The Recall Desk

Archive

December 2016 recalls

806 recalls were announced in December 2016.

What the numbers show

Critical
107
Severe
181
High
298
Moderate
178
Low
42

Of the 806 recalls this month scored against our rubric, 13% are Critical, 22% are Severe.

601–700 of 806

  • HighNHTSA·16V898000·2016-12-14

    KZRV Recalls 2016-2017 Durango and Venom Trailers for Door Hinge Defect

    KZRV is recalling 2016-2017 Durango and Venom trailers because rear cargo door hinges may have insufficient welds, causing the door to swing down with excessive force.

    Product
    KZRV — KZRV DURANGO, VENOM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V896000·2016-12-14

    DRV Recalls 2017 Full House Trailers Due to Door Hinge Weld Defect

    DRV Suites is recalling 2017 Full House recreational trailers because rear cargo door hinge welds may be insufficient, causing the door to swing down with excessive force.

    Product
    DRV — DRV FULL HOUSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0609-2017·2016-12-14

    Calbee Recalls Black Pepper Green Pea Crisps Due to Undeclared Milk

    Calbee North America is recalling one lot of black pepper flavored green pea crisps because they may contain undeclared milk.

    Product
    HARVEST SNAPS, SNAPEA CRISPS, BLACK PEPPER FLAVORED GREEN PEA CRISPS, NET WT 3.3 OZ (93g)
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0680-2017·2016-12-14

    Olympus Vanta Analytical X-Ray System Recalled for Unintentional Emission Risk

    Olympus is recalling 41 Vanta Analytical X-Ray Systems due to a risk of unintentional x-ray emission if users attempt to terminate the sequence early.

    Product
    Olympus Scientific Solutions Americas Corporation (OSSA) Model: VANTA Analytical X-Ray System
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Food)·F-0562-2017·2016-12-14

    SSI-GoPicnic Turkey and Cheese Snacks Recalled for Gluten Mislabeling

    SSI-GoPicnic LLC is recalling 1,584 cartons of Turkey Slices & Cheddar Cheese snacks labeled gluten-free because they contain wheat gluten.

    Product
    GoPicnic Turkey Slices & Cheddar Cheese; 4 Individually Packed Snacks; GLUTEN FREE; Best by: 31 JAN 2017
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0693-2017·2016-12-14

    Philips Brilliance 64 CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 184 Brilliance 64 CT systems worldwide due to a software error involving the filament on timer.

    Product
    Brilliance 64 728231 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Food)·F-0672-2017·2016-12-14

    Mondelez Recalls Oreo Fudge Creme Cookies for Undeclared Milk Allergen

    Mondelez Global LLC is recalling Oreo Fudge Creme cookies (Original and Mint varieties) because milk is not declared on the ingredient list.

    Product
    Nabisco Oreo Fudge Creme Mint Variety, Net Wt. 11.3 oz Distributed by: Mondelez Global LLC East Hanover, NJ UPC 044000026967
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0583-2017·2016-12-14

    Pastian's Bakery Recalls Home Wheat Texas Toast for Undeclared Wheat

    Pastian's Bakery is voluntarily recalling Home Wheat Texas Toast loaves due to undeclared wheat allergen. The product was distributed only in New Mexico.

    Product
    Home Wheat Texas Toast 1 lb. 8 oz. Clear Plastic Bag. 1 loaf
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0648-2017·2016-12-14

    E S Foods Recalls Chicken/BBQ Product Due to Listeria Risk

    E S Foods is recalling Chicken/BBQ, Item # 61405, because a raw material supplier verified a potential for Listeria monocytogenes contamination.

    Product
    Chicken/BBQ, Item # 61405
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0632-2017·2016-12-14

    4C Homestyle Pecorino Romano Cheese Recalled for Salmonella Contamination

    4 C Foods, Corp. is recalling 4C Homestyle All Natural 100% Imported Italian Pecorino Romano Cheese because FDA samples revealed Salmonella contamination.

    Product
    4C Homestyle All Natural 100% Imported Italian Pecorino Romano Cheese, UPC 41387-12302, 6 oz
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0617-2017·2016-12-14

    Meijer Potato Chips Recalled for Undeclared Milk and Soy Allergens

    Shearers Foods is recalling Meijer brand No Salt Added Original Kettle Cooked Potato Chips due to undeclared milk and soy allergens.

    Product
    Meijer brand No Salt Added Original Kettle Cooked Potato Chips, 8.5oz bag. 15 bags per case.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0697-2017·2016-12-14

    Philips Ingenuity CT Systems Recalled for Software Timer Error

    Philips Medical Systems is recalling 371 Ingenuity CT systems worldwide due to a software error involving the filament on timer.

    Product
    Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and e
    Category
    Medical Device
    Distribution
    46 states
  • HighNHTSA·16E093000·2016-12-14

    MORryde Recalls Zero G Ramp Door Hinges Due to Insufficient Welds

    MORryde is recalling approximately 2,500 Zero G Ramp Door hinges manufactured between August 21, 2016, and December 12, 2016, because insufficient welds may cause the door to swing down with excessive force.

    Product
    STRUCTURE:BODY:DOOR:HINGE AND ATTACHMENTS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2017·2016-12-14

    DePuy Recalls LCS Knee Revision Insert Due to Manufacturing Defect

    DePuy Orthopaedics is recalling one lot of LCS Complete Knee Revision System VVC Inserts because they were manufactured outside of specifications, preventing proper seating in the tibial tray.

    Product
    LCS Complete Knee Revision System VVC Insert Product Usage: LCS VVC Insert is used in Knee Revision Surgery
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0599-2017·2016-12-14

    Seely Family Farm Spearmint Candy Canes Recalled for Undeclared Soy

    Seely Family Farm is recalling spearmint candy canes due to undeclared soy lecithin. The product was distributed in Washington state.

    Product
    Spearmint candy canes, Net wt. 1.4 oz. The UPC is 8 54502 00321 8
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0723-2017·2016-12-14

    Siemens ADVIA 560 Hematology Systems Recalled for Incorrect Results

    Siemens is recalling ADVIA 560 Hematology Systems because a database issue may cause multiple discordant records to be generated for the same sample, leading to incorrect results.

    Product
    ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Food)·F-0623-2017·2016-12-14

    Green Dirt Farm Sheep's Milk Cheese Recalled for Staphylococcus Aureus Contamination

    Green Dirt Farm is recalling "Dirt Lover" sheep's milk cheese due to Staphylococcus aureus contamination exceeding action limits.

    Product
    Green Dirt Farm "Dirt Lover" sheep's milk cheese packaged in cases of 8, 4-6 oz.. units, sold by case weight. Made by Green Dirt Farm, LLC, Weston, MO 64098.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0666-2017·2016-12-14

    Saputo Recalls Whole Milk Cheese Due to Foreign Material

    Saputo Cheese USA is recalling specific lots of Vesuvio Bella Whole Milk Cheese after a customer reported finding white plastic in the product.

    Product
    WHOLE MILK CHEESE 8/6# VESUVIO BELLA; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. Distributed by US Foods UPC: #075805891658 Saputo code: #989165
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0712-2017·2016-12-14

    DeRoyal Recalls PneuGel Tennis Elbow Supports Due to Mold Complaints

    DeRoyal Industries is recalling 56 units of PneuGel tennis elbow supports because of complaints regarding mold on the straps.

    Product
    TENNIS ELBOW SUPPORT, PneuGel(TM), UNIVERSAL, REF 200A10, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0655-2017·2016-12-14

    Saputo Recalls Mozzarella Cheese Due to Foreign Material Complaint

    Saputo Cheese USA is recalling specific lots of Mozzarella Low Moisture Whole Milk cheese after a customer reported finding white plastic in the product.

    Product
    MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# ARREZZIO IMPERIAL; UPC: 0 74865 30185 5 Saputo code: #101379 ;
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0667-2017·2016-12-14

    Saputo Mozzarella Supreme Recalled for Foreign Material Contamination

    Saputo Cheese USA is recalling Mozzarella Supreme due to a report of white plastic found in the product.

    Product
    MOZZARELLA SUPREME 8/6# CONTADINO ; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: #075805888825 Saputo code: #988882
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0726-2017·2016-12-14

    Merge PACS software recall for horizontal image cut lines

    Merge Healthcare is recalling Merge PACS software because image cut lines may appear horizontally instead of vertically.

    Product
    Merge PACS software. Merge PACS (Picture Archiving Communication System) is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, including digital mammography.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0577-2017·2016-12-14

    Eola Bottling Company Recalls Oregon Rain Bottled Water Due to Mold

    Eola Bottling Company is recalling one lot of Oregon Rain bottled water due to mold. The product was distributed in Oregon and Washington.

    Product
    Label reads in part "***Oregon RAIN Natural VIRGIN WATER***" The product is packaged in a blue colored plastic bottle. 16.9 FL OZ. Case contains 12/16.9 FL OZ. or 24/16.9 FL OZ.
    Category
    Food
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-0698-2017·2016-12-14

    Elana Surgical KitHUD Recalled Due to Compromised Sterile Packaging Integrity

    Elana, Inc. is voluntarily removing four Elana Surgical KitHUD units because the sterile packaging of the included catheter may be compromised.

    Product
    Elana Surgical KitHUD The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Food)·F-0662-2017·2016-12-14

    Saputo Recalls Mozzarella Cheese Due to Foreign Material Complaint

    Saputo Cheese USA is recalling specific lots of low-moisture mozzarella cheese after a customer reported finding white plastic in the product.

    Product
    MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# CHEESECAKE FACTORY TCCFI; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: # #075805884759 Saputo code: #988475
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0676-2017·2016-12-14

    Airheads Mini Bars Recalled Due to Blood Observed on Packaging Equipment

    Perfetti Van Melle USA Inc is recalling Airheads Mini Bars because blood was observed on packaging equipment. The recall covers 4,147 cases distributed nationwide.

    Product
    Airheads Mini Bars 12oz bags of assorted flavors. 12 - 12oz bags are included in cardboard cartons. Assorted flavors include Cherry, Watermelon, Blue Raspberry, and White Mystery.
    Category
    Food
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0661-2017·2016-12-14

    Saputo Recalls Arrezzo Classic Whole Milk Cheese Due to Foreign Material

    Saputo Cheese USA is recalling Arrezzo Classic whole milk cheese after a customer reported finding white plastic in the product.

    Product
    WHOLE MILK CHEESE 8/6# ARREZZIO CLASSIC; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: # #074865692694 Saputo code: #987371
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0557-2017·2016-12-14

    Bindi Amerana Cherry Grana Gelato Recalled for Plastic Contamination

    Bindi North America is recalling specific lots of Amerana Cherry Grana Gelato due to potential plastic contamination or cracked lids.

    Product
    Bindi Amerana Cherry Grana Gelato 1.24 Gal Container (4.8L) UPC 815073016588
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0715-2017·2016-12-14

    Angiodynamics Recalls PICC Catheters Due to Stylet Diameter Labeling Error

    Angiodynamics is recalling PICC catheters because the stylet diameter may be larger than stated on the label.

    Product
    Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Techn
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0615-2017·2016-12-14

    Cre 8 It Stuffing Recalled Due to Temperature Control Issues

    Cre 8 It, Inc. is recalling stuffing mix after a complaint of sour taste indicated a storage thermometer error.

    Product
    Cre 8 It, Inc. Stuffing, 011951311916 in covered aluminum foil pans. Net Weight 2/4 lb. (3.63kg) containers per shipping case
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0660-2017·2016-12-14

    Saputo Recalls Mozzarella Cheese Due to Foreign Material Complaint

    Saputo Cheese USA is recalling specific lots of low-moisture mozzarella cheese after a customer reported finding white plastic in the product.

    Product
    MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# ROSELI; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. US Foods UPC: # #758108015111 Saputo code: #984639
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0658-2017·2016-12-14

    Saputo Recalls Low-Moisture Mozzarella Due to Foreign Material

    Saputo Cheese USA is recalling low-moisture mozzarella cheese after a customer reported finding white plastic in the product.

    Product
    MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# ANTONIO Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: # #90075805843919 Saputo code: #984391
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0561-2017·2016-12-14

    Coca-Cola Recalls Dr. Pepper Cherry Cans for Undeclared Corn Syrup

    The Coca-Cola Company is recalling 1,020 cases of Dr. Pepper Cherry 12oz 12-packs in California due to undeclared high-fructose corn syrup.

    Product
    Dr. Pepper Cherry, 12oz (12 pack cans), Manufactured under the authority of Doctor Pepper Company, 5301 Legacy Drive, Plano, TX.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0713-2017·2016-12-14

    DeRoyal Recalls Pneugel Tennis Elbow Straps Due to Mold Complaints

    DeRoyal Industries is recalling 791 units of Pneugel Tennis Elbow Straps because of complaints regarding mold on the product.

    Product
    PNEUGEL(R) TENNIS ELBOW STRAP, UNIVERSAL, REF 12840000, QTY: 1 Each, Rx Only, Product Usage: Lateral and medial epicondylitis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0663-2017·2016-12-14

    Saputo Whole Milk Mozzarella Cheese Recalled for Foreign Material

    Saputo is recalling specific lots of Whole Milk Mozzarella cheese after a customer reported finding white plastic in the product.

    Product
    WHOLE MILK CHEESE 8/6# MOZZERIA - Saputo; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: #075805888948 Saputo code: #988947
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0659-2017·2016-12-14

    Saputo Mozzarella Recalled for White Plastic Contamination

    Saputo Cheese USA is recalling low-moisture mozzarella cheese after a customer reported finding white plastic in the product.

    Product
    MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# CHUCK E CHEESE Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: # #075805845347 Saputo code: #984534
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0556-2017·2016-12-14

    Bindi USA Chocolate Gelato Recalled for Potential Plastic Contamination

    Bindi North America is recalling 177 tubs of Bindi USA Chocolate Gelato in Illinois due to potential plastic strands or cracked lids.

    Product
    Bindi USA Chocolate Gelato 1.24 Gal Container (4.8 L) UPC 815073016564
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Food)·F-0675-2017·2016-12-14

    A&W Cream Soda Recalled for Caffeine Presence Despite Labeling

    Chesterman Co is recalling A&W Cream Soda, 20 FL OZ, Caffeine Free, because testing revealed the presence of caffeine despite the product being labeled as caffeine-free.

    Product
    A&W Cream Soda, 20 FL OZ, Caffeine Free
    Category
    Food
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-0717-2017·2016-12-14

    Ivoclar Vivadent Recalls Virtual XD Dental Impression Material

    Ivoclar Vivadent is recalling Virtual XD Refill Light Body Fast Set Wash Material because the dental impression material may fail to set up properly.

    Product
    Virtual XD Refill Light Body Fast Set Wash Material, 2X50 ml, REF #/Product Code 646461, Rx ONLY -- product Usage: Dental impression material
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0716-2017·2016-12-14

    Sorin Perceval Sutureless Aortic Heart Valve Field Action

    Sorin Group USA is conducting a voluntary field action for Perceval Sutureless Aortic Heart Valves due to updated implantation procedure steps.

    Product
    Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25; Perceval Sutureless Aortic Heart Valve size XL, Item # ICV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0656-2017·2016-12-14

    Saputo Recalls Mozzarella Cheese Due to Foreign Material Complaint

    Saputo Cheese USA is recalling specific lots of Mozzarella cheese after a complaint of white plastic found in the product.

    Product
    WHOLE MILK CHEESE 8/6# LA GONDOLA; Mozzarella Cheese Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: #075805010141 Saputo code: #1014 ;
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0710-2017·2016-12-14

    BioFlo PICC Nursing Kits Recalled for Incorrect Glove Expiration Dates

    Angiodynamics is recalling BioFlo PICC Maximal Barrier Nursing Kits because included sterile gloves have incorrect expiration dates.

    Product
    BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0657-2017·2016-12-14

    Saputo Recalls Low Moisture Mozzarella Cheese Due to Foreign Material

    Saputo Cheese USA is recalling specific lots of low moisture mozzarella cheese after a customer reported finding white plastic in the product.

    Product
    MOZZARELLA LOW MOISTURE WHOLE MILK 8/6# DRAGONE ; Low moisture Mozzarella Cheese Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: #070348121002 Saputo code: #112100
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0692-2017·2016-12-14

    Siemens Recalls SOMATOM Force CT Systems for Software Bugs

    Siemens is recalling 48 SOMATOM Force CT systems to install a software update that fixes bugs causing image errors and scan aborts.

    Product
    SOMATOM Force, System x-ray, tomography, computed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0705-2017·2016-12-14

    Philips IQon Spectral CT Software Defect Recall

    Philips is recalling 24 IQon Spectral CT systems due to a software defect that causes issues with filming, saving, and annotating images.

    Product
    IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0709-2017·2016-12-14

    BioFlo PICC Nursing Kits Recalled for Incorrect Glove Expiration Dates

    Navilyst is recalling BioFlo PICC Maximal Barrier Nursing Kits because the included sterile gloves have incorrect expiration dates.

    Product
    BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN #
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0725-2017·2016-12-14

    Randox Magnesium IVD Reagent Recalled for Carryover Interference

    Randox Laboratories is recalling 15 units of Magnesium IVD reagents for the RX Imola analyser due to carryover interference from amylase tests.

    Product
    Magnesium on RX Imola analyser IVD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0695-2017·2016-12-14

    Philips Ingenuity Core CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 337 Ingenuity Core CT systems worldwide due to a software error involving the filament on timer.

    Product
    Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Food)·F-0665-2017·2016-12-14

    Saputo Recalls Whole Milk Cheese Due to Foreign Material

    Saputo Cheese USA is recalling specific lots of Whole Milk Cheese after a customer reported finding white plastic in the product.

    Product
    WHOLE MILK CHEESE 8/6# MAGIC MOZZI; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: #075805890378 Saputo code: #989037
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0708-2017·2016-12-14

    Navilyst Recalls Xcela PICC Kits Due to Incorrect Glove Expiration Dates

    Navilyst Medical is recalling Xcela Power Injectable PICC Maximal Barrier Nursing Kits because included sterile gloves have incorrect expiration dates.

    Product
    Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is indicated for short or long-term peripheral access to the central venous system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0664-2017·2016-12-14

    Saputo Recalls Mozzarella Cheese Due to Foreign Material Complaint

    Saputo Cheese USA is recalling specific lots of Mozzarella Style Low Moisture Whole Milk cheese after a complaint of white plastic found in the product.

    Product
    MOZZARELLA STYLE LOW MOISTURE WHOLE MILK 8/6# HARVEST VALUE; Pasteurized Milk, Cheese Cultures, Salt, Enzymes. UPC: #758108633766 Saputo code: #988995
    Category
    Food
    Distribution
    24 states
  • ModerateFDA (Food)·F-0558-2017·2016-12-14

    Bindi Cappucino Gelato Recalled for Plastic Strands and Cracked Lids

    Bindi North America is recalling 165 tubs of Cappucino Gelato in Illinois due to potential plastic strands or cracked lids.

    Product
    Bindi Cappucino Gelato 1.24 Gal Container (4.8L) UPC 815073016595
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0700-2017·2016-12-14

    Medtronic Recalls Model 37751 Recharger for Spinal Cord Stimulation

    Medtronic is recalling Model 37751 Rechargers used for spinal cord stimulation because they may become unresponsive with a blank display and beeping sound.

    Product
    Model 37751 Recharger Product Usage: The Medtronic 37751 Recharger is a hand-held device used to charge the battery in a patient s neurostimulator. It includes a display to provide information on the charging system. The charging system consists of the Model 37751 Recharger,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0555-2017·2016-12-14

    Bindi Vanilla Bean Gelato Recalled for Potential Plastic Contamination

    Bindi North America is recalling 373 tubs of Vanilla Bean Gelato in Illinois due to potential plastic strands or cracked lids.

    Product
    Bindi USA Vanilla Bean Gelato 1.24 Gal Container (4.8 L) UPC 815073016557
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0719-2017·2016-12-14

    Ivoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures

    Ivoclar Vivadent is recalling Virtual XD Test Pack dental impression material because it may fail to set properly as it ages.

    Product
    Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0704-2017·2016-12-14

    Ultradent Recalls UltraSeal XT Plus Clear Refill Due to Labeling Error

    Ultradent Products, Inc. is recalling 31 units of UltraSeal XT Plus Clear Refill, Lot BD79T, because the package was mislabeled with an incorrect part number.

    Product
    UltraSeal XT Plus Clear Refill. The package contains 4x 1.2 ml UltraSeal XT Plus. Product Usage: The UltraSeal XT Plus is used for prophylactic sealing of pits and fissures. It may also be used for micro restorative or initial layer of composite restorations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0714-2017·2016-12-14

    Angiodynamics Recalls PICC Catheters Due to Stylet Diameter Labeling Error

    Angiodynamics Inc. is recalling specific PICC catheters because the stylet diameter may differ from the label, potentially causing stiffening.

    Product
    Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technolo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0724-2017·2016-12-14

    Halyard C-Section Drapes Recalled for Manufacturing Variation

    Halyard Health is recalling specific lots of C-Section drapes because a manufacturing variation may prevent the removal of coated release paper, inhibiting easy access to the surgical site.

    Product
    Halyard C-Section Drape with Clear Screen and Full Incise (Non-Sterile), Product Code 44965 NS; C-Section Drape with Clear Screen and Full Incise (Sterile), Product Code 44966 00; C-Section Drape with Clear Screen (Non-Sterile), Product Code 44967 NS; C-Section Drape with Clear S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0711-2017·2016-12-14

    Encore Medical Recalls Mislabeled Empowr Knee Baseplate Implants

    Encore Medical is recalling seven Empowr Knee System baseplates that were mislabeled as size 6 but are actually size 4.

    Product
    Empowr Knee System Product Usage: Non-porous proximal tibial baseplate implants, utilized in either posterior cruciate ligament (PCL) retaining or PCL substituting total knee arthroplasty procedure.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0718-2017·2016-12-14

    Ivoclar Vivadent Recalls Virtual XD Dental Impression Material Due to Setting Failures

    Ivoclar Vivadent is recalling Virtual XD Refill Light Body dental impression material because it may fail to set properly as it ages.

    Product
    Virtual XD Refill Light Body Regular Set Wash Material, 2X50 ml, REF #/Product Code 646462, Rx ONLY -- Product Usage: Dental impression material
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0694-2017·2016-12-14

    Philips Brilliance 64 CT Systems Recalled for Software Error

    Philips Medical Systems is recalling 18 Brilliance 64 CT systems due to a software error involving the filament on timer.

    Product
    Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and
    Category
    Medical Device
    Distribution
    46 states
  • LowFDA (Food)·F-0616-2017·2016-12-14

    Newly Weds Foods Recalls Ham Pump Seasoning for Wood Chips

    Newly Weds Foods Inc is recalling G72642 Ham Pump 35% seasoning bags distributed in Oregon due to potential wood chip contamination.

    Product
    G72642 Ham Pump 35%, 41.92 LB bag composed of one 39.67 LB bag of seasoning and one 2.25 LB bag of cure.
    Category
    Food
    Distribution
    1 state
  • LowFDA (Drugs)·D-0170-2017·2016-12-14

    Teva Recalls Qnasl Nasal Aerosol Due to Content Uniformity Failure

    Teva Pharmaceuticals is recalling Qnasl nasal aerosol canisters because the product failed stability testing for spray content uniformity.

    Product
    Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples).
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0171-2017·2016-12-14

    Teva Recalls Qnasl Nasal Aerosol Due to Content Uniformity Failure

    Teva Pharmaceuticals USA is recalling Qnasl nasal aerosol because stability testing showed the product failed content uniformity specifications.

    Product
    Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0169-2017·2016-12-14

    Hospira Recalls Lidocaine and Dextrose Injection for Stability Failures

    Hospira Inc. is recalling specific lots of 5% Lidocaine HCL and 7.5% Dextrose Injection because they failed stability specifications for color and pH.

    Product
    5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Devices)·Z-0722-2017·2016-12-14

    OraSure Barbiturate Micro-Plate EIA Recalled for Shipping Error

    OraSure Technologies is recalling four kits of Barbiturates Intercept Micro-Plate EIA because cocaine metabolite microplates were shipped instead.

    Product
    Barbiturates Intercept Micro-Plate EIA (enzyme immunoassay, barbiturate) Product is intended for use by clinical laboratories in the qualitative determination of barbiturates in oral fluids.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Food)·F-0606-2017·2016-12-14

    Safecor Vitamin B-1 Tablets Recalled for Incorrect Ingredient Labeling

    Safecor Health is recalling Vitamin B-1 tablets because the boxes are labeled with the wrong chemical form of thiamine.

    Product
    Safecor Vitamin B-1 (THIAMINE) 100 mg tablets NDC: 48433-0108-01 Distributed by: SAFECOR HEALTH, 317 NEW BOSTON STREET, WOBURN, MA
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0172-2017·2016-12-14

    West-Ward Recalls Sodium Ferric Gluconate Injection Due to Low Iron Content

    West-Ward Pharmaceuticals is recalling 5,142 shelf-packs of Sodium Ferric Gluconate Complex in Sucrose Injection because stability testing revealed the product had lower iron content than specified.

    Product
    SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE — SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE (SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereCPSC·17050·2016-12-13

    Cuisinart Food Processors Recalled by Conair Due to Laceration Hazard

    Conair is recalling Cuisinart food processors because riveted blades can crack, posing a laceration hazard. Consumers should stop using the blades and contact Cuisinart for a free replacement.

    Product
    Cuisinart® food processors
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16E092000·2016-12-13

    Agility Recalls CNG Fuel Systems Due to Hose Corrosion Risk

    Agility Fuel Systems is recalling specific CNG fuel systems because high-pressure hoses may corrode, potentially causing a gas leak and fire.

    Product
    FUEL SYSTEM, OTHER:DELIVERY:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V893000·2016-12-13

    Thor Motor Coach Recalls 2016-2017 Outlaw Motorhomes for Door Hinge Defect

    Thor Motor Coach is recalling 2016-2017 Outlaw motorhomes because rear cargo door hinge welds may be inadequate, potentially causing the door to open with excessive force.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH, THOR MOTOR OUTLAW
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17051·2016-12-13

    World Trading Recalls Orbit Self-Balancing Scooters Due to Fire Hazard

    World Trading is recalling Orbit self-balancing scooters sold by Evine because the lithium-ion batteries can overheat, posing a risk of fire or explosion.

    Product
    Self-balancing scooters/hoverboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V891000·2016-12-12

    Ducati Recalls 2015-2016 Scrambler Motorcycles for Side Stand Defect

    Ducati is recalling 2015-2016 Scrambler motorcycles because a side stand pivot nut can detach, potentially causing the engine to stall or allowing the bike to be ridden with the stand down.

    Product
    DUCATI — DUCATI SCRAMBLER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·117-2016·2016-12-12

    King Meat Services Recalls Beef Products Due To Misbranding

    King Meat Services is recalling approximately 50,991 pounds of beef products due to misbranding. The recall covers items shipped to California distributors, retail, and food service locations.

    Product
    King Meat Service Inc. — King Meat Services, Inc. Recalls Beef Products Due To Misbranding
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·16V886000·2016-12-09

    Micro Bird Recalls 2015-2016 T-Series School Buses for Lift Interlock Defect

    Micro Bird is recalling 2015-2016 T-Series school buses because the wheelchair lift interlock can be deactivated, allowing the bus to be driven with the lift open or deployed.

    Product
    MICRO BIRD — MICRO BIRD T-SERIES SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V889000·2016-12-09

    Land Rover Recalls 2016-2017 Models for Front Control Arm Defect

    Jaguar Land Rover is recalling 2016-2017 Discovery Sport and Range Rover Evoque vehicles because front lower control arm fasteners may fail, potentially causing the steering knuckle to separate.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER EVOQUE, DISCOVERY SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V888000·2016-12-09

    Honda Recalls 2017 Ridgeline AWD Vehicles for Wiring Harness Defect

    Honda is recalling 2017 Ridgeline AWD vehicles because water may enter the rear wiring harness, causing corrosion that could unexpectedly activate the stability assist system and increase crash risk.

    Product
    HONDA — HONDA RIDGELINE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·16V887000·2016-12-09

    Smeal Aerial Fire Apparatus Recalled for Guardrail Defect

    Smeal is recalling 216 aerial fire apparatus vehicles because a movable ladder access guardrail may bend or break under heavy loads, increasing injury risk.

    Product
    SMEAL — SMEAL AERIAL, AERIAL FIRE APPARATUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-120916·2016-12-09

    Undercooked Chicken in Ready-to-Eat Products Recalled Nationwide

    USDA FSIS issued a public health alert for ready-to-eat chicken products that may be undercooked and incorporated into other foods. Consumers are urged not to consume these items.

    Product
    National Steak Processors (2024), LLC. — FSIS Issues Public Health Alert For Possibly Undercooked Ready-To-Eat Chicken Products That Have Been Incorporated Into Other Food Products
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·116-2016·2016-12-08

    Taylor Farms Recalls Meatloaf Products Due to Misbranding and Undeclared Allergens

    Taylor Farms Northwest is recalling approximately 79 pounds of meatloaf products due to misbranding and undeclared allergens, including milk, fish, beef, and pork.

    Product
    Taylor Farms Northwest LLC — Taylor Farms Northwest, LLC Recalls Meatloaf Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    2 states
  • SevereCPSC·17048·2016-12-08

    Masterbuilt and Cabela's 7-in-1 Gas Smokers Recalled for Fire Hazard

    Masterbuilt is recalling about 41,000 7-in-1 gas smokers because the PVC gas hose can disconnect, posing a fire hazard. Consumers should stop using the units and contact the manufacturer for a free replacement hose.

    Product
    Masterbuilt and Cabela's 7-in-1 gas smokers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·16V882000·2016-12-08

    Starcraft RV Recalls 2017 Mini Trailers With Incorrect Tire Labels

    Starcraft RV is recalling 125 model year 2017 mini trailers because federal labels may list incorrect tire and rim sizes, potentially leading to unsafe replacements.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT AUTUMN RIDGE, COMET MINI, LAUNCH, SATELLITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17047·2016-12-08

    Yankee Candle Recalls Luminous Candles Due to Glass Cracking Hazard

    Yankee Candle is recalling Luminous Collection candles because the glass jars can crack when lit, posing a laceration hazard. No injuries have been reported.

    Product
    Luminous Candle Collection
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0438-2017·2016-12-07

    Kuster's Recalls PepperJack Shredded Cheese Due to Listeria Risk

    Kuster's Inc. is voluntarily recalling specific lots of Fata's Best PepperJack shredded cheese due to potential Listeria monocytogenes contamination or inadequate pasteurization.

    Product
    Fata's Best PepperJack Feather Shred Shredded Cheese, 5 lb. packages packed in plastic bags, keep refrigerated
    Category
    Food
    Distribution
    6 states
  • CriticalCPSC·17718·2016-12-07

    Playworld Recalls Stainless Steel Playground Slides Due to Amputation Hazard

    Playworld is recalling about 1,300 stainless steel playground slides because a weld can crack, creating a space where a child's fingers can be caught and amputated.

    Product
    Lightning Slide stainless steel playground slide
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0439-2017·2016-12-07

    Kuster's Inc. Recalls Shredded Cheese for Listeria Risk

    Kuster's Inc. is voluntarily recalling shredded, sliced, and cubed cheese due to potential Listeria monocytogenes contamination or inadequate pasteurization.

    Product
    Nor-Tech Dairy Mozz/Muenster/Prov Feather Shred Shredded Cheese, 5 lb. packages packed in plastic bags, keep refrigerated
    Category
    Food
    Distribution
    6 states

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