The Recall Desk

Archive

September 2014 recalls

675 recalls were announced in September 2014.

What the numbers show

Critical
61
Severe
148
High
363
Moderate
91
Low
12

Of the 675 recalls this month scored against our rubric, 9% are Critical, 22% are Severe.

601–675 of 675

  • HighFDA (Devices)·Z-2537-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Food)·F-2319-2014·2014-09-03

    Readington Farms Recalls Shoprite Spring Water Due to E. Coli

    Readington Farms Inc. is recalling Shoprite Spring Water because it tested positive for E. Coli bacteria. The product was distributed in seven states.

    Product
    Shoprite Spring Water Net 1 GAL (120 Fl Oz.) 3.78L Distributed by Wakefern Food Corp Elizabeth, NJ Made in USA UPC 041190007196
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-2393-2014·2014-09-03

    Organic Traditions Sprouted Chia and Flax Seed Powder Recalled for Salmonella

    Health Matters America Inc. is voluntarily recalling Organic Traditions Sprouted Chia and Flax Seed Powder due to possible Salmonella contamination.

    Product
    ORGANIC TRADITIONS SPROUTED CHIA & FLAX SEED POWDER; NET WT. 8 oz., 16 oz and 50 lbs, UPC 854260006216, item AHM621, UPC 854260005479, item number AHM547 and item number BLK622
    Category
    Food
    Distribution
    25 states
  • HighFDA (Devices)·Z-2539-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-2540-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Compression

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty locking the holder or passing a suction catheter.

    Product
    H4051 Endo Tube Holder, Pedi 2.5mm Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Food)·F-2378-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles are being recalled because they were made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Chocolate Truffles: Gluten Free, Raw, Vegan; Sold in 4 pack box - 4 oz: Flavors: Sea Salt, Coconut, Macadamia Nut, Mint Crunch Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2388-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles Mint Crunch are being recalled due to potential Salmonella contamination in the carob powder used to make them.

    Product
    Tiny Isle Chocolate Truffles Mint Crunch: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2391-2014·2014-09-03

    Tiny Isle Fudge Pack Recalled for Potential Salmonella Contamination

    Tiny Isle Fudge Pack is being recalled because it was made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Fudge Pack, Organic-Raw- Gluten Free: Mint Crunch, Mac Nut Fudge, Lava Fudge, 5-oz. Tiny Isle 4505 Kukui St. 20A Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2551-2014·2014-09-03

    Zimmer Recalls Moore & Thompson Hip Stems Due to Packaging Failures

    Zimmer, Inc. is recalling Moore & Thompson Hip Stems because packaging design verification tests failed, resulting in compromised seal integrity or breached trays.

    Product
    Moore & Thompson Hip Stems: FNSTRD HIP 38HDX127ST FNSTRD HIP 40HDX127ST FNSTRD HIP 41HDX127ST FNSTRD HIP 42HDX127ST FNSTRD HIP 43HDX127ST FNSTRD HIP 44HDX127ST FNSTRD HIP 45HDX140ST FNSTRD HIP 46HDX140ST FNSTRD HIP 47HDX140ST FNSTRD HIP 48HDX140ST FNSTRD HIP 49HDX140ST
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2367-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix Due to Undeclared Wheat

    Custom Ingredients LLC is recalling 28,500 lbs of Cheese Pre-mix JC 6-1 because it contains undeclared wheat. The product was distributed in Texas and New York.

    Product
    Cheese Pre-mix JC 6-1, in 50 lbs bags intended to be used in the manufacture of dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2353-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 600 lbs of Cheese Pre-mix JD 6-4 due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Cheese Pre-mix JD 6-4, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2361-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 2,900 lbs of All Natural Cheese Pre-mix JF 12-1 due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    All Natural Cheese Pre-mix JF 12-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2362-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix Due to Undeclared Wheat

    Custom Ingredients LLC is recalling Cheese Pre-mix ME 14-1 because it contains undeclared wheat, a major food allergen.

    Product
    Cheese Pre-mix ME 14-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2365-2014·2014-09-03

    Custom Ingredients Recalls Monterey Jack Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 6,000 lbs of Monterey Jack Pre-mix HI 10-3 due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Monterey Jack Pre-mix HI 10-3, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2556-2014·2014-09-03

    Cordis EMPIRA NC RX PTCA Dilatation Catheter Recalled for Balloon Defect

    Cordis Corporation is recalling 250,000 EMPIRA NC RX PTCA Dilatation Catheters because the balloon cover may be difficult to remove, potentially causing the balloon to burst or the shaft to separate during use.

    Product
    Cordis EMPIRA NC RX PTCA Dilatation Catheter
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Food)·F-2320-2014·2014-09-03

    PriceRite Spring Water Recalled Due to E. Coli Bacteria Presence

    Readington Farms Inc. is recalling PriceRite Spring Water because it tested positive for E. Coli bacteria. The recall affects 53,008 gallons distributed in seven states.

    Product
    PriceRite Spring Water Net 1 GAL (3.78 L) Distributed by P.R.R.C. Inc. 5000 Riverside Drive Keasby, NJ 00832 UPC 041190755189
    Category
    Food
    Distribution
    7 states
  • HighCPSC·14267·2014-09-03

    iDevices Recalls Cooking Thermometer Probes Due to Ingestion Hazard

    iDevices is recalling about 48,500 cooking thermometer probes in the U.S. and 510 in Canada because the internal plastic insulator can melt and fall into food.

    Product
    Cooking thermometer probes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2366-2014·2014-09-03

    Custom Ingredients LLC Recalls Spinach Pre-mix Due to Undeclared Wheat

    Custom Ingredients LLC is recalling Spinach Pre-mix HG 25-3 because it contains undeclared wheat. The product was distributed in Texas and New York.

    Product
    Spinach Pre-mix HG 25-3, in 50 lbs bags intended to be used in the manufacture of dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2380-2014·2014-09-03

    Tiny Isle Original Fudge Recalled for Potential Salmonella Contamination

    Tiny Isle Original Fudge is being recalled because it was made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Original Fudge, 2 oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil. agave nectar, carob powder, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2373-2014·2014-09-03

    Silver Star Tex-Mex Queso Recalled for Undeclared Wheat

    Creative Foodworks is recalling Silver Star Tex-Mex Queso because a supplier accidentally used wheat instead of whey in the cheese pre-mix.

    Product
    SILVER STAR; TEX-MEX QUESO; CHIPOTLE QUESO; Medium Dip; NET WT. 16 OZ; (453g); Brought To You By: Silver Star Salsas; Box 50583; Austin, TX 78763
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2351-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 7,650 lbs of cheese pre-mix used in cheese dip due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Cheese Pre-mix, LG 18-1,in 50 lbs bags, used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2371-2014·2014-09-03

    Dos Padres Chipotle Queso Recalled for Undeclared Wheat

    Consolidated Mills is recalling Dos Padres Chipotle Queso because it contains undeclared wheat. The product was distributed in Texas.

    Product
    DOS PADRES BRAND; CHIPOTLE QUESO; NET WT. 15.6 oz. (442g); Distributed by; CYCLONE ENTERPRISES; Houston, Texas 77060 UPC: 64258 20120
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2350-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix Due to Undeclared Wheat

    Custom Ingredients LLC is recalling 10,300 lbs of cheese pre-mix intended for cheese dip due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Cheese Pre-mix, CF 21-1, in 50 lbs bags, intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2370-2014·2014-09-03

    Dos Padres Southwest Queso Recalled for Undeclared Wheat

    Consolidated Mills is recalling Dos Padres Southwest Queso due to undeclared wheat. The error occurred when a supplier used wheat instead of whey in the cheese premix.

    Product
    DOS PADRES BRAND; SOUTHWEST QUESO; NET WT. 15.6 oz. (442g); Distributed by; Cyclone ENTERPRISES; Houston, Texas 77060 UPC: 64258 20110
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2381-2014·2014-09-03

    Tiny Isle Coconut Fudge Recalled for Potential Salmonella Contamination

    Tiny Isle Coconut Fudge is being recalled because it was made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Coconut Fudge, 2-oz.; Organic-Raw- Gluten Free; Ingredients: Cacao powder, coconut oil, agave nectar, carob powder,coconut, vanilla, sea salt. Keep cold. Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2376-2014·2014-09-03

    Native Texan Hatch Green Chile Queso Salsa Recalled for Undeclared Wheat

    Creative Foodworks is recalling Native Texan Hatch Green Chile Queso Salsa because a supplier used wheat instead of whey in the cheese pre-mix.

    Product
    Native Texan HATCH GREEN CHILE QUESO SALSA, NET WT. 16 OZ (1 LB) 453g; DISTRIBUTED BY Native Texan Food Co. Box 50583, Austin 78763 www.NATIVETEXAN1836.com
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2339-2014·2014-09-03

    Rising Moon Organics Butternut Squash Ravioli Recalled for Undeclared Allergens

    Carmel Food Group is recalling Rising Moon Organics Butternut Squash Ravioli because a consumer complaint indicated the product may contain undeclared milk, egg, and soy.

    Product
    Rising Moon Organics Butternut Squash Ravioli, Organic, Vegetarian & Delicious; Keep Frozen; Net Wt. 8 oz. UPC: 7-85030-55557-6. Manufactured for Rising Moon Organics. Manufactured by: Carmel Food Group, Hayward, CA
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-2554-2014·2014-09-03

    Curbell Medical Recalls CareSense Bed and Chair Monitors

    Curbell Medical is recalling CareSense Wireless Advanced LCD Bed and Chair Monitors because a circuit board modification disabled the alarm function.

    Product
    CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMON/USUAL NAME: Bed Patient Monitor; CLASSIFICATION NAME: Bed Patient Monitor --- Monitor is connected to a sensor pad that monitors the patient if they attempt to arise from a bed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2357-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 350 lbs of All Natural Cheese Pre-mix IA 9-4 due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    All Natural Cheese Pre-mix IA 9-4, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2243-2014·2014-09-03

    Cook CloverSnare 4-Loop Vascular Retrieval Snare Recalled for Tip Separation

    Cook Inc. is recalling CloverSnare 4-Loop Vascular Retrieval Snares because the snare may separate from the distal tip of the wire.

    Product
    CloverSnare 4-Loop Vascular Retrieval Snare. Product is packaged in a Tyvek-film sterilizable outer package and is supplied one pouch in a box. The CloverSnare 4-Loop Vascular Retriever is intended for use in the cardiovascular system to manipulate and retrieve foreign object
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-2553-2014·2014-09-03

    Siemens Dimension EXL Chemistry System Recalled for Hinge Injury Risk

    Siemens is recalling 2,757 Dimension EXL Integrated Chemistry Systems because a reagent lid hinge may shift during maintenance, posing a risk of physical injury to operators.

    Product
    Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a variety of analytes in human body fluids. All Serial #s of material #s: 10636929, 10636928, 10486890, 10472176, 10639337, and 10639338.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2014·2014-09-03

    Medtronic MiniMed Paradigm Insulin Pumps Recalled for Programming Error

    Medtronic is recalling MiniMed Paradigm insulin pumps because users may have accidentally programmed them to deliver the maximum bolus amount.

    Product
    Medtronic MiniMed Paradigm Insulin Infusion Pumps, Paradigm models: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. MiniMed 530G: MMT-551, and MMT-751 Paradigm insu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2364-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 19,000 lbs of Cheese Pre-mix DRNC due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Cheese Pre-mix DRNC, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2356-2014·2014-09-03

    Custom Ingredients Recalls Monterey Jack Pre-mix Due to Undeclared Wheat

    Custom Ingredients LLC is recalling 200 lbs of Monterey Jack Pre-mix in 50-lb bags due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Monterey Jack Pre-mix EI 20-3, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2354-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 495 lbs of Cheese Pre-mix ACNC due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Cheese Pre-mix ACNC, in 45 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2368-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 83,050 lbs of Cheese Pre-mix JE 4-2 due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Cheese Pre-mix JE 4-2, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2387-2014·2014-09-03

    Tiny Isle Chocolate Truffles Recalled for Potential Salmonella Contamination

    Tiny Isle Chocolate Truffles Macadamia Nut are being recalled because they were made with carob powder under recall for potential Salmonella contamination.

    Product
    Tiny Isle Chocolate Truffles Macadamia Nut: Gluten Free, Raw, Vegan; individual 1 oz. candies, Tiny Isle 5915 Olohena Road, Unit H Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2377-2014·2014-09-03

    Crazy Jerry's Da Big Cheese Recalled for Undeclared Wheat

    Creative Foodworks, Inc. is recalling Crazy Jerry's Da Big Cheese due to undeclared wheat caused by a supplier error.

    Product
    CRAZY JERRY"S DA BIG CHEESE; NET WT. 16 OZ. ( 1 LB.) 454g; Prepared for Crazy Jerry's Inc. P.O. Box 891 Roswell, GA 30077
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2359-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 5,200 lbs of Cheese Pre-mix JG 9-1 due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Cheese Pre-mix JG 9-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2404-2014·2014-09-03

    La Finquita Fresh Farmer's Cheese Recalled for Peanut and Tree Nut Contamination

    La Finquita is recalling 1,171 units of Fresh Farmer's Cheese because the milk used may be contaminated with peanuts and pistachios.

    Product
    La Finquita Quesito Fresco Campesino / Fresh Farmers Cheese. The product is packaged in a 14.11oz. plastic container, UPC Code: 0 94922 76809 4
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-2352-2014·2014-09-03

    Custom Ingredients Recalls French Onion Dip Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling French Onion Dip Pre-mix CJ 7-3 due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    French Onion Dip Pre--mix CJ 7-3, in 50 lbs bags intended to be used in the manufacture of French onion dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2363-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 500 lbs of Cheese Pre-mix EF 18-1 due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Cheese Pre-mix EF 18-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2374-2014·2014-09-03

    Native Texan Queso Recalled for Undeclared Wheat Allergen

    Creative Foodworks is recalling Native Texan Queso due to undeclared wheat. The error occurred when a supplier used wheat instead of whey in the cheese pre-mix.

    Product
    NATIVE TEXAN QUESO; NACHO; Medium; NATIVE TEXAN FOOD Co.; NET WT 16oz 453g 1LB.; NATIVE TEXAN FOOD CO. box 50583, Austin TX 78763 www.NativeTexan1836.com
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2360-2014·2014-09-03

    Custom Ingredients Recalls Cheese Pre-mix Due to Undeclared Wheat

    Custom Ingredients LLC is recalling 1,000 lbs of Cheese Pre-mix JC 9-3 because it contains undeclared wheat. The product was distributed in Texas and New York.

    Product
    Cheese Pre-mix JC 9-3, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2355-2014·2014-09-03

    Custom Ingredients Recalls Chipotle Cheese Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 1,000 lbs of Chipotle Cheese Pre-mix due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Chipotle Cheese Pre-mix DA 15-1, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2369-2014·2014-09-03

    Custom Ingredients Recalls Natural Cheese Pre-mix for Undeclared Wheat

    Custom Ingredients LLC is recalling 4,350 lbs of Natural Cheese Pre-mix DRWC DJ 6-2 due to undeclared wheat. The product was distributed in Texas and New York.

    Product
    Natural Cheese Pre-mix DRWC DJ 6-2, in 50 lbs bags intended to be used in the manufacture of cheese dip
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2375-2014·2014-09-03

    Central Market Hatch Green Chile Queso Salsa Recalled for Undeclared Wheat

    Creative Foodworks is recalling Central Market Hatch Green Chile Queso Salsa because a supplier used wheat instead of whey in the cheese pre-mix, creating an undeclared allergen.

    Product
    Central Market HATCH GREEN CHILE QUESO SALSA, NET WT. 16 OZ (1 LB) 454g; DISTRIBUTED BY H-E-B CENTRAL MARKET, AUSTIN, TX 78735
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2372-2014·2014-09-03

    Truly Texas Chipotle Con Queso Recalled for Undeclared Wheat

    Consolidated Mills is recalling Truly Texas Chipotle Con Queso because a supplier used wheat instead of whey in the cheese premix, creating an undeclared wheat allergen.

    Product
    TRULY TEXAS; CHIPOTLE CON QUESO; Queso With Chipotles; NET WT.; 16 OZ. (453g) and NET WT. 8 OZ. (226g); Distributed by: Double T Gourmet Foods, Inc.; PO Box 1582 Montgomery, TX 77356; Phone 936-582-6798; ww.trulytexasfoods.com UPC: 90191 00105 (16 oz.) and UPC: 90191 00129 (8
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-2545-2014·2014-09-03

    Zimmer Patello-Femoral Knee Prosthesis Recalled for Forging Defects

    Zimmer, Inc. is recalling 15 units of a specific knee prosthesis component because internal review found five raw material forgings with defects that were not segregated.

    Product
    Zimmer Gender Solution Patello-Femoral Joint (PFJ) System Patello-Femoral Trochlea Component, Precoat, Size 4, Left. Knee prosthesis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2390-2014·2014-09-03

    Tiny Isle Fudge Mix Recalled for Potential Salmonella Contamination

    Florimont, Inc. is recalling Tiny Isle Fudge Mix Organic due to potential Salmonella contamination in the carob powder used.

    Product
    Tiny Isle Fudge Mix Organic, Organic-Raw- Gluten Free; Cacao powder, carob powder, Hawaiian sea salt. Tiny Isle 4505 Kukui St. 20A Kapaa, HI 96746
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2552-2014·2014-09-03

    Zimmer Recalls Knee Stem Extensions Due to Packaging Design Failures

    Zimmer, Inc. is recalling specific knee stem extensions and impactor sleeves because packaging design verification tests failed, potentially compromising device sterility.

    Product
    Knee Stem Extensions & Impactor Sleeve: STEM IMPLANT 20MMDX145MM STEM IMPLANT 22MMDX145MM STEM IMPLANT 24MMDX145MM SHARP FLUTED ST 20MMDX75MM SHARP FLUTED ST 22MMDX75MM SHARP FLTD ST 24MMDX75MM SHARP FLUTED ST 20MMDX130MM SHARP FLUTED ST 22MMDX130MM SHARP FLUTED ST 24MMD
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2548-2014·2014-09-03

    Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures

    Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.

    Product
    Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO FEMORAL HEAD 50MM DIA, ENDO FEMORAL HEAD 42MM DIA, ENDO FEMORAL HEAD 54MM DIA, ENDO FEMORAL HEAD 48MM DIA, ENDO FEMORAL HEAD 41MM DIA, ENDO FEMORAL HEAD 42MM D
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1558-2014·2014-09-03

    Perrigo Recalls CareOne Nicotine Lozenges for Dissolution Failures

    Perrigo Holland Inc is recalling CareOne Nicotine Polacrilex Lozenges because they failed dissolution tests and contained broken lozenges.

    Product
    CAREONE NICOTINE — CAREONE NICOTINE (NICOTINE POLACRILEX)
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-2558-2014·2014-09-03

    Civco Medical Instruments Recalls CollectEVAC Sterile Devices Due to Packaging Leak

    Civco Medical Instruments is recalling 52 kits of CollectEVAC sterile devices because a pinhole leak in the packaging could compromise sterility.

    Product
    CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate o
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-2546-2014·2014-09-03

    Zimmer Recalls Knee Instrument Fixation Screws Due to Packaging Failures

    Zimmer, Inc. is recalling 972,125 units of knee fixation screws worldwide because packaging design verification tests failed, potentially compromising sterility.

    Product
    Knee Instrument Fixation Screws: 48MM HEADED SCREW 48MM HEADLESS SCREW MIS HEADED SCREW, 48MM MIS HEADLESS SCREW, 48MM
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2549-2014·2014-09-03

    Zimmer Recalls Trauma Large Screws Due to Packaging Design Failures

    Zimmer, Inc. is recalling 972,125 units of sterile-packaged Trauma Large Screws because packaging design verification tests failed, resulting in compromised seal integrity.

    Product
    Trauma Large Screws: CANN BONE SCREW 7.0MMX100MMLG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0X105LG CANN BONE SCREW 7.0MMX105MMLG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0X110LG CANN BONE SCREW 7.0MMX110MMLG CANN BONE SCREW 7.0X115LG CANN BONE SCREW 7.0X115LG CAN
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2550-2014·2014-09-03

    Zimmer Recalls Trauma Tubes and Plates Due to Packaging Failures

    Zimmer, Inc. is recalling specific trauma tubes and plates because packaging design verification tests failed, resulting in compromised seal integrity.

    Product
    Trauma Tubes and Plates: TUBE & SCP PLT 90DX150LG TUBE & SCP PLT 90DX205LG TUBE & SCP PLT 90DX255LG TUBE & SCP PLT 95DX150LG TUBE & SCP PLT 95DX205LG TUBE & SCP PLT 95DX255LG TUBE&SCP PLT 130DX8H TUBE&SCP PLT 130DX10H TUBE&SCP PLT 130DX12H TUBE&SCP PLT 130DX14H TUBE&SC
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2543-2014·2014-09-03

    Zimmer Persona Distal Valgus Alignment Guide Recalled for Mechanical Defect

    Zimmer, Inc. is recalling 2,248 units of the Persona Distal Valgus Alignment Guide because the collet locks are seizing in the unlocked position.

    Product
    Zimmer PERSONA Distal Valgus Alignment Guide, Nonsterile. orthopedic surgical instrument. The device sets the proper Varus/Valgus alignment of a patient's knee prior to the initial femoral resection cut being made.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2547-2014·2014-09-03

    Zimmer Recalls Endo and Unipolar Femoral Heads Due to Packaging Failures

    Zimmer, Inc. is recalling 972,125 units of Endo and Unipolar Femoral Heads because packaging design verification tests failed, potentially compromising sterility.

    Product
    Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 41MM DIA ENDO FEMORAL HEAD 42MM DIA ENDO FEMORAL HEAD 43MM DIA ENDO FEMORAL HEAD 44MM DIA ENDO FEMORAL HEAD 45MM DIA ENDO FEMORAL HEAD 46MM DIA ENDO FEMORAL HEAD 47MM DIA ENDO FEMORAL HEAD 48MM DIA ENDO FEMORAL HEAD 49MM D
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2555-2014·2014-09-03

    Thermedx Fluid Management System Recalled for Canister Ring Manufacturing Change

    Thermedx LLC is recalling 21 units of the P4000 Fluid Management System because a manufacturing change to the canister ring may cause the deficit display to read higher than the actual fluid deficit.

    Product
    The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-2398-2014·2014-09-03

    Beta Labs Recalls Oxyphen XR Fat Burner Due to Illegal DMAA Content

    Beta Labs is recalling Oxyphen XR fat burner capsules because they contain DMAA, a substance not permitted in dietary supplements.

    Product
    Oxyphen XR, 12 HR / CLINICAL STRENGTH FAT BURNER, 45 FAST ACTING EXTENDED RELEASE CAPSULES, Distributed by Beta Labs, LTD, Newark, DE 19711, UPC 670541599747
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2542-2014·2014-09-03

    BD Vacutainer CPT Cell Preparation Tubes Recalled for Poor Separation

    Becton Dickinson is recalling specific lots of BD Vacutainer CPT Cell Preparation Tubes due to poor separation that reduces the number of recovered mononuclear cells.

    Product
    BD Vacutainer CPT Cell Preparation Tube with Sodium Heparin, 8 mL, 16 x 125 mm, Catalog #REF 362753, Lot #4063409 with expiry 03/2015, intended for the collection of whole blood and the separation of mononuclear cells.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-1557-2014·2014-09-03

    Mylan Recalls Diltiazem HCl Extended Release Capsules Due to Impurities

    Mylan Pharmaceuticals is recalling Diltiazem HCl Extended Release Capsules because routine stability testing found high levels of a related compound.

    Product
    Diltiazem HCl Extended Release Capsules, USP 120 mg, 500 count bottles, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505. NDC 0378-5220-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2559-2014·2014-09-03

    Nanosphere Recalls Verigene CYP2C19 Nucleic Acid Test Kits

    Nanosphere is recalling 78 Verigene CYP2C19 Nucleic Acid Test kits due to an unacceptable increase in initial no-call rates.

    Product
    Verigene CYP2C19 Nucleic Acid Test (CYP2C19 Test). Each CYP2C19 kit consists of 20 Verigene CYP2C19 Nucleic Acid Test Cartridges and 20 Verigene CYP2C19 Nucleic Acid Extraction Trays (with Tip Holder Assemblies). Clinical laboratory test.
    Category
    Medical Device
    Distribution
    7 states
  • LowFDA (Devices)·Z-2538-2014·2014-09-03

    Smiths Medical Recalls Pediatric Endotracheal Intubation Kits Due to Tube Fastener Issue

    Smiths Medical ASD, Inc. is recalling 135,518 Pediatric Endotracheal Intubation Kits because the tube fastener may compress the tracheal tube, causing difficulty in locking the holder or passing a suction catheter.

    Product
    H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
    Category
    Medical Device
    Distribution
    41 states
  • LowFDA (Drugs)·D-1484-2014·2014-09-03

    Novel Laboratories Recalls Famotidine Oral Suspension Due to Impurity Failure

    Novel Laboratories is recalling 25,776 containers of Famotidine Oral Suspension because the product failed an impurity specification. The recall is classified as FDA Class III.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V524000·2014-09-02

    Ford Recalls 2015 F-650 and F-750 Trucks for Fuel Filter Defect

    Ford is recalling 2015 F-650 and F-750 SD trucks because a fuel filter defect may cause the engine to stall without warning, increasing crash risk.

    Product
    FORD — FORD F-750 SD, F-650 SD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14E058000·2014-09-02

    Genera Aftermarket Headlamp Assemblies Recalled for Fire Risk

    Genera is recalling specific aftermarket headlamp assemblies for 2013-2014 Acura ILX vehicles due to overheating risks that could cause smoke, melting, or fire.

    Product
    EXTERIOR LIGHTING:HEADLIGHTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·14V525000·2014-09-02

    Ford Recalls 2014-2015 Vehicles for Fuel Delivery Module Cracks

    Ford is recalling specific 2014 Focus, 2014 Escape, and 2015 Lincoln MKC vehicles because a fuel delivery module may crack, causing low fuel pressure and potential vehicle stalls.

    Product
    FORD — FORD, LINCOLN ESCAPE, MKC, FOCUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·14265·2014-09-02

    Tray Vous Recalls Stroller Snack Trays Due to Strangulation Hazard

    Tray Vous is recalling snack and activity trays for strollers because the design poses a strangulation hazard to unharnessed children.

    Product
    Tray Vous™ snack and activity trays with connectors
    Category
    Consumer Product
    Distribution
    Distributed nationwide

Looking for a different month? Back to 2014.