The Recall Desk

Archive

May 2017 recalls

771 recalls were announced in May 2017.

What the numbers show

Critical
44
Severe
214
High
219
Moderate
255
Low
39

Of the 771 recalls this month scored against our rubric, 6% are Critical, 28% are Severe.

701–771 of 771

  • SevereFDA (Food)·F-2113-2017·2017-05-03

    Valley Bakery Rusk Buns Recalled for Undeclared Egg Allergen

    Valley Bakery Wholesalers Inc is recalling Rusk Buns because they contain egg but do not declare it on the label.

    Product
    Rusk Buns, Valley Bakery, Rock Valley, IA, 1 count. UPC 290212603209, packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0682-2017·2017-05-03

    Isomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,352 vials of Methylprednisolone Acetate and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Methylprednisolone Acetate 80 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1011, barcode 3 70285 10111 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2128-2017·2017-05-03

    Valley Bakery Strawberry Tea Ring Recalled for Undeclared Egg Allergen

    Valley Bakery Wholesalers Inc is recalling Strawberry Tea Ring products because they contain egg but do not declare it on the label.

    Product
    Strawberry Tea Ring, Valley Bakery, Rock Valley, IA, 1 count. UPC 290406306006, packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1879-2017·2017-05-03

    Arrow International Recalls Central Venous Catheter Kits Due to Hub Voids

    Arrow International is recalling 310 units of Arrowg+ard Blue Plus Central Venous Catheterization Kits due to possible voids in the catheter hub that could lead to interlumen crossover.

    Product
    Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1538-2017·2017-05-03

    Heartware Recalls HVAD System Controllers for Exchange

    Heartware is recalling all HVAD System Controllers currently on the market to exchange them for the next generation HVAD Controller (Controller 2.0).

    Product
    HeartWare HVAD System Controller The HeartWare Ventricular Assist System (VAS is indicated for use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HeartWare Ventricular Assist System…
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Food)·F-2114-2017·2017-05-03

    Valley Bakery Hamburger Buns Recalled for Undeclared Egg Allergen

    Valley Bakery Wholesalers Inc is recalling 91 packages of hamburger buns because they contain egg but do not declare it on the label.

    Product
    Hamburger Buns, Valley Bakery, Rock Valley, IA, 12 count. UPC 290202003804, packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2130-2017·2017-05-03

    Valley Bakery Raspberry Tea Ring Recalled for Undeclared Egg

    Valley Bakery Wholesalers Inc is recalling Raspberry Tea Rings because the product contains egg but does not declare it on the label.

    Product
    Raspberry Tea Ring, Valley Bakery, Rock Valley, IA, 1 count. UPC 290400306004, packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1893-2017·2017-05-03

    Pepper Colby-Jack Cheese Recalled for Potential Listeria Contamination

    Deutsch Kase Haus, LLC is recalling various brands of pepper cheese due to potential Listeria monocytogenes contamination. The product was distributed across 11 states.

    Product
    Pepper Colby-Jack (or: Pepper Marble Jack; Lightning Jack; Thunder Jack; Firecracker; Jalapeno Jack; Jumping Jack) cheese. All affected product private labeled for other companies. Brands: Guggisberg; Dutch Farms; Amish Classics; Lipari Old Tyme; Walnut Creek…
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-2127-2017·2017-05-03

    Valley Bakery Hamburger Buns Recalled for Undeclared Egg Allergen

    Valley Bakery Wholesalers Inc is recalling Large Hamburger Buns because they contain egg but do not declare it on the label.

    Product
    Large Hamburger Buns, Valley Bakery, Rock Valley, IA, 4 count. UPC 290223201401, packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2099-2017·2017-05-03

    Guggisberg Cheese Recalls Butter Cheese for Potential Listeria Contamination

    Guggisberg Cheese Inc is recalling Amish Creamery Butter Cheese because it may contain Listeria monocytogenes. The product was distributed to 13 states.

    Product
    Amish Creamery Butter Cheese Sold under the following brand names: Amish Classic 6 lb & 15 ib and Guggisberg 15 ib Distributed by: Guggisberg Cheese, 5060 S.R. 557, Millersburg, OH 44654
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Food)·F-2119-2017·2017-05-03

    Valley Bakery Sno-Flake Buns Recalled for Undeclared Egg Allergen

    Valley Bakery Wholesalers Inc is recalling Sno-Flake Buns because they contain egg but do not declare it on the label.

    Product
    Sno-Flake Buns, Valley Bakery, Rock Valley, IA, 12 count. UPC 290713203606, packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2111-2017·2017-05-03

    Valley Bakery Cinnamon Swirl Crimp Bread Recalled for Undeclared Egg

    Valley Bakery Wholesalers Inc is recalling Cinnamon Swirl Crimp Bread because it contains egg but does not declare it on the label.

    Product
    Cinnamon Swirl Crimp Bread, Valley Bakery, Rock Valley, IA, 1 count. UPC 290113203607, packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2133-2017·2017-05-03

    Valley Bakery Blueberry Tea Ring Recalled for Undeclared Egg

    Valley Bakery Wholesalers Inc is recalling Blueberry Tea Rings because the product contains egg but does not declare it on the label.

    Product
    Blueberry Tea Ring, Valley Bakery, Rock Valley, IA, 1 count. UPC 290404306000, packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2129-2017·2017-05-03

    Valley Bakery Apple Tea Ring Recalled for Undeclared Egg Allergen

    Valley Bakery Wholesalers Inc. is recalling Apple Tea Ring products because they contain egg but do not declare it on the label.

    Product
    Apple Tea Ring, Valley Bakery, Rock Valley, IA, 1 count. UPC 290400306006, packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2110-2017·2017-05-03

    Valley Bakery White Crimp Recalled for Undeclared Egg Ingredient

    Valley Bakery Wholesalers Inc is recalling White Crimp products because they contain egg but do not declare it on the label.

    Product
    White Crimp, Valley Bakery, Rock Valley, IA, 1 count. UPC 290113203607, packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2097-2017·2017-05-03

    TP Food Processing Recalls Shrimp Satay Sauce Due to Botulism Risk

    TP Food Processing Inc. is recalling Shrimp Satay and Lemongrass Satay sauces because improper production makes them susceptible to Clostridium botulinum contamination.

    Product
    Shrimp Satay Hot Dry Shrimp-Chili Sauce, Net: 6 and 9oz , 12 units/case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2103-2017·2017-05-03

    Guggisberg Garden Vegetable Natural Cheese Recalled for Listeria Risk

    Guggisberg Cheese Inc is recalling Garden Vegetable Natural Cheese because it may contain Listeria monocytogenes. The product was distributed to 13 states.

    Product
    GUGGISBERG GARDEN VEGETABLE NATURAL CHEESE INGREDIENTS: Pasterized Milk, Cultures, Red & Green Pell Peppers, Parsley, Salt, Onion, Celery, Carrots, Cucumbers, Califlower, Enzymes, LIve Yogurt Cultures 11275 W 250 N MIDDLEBURY, IN 46540
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0686-2017·2017-05-03

    Isomeric Pharmacy Recalls Testosterone Injection Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 2,156 vials of Testosterone Cypionate and Propionate injection due to production processes that cannot assure sterility.

    Product
    Testosterone Cypionate 200 mg/mL, Testosterone Propionate 20 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Dr, SLC, UT 84109, Part # 1200, barcode 3 70285 12003 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V298000·2017-05-03

    Audi Recalls Q5 and Q7 Models for Fuel Pump Flange Crack Risk

    Volkswagen Group of America is recalling 2013-2017 Audi Q5 and Q7 vehicles because a fuel pump flange may crack, allowing fuel to leak and increasing fire risk.

    Product
    AUDI — AUDI Q5, Q7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2101-2017·2017-05-03

    Guggisberg Cheese Recalls Colby Cheese for Potential Listeria Contamination

    Guggisberg Cheese Inc is recalling Colby Cheese sold under multiple brands due to potential Listeria monocytogenes contamination.

    Product
    Colby Cheese sold under the following brand names: Amish Classic 6lb & 15lb, Dietz & Watson 6lb, Dutch Farms 6lb, Guggisberg 8oz, 12oz, 1ib, 6lb, 14lb & 15lb, Lipari 6lb & 15lb, Meijer & Walnut Creek 6lb & 15lb
    Category
    Food
    Distribution
    13 states
  • SevereFDA (Drugs)·D-0685-2017·2017-05-03

    Isomeric Pharmacy Recalls Injection Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 851 vials of a multi-dose injection product because production processes cannot assure sterility.

    Product
    Cyanocobalamin 1 mg/mL/ Methionine 25 mg/mL/ Inositol 50 mg/mL/ Choline 50 mg/mL, 30 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1101, barcode 3 70285 11013 9.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-2112-2017·2017-05-03

    Valley Bakery Bread Recalled for Undeclared Egg Allergen

    Valley Bakery Wholesalers Inc is recalling Holstein Crimp Bread because it contains egg but does not declare it on the label.

    Product
    Holstein Crimp Bread, Valley Bakery, Rock Valley, IA, 1 count. UPC 290113203607, packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-2096-2017·2017-05-03

    TP Food Processing Recalls Lemongrass Satay Due to Botulism Risk

    TP Food Processing is recalling Lemongrass Satay and Shrimp Satay because the acidified sauces were not properly produced, making them susceptible to Clostridium botulinum contamination.

    Product
    Lemongrass Satay, Net: 9oz (265gr), 12units/case and 1/2 gallon, 6 units/case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-2109-2017·2017-05-03

    Valley Bakery Recalls Raisin Bread for Undeclared Egg Allergen

    Valley Bakery Wholesalers Inc is recalling Raisin Bread because it contains egg but does not declare it on the label.

    Product
    Raisin Bread, Valley Bakery, Rock Valley, IA, 1 count. UPC 290104404006, packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0681-2017·2017-05-03

    Isomeric Pharmacy Recalls Methylprednisolone Acetate Injection Vials for Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 4,001 vials of Methylprednisolone Acetate and Lidocaine HCl injection due to production processes that cannot assure sterility.

    Product
    Methylprednisolone Acetate 40 mg/mL, Lidocaine HCl 10 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1010, barcode 3 70285 10101 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·043-2017·2017-05-03

    Blount Fine Foods Recalls Beef Chile Colorado Meals for Undeclared Milk

    Blount Fine Foods is recalling 8,685 pounds of Beef Chile Colorado frozen meals because they contain milk, an undeclared allergen, and are mislabeled.

    Product
    Blount Fine Foods, Corp. Recalls Beef Chile Colorado Frozen Meals Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1956-2017·2017-05-03

    Pastry Foods Recalls Corn Sticks with Cheese for Undeclared Wheat

    Pastry Food Products Inc. is recalling 1 lb packages of Corn Sticks with Cheese because wheat is not declared on the ingredient list.

    Product
    Trigal Sorullos de Maiz con Queso (Corn Sticks with Cheese), Peso Neto (Net Weight) 1lb (454g), Manufacturado Por: Pastry Foods, Inc., Calle Elver #932, 1 Ext. Country Club, Rio Piedras, PR
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2095-2017·2017-05-03

    ConAgra Recalls Premium Hunt's Chili Kits for Potential Salmonella

    ConAgra Foods is recalling Premium Hunt's Chili Kits due to potential Salmonella contamination in the spice packets. The recall covers 5,458 cases distributed nationwide.

    Product
    Premium Hunt's Chili Kit, Total NET WT 44.8 OZ (2.80 LB) 1.27kg; Directions: 1) Cook and stir meat in saucepan over medium-high 7 minutes or until done; drain. 2) Stir in all remaining ingredients; simmer 10 minutes, stirring occasionally. Con Agra Foods, P.O BOX 3768, Dept.…
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2108-2017·2017-05-03

    Lakeside Foods Recalls Season's Choice Frozen Sweet Peas Due to Listeria

    Lakeside Foods is recalling Season's Choice Garden Fresh Sweet Peas because testing found Listeria monocytogenes. The product was sold at ALDI stores in eight states.

    Product
    Season's Choice Garden Fresh Sweet Peas, Net Wt 16 oz (1lb) 454g, Keep Frozen. UPC 41498-164294.
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-1888-2017·2017-05-03

    Remel Blood Agar Plates Recalled for Listeria Contamination

    Remel Inc is recalling Blood Agar plates due to confirmed surface contamination with Listeria monocytogenes. The products were distributed nationwide and in Puerto Rico.

    Product
    Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Product Usage: Blood Agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2149-2017·2017-05-03

    USN B4 Bomb Extreme Pre-Workout Recalled for Staphylococcus Aureus Concern

    Armada Nutrition is recalling USN B4 Bomb Extreme Pre-Workout due to a raw material testing failure for Staphylococcus aureus that was not fully investigated.

    Product
    USN B4 -BOMB EXTREME PRE-WORKOUT, LIME LEMONADE FLAVOUR, 300g, USN North America, 1560 Sawgrass Corporation Pkwy, 4th Floor, Sunrise, FL, 33323
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2139-2017·2017-05-03

    Roundy's and Harris Teeter Hash Browns Recalled for Golf Ball Material

    McCain Foods USA is recalling Roundy's and Harris Teeter Southern Style Diced Hash Browns because they are contaminated with extraneous golf ball material.

    Product
    Roundy's Southern Style Diced Hash Browns, frozen, net wt. 32 oz per package, UPC 0 01115 05501 9. Harris Teeter Southern Style Diced Hash Browns, frozen, net wt. 32 oz per package, UPC 0 07203 64902 0.
    Category
    Food
    Distribution
    10 states
  • HighFDA (Food)·F-2148-2017·2017-05-03

    Armada Nutrition Recalls Performix Crea-Bead Creatine Due to Staphylococcus Aureus Concerns

    Armada Nutrition is recalling Performix Crea-Bead creatine powder because a raw material initially tested positive for Staphylococcus aureus, raising concerns about potential contamination.

    Product
    PERFORMIX(TM) CREA-BEAD, MULTI-PHASE CREATINE, UNFLAVOURED, (a) 30 SERVINGS, UPC 8 11274 02239 8; (b) 45 SERVINGS, Distributed by Performix LLC, 221 S. Cherokee St., Denver, CO 80223, UPC 8 11274 02203 8
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1882-2017·2017-05-03

    Savaria Stairfriend Stair Lifts Recalled for Welding Defect

    Savaria Concord Lifts is recalling 226 Stairfriend stair lifts due to poor quality welding on the seat post.

    Product
    The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1955-2017·2017-05-03

    Trigal Corn Sticks Recalled for Undeclared Wheat Allergen

    Pastry Food Products Inc. is recalling Trigal Corn Sticks because wheat is not declared on the ingredient list.

    Product
    Trigal Sorullitos de Maiz (Corn Sticks), Peso Neto (Net Weight) 10oz (283.5g), Manufacturado Por: Pastry Foods, Inc., Calle Elver #932, 1 Ext. Country Club, Rio Piedras, PR
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-2144-2017·2017-05-03

    Econo Octopus Style in Oil Recalled for Squid Mislabeling

    Supermercado Econo Inc. is recalling Econo Octopus Style in Oil because the product contains squid but is labeled as octopus.

    Product
    Econo, Estilo Pulpo en Aceite, Octopus Style in Oil, Net Wt. 4oz (115g)
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1877-2017·2017-05-03

    Cardiovascular Systems Recalls ViperWire Advance Guide Wires Due to Packaging Error

    Cardiovascular Systems Inc is recalling 595 units of ViperWire Advance guide wires because 0.018-inch products were packaged as 0.014-inch.

    Product
    ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. Product Usage: The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-2146-2017·2017-05-03

    Armada Nutrition Recalls MYPRE V2 Preworkout Powder Due to Staphylococcus aureus Concerns

    Armada Nutrition is recalling MYPRE V2 preworkout powder because a raw material initially failed testing for Staphylococcus aureus, raising concerns about potential contamination in the finished product.

    Product
    MYPROTEIN, MYPRE V2(TM) Net Wt. 17.6 Oz (1.1 lb) /500g, Blue Raspberry, preworkout, 500g, THE HUT GROUP(R), 1350 Cedar Grove Park, Shepherdsville, KY, UPC 5 065104 570111
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1878-2017·2017-05-03

    Ulrich Medical Recalls uNion Cervical Plate System for Screw Mechanism Defect

    Ulrich Medical USA Inc is recalling 4,854 uNion Cervical Plate Systems because static plate screws may disassociate. The recall covers devices distributed in 20 US states.

    Product
    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0684-2017·2017-05-03

    Isomeric Pharmacy Recalls Triamcinolone Diacetate Vials Due to Sterility Concerns

    Isomeric Pharmacy Solution, LLC is recalling 1,951 vials of Triamcinolone Diacetate injection because production processes cannot assure sterility. The FDA has classified this as a Class II recall.

    Product
    Triamcinolone Diacetate 40 mg/mL, 10 mL Multi-Dose Vial For Injection, Rx Only, Isomeric Pharmacy Solutions, 2401 Foothill Drive, SLC, UT 84109, Part # 1021, barcode 3 70285 10211 0.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1889-2017·2017-05-03

    Merit Medical Recalls 1 mL Medallion Syringes Due to Plunger Tip Defect

    Merit Medical Systems is voluntarily recalling 1 mL Medallion Syringes because of a defect in the syringe plunger tip.

    Product
    1 mL Medallion¿ Syringe. Catalog Numbers: 701989001, K01-05197P, MSS011-YP, K01-07946P, MSS011, MSS011-LB, MSS011-R, MSS011-Y, MSS011P, MSS011-LBP, MSS011-DG, K08-02926AP, K01-07742P, K10-05457P.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1883-2017·2017-05-03

    CareFusion Recalls SmartSite Add-On Bag Access Device Due to Leakage

    CareFusion is recalling 384,923 units of the SmartSite Add-On Bag Access Device because the spike port may separate or leak, potentially interrupting medication infusion.

    Product
    SmartSite Add-On Bag Access Device, Model No. 10013365
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-2150-2017·2017-05-03

    Muscle Meds Carnivor Beef Protein Isolate Recalled for Staphylococcus Aureus Concern

    Armada Nutrition is recalling Muscle Meds Carnivor beef protein isolate due to concerns that the product may contain Staphylococcus aureus.

    Product
    Muscle Meds(TM) PERFORMANCE TECHNOLOGIES, BIOENGINEERED BEEF PROTEIN ISOLATE CARNIVOR(TM) Dietary Supplement, Net Wt. 2 lbs. (904.4g), ADVANCED FLAVOR TECHNOOGY FRUIT PUNCH, (a) 904.4g, (b)1808.8g, Manufactured for and Distributed by: MuscleMeds Performace Technologies 165…
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-2157-2017·2017-05-03

    Apple Cider Recalled for Elevated Patulin Levels

    Bevovations, LLC is recalling specific apple cider products due to elevated levels of patulin. The recall affects 1,409 cases distributed in New England states.

    Product
    Apple Cider with Potassium Sorbate, packed under the following labels: RUDY'S BLEND APPLE CIDER; 1 GAL. (3.78L), UPC: 8 56005 00344 3; RUDY'S BLEND APPLE CIDER, 1/2 GAL (1.89L), 8 56005 00434 6; FRESHLY PRESSED APPLE CIDER Carlson Orchards Harvard, Mass, 1/2 GAL (1.89L), 8 56005…
    Category
    Food
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1884-2017·2017-05-03

    XTANT Medical Recalls 5.5mm CoCr Straight Rods Due to Labeling Error

    XTANT Medical Inc. is recalling 97 units of 5.5mm CoCr Straight Rods because the labels may incorrectly identify the material as Ti6Al-4V ELI instead of Cobalt Chromium.

    Product
    5.5mm Diameter x 500mm CoCr Straight Rod, Model number X077-0420. The product is packaged in plastic bags with one piece per bag. Product Usage: The 5.5mm dia. X 500 mm CoCr Straight Rod is an accessory to the Fortex Pedicle Screw System. It is a straight rod connected…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1887-2017·2017-05-03

    Ortho VITROS VANC Reagent Recalled for Potential Biased Test Results

    Ortho-Clinical Diagnostics is recalling specific lots of VITROS VANC Reagent because they may produce biased test results after being loaded on the analyzer.

    Product
    VITROS Chemistry Products VANC Reagent, REF/Product Code 680 1709, Unique Identifier No. 10758750006731, Rx ONLY, IVD --- Ortho Clinical Diagnostics - USA -- Ortho-Clinical Diagnostics Pencoed, CF35 5PZ, UK ---- The VITROS VANC reagent is for ORTHO Clinical Diagnostics…
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-2142-2017·2017-05-03

    Econo Octopus Style Product Recalled for Squid Mislabeling

    Supermercado Econo Inc. is recalling Econo Estilo Pulpo al Ajillo because the product contains squid but is labeled as octopus.

    Product
    Econo, Estilo Pulpo al Ajillo, Octopus Style with Garlic Flavor, Net Wt. 4oz (115g)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1885-2017·2017-05-03

    Amendia Recalls Mislabeled Nitinol Guide Wires for Spinal Surgery

    Amendia is recalling 15 units of K-Wires labeled as stainless steel but made of nitinol. The wires were distributed to Georgia, Kansas, and Texas.

    Product
    01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack, Material: SS 316L, Full Temper, per ASTM F138, Amendia, 1755 West Oak Parkway, Marietta, GA 30062 Guide Wires are used to establish a pathway into the bony pedicle to place implants during spinal…
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1875-2017·2017-05-03

    Siemens ACUSON S Family Ultrasound Systems Recalled for Image Display Defects

    Siemens is recalling 2,045 ACUSON S Family ultrasound systems because the 18L6 HD transducer may display a triple image or a dark band, potentially affecting diagnostic accuracy.

    Product
    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1881-2017·2017-05-03

    Zimmer CAS Recalls Navitrack Knee Software Due to Calibration Crash

    Zimmer CAS is recalling Navitrack System - OS Knee Universal software due to a calibration sequence crash. The recall affects 105 units distributed worldwide.

    Product
    Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Food)·F-2143-2017·2017-05-03

    Econo Octopus Style Marinera Sauce Recalled for Squid Mislabeling

    Supermercado Econo Inc. is recalling Econo Octopus Style Marinera Sauce because the product contains squid but is labeled as octopus.

    Product
    Econo, Estilo Pulpo a la Marinera, Octopus Style Marinera Sauce, Net Wt. 4oz (115g)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2137-2017·2017-05-03

    Malgor Recalls Cedeira Octopus Tins Due to Mislabeling

    Malgor & Co. is recalling Cedeira Octopus in Oil Spiced Piquant tins because the label says octopus but the ingredients list jumbo squid.

    Product
    Cedeira Octopus in Oil Spiced Piquant, Net Weight 4.4oz (125g)
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-2145-2017·2017-05-03

    Fresh Express Organic Marketside Spring Mix Recalled for Foreign Animal Matter

    Fresh Express is recalling Organic Marketside Spring Mix because foreign animal matter was allegedly found in a single container. The product was distributed in five states.

    Product
    Organic Marketside Spring Mix, net Wt. 5 oz. (142g) packed in rigid plastic container, UPC code 6 8113132897 5.
    Category
    Food
    Distribution
    5 states
  • ModerateFDA (Devices)·Z-1886-2017·2017-05-03

    Stryker SmartLife Large Aseptic Housing Recall for Weld Separation

    Stryker is recalling 302 SmartLife Large Aseptic Housings due to complaints of housing deterioration and weld separation caused by improper cleaning practices.

    Product
    Stryker SmartLife Large Aseptic Housing (7126-120-000)
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0678-2017·2017-05-03

    Novartis Recalls Isopto Carpine Eye Drops for Impurity Failures

    Novartis Pharmaceuticals is recalling specific lots of Isopto Carpine eye drops due to failed impurities and degradation specifications.

    Product
    Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA NDC 0998-0206-15
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1876-2017·2017-05-03

    Becton Dickinson Recalls Trypticase Soy Agar and Chocolate Agar I-Plates

    Becton Dickinson is recalling one lot of Trypticase Soy Agar and Chocolate Agar I-Plates because they may fail to recover specific Haemophilus organisms.

    Product
    BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX)  I Plate Product Usage: Testing - Trypticase Soy Agar with 5% Sheep Blood is used for the growth of fastidious organisms and for the visualization of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0680-2017·2017-05-03

    McKesson Recalls Donepezil HCl Tablets Due to Out-of-Specification Assay

    McKesson Packaging Services is recalling 476 cartons of Donepezil HCl 10mg tablets because routine stability testing revealed an out-of-specification assay result.

    Product
    Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC…
    Category
    Drug
    Distribution
    3 states
  • SevereNHTSA·17V292000·2017-05-02

    Forest River Recalls 2014 XLR Toyhaulers Due to Axle Bolt Issue

    Forest River is recalling 2014 XLR Hyperlite toyhaulers because an axle bolt may not be properly seated, which could cause the axle to shift and lead to a loss of vehicle control.

    Product
    FOREST RIVER — FOREST RIVER XLR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V299000·2017-05-02

    Prevost Recalls Motor Coaches Due to Trailer Hitch Fastener Loosening Risk

    Prevost is recalling 2014-2017 motor coaches because trailer hitch fasteners may loosen, potentially causing the hitch to detach and increasing crash risk.

    Product
    PREVOST — PREVOST X3-45, H3-45, H3-45 VIP, X3-45 VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17145·2017-05-02

    Goodman Recalls Gas Furnaces Due to Electrical Shock Hazard

    Goodman is recalling about 4,100 gas-fired furnaces because the blower motor is not grounded, posing an electrical shock hazard to individuals servicing the units.

    Product
    Gas-fired furnaces
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V295000·2017-05-02

    Toyota Recalls 2017 Models for Improper Spare Tire Pressure

    Gulf States Toyota is recalling 2017 models because spare tires were not inflated to the proper pressure, increasing crash risk.

    Product
    TOYOTA — TOYOTA SIENNA, YARIS, RAV4 HYBRID, COROLLA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V293000·2017-05-01

    Audi A7 Recall: Head Curtain Air Bags May Not Deploy Properly

    Volkswagen Group of America is recalling 2015-2017 Audi A7 vehicles because head curtain air bags may fail to deploy in a crash, increasing injury risk.

    Product
    AUDI — AUDI A7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V290000·2017-05-01

    Jayco Recalls 2017 Trailers Due to Overheating LED Ceiling Lights

    Jayco is recalling 2017 Jay Flight, Jay Feather, and Hummingbird trailers because LED ceiling lights may overheat, increasing fire risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FEATHER, JAY FEATHER 7, HUMMINGBIRD, JAY FLIGHT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V288000·2017-05-01

    Highland Ridge RV Recalls 2017 Models for Overheating LED Ceiling Lights

    Highland Ridge RV is recalling 3,379 2017 fifth wheels and travel trailers because LED ceiling lights may produce excessive heat, increasing the risk of a fire.

    Product
    HIGHLAND RIDGE FW — HIGHLAND RIDGE FW, HIGHLAND RIDGE TT OPEN RANGE, LIGHT, ROAMER, HIGHLANDER
    Category
    Vehicle
    Distribution
    Distributed nationwide

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