The Recall Desk

Archive

June 2016 recalls

896 recalls were announced in June 2016.

What the numbers show

Critical
58
Severe
216
High
442
Moderate
156
Low
24

Of the 896 recalls this month scored against our rubric, 6% are Critical, 24% are Severe.

Which agencies issued them

201–300 of 896

  • HighFDA (Devices)·Z-1974-2016·2016-06-22

    Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 105 Xcela PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1444-2016·2016-06-22

    CSM Bakery Recalls 7 Eleven Chocolate Chunk Cookies for Undeclared Peanut

    CSM Bakery Products NA is recalling 7 Eleven Chocolate Chunk Cookies because they contain undeclared peanut protein. Consumers should not eat the product.

    Product
    7 Eleven, Chocolate Chunk Cookie (2.2 oz Pucks), Net Weight 33 lb (14.96 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1977-2016·2016-06-22

    Navilyst Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling specific Xcela Hybrid PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2016·2016-06-22

    Navilyst Medical Recalls BioFlo Hybrid PICC Catheters with Valve Technology

    Navilyst Medical is recalling specific BioFlo Hybrid PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.

    Product
    BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the cent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1471-2016·2016-06-22

    CSM Bakery Products Recalls Chocolate Chip Cookie Dough for Undeclared Peanut

    CSM Bakery Products is recalling specific batches of TranSmart Chocolate Chip Cookie Dough because the product contains undeclared peanut protein.

    Product
    1.25 oz. TranSmart, Chocolate Chip Cookie Dough, Net Weight: 23.44 lbs. (10.63 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1970-2016·2016-06-22

    Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk

    Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specifications that reduce hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1991-2016·2016-06-22

    CarboFix Recalls Piccolo Composite Tibia and Femoral Nailing System Guide Wires

    CarboFix Orthopedics is recalling 638 Piccolo Composite Ball Tip Guide Wires because the internal package was compromised, potentially affecting sterility.

    Product
    Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Devices)·Z-1992-2016·2016-06-22

    Med Tec Recalls Protura Robotic Couch System Software Due to Positioning Issues

    Med Tec Inc is recalling specific versions of Protura Robotic Couch System Software because non-sub-millimeter positioning is inconsistent with settings in split shift mode.

    Product
    Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1963-2016·2016-06-22

    Arthrex BioSync Anatomic Cotton Wedge Recalled for Polystyrene Particulate Presence

    Arthrex, Inc. is recalling BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices are used for internal bone fixation in the ankle and foot.

    Product
    BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Food)·F-1474-2016·2016-06-22

    CSM Bakery Recalls Flik Chocolate Chip Cookies for Undeclared Peanut

    CSM Bakery Products NA is recalling Flik chocolate chip cookies because they contain undeclared peanut protein. The recall covers 34,525 cases distributed across 19 states and Colombia.

    Product
    FLIK, ZT Thin & Crispy Chocolate Chip Cookies, Contains 300 cookies weighing approximately 1.2 oz, Net Weight 22.5 lbs (10.2 kg), Manufactured for FLIK International, Rye Brook, NY 10573.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1950-2016·2016-06-22

    Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to a defect in the foil pouches used for sterile integrity.

    Product
    POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM - 00587806538 POROUS PATELLA 41MM X 10MM - 00587806541
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1493-2016·2016-06-22

    Masbia Canola Oil Recalled for Foreign Material in Bottles

    Oasis Trading Co. is recalling 1,200 containers of Masbia Canola Oil because bottles were found to contain high density polyethylene resin trim rings.

    Product
    Masbia Canola Oil, Net Wt. 35 LB (15.88), Distributed by Dependable Food Corp, Edison, NJ 08817, UPC 7 32146 50866 8
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1490-2016·2016-06-22

    Frosty Acres Fry Oil Recalled for Foreign Material Contamination

    Oasis Trading Co. is recalling 180 containers of Frosty Acres fry oil because the bottles contained high density polyethylene resin trim rings.

    Product
    Frosty Acres Restaurant's Pride Advantage Clear Fry Oil, Net Wt. 35 LB (15.88), Packed for F.A.B. Inc., General Offices: Alpharetta, GA 30005, UPC 0 4820054764 2
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1475-2016·2016-06-22

    CSM Bakery Products Recalls Chocolate Chip Cookies Due to Undeclared Peanut

    CSM Bakery Products is recalling TranSmart Chocolate Chip Message Cookies because they contain undeclared peanut protein. Consumers with peanut allergies should not eat the product.

    Product
    TranSmart, 12 Chocolate Chip Message Cookie, 24/24 ounce chocolate chip cookies in Bakeable Plastic Pans with Domes, Net Weight 36 lbs/16.33 kg.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1445-2016·2016-06-22

    CSM Bakery Recalls Cranberry Nut Crunch Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling 4 oz. Cranberry Nut Crunch Cookie Dough due to undeclared peanut protein. The product was distributed in 20 US states and Colombia.

    Product
    4 oz. Cranberry Nut Crunch Cookie Dough, TransSmart, Net Weight 24 lbs (10.88 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1961-2016·2016-06-22

    Arthrex Recalls BioSync Anatomic Cotton Wedges Due to Polystyrene Particulate

    Arthrex, Inc. is recalling 138 BioSync Anatomic Cotton Wedges due to the potential presence of polystyrene particulate. The devices were distributed in 15 states.

    Product
    BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1985-2016·2016-06-22

    Navilyst Medical Recalls BioFlo and Xcela PICC Catheters with Valve Technology

    Navilyst Medical is recalling 445 units of BioFlo and Xcela PICC catheters manufactured before July 15, 2014, due to a lack of a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211 The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central veno
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1506-2016·2016-06-22

    Silver Source Creamy Fry Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling Silver Source Creamy Fry Oil because bottles were found to contain high density polyethylene resin trim rings.

    Product
    Silver Source Creamy Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795022360
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1457-2016·2016-06-22

    CSM Bakery Products Recalls Macadamia Nut Cookies for Undeclared Peanut

    CSM Bakery Products is recalling TranSmart White Chunk Macadamia Nut cookies due to undeclared peanut protein. The recall covers 34,525 cases distributed across 19 states and Colombia.

    Product
    TranSmart White Chunk Macadamia Nut, 168 2.5 oz. Cookies, Net Weight: 26.25 lbs 11.91 kg.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1477-2016·2016-06-22

    CSM Bakery Chocolate Chip Cookies Recalled for Undeclared Peanut Allergen

    CSM Bakery Products NA is recalling 21-pound cases of Chocolate Chip Cookies due to undeclared peanut protein. The product was distributed across 19 U.S. states and Colombia.

    Product
    Chocolate Chip Cookie, Net Weight: 21 lbs (9.53 kgs).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1966-2016·2016-06-22

    Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for admin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1482-2016·2016-06-22

    CSM Bakery Recalls Oatmeal Raisin Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling frozen Oatmeal Raisin cookie dough because it contains undeclared peanut protein. Consumers should not eat the product.

    Product
    Oatmeal Raisin, TranSmart Frozen Pre-cut Cookie Dough, Contains Approx. 120 Cookies, Net Weight 22.5 lbs (10.22 kgs).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1469-2016·2016-06-22

    CSM Bakery Products Recalls Frozen Cookie Dough for Undeclared Peanut

    CSM Bakery Products is recalling specific lots of frozen pre-cut cookie dough because they contain undeclared peanut protein.

    Product
    Chocolate Chip with Colored Candy Pieces, Frozen Pre-cut Cookie Dough, Net Weight; 24.61 lbs/11.17 kgs. and 23.44 lbs/10.64 kgs.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1947-2016·2016-06-22

    Cordis PRECISE RX Nitinol Stent System Recalled for Deployment Failure

    Cordis Corporation is recalling PRECISE RX Nitinol Stent Systems (Biliary) due to the inability to deploy the stent or partial deployment.

    Product
    Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1972-2016·2016-06-22

    Navilyst Medical Recalls Vaxcel PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 1,127 Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980 The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fl
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1500-2016·2016-06-22

    Oasis Trading Recalls Chef's Quality Creamy Liquid Fry Oil Due to Foreign Material

    Oasis Trading Co., Inc. is recalling 8,399 containers of Chef's Quality Creamy Liquid Fry Oil because the bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Chef's Quality Creamy Liquid Fry Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00482 9
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1893-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Failure Risk

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1890-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2016·2016-06-22

    Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns

    Zimmer Biomet is recalling specific lots of Trabecular Metal implants manufactured between April 2011 and October 2012 due to concerns about the sterile integrity of the foil pouches.

    Product
    00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622 ACETAB.CUPW/SH,0DEG,22MMX46MM 00720504828 ACETAB.CUPW/SH,0DEG,28MMX48MM 00720505228 ACETAB.CUPW/SH,0DEG,28MMX52MM 00720505628 ACETAB.CUPW/SH,0DEG,28MMX56MM 00720505828 ACET
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1888-2016·2016-06-22

    CareFusion Recalls AVEA Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Comprehensive ventilators because an incorrect fuse may fail, causing loss of power to the user interface module.

    Product
    AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1515-2016·2016-06-22

    Dessert Innovations II Recalls White Cupcakes Due to Undeclared Peanut

    Dessert Innovations II is recalling White Cupcakes with White Icing because they contain undeclared peanut protein. The products were distributed in Georgia and North Carolina.

    Product
    White Cupcakes with White Icing, UPC #10074865110102
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1440-2016·2016-06-22

    CSM Bakery Recalls Frozen Ginger Cookies for Undeclared Peanut Allergen

    CSM Bakery Products NA is recalling frozen TranSmart Ginger Cookies because they contain undeclared peanut protein. The recall covers 34,525 cases distributed across 20 US states and Colombia.

    Product
    TranSmart, Ginger Cookie, 300-1.2oz Cookies, Net Weight 22.5 lbs/10.22 kg (Frozen).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1487-2016·2016-06-22

    CSM Bakery Red Velvet Cake Recalled for Unlabeled Peanut Trace

    CSM Bakery Products is recalling 8-inch single-layer red velvet cakes because lab testing found trace amounts of peanuts, which were not declared on the label.

    Product
    8 " Single Layer Red Velvet Cake
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1969-2016·2016-06-22

    Navilyst Recalls Vaxcel PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling Vaxcel PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces the incidence of hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1523-2016·2016-06-22

    Harris Teeter Recalls 12 Count Sugar Cookies for Undeclared Peanut Allergen

    Harris Teeter is recalling 12 Count Sugar Cookies because they contain undeclared peanut protein. Consumers with peanut allergies should not eat these products.

    Product
    12 Count Sugar Cookies, UPC 0007203695601, 12 Ct (Pack 25/12 Ct)
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1491-2016·2016-06-22

    Pocahontas Clear Liquid Frying Shortening Recalled for Foreign Material

    Oasis Trading Co. is recalling 4,905 containers of Pocahontas Clear Liquid Frying Shortening because the product was reported to contain high density polyethylene resin trim rings.

    Product
    Pocahontas Clear Liquid Frying Shortening, Net Wt. 35 LB (15.88), Distributed by Progressive Group Alliance, Inc., Richmond, VA 23228, UPC 7 32146 18196 0
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1447-2016·2016-06-22

    CSM Bakery TransSmart Brownie Cookies Recalled for Undeclared Peanut

    CSM Bakery Products NA is recalling TransSmart Brownie Cookies because they contain undeclared peanut protein. Consumers should not eat the product.

    Product
    TransSmart, Brownie Cookie, 300 1.2oz Cookies, Net Weight 22.5 lbs/10.22 kg.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1510-2016·2016-06-22

    Clight Drink Mix Recalled for Undeclared Soy Ingredient

    Mondelez Puerto Rico is recalling Clight drink mix products because they contain soy lecithin but do not declare soy on the label.

    Product
    Label reads in part as: "Clight***Naranja*** Orange***CALORIE FREE ARTIFICIALLY FLAVORED DRINK MIX***TWO PACKAGES IN ONE***MAKES 1 LITER***NET: 0.49 oz*** Distributed by: Mondelez Puerto Rico, LLC, Montehiedra Office Center Suite 801, 9615 Ave. Los Romeros, San Juan PR 00926-7037
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1511-2016·2016-06-22

    Clight Drink Mix Recalled for Undeclared Soy Ingredient

    Mondelez Puerto Rico is recalling Clight drink mix products in four flavors because they contain soy lecithin but do not declare soy on the label.

    Product
    Label reads in part as: "Clight***Mandarina*** Tangerine***CALORIE FREE ARTIFICIALLY FLAVORED DRINK MIX***TWO PACKAGES IN ONE***MAKES 1 LITER***NET: 0.49 oz*** Distributed by: Mondelez Puerto Rico, LLC, Montehiedra Office Center Suite 801, 9615 Ave. Los Romeros, San Juan PR 00926
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1480-2016·2016-06-22

    CSM Bakery Recalls 7-Eleven Oatmeal Raisin Cookies for Undeclared Peanut

    CSM Bakery is recalling 7-Eleven Oatmeal Raisin Cookies because they contain undeclared peanut protein. The product was distributed in 19 states and Colombia.

    Product
    7 Eleven, Oatmeal Raisin Cookie (2.2 oz. Pucks)/ Net Weight 33 lbs (14.96 kg), Made in the USA By: CSM Bakery, Inc., Tucker, GA 30084.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1492-2016·2016-06-22

    Oasis Foods Creamy Liquid Fry Shortening Recalled for Foreign Material

    Oasis Trading Co. is recalling 2,360 containers of Oasis Foods Creamy Liquid Fry Shortening because the product was reported to contain high density polyethylene resin trim rings.

    Product
    Oasis Foods Creamy Liquid Fry Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc., Hillside, NJ 07205, UPC 7 32146 10540 9
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1982-2016·2016-06-22

    Navilyst Medical Recalls BioFlo PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 438 BioFlo PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1954-2016·2016-06-22

    Zimmer Biomet Recalls Specific Lots of Trabecular Metal Implants

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouches used for sterile integrity.

    Product
    REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52 00701005228 REV. SHELL LINER 10D 28X54 00701005428 REV. SHELL LINER 10D 28X56 00701005628 REV. SHELL LINER 10D 28X58 00701005828 REV. SHELL LINER 10D 28X6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1478-2016·2016-06-22

    CSM Bakery Recalls Chick-fil-A Chocolate Chunk Cookies for Undeclared Peanut

    CSM Bakery Products NA is recalling specific batches of chocolate chunk cookies produced for Chick-fil-A due to undeclared peanut protein.

    Product
    Brill, New Cookie, Chocolate Chunk, No Thaw, 160-2.75 oz. Cookies, Net Weight 27.5 lbs. (12.47 kg), Produced for Chick-Fil-A, Inc., Manufactured by: CSM bakery Products NA, Inc., Tucker, GA 30084.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-2002-2016·2016-06-22

    Datascope Small Patient ECC Pack Recalled for Excess Endotoxin

    Datascope Corporation is recalling 17 units of Small Patient ECC Packs due to endotoxin levels exceeding regulatory limits. The affected units were distributed in Georgia.

    Product
    Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surg
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1468-2016·2016-06-22

    CSM Bakery Recalls White Chocolate Chip Fudge Cookies for Undeclared Peanut

    CSM Bakery Products NA is recalling TranSmart White Chocolate Chip Fudge Cookies because they contain undeclared peanut protein.

    Product
    TranSmart, White Chocolate Chip Fudge Cookie, 240 1.5 oz. Cookies, Net Weight: 22.5 lbs/10.21 kg.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1472-2016·2016-06-22

    CSM Bakery Products Recalls Frozen Cookie Dough for Undeclared Peanut

    CSM Bakery Products is recalling frozen pre-cut cookie dough because it contains undeclared peanut protein. Consumers should not eat the product.

    Product
    Chocolate Chip, TranSmart, Frozen Pre-cut Cookie Dough, Net Weight 22.5 lbs (10.22 kgs).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1946-2016·2016-06-22

    Cordis PRECISE PRO RX Nitinol Stent System Recalled for Deployment Failure

    Cordis Corporation is recalling PRECISE PRO RX Nitinol Stent Systems (Carotid) due to a risk of inability to deploy or partial deployment.

    Product
    Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1997-2016·2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT scanner because unwelded bolts may cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic infor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2016·2016-06-22

    Navilyst Vaxcel PICC Catheters Recalled for Hemolysis Risk

    Navilyst Medical is recalling 328 Vaxcel PICC catheters manufactured before July 15, 2014, due to a lack of specification changes that reduce hemolysis during blood sampling.

    Product
    Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1889-2016·2016-06-22

    CareFusion Recalls AVEA Standard Ventilators Due to Fuse Defect

    CareFusion is recalling AVEA Standard ventilators because an incorrect fuse may fail, causing a loss of power to the user interface module.

    Product
    AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1460-2016·2016-06-22

    CSM Bakery Products Recalls Frozen Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling frozen pre-cut cookie dough because it contains undeclared peanut protein. Consumers should not eat the product.

    Product
    Sugar, Frozen Pre-cut Cookie Dough, Net Weight 24.61 lbs/11.16 kgs and 23.44 lbs/10.64 kgs.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1503-2016·2016-06-22

    Chef's Quality Canola Frying Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling Chef's Quality Canola Frying Oil because bottles were reported to contain a high density polyethylene resin trim ring.

    Product
    Chef's Quality Canola Frying Oil for Heavy Duty Frying, Net Wt. 35 LBS (15.87 KG), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00938 1
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1976-2016·2016-06-22

    Navilyst Recalls Xcela PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling specific Xcela PICC catheters because they lack a manufacturing change that reduces the risk of hemolysis during blood sampling.

    Product
    Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central ve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2000-2016·2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic infor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1459-2016·2016-06-22

    CSM Bakery Recalls 7 Eleven Sugar Cookies Due to Undeclared Peanut

    CSM Bakery Products NA is recalling 7 Eleven Sugar Cookies because they contain undeclared peanut protein. The product was distributed in 19 states and Colombia.

    Product
    7 Eleven, Sugar Cookie (2.2 oz. Pucks), Net Weight 33 lbs (14.96 kg), Manufactured by; CSM Bakery, Tucker, GA 30084.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1464-2016·2016-06-22

    CSM Bakery Products Recalls Mini Sugar Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling 0.5 oz. TranSmart Mini Sugar Cookie Dough because it contains undeclared peanut protein. The product was distributed in 20 US states and Colombia.

    Product
    0.5 oz. TranSmart, Mini Sugar Cookie Dough, Net Weight 22.5 lbs (10.20 kg).
    Category
    Food
    Distribution
    19 states
  • HighFDA (Devices)·Z-1952-2016·2016-06-22

    Zimmer Trabecular Metal Implants Recalled for Sterile Integrity Concerns

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouch sterile barrier system.

    Product
    TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM - 00588605314 TM LPS TIB SZ 3 C/D, 17MM - 00588605317 TM LPS TIB SZ 4 C/D, 10MM - 00588605410 TM LPS TIB SZ 4 C/D, 12MM - 00588605412 TM LPS TIB SZ 4 C/D, 1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1998-2016·2016-06-22

    Siemens Biograph mCT-S(64) 4R PET/CT Scanners Recalled for Cover Bracket Defect

    Siemens Medical Solutions USA Inc. is recalling two Biograph mCT-S(64) 4R PET/CT scanners because a cover bracket may not be welded, posing a risk of the cover falling during service.

    Product
    Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic informa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1999-2016·2016-06-22

    Siemens Biograph mCT Scanner Recall Due to Unwelded Cover Bolts

    Siemens is recalling one Biograph mCT S(20) - 3R scanner because unwelded bolts on the cover-lifting bracket could cause the cover to fall during service.

    Product
    BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956 Product Usage: The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic infor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1521-2016·2016-06-22

    Harris Teeter Recalls 12 Inch Message Cookies Due to Undeclared Peanut

    Harris Teeter is recalling 12 Inch Message Cookies because they contain undeclared peanut protein. Consumers should not eat the product.

    Product
    12 Inch Message Cookies, UPC 0007203695587, 1 Pk (Pack 24/1 Ct)
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1990-2016·2016-06-22

    Stryker PowerPRO Cots Recalled for Smoke and High-Speed Retract Reports

    Stryker is recalling 770 PowerPRO ambulance cots due to reports of smoke from the foot end and unexpected high-speed retraction.

    Product
    Stryker PowerPRO (XT, IT, or TL) Cots Stretcher, Wheeled The Stryker Power-PRO" are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1987-2016·2016-06-22

    Navilyst Recalls BioFlo Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 190 units of BioFlo Hybrid PICC catheters because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the cent
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1463-2016·2016-06-22

    CSM Bakery Products Recalls TranSmart Sugar Cookie Dough for Undeclared Peanut

    CSM Bakery Products NA is recalling TranSmart Sugar Cookie Dough because it contains undeclared peanut protein. Consumers should check their pantries for the specific batch numbers listed.

    Product
    TranSmart, Sugar Cookie Dough, 576/0.75 ounce cookies, Net Weight 27 lbs/12.26 kgs and 96/4 ounce cookies, Net Weight 24 lbs/10.9 kgs.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-1496-2016·2016-06-22

    Ex-Seed Liquid Shortening Recalled for Foreign Material Contamination

    Oasis Trading Co. is recalling Ex-Seed Premium Creamy Liquid Shortening because 35 lb bottles were found to contain high density polyethylene resin trim rings.

    Product
    Ex-Seed Premium Creamy Liquid Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 18896 9
    Category
    Food
    Distribution
    13 states
  • HighFDA (Devices)·Z-1951-2016·2016-06-22

    Zimmer Trabecular Metal Implants Recalled for Sterility Concerns

    Zimmer Biomet is recalling specific lots of sterile Trabecular Metal implants manufactured between April 2011 and October 2012 due to potential issues with the foil pouch barrier system.

    Product
    TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM - 00588604314 TM CR TIB SZ 3 C-H, 17MM - 00588604317 TM CR TIB SZ 4 C-H 10 MM - 00588604410 TM CR TIB SZ 4 C-H, 12MM - 00588604412 TM CR TIB SZ 4 C-H, 14MM -
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1035-2016·2016-06-22

    Valeant Recalls Chlordiazepoxide HCl/Clidinium Bromide Capsules Due to Impurities

    Valeant Pharmaceuticals is recalling specific lots of Chlordiazepoxide HCl/Clidinium Bromide capsules because they failed impurities and degradation specifications.

    Product
    Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North A
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1996-2016·2016-06-22

    Ethicon Recalls EVARREST Fibrin Sealant Patch Due to Labeling Error

    Ethicon is recalling 228 units of EVARREST Fibrin Sealant Patch because the expiration date field on the foil pouch labels contains the text '0-bad' instead of the valid date.

    Product
    EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel. Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1030-2016·2016-06-22

    Nostrum Recalls Nitrofurantoin Oral Suspension for Failed Dissolution Specifications

    Nostrum Laboratories is recalling Nitrofurantoin Oral Suspension because it failed to meet dissolution specifications. The recall covers 2,839 bottles distributed nationwide.

    Product
    Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1489-2016·2016-06-22

    Town & Country Pan & Grill Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling Town & Country Pan & Grill Oil because 35 lb bottles were found to contain high density polyethylene resin trim rings.

    Product
    Town & Country Pan & Grill Oil Net Wt. 35 LB (15.88), Distributed by: Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 24948 4
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1993-2016·2016-06-22

    Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Display Obstruction

    Physio-Control is recalling LIFEPAK 15 monitor/defibrillators with the EtCO2 feature because the respiratory rate display may obscure the leading digit of the EtCO2 value.

    Product
    LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical pe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1509-2016·2016-06-22

    Silver Source Canola Fry Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling Silver Source Clear Canola Fry Oil because 35 lb bottles were reported to contain a high density polyethylene resin trim ring.

    Product
    Silver Source Clear Canola Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 008 06795 02237 7
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1981-2016·2016-06-22

    Navilyst Medical Recalls BioFlo and Xcela PICC Catheters

    Navilyst Medical is recalling specific BioFlo and Xcela PICC catheters because they lack a manufacturing change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1984-2016·2016-06-22

    Navilyst Medical Recalls BioFlo PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling BioFlo PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central ve
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1995-2016·2016-06-22

    FSC Laboratories Recalls Flexichamber Holding Chambers Due to Seal Defects

    FSC Laboratories is recalling 1,435 Flexichamber Anti-Static Valved Collapsible Holding Chambers because the seal around the mouthpiece was torn or loose.

    Product
    Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1980-2016·2016-06-22

    Navilyst Medical Recalls Xcela Hybrid PICC Catheters Due to Hemolysis Risk

    Navilyst Medical is recalling 357 Xcela Hybrid PICC catheters manufactured before July 15, 2014, because they lack a specification change that reduces hemolysis during blood sampling.

    Product
    Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1497-2016·2016-06-22

    Oasis Foods Liquid Shortening Recalled for Foreign Material Contamination

    Oasis Foods is recalling Golden Fry Clear Liquid Shortening because 35 lb bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Oasis Foods Golden Fry Clear Liquid Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10458 7
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-1499-2016·2016-06-22

    Chef's Quality Clear Liquid Shortening Recalled for Foreign Material

    Oasis Trading Co. is recalling Chef's Quality Clear Liquid Shortening because bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Chef's Quality Clear Liquid Shortening, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00481 2
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2001-2016·2016-06-22

    Natus neoBLUE Phototherapy System Recall for Warning Label Update

    Natus Medical is recalling 13,541 neoBLUE Phototherapy systems to add a warning statement to the instructions and provide a laminated Quick Guide for each device.

    Product
    Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066. Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680. Product Usage: Used to provide treatment for neonatal hyperbilirubinemia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1495-2016·2016-06-22

    Oasis Foods Soybean Oil Recalled for Foreign Object Contamination

    Oasis Foods is recalling 35 lb bottles of soybean oil because they may contain high density polyethylene resin trim rings.

    Product
    Oasis Foods Soybean Oil, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 11099 1
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-1488-2016·2016-06-22

    Oasis Foods Canola Fry Shortening Recalled for Foreign Material

    Oasis Foods is recalling Canola Fry Shortening because 35 lb bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Oasis Foods Canola Fry Shortening, Net Wt. 35 LB (15.88), Distributed by: Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10378 8
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1956-2016·2016-06-22

    Beckman Coulter Access 2 Immunoassay System Recall for Thermal Component Defects

    Beckman Coulter is recalling four Access 2 Immunoassay Systems because missing thermal components may cause internal temperature excursions, delaying patient result reporting.

    Product
    Access 2 Immunoassay System, Remanufactured, Catalog No. 386220 is an invitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1505-2016·2016-06-22

    Silver Source Clear Fry Oil Recalled for Foreign Object Contamination

    Oasis Trading Co. is recalling 13,740 containers of Silver Source Clear Fry Oil because the bottles were reported to contain high density polyethylene resin trim rings.

    Product
    Silver Source Clear Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food group, Richmond, VA 23238, UPC 00806795022353
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-1994-2016·2016-06-22

    Anspach Universal Battery Charger II Recalled for Failure to Charge

    The Anspach Effort, Inc. is recalling 1,992 Universal Battery Charger II units because they enter safe mode and fail to charge batteries.

    Product
    Universal Battery Charger II (UBC II)
    Category
    Medical Device
    Distribution
    27 states
  • ModerateFDA (Food)·F-1508-2016·2016-06-22

    Silver Source Soy Salad Oil Recalled for Foreign Material

    Oasis Trading Co. is recalling 1,200 containers of Silver Source Soy Salad Oil due to reports of high density polyethylene resin trim rings in the bottles.

    Product
    Silver Source Soy Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795022346
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-1504-2016·2016-06-22

    Chef's Quality Canola Oil Recalled for Foreign Object Contamination

    Oasis Trading Co. is recalling Chef's Quality 100% Canola Oil because bottles were found to contain high density polyethylene resin trim rings.

    Product
    Chef's Quality 100% Canola Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00935 0
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Food)·F-1486-2016·2016-06-22

    Brookshire Brothers Recalls Fresh Harvest Ice Due to Foreign Object

    Brookshire Brothers is recalling Fresh Harvest Ice in 8 and 16-pound bags because a foreign object was found in the product.

    Product
    Fresh Harvest Ice NET WT 8 LB and Fresh Harvest Ice NET WT 16 LB packaged in clear plastic bags
    Category
    Food
    Distribution
    2 states

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