's skin.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2313-2012·2012-09-12

    Siemens ADVIA Centaur Multi-Diluent 1 Recalled for Decreased Dilution Recovery

    Siemens Healthcare Diagnostics is recalling ADVIA Centaur Multi-Diluent 1 because it may show decreased dilution recovery when stored on-board the system.

    Product
    Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and TSH3 Ultra assays when on-board the ADVIA Centaur or ADVIA Centaur XP systems. Catalog Numbers: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313). Used for…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2126-2012·2012-09-12

    Drucker Labs Recalls intraKID Due to Incorrect Vitamin B3 Form

    Drucker Labs is recalling intraKID Lot 658 because it was manufactured with an incorrect form of Vitamin B3, which may cause temporary skin symptoms.

    Product
    intraKID Lot 658 with a Best By date of 12/12, 33 oz and 2 oz bottles
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2308-2012·2012-09-12

    Princeton Biomeditech Recalls Status Flu A + B Test Kits

    Princeton Biomeditech is recalling 90 kits of the Status Flu A + B Test due to reports of dual positive results.

    Product
    Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2318-2012·2012-09-12

    BD GeneOhm Cdiff Assay Recalled Due to Leakage in Reaction Tubes

    Becton Dickinson & Co. is recalling 57 kits of the BD GeneOhm Cdiff Assay because of leakage in Cepheid SmartCycler reaction tubes.

    Product
    BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2317-2012·2012-09-12

    BD GeneOhm MRSA ACP Assay Recalled for Leakage in Reaction Tubes

    Becton Dickinson & Co. is recalling 68 kits of the BD GeneOhm MRSA ACP Assay due to leakage in Cepheid SmartCycler reaction tubes.

    Product
    BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2129-2012·2012-09-12

    Clif Bar Recalls Blueberry Crisp Bars Due to Mislabeling

    Clif Bar and Company is recalling Blueberry Crisp CLIF Bars because some were mistakenly packaged in Chocolate Chip wrappers.

    Product
    Blueberry Crisp CLIF Bars, 12 pack boxes, UPC: 7-22252-30260-1
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Food)·F-2120-2012·2012-09-12

    Clif Bar White Chocolate Macadamia Recalled for Undeclared Coconut

    Clif Bar is recalling White Chocolate Macadamia bars because they contain undeclared coconut. The error occurred when Coconut Chocolate Chip bars were placed in the wrong wrappers.

    Product
    CLIF Bar Brand White Chocolate Macadamia CLIF Bar, 2.4 oz (68g), Individually wrapped bars Product is manufactured by Harlan Bakeries in Indianapolis, IN.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2312-2012·2012-09-12

    Capintec Captus 3000 Thyroid Uptake System Software Error Recall

    Capintec is recalling Captus 3000 Thyroid Uptake Systems with specific software revisions due to a potential error in the 'Measure Liquid and Subtract Residual' protocol.

    Product
    Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2307-2012·2012-09-12

    Princeton Biomeditech Recalls Poly stat Flu A & B Test Kits

    Princeton Biomeditech Corp is recalling 103 kits of the Poly stat Flu A & B Test due to reports of dual positive results.

    Product
    Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2119-2012·2012-09-12

    CLIF Bar Coconut Chocolate Chip Bars Recalled for Undeclared Coconut

    Clif Bar and Company is recalling Coconut Chocolate Chip bars due to undeclared coconut in the ingredient statement.

    Product
    CLIF Bar Brand Coconut Chocolate Chip CLIF Bars, 6-pack boxes, UPC: 7-22252-66030-5 Product is manufactured by Harlan Bakeries in Indianapolis, IN.
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2319-2012·2012-09-12

    Becton Dickinson Recalls BD GeneOhm Cdiff Assay Due to Tube Leakage

    Becton Dickinson & Co. is recalling 32 kits of the BD GeneOhm Cdiff Assay because reaction tubes may leak. The product is distributed nationwide.

    Product
    BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2316-2012·2012-09-12

    BD GeneOhm MRSA ACP Assay Recalled for Leakage in Reaction Tubes

    Becton Dickinson & Co. is recalling 38 kits of the BD GeneOhm MRSA ACP Assay due to leakage in Cepheid SmartCycler reaction tubes.

    Product
    BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2320-2012·2012-09-12

    BD GeneOhm VanR Assay Recalled Due to Reaction Tube Leakage

    Becton Dickinson is recalling BD GeneOhm VanR Assay kits because reaction tubes may leak. The recall affects 5 kits distributed nationwide.

    Product
    BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***. The BD GeneOhm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2315-2012·2012-09-12

    Toshiba MRI System Recalled for Potential Power Cable Terminal Issue

    Toshiba American Medical Systems Inc. is recalling three MRI systems due to a potential problem with the position of the hold in the lug terminals on power cables.

    Product
    Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2130-2012·2012-09-12

    Clif Bar Recalls Chocolate Chip Bars Due to Incorrect Packaging

    Clif Bar and Company is recalling 4,608 Chocolate Chip CLIF Bars because some Blueberry Crisp bars were mistakenly placed in Chocolate Chip wrappers.

    Product
    Chocolate Chip CLIF Bars, 2.4-oz (68g), individually wrapped, UPC: 7-22252-10090
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-1673-2012·2012-09-12

    Medtech Recalls Little Remedies For Tummys Laxative Drops for Subpotency

    Medtech Products Inc. is recalling Little Remedies For Tummys Stimulant Laxative Drops because the sennosides ingredient is subpotent.

    Product
    Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2121-2012·2012-09-12

    Apio Recalls Brussels Sprouts, Broccoli, and Peas for Plastic Contamination

    Apio Inc. is recalling specific fresh vegetables due to potential contamination with small plastic shavings from a production line.

    Product
    Fresh Select Brussels Sprouts, 6x8oz, 9x12oz. Item # 22986, 22707, UPC 0 11110 91610 5, 7 09351 32222 8.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2122-2012·2012-09-12

    Apio Recalls Brussels Sprouts, Broccoli, and Snap Peas for Plastic Contamination

    Apio Inc. is recalling specific lots of Brussels sprouts, broccoli-cauliflower, and snap peas due to potential foreign material contamination from small plastic shavings.

    Product
    Eat Smart Snap Peas, 14x2lbs, 6x8oz , 12x8oz. Item # 18786, 22216, 10094, UPC 7 09351 00035 5, 7 09351 00901 3
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2323-2012·2012-09-12

    Trek Diagnostic Systems Recalls VersaTREK Windows Software Version 5.4.3

    Trek Diagnostic Systems is recalling VersaTREK Windows Software Version 5.4.3 because positive test results may incorrectly revert to negative in the database.

    Product
    VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms…
    Category
    Medical Device
    Distribution
    38 states
  • LowFDA (Devices)·Z-2325-2012·2012-09-12

    Steris recalls 77 packs of medical tubing due to failed process indicators

    Steris Corporation is recalling 77 packs of medical tubing that failed process indicators. The tubing is used to maintain the sterility of enclosed medical devices.

    Product
    100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2314-2012·2012-09-12

    Quality Electrodynamics Recalls 17 Non-Functional MRI Knee Coils

    Quality Electrodynamics LLC is recalling 17 TxRx Knee 15 Coil 3T units because the coil identification code is incorrect, rendering the devices non-functional.

    Product
    TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V446000·2012-09-11

    Tracker Marine Recalls Mako 18 LTS Boats Due to Trailer Overload Risk

    Tracker Marine is recalling 2010-2013 Mako 18 LTS boat and trailer packages because the trailers may lack sufficient load capacity, increasing crash risk.

    Product
    TRACKER MARINE — TRACKER MARINE MAKO 18 LTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V443000·2012-09-11

    C & C Ford Recalls 2010-2011 E-Series Wheelchair Lifts

    C & C Ford is recalling 2010-2011 E-250 and E-350 vans with specific wheelchair lifts due to latch defects that could cause occupant falls.

    Product
    C & C FORD — C & C FORD FORD E-350, FORD E-250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V441000·2012-09-11

    Utilimaster Recalls 2012 Reach Vehicles Due to Floor Mat Interference

    Utilimaster is recalling 249 model year 2012 Reach vehicles because the floor mat adhesive may deteriorate, allowing the mat to interfere with the throttle pedal.

    Product
    UTILIMASTER — UTILIMASTER REACH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V440000·2012-09-11

    New England Wheels Recalls Ford Vans with Defective Wheelchair Lifts

    New England Wheels is recalling 2006-2010 Ford E-series vans equipped with specific wheelchair lifts due to a latch defect that could cause occupant falls.

    Product
    NEW ENGLAND WHEELS — NEW ENGLAND WHEELS FORD E-350, FORD E-150, FORD E-250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V439000·2012-09-10

    Volvo Recalls 2013 S60 and XC60 for Airbag Control Defect

    Volvo is recalling 2013 S60 and XC60 vehicles because a manufacturing defect in the SRS control unit may cause unintended airbag deployment.

    Product
    VOLVO — VOLVO S60, XC60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·12V438000·2012-09-07

    Ford Recalls 2012 Edge Vehicles Due to Fuel Line Leak Risk

    Ford is recalling 2012 Edge vehicles with 2.0L engines because a fuel line component may crack and leak fuel, posing a fire risk.

    Product
    FORD — FORD EDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·12V437000·2012-09-07

    National Van Ford E-Series Wheelchair Lift Roll Stop Latch Recall

    National Van Builders is recalling 2006-2011 Ford E-Series vans with wheelchair lifts due to roll stop latches that may bend or misalign, posing a fall risk to occupants.

    Product
    NATIONAL VAN — NATIONAL VAN FORD E-250, FORD E-150, FORD E-350
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalCPSC·12273·2012-09-06

    Blind Xpress Recalls Custom Window Blinds Due to Cord Strangulation Hazard

    Blind Xpress is recalling custom vertical and horizontal window blinds because unsecured cords pose a strangulation risk to children. A 2009 child death prompted this safety action.

    Product
    Custom-made Vertical and Horizontal blinds
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·12V435000·2012-09-06

    Prevost Recalls 2013 Buses Due to Fire Suppression System Defect

    Prevost is recalling 2013 X3-45 and XLII-45E buses because a fire detection wire may chafe, causing the engine to stop unexpectedly and increasing crash risk.

    Product
    PREVOST — PREVOST XLII-45 ENTERTAINER, X3-45
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·12274·2012-09-06

    Legrand Wiremold Recalls Under-Cabinet Power Strips Due to Electric Shock Hazard

    Legrand Wiremold is recalling approximately 14,200 under-cabinet power strips because reversed electrical wires pose a risk of electric shock. Consumers should unplug the units and return them for a replacement or refund.

    Product
    Legrand Under Cabinet Power and Lighting four outlet power strip
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2067-2012·2012-09-05

    Fresh Ideas Recalls Costa Whole Peeled Onions Due to Listeria Risk

    Fresh Ideas Inc. is recalling 25 lb bags of Costa Whole Peeled Onions because they contain recalled Gill's Onions linked to Listeria monocytogenes.

    Product
    Costa Whole Peeled Onions (Item #00841, #B841) 25 lb poly bag Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00254
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2065-2012·2012-09-05

    Fresh Ideas Recalls Costa Sliced Onions Due to Listeria Risk

    Fresh Ideas Inc. is recalling Costa sliced onions because they contain recalled Gill's Onions linked to Listeria monocytogenes.

    Product
    Costa 1/16" Sliced Onions, 5 lb poly bag (Item # 00254); Costa 1/4" Sliced Onions, 5 lb poly bag (Item #C50) Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2074-2012·2012-09-05

    Fresh Ideas Costa Multiple Bean Salad Recalled for Listeria

    Fresh Ideas Inc. is recalling Costa Multiple Bean Salad because the product contains recalled Gill's Onions contaminated with Listeria monocytogenes.

    Product
    Costa Multiple Bean Salad 4.5 lbs Poly Tub (Item #01407) Black Beans (black beans, water. salt, calcium chloride, ferrous gluconate), Kidney Beans (kidney beans, water. salt, CaCI2), Black Eyed Peas(blackeye peas. water, sail. calcium chloride and disodium EDTA to preserve…
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2068-2012·2012-09-05

    Fresh Ideas Recalls Diced Onions Due to Listeria monocytogenes

    Fresh Ideas Inc. is recalling specific diced onion products because they contain recalled Gill's Onions contaminated with Listeria monocytogenes.

    Product
    Costa: 1/2" Diced Onions (Item #C228); 3/4" Diced Onions (Item #C244) 1/4" Diced Onions (Item#C32) 5 lb poly bags Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Legal Seafood Diced Onions 1/16" (Item #L163) 10 lb poly bag OB Double Diced…
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2073-2012·2012-09-05

    Fresh Ideas Recalls Calico Bean Salad Due to Listeria Contamination

    Fresh Ideas Inc. is recalling Calico Bean Salad packaged under Costa and Stop & Shop brands because the product contains recalled Gill's Onions contaminated with Listeria monocytogenes.

    Product
    Calico bean Salad 5 lbs Poly Tub (Item #01409) packaged under Costa and Stop & Shop brand, Item T1407, C1407, 5 lb Poly Bag Black eye peas , water, salt, calcium chloride and disodium EDTA to preserve color), Chick Peas (cooked dried chick peas, water,salt), Kidney Beans…
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2080-2012·2012-09-05

    Trader Giotto Pesto Pizza Recalled for Undeclared Peanut

    Amy's Kitchen is recalling Trader Giotto brand Pesto Pizza because pinenuts contained undeclared peanuts.

    Product
    Trader Giotto brand Pesto Pizza in 13.5 oz; SKU# 00539937; Product is processed and packaged by Amy's Kitchen, White City, Oregon
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-2103-2012·2012-09-05

    Tanimura & Antle Romaine Lettuce Recalled for E. coli O157:H7

    Tanimura & Antle is recalling Romaine Lettuce after a positive test for E. coli O157:H7. The product was distributed in 18 US states and Canada.

    Product
    Tanimura & Antle Romaine Lettuce (Laitue Romaine) in plastic bag Wrapped Single Head Romaine marked Field Packed for Freshness.. Distributed by Tanimura & Antle, Salinas, CA.
    Category
    Food
    Distribution
    18 states
  • CriticalFDA (Food)·F-2034-2012·2012-09-05

    Real Mex Foods Recalls Cheese and Red Onion Enchiladas Due to Salmonella Risk

    Real Mex Foods is recalling cheese and red onion enchiladas because the cilantro used may be contaminated with Salmonella.

    Product
    Cheese and red onion enchilada, 2 oz packaged in 240/2oz case, net weight 30 lbs. Product labeling reads in part:" REAL MEX FOODS Item # 14800 CHEESE & RED ONION ENCHILADA***KEEP REFRIGERATED*** PACK SIZE: 240/2 OZ. NET WEIGHT:30.00 LBS Real Mex Foods 3305 E. Vernon Ave. Vernon…
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2070-2012·2012-09-05

    Fresh Ideas Inc. Recalls Julienne Onions and Onion Strings Due to Listeria

    Fresh Ideas Inc. is recalling specific lots of Julienne Onions and Legal Onion Strings because they contain recalled Gill's Onions contaminated with Listeria monocytogenes.

    Product
    Julienne Onions, Item #J705 4.0 lbs poly tub; Legal Onion Strings (Item #L165), 5 lb poly bag Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00254
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2031-2012·2012-09-05

    Burch Farms Cantaloupes Recalled Due to Listeria Monocytogenes Contamination

    Burch Farms is recalling whole fresh cantaloupes contaminated with Listeria monocytogenes. The recall covers specific PLU codes and distribution states.

    Product
    Whole Fresh Cantaloupe, PLU# 4319, Burch Farms, Faison, NC 28341. On 8/2/2012 the recall was expanded to include cantaloupes labeled, Cottle Strawberry, Inc., #4319, Faison, NC. (Cottle Farms is not involved in this recall).
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Food)·F-2097-2012·2012-09-05

    Pure Hothouse Foods Recalls Fresh Grillers Asparagus Blend for Listeria Risk

    Pure Hothouse Foods is voluntarily recalling fresh Grillers Asparagus Blend sold at Meijer stores due to potential Listeria monocytogenes contamination.

    Product
    Markets of Meijer, fresh Grillers Aparagus Blend, 14 oz, Ingredients: Asparagus, Sweet Bell Peppers, Mushrooms,, Sweet White Onions, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave...
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2064-2012·2012-09-05

    Fresh Ideas UNH Stir Fry Recalled for Listeria Contamination

    Fresh Ideas Inc. is recalling UNH Stir Fry bags because they contain recalled Gill's Onions contaminated with Listeria monocytogenes.

    Product
    UNH Stir Fry: 5 lbs ply bag Broccoli. Bock Choy. Spanish Onions (1" x 1" cut). Celery Packed by: fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129 Item # 00137
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2072-2012·2012-09-05

    Fresh Ideas Recalls Costa Four Bean Salad Due to Listeria

    Fresh Ideas Inc. is recalling Costa Four Bean Salad because it contains recalled Gill's Onions contaminated with Listeria monocytogenes.

    Product
    Costa Four Bean Salad 4.50 lbs Poly Tub (Item #01385 Green Beans, Kidney Beans (kidney beans, water, salt, CaCI2), Chick Peas (chick peas. water. salt, EDTA to promote color retention), Black Eyed Peas (black eye peas, water, salt, calcium chloride and disodium EDTA to…
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2071-2012·2012-09-05

    Fresh Ideas Recalls Costa Asian Stir-Fry Blend Due to Listeria

    Fresh Ideas Inc. is recalling Costa Asian Stir-Fry Blend because it contains recalled Gill's Onions contaminated with Listeria monocytogenes.

    Product
    Costa Asian Stir- Fry Blend (Item #SAL3) 5 lb poly bag Spanish Onions {1/4" Sliced), Red Onions, Green Peppers. Red Peppers, Zucchini, Carrots, Broccoli, Broccoli Stems, Green Cabbage, Pea Pods, Bok Choy Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA…
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2096-2012·2012-09-05

    Pure Hothouse Foods Recalls Fresh Grillers Steak Toppers for Listeria Risk

    Pure Hothouse Foods is voluntarily recalling fresh Grillers Steak Toppers sold at Meijer stores in five states due to potential Listeria monocytogenes contamination.

    Product
    Markets of Meijer, fresh Grillers Steak Toppers, 10 oz, Ingredients: Red Onions, Mushrooms, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave...
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2075-2012·2012-09-05

    Fresh Ideas Fajita Mix Recalled for Listeria Contamination

    Fresh Ideas Inc. is recalling Fajita Mix products containing recalled Gill's Onions due to Listeria monocytogenes contamination.

    Product
    Fajita Mix-Red Pepper, Green Pepper, Spanish Onion {1/4" Sliced) Item #SAL4, 5 lb poly bag
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2079-2012·2012-09-05

    Amy's Pizza Pesto Recalled for Undeclared Peanut Allergen

    Amy's Kitchen is recalling specific lots of Pizza Pesto because pinenuts contained undeclared peanuts. Consumers with peanut allergies should not eat the product.

    Product
    Amy's Brand Pizza Pesto Made with Organic Vegetables & Basil in 7 oz; ; 13.5 oz; Sku# 42272-00104 Product is processed and packaged by Amys Kitchen, White City, Oregon
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-2033-2012·2012-09-05

    Real Mex Foods Recalls Pico de Gallo Salsa Due to Salmonella Risk

    Real Mex Foods is recalling Pico de Gallo salsa because it contains cilantro that may be contaminated with Salmonella.

    Product
    Pico de Gallo salsa, 2 lbs pouch, packaged in a case of 5/2 lbs. Product labeling reads in part:" REAL MEX FOODS ITEM # 15102 "MILD" PICO DE GALLO*** PACK SIZE: 5/2 LBS. NET WEIGHT: 10 LBS Real Mex Foods 3305 Vernon Ave. Vernon, Ca 90058***".
    Category
    Food
    Distribution
    0 states
  • CriticalFDA (Food)·F-2099-2012·2012-09-05

    Dole Italian Blend Recalled for Listeria Monocytogenes Contamination

    Dole Fresh Vegetables Inc is recalling Dole Italian Blend due to positive Listeria Monocytogenes test results. The product was distributed in seven southeastern states.

    Product
    Dole Italian Blend; Romaine, Radicchio; 10 oz plastic bag (283g); UPC:7143000819. Dole, Monterey, CA 93942.
    Category
    Food
    Distribution
    7 states
  • CriticalFDA (Food)·F-2095-2012·2012-09-05

    Pure Hothouse Foods Recalls Mushrooms with Rosemary Due to Listeria Risk

    Pure Hothouse Foods is voluntarily recalling fresh Mushrooms with Rosemary sold at Meijer stores in five states due to potential Listeria monocytogenes contamination.

    Product
    Markets of Meijer, fresh Grillers, Mushrooms with Rosemary, 10 oz, Ingredients: Mushrooms, Rosemary, Product of Canada, Keep Refrigerated, Pre-heat grill or over to 450 F... Cook 15-20 minutes in oven/BBQ or 4-5 minutes in microwave...
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2066-2012·2012-09-05

    Fresh Ideas Recalls Costa Kabob Cut White Onions Due to Listeria

    Fresh Ideas Inc. is recalling Costa Kabob Cut White Onions due to Listeria monocytogenes contamination. The product was distributed in several northeastern states.

    Product
    Costa Kabob Cut White Onions 1" x 1", 5 lb poly bag (Item #00275) Packed by: Fresh Ideas Co., 18 Bunker Hill Industrial Park, Boston, MA 02129
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-2077-2012·2012-09-05

    Reichel Foods Recalls Sliced Apples for Listeria Contamination Risk

    Reichel Foods is recalling Dippin' Stix Sliced Apples & Caramel with Peanuts nationwide due to potential Listeria monocytogenes contamination.

    Product
    Dippin' Stix Sliced Apples & Caramel with Peanuts
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • SevereFDA (Food)·F-2030-2012·2012-09-05

    Smith's Lemon Iced Tea Recalled for Undeclared Milk Residue

    Smith Dairy Products Co. is recalling 12,405 gallons of lemon-flavored iced tea in Ohio due to undeclared milk residue.

    Product
    Smith's Old Fashioned Lemon Flavor Iced Tea, pasteurized, packed in 1 gallon (3.78L) containers. The label also reads: 'Smith's The Dairy in the Country' Smith Dairy Products Co. Orrville, OH 44667 * 1-800-776-7076 www.smithdairy.com * 2009 Smith Dairy Products Company…
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2281-2012·2012-09-05

    Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Systems

    Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation Systems due to reports of warmth or heating at the implant site during charging.

    Product
    The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2110-2012·2012-09-05

    Lucky Country Soft Licorice Recalled for Lead Contamination

    Lucky Country, Inc. is recalling 1,577 trays of Aussie-Style Soft Licorice due to lead contamination. The product was distributed in Arizona, California, and Utah.

    Product
    Aussie-Style Lucky Country Soft Licorice in 1.5 lb. bags. The product is packaged 1.5lb x 18 bags per tray.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2274-2012·2012-09-05

    Atlas Spine Recalls Apelo Modular Screwdriver Due to Tip Breakage

    Atlas Spine, Inc. is recalling the Apelo Modular Screwdriver because the tip may break and become implanted in the body or delay surgery.

    Product
    Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date…
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Food)·F-2078-2012·2012-09-05

    Reichel Foods Recalls Armour Active Packs Cheese Pizza Lunch Kits

    Reichel Foods is recalling 8,096 Armour Active Packs Cheese Pizza Lunch Kits nationwide because the apple slices may be contaminated with Listeria monocytogenes.

    Product
    Apple Slices & Fat Free Caramel Dip contained in the Armour Active Packs Cheese Pizza Lunch Kit
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (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
  • SevereFDA (Food)·F-2092-2012·2012-09-05

    Busch's Soup Recalled Due to Contaminated Onion Ingredient

    Busch's Inc. is recalling soup from its food bar because an onion ingredient was subject to a prior recall.

    Product
    BUSCHS SOUP FROM FOOD BAR Random weight/Sold by the pound
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2098-2012·2012-09-05

    Honey Heaven Wholesale Recalls Organic Pinenuts Due to Peanut Contamination

    Honey Heaven Wholesale, Inc. is recalling Organic Pinenuts due to potential contamination with peanuts or traces of peanuts. The product was distributed to retail stores in California, Oregon, and Washington.

    Product
    Organic Pinenuts. 5lb bag: Organic Pine nuts packed into plastic bag with a twist tie with a White stick on label with hand written product description. 27.5lb bag: Organic Pine nuts inside of a plastic bag with a white stick on label with typed product description.
    Category
    Food
    Distribution
    3 states
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (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
  • SevereFDA (Food)·F-2076-2012·2012-09-05

    Fresh Ideas Vegetable Blend Recalled Due to Listeria Contamination

    Fresh Ideas Inc. is recalling Tex Mex Sliced Vegetable Blend because it contains recalled Gill's Onions contaminated with Listeria monocytogenes.

    Product
    Tex Mex Sliced Vegetable Blend, Item #TMEX Red Pepper, Green Pepper, Spanish Onion {1/4" Sliced) 5 lb poly bag
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-2100-2012·2012-09-05

    Interstate Seafood Recalls Frozen Oysters Due to Insanitary Conditions

    Interstate Seafood is recalling frozen tiny oyster meat because it was prepared under insanitary conditions, potentially rendering it injurious to health.

    Product
    Frozen tiny oyster meat I.Q.F. , 40x8oz (20lbs/case);
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1661-2012·2012-09-05

    Apotex Recalls Subpotent Leflunomide Tablets Nationwide

    Apotex Corp. is recalling specific lots of Leflunomide 10 mg tablets because they did not meet potency specifications.

    Product
    LEFLUNOMIDE — LEFLUNOMIDE (LEFLUNOMIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2301-2012·2012-09-05

    Recall of DGHP RFA High-Power Grounding Pads Due to Burn Risk

    Nellcor Puritan Bennett Inc. is recalling DGHP RFA High-Power grounding pads and electrode kits because foil degradation may cause electrical burns to patients.

    Product
    DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1665-2012·2012-09-05

    Bracco Recalls Multihance Injection Due to Sterility Concerns

    Bracco Diagnostics is recalling 4,870 vials of Multihance injection because aluminum crimp caps may displace during use, compromising sterility.

    Product
    MULTIHANCE — MULTIHANCE (GADOBENATE DIMEGLUMINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2280-2012·2012-09-05

    Advanced Neuromodulation Systems Recalls Eon IPG for Heating Complaints

    Advanced Neuromodulation Systems is recalling Eon IPGs due to reports of warmth or heating at the implant site during charging.

    Product
    Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1670-2012·2012-09-05

    CosMedix Sunscreen Recalled for Microbial Contamination and Mold

    Island Kinetics is recalling CosMedix Serious Protection SPF 28 Sunscreen due to microbial contamination and mold. Consumers should stop using the product.

    Product
    CosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g.
    Category
    Drug
    Distribution
    1 state

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