The Recall Desk

Archive

February 2015 recalls

651 recalls were announced in February 2015.

What the numbers show

Critical
223
Severe
185
High
173
Moderate
60
Low
10

Of the 651 recalls this month scored against our rubric, 34% are Critical, 28% are Severe.

201–300 of 651

  • SevereFDA (Food)·F-1177-2015·2015-02-18

    Numbskull LLC Recalls Key Lime Sorbet Due to Listeria Risk

    Numbskull LLC is recalling approximately 4 gallons of Key Lime Sorbet because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to Washington and Idaho.

    Product
    Key Lime Sorbet; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1008-2015·2015-02-18

    Teleflex Recalls MAQUET Servo Humidifier 163 Due to Connector Cracks

    Teleflex is recalling 18 MAQUET Servo Humidifier 163 units because connector mount cracks may cause leaks, potentially depriving patients of adequate anesthetic gases.

    Product
    MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-8125-8. A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the t
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Food)·F-1057-2015·2015-02-18

    Full Tilt Thai Iced Tea Ice Cream Recalled for Listeria Risk

    Full Tilt Ice Cream is recalling Thai Iced Tea ice cream due to potential Listeria monocytogenes contamination from a recalled ingredient.

    Product
    Thai Iced Tea ice cream, labeled in part, "***Full Tilt ice cream Thai Iced Tea ***Ingredients: Cream, milk, skim milk, sugar, ceylon tea, cardamom, star anise, vanilla, corn syrup solids, carob bean gum, guar gum, soy lecithin, carrageenan***Seattle WA 98106 www.fulltilticecream
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1165-2015·2015-02-18

    Numbskull Chocolate Almond Fudge Gelato Recalled for Listeria Risk

    Numbskull LLC is recalling Chocolate Almond Fudge Gelato because raw materials may be contaminated with Listeria monocytogenes.

    Product
    Chocolate Almond Fudge Gelato; 5 liter plastic trays. Product is labeled with flavor name and production code.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1136-2015·2015-02-18

    Numbskull Pumpkin Cheese Ice Cream Recalled for Listeria Risk

    Numbskull LLC is recalling Pumpkin Cheese ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to scoop shops and restaurants in Washington and Idaho.

    Product
    Pumpkin Cheese ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1079-2015·2015-02-18

    Numbskull LLC Recalls Black Raspberry Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling approximately 28 gallons of Black Raspberry Ice Cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to scoop shops and restaurants in Washington and Idaho.

    Product
    Black Raspberry Ice Cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1086-2015·2015-02-18

    Numbskull LLC Recalls Celebration Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling approximately 124.5 gallons of Celebration ice cream because raw materials may be contaminated with Listeria monocytogenes.

    Product
    Celebration ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1149-2015·2015-02-18

    Numbskull LLC Recalls Twix Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling approximately 50.5 gallons of Twix ice cream because raw materials used in production may be contaminated with Listeria monocytogenes.

    Product
    Twix ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1110-2015·2015-02-18

    Numbskull LLC Recalls Jungle Macademia Chip Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling approximately 9 gallons of Jungle Macademia Chip ice cream because raw materials may be contaminated with Listeria monocytogenes.

    Product
    Jungle Macademia Chip ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1158-2015·2015-02-18

    Numbskull LLC Recalls White Chocolate Macadamia Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling White Chocolate Macadamia ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to Washington and Idaho businesses.

    Product
    White Chocolate Macademia ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1113-2015·2015-02-18

    Numbskull Licorice Ice Cream Recalled for Potential Listeria Contamination

    Numbskull LLC is recalling approximately 35.75 gallons of licorice ice cream due to potential Listeria monocytogenes contamination in raw materials.

    Product
    Licorice ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1169-2015·2015-02-18

    Numbskull LLC Recalls Huckleberry Gelato Due to Listeria Risk

    Numbskull LLC is recalling Huckleberry Gelato because raw materials may be contaminated with Listeria monocytogenes. The product was sold in Washington and Idaho.

    Product
    Huckleberry Gelato; 5 liter plastic trays. Product is labeled with flavor name and production code.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1143-2015·2015-02-18

    Numbskull LLC Recalls Shake Base Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling Shake Base ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to scoop shops and restaurants in Washington and Idaho.

    Product
    Shake Base ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1092-2015·2015-02-18

    Numbskull LLC Recalls Chocolate Cheesecake Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling approximately 6 gallons of Chocolate Cheesecake ice cream because raw materials may be contaminated with Listeria monocytogenes.

    Product
    Chocolate Cheesecake ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1071-2015·2015-02-18

    Numbskull LLC Recalls Pear Huckleberry Sorbet Due to Listeria Risk

    Numbskull LLC is recalling approximately 9 gallons of Pear Huckleberry Sorbet because raw materials may be contaminated with Listeria monocytogenes.

    Product
    Pear Huckleberry Sorbet; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1156-2015·2015-02-18

    Numbskull LLC Recalls Vegan Strawberry Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling approximately 28.50 gallons of Vegan Strawberry ice cream because raw materials may be contaminated with Listeria monocytogenes.

    Product
    Vegan Strawberry ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1073-2015·2015-02-18

    Numbskull Strawberry Sorbet Recalled for Potential Listeria Contamination

    Numbskull LLC is recalling approximately 13.5 gallons of bulk Strawberry Sorbet because raw materials may be contaminated with Listeria monocytogenes.

    Product
    Strawberry Sorbet; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1081-2015·2015-02-18

    Numbskull LLC Recalls Bubble Gum Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling Bubble Gum ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to shops in Washington and Idaho.

    Product
    Bubble Gum ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1181-2015·2015-02-18

    Numbskull LLC Recalls Peach Sorbet Due to Listeria Risk

    Numbskull LLC is recalling approximately 59.5 pints of Peach Sorbet because raw materials may be contaminated with Listeria monocytogenes.

    Product
    Peach Sorbet; Pint containers. Product is labeled in part, "***brain freeze creamery***Manufactured by Brain Freeze Creamery, Spokane, WA www.brainfreezecreamery.com***"
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1189-2015·2015-02-18

    Pink's Ice Cream Recalls Mango Products Due to Listeria Risk

    Pink's Ice Cream is recalling mango ice cream products in Washington State due to a potential Listeria monocytogenes contamination in raw materials.

    Product
    Pink's Ice Cream - Mango. 16 oz Paper Carton and 1 gallon plastic container
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1091-2015·2015-02-18

    Chocolate Car Alarm ice cream recalled for Listeria contamination

    Numbskull LLC is recalling Chocolate Car Alarm ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was sold in Washington and Idaho scoop shops and restaurants.

    Product
    Chocolate Car Alarm ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1152-2015·2015-02-18

    Numbskull LLC Recalls VCP Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling approximately 51 gallons of VCP ice cream because raw materials may be contaminated with Listeria monocytogenes.

    Product
    VCP ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1094-2015·2015-02-18

    Numbskull LLC Recalls Chocolate Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling approximately 317.50 gallons of chocolate ice cream because raw materials may be contaminated with Listeria monocytogenes.

    Product
    Chocolate ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1170-2015·2015-02-18

    Numbskull Pistachio Gelato Recalled for Potential Listeria Contamination

    Numbskull LLC is recalling Pistachio Gelato in 5-liter trays because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to shops in Washington and Idaho.

    Product
    Pistachio Gelato; 5 liter plastic trays. Product is labeled with flavor name and production code.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1138-2015·2015-02-18

    Numbskull LLC Recalls Rice Krispy Treat Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling Rice Krispy Treat ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to scoop shops and restaurants in Washington and Idaho.

    Product
    Rice Krispy Treat ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1105-2015·2015-02-18

    Numbskull LLC Recalls Egg Nog Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling bulk Egg Nog ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to scoop shops and restaurants in Washington and Idaho.

    Product
    Egg Nog ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1122-2015·2015-02-18

    Numbskull LLC Recalls Cookie Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling Name Brand Cookie ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to shops in Washington and Idaho.

    Product
    Name Brand Cookie ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1157-2015·2015-02-18

    Numbskull LLC Recalls White Chocolate Raspberry Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling White Chocolate Raspberry ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to scoop shops and restaurants in Washington and Idaho.

    Product
    White Chocolate Raspberry ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1025-2015·2015-02-18

    Kkot Saem Recalls Soybean Sprouts Due to Listeria Contamination Risk

    Kkot Saem Bean Sprouts is recalling Winter Blossom brand soybean sprouts in Oregon and Washington due to potential Listeria monocytogenes contamination.

    Product
    Soybean Sprouts, net wt. 1.5 lbs., sold under brand Winter Blossom Bean Sprouts brand. Product is packaged in plastic bag, multi-colored with orange stripe on top, lower middle portion and at bottom. The orange & black English and Korea letters on white background on front of
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1182-2015·2015-02-18

    Numbskull LLC Recalls Pear Sorbet Due to Listeria Risk

    Numbskull LLC is recalling bulk Pear Sorbet because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to shops in Washington and Idaho.

    Product
    Pear Sorbet; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·15V092000·2015-02-18

    Land Rover Recalls 2015 Models for Cracking Wheel Lug Nuts

    Jaguar Land Rover is recalling 2015 Range Rover, Range Rover Sport, and LR4 vehicles because wheel lug nuts may crack and detach, increasing crash risk.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER SPORT, LR4, RANGE ROVER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1092-2015·2015-02-18

    Stryker Recalls MEDPOR BARRIER Sheets Due to Deformation and Cracking Risks

    Stryker is recalling MEDPOR BARRIER Sheets due to potential implant deformation, mechanical instability, and cracking during surgery.

    Product
    MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1076-2015·2015-02-18

    Numbskull LLC Recalls Anvil Dark Chocolate Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling Anvil Dark Chocolate ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed in Washington and Idaho.

    Product
    Anvil Dark Chocolate ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1187-2015·2015-02-18

    Pink's Ice Cream Recalls Durian Products Due to Listeria Risk

    Pink's Ice Cream is recalling Durian ice cream products in Washington State due to a potential contamination with Listeria monocytogenes.

    Product
    Pink's Ice Cream - Durian. 16 oz Paper Carton and 1 gallon plastic container
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1026-2015·2015-02-18

    Kkot Saem Mungbean Sprouts Recalled for Listeria monocytogenes Contamination

    Kkot Saem Bean Sprouts is recalling mungbean sprouts sold in Oregon and Washington because the product tested positive for Listeria monocytogenes.

    Product
    Mungbean Sprouts, net wt. 0.8 lb., sold under brand Kkot Saem Winter Blossom Bean Sprouts brand. Product is packaged in clear plastic bag with blue letters on white background. English and Korea letters on front of bag. The UPC is 1 80036 83737 2. Mungbean Sprouts, net wt.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1176-2015·2015-02-18

    Numbskull LLC Recalls Huckleberry Sorbet Due to Listeria Risk

    Numbskull LLC is recalling Huckleberry Sorbet because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to shops in Washington and Idaho.

    Product
    Huckleberry Sorbet; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1031-2015·2015-02-18

    Schiff Foods Recalls Ground Cumin Seeds Due to Peanut Contamination

    Schiff Foods Products is recalling 231,350 lbs of ground cumin seeds because they may be contaminated with peanut protein.

    Product
    Ground Cumin Seeds, ETO Treated, 50 lbs packaged in 50 lb brown paper bags
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-1039-2015·2015-02-18

    La Flor Ground Comino Recalled for Undeclared Peanut Protein

    La Flor Products Co., Inc. is recalling ground comino in 2 oz, 6 oz, and 5 lb packages due to undeclared peanut protein.

    Product
    La Flor ground COMINO, 1) NET WT. 2 OZ, 2) NET WT 6 OZ (170.1g), 3) NET WT. 5 LBS. Packed By La Flor Products Co., Inc., Hauppauge, NY 11788 Tel 631-851-9601. http://www.laflor.com
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1096-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 101 SW Humidifier Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak 101 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 101 SW, 190ML W/040 ADAPTOR, JAPA Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·15719·2015-02-18

    Hayneedle Recalls Fiber Optic Christmas Trees Due to Fire Hazard

    Hayneedle is recalling about 220 fiber optic lighted Christmas trees because the motor can overheat and cause a fire. No injuries or property damage have been reported.

    Product
    Artificial Christmas trees
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2015·2015-02-18

    Teleflex Medical Recalls AQUAPAK 640 SW Humidifier Adaptors for Foreign Material

    Teleflex Medical is recalling AQUAPAK 640 SW humidifier adaptors because packages may contain black particles. The recall covers 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 640 SW, 650ML W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor pac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1198-2015·2015-02-18

    Starwest Botanicals Recalls Ground Cumin Seed for Potential Peanut Contamination

    Starwest Botanicals is recalling specific lots of ground cumin seed because it may contain peanut protein. The product was distributed in Kansas and California.

    Product
    Ground cumin seed; Received in 50 lb. bags Shipped in 25# bags Country of Origin - Turkey: Certified Kosher; Starwest Botanicals, Sacramento, CA Received from Schiff Food Products Co. ,Inc. Totowa, NJ 07512
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1101-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 340 Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 340 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1087-2015·2015-02-18

    Siemens Symbia T Series Medical Imaging Systems Recalled for Bearing Failure

    Siemens Medical Solutions is recalling Symbia T series imaging systems because a linear bearing car may fail, allowing ball bearings to fall out.

    Product
    The Siemens Symbia T series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in ra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1196-2015·2015-02-18

    Freeland Foods Recalls Organic Sunflower Seeds Due to Salmonella

    Freeland Foods is recalling Go Raw 100% Organic Sunflower Seeds because CFIA detected Salmonella in the product.

    Product
    Go Raw 100% Organic Sunflower Seeds; Net Wt. 1 lb (454 g) USDA Organic UPC 8 59888 00009 7 Ingredients: Sprouted Organic Sunflower seeds, Celtic Sea Salt. All Handmade by Freeland Foods Mountain View, CA 94040
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1111-2015·2015-02-18

    Arthrosurface Shoulder Prosthetic Components Recalled for Marketing Clearance Issues

    Arthrosurface, Inc. is recalling 143 Taper Post Fixation Components because they were not cleared for marketing in the US with current indications.

    Product
    Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1111-2015·2015-02-18

    Numbskull LLC Recalls Lemon Bean Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling Lemon Bean ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to scoop shops and restaurants in Washington and Idaho.

    Product
    Lemon Bean ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1062-2015·2015-02-18

    Maquet Intra-Aortic Balloon Pump Demonstration Units Recalled for Ferrule Cap Defect

    Maquet Datascope is recalling specific intra-aortic balloon pump demonstration units because a ferrule cap was not removed, which could prevent connection or become dislodged in the device.

    Product
    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system use
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1088-2015·2015-02-18

    Elekta Precise Digital Accelerator Recall for Potential Securing Bolt Failure

    Elekta is recalling 46 Precise Digital Accelerators because securing bolts for the gantry counter frame weight stack may fail.

    Product
    Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Food)·F-1151-2015·2015-02-18

    Numbskull LLC Recalls Vanilla Fudge Peanut Bruttle Ice Cream for Listeria Risk

    Numbskull LLC is recalling approximately 6 gallons of Vanilla Fudge Peanut Bruttle ice cream because raw materials may be contaminated with Listeria monocytogenes.

    Product
    Vanilla Fudge Peanut Bruttle ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1086-2015·2015-02-18

    Siemens Symbia S Series Medical Imaging Systems Recalled for Bearing Failure

    Siemens Medical Solutions is recalling 719 Symbia S series systems because a linear bearing car may fail, allowing ball bearings to fall out.

    Product
    The Siemens Symbia S series is intended to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders. The images produced by the system can also be used by the physician to aid in ra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1064-2015·2015-02-18

    Virtual Imaging Recalls Digital Mobile X-ray Systems Due to Motion Defect

    Virtual Imaging, Inc. is recalling 316 digital mobile X-ray systems in the US and 6 in Canada due to a potential for unintended and erratic motion.

    Product
    Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1087-2015·2015-02-18

    ChCFCh Ice Cream Bulk Product Recall Due to Potential Listeria Contamination

    Numbskull LLC's bulk ChCFCh ice cream may contain Listeria monocytogenes due to raw material contamination risks.

    Product
    ChCFCh ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1199-2015·2015-02-18

    El Campestre Seasoning Products Recalled for Undeclared Dyes

    El Campestre, Inc. is recalling Chicken Sasonador, Beef Sasonador, and Adobo Mix due to undeclared Yellow #5 and Yellow #6 dyes.

    Product
    El Campestre Chicken Sasonador Ingredients: Water, Salt, Orange Juice Concentrate, Paprika, Guar Gum, Vinegar, Bijol, Garlic, Onion, Spices, Sugar, 0.1% Sodium Benzoate, and Potassium Sorbate NET WT. 1 GAL. (3.79L) After Opening Keep Refrigerated Ingredients: Water,
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-1064-2015·2015-02-18

    Damon Industries Recalls Bloody Mary Concentrate Due to Undeclared Anchovies

    Damon Industries is recalling Bloody Mary beverage concentrate because Worcestershire sauce used in the product contains anchovies that were not declared on the label.

    Product
    Fruitful Juice Product Bloody Mary with Tabasco, Beverage Concentrate; Contains 63% Juice; 2 + 1 packed in 2 gal Bag in Box and 3 gallons Bag in Box; UPC - 2 gallon 7 0073 05744 3; UPC - 3 gallon 7 00073 05703 0; Manufactured by Damon Industries, Sparks, NV
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1041-2015·2015-02-18

    Son In Law BBQ Sauce Recalled for Undeclared Anchovies

    Son In Law Products is recalling Medium Smoking BBQ Sauce and other varieties because they contain anchovies not listed on the label.

    Product
    Medium Smoking BBQ Sauce
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1141-2015·2015-02-18

    Numbskull LLC Recalls S'more Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling S'more ice cream because raw materials may be contaminated with Listeria monocytogenes. The product was distributed to scoop shops and restaurants in Washington and Idaho.

    Product
    S'more ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1052-2015·2015-02-18

    Full Tilt Huckleberry Chip Ice Cream Recalled for Listeria Risk

    Full Tilt Ice Cream is recalling Huckleberry Chip ice cream due to potential Listeria monocytogenes contamination from a recalled ingredient.

    Product
    Huckleberry Chip ice cream, labeled in part, "***Full Tilt ice cream Huckleberry Chip***Ingredients: Cream, milk, sugar, skim milk powder, huckleberries, chocolate chips (unsweetened chocolate, sugar, cocoa fat, soy lecithin, vanilla), vanilla, carob bean gum, corn syrup solids,
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1062-2015·2015-02-18

    Fruitful Juice Bloody Mary Concentrate Recalled for Undeclared Anchovies

    Damon Industries is recalling Fruitful Juice Bloody Mary Beverage Concentrate because it contains anchovies that were not declared on the label.

    Product
    Fruitful Juice Products Bloody Mary Beverage Concentrate with Jalapeno Flavor; Contains 59% Juice; 2 + 1 packed in 3 gal Bag in Box UPC 7 00073 02003 4 Manufactured by Damon Industries, Sparks, NV
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1097-2015·2015-02-18

    Numbskull LLC Recalls Coconut Ice Cream Due to Listeria Risk

    Numbskull LLC is recalling approximately 121 gallons of bulk coconut ice cream because raw materials may be contaminated with Listeria monocytogenes.

    Product
    Coconut ice cream; Bulk product is labeled with flavor name and date code, which is affixed to the plastic container (1, 1.5 and 3 gallon).
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1063-2015·2015-02-18

    Damon Industries Recalls Bloody Mary Concentrate Due to Undeclared Anchovies

    Damon Industries is recalling Bloody Mary Beverage Concentrate because it contains anchovies that were not declared on the label.

    Product
    Citrus Systems Bloody Mary Beverage Concentrate with Citrus o Flavor; Contains 54% Juice; 2 + 1 packed in 5 gal Bag in Box Manufactured by Damon Industries, Sparks, NV
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1065-2015·2015-02-18

    Damon Industries Recalls Bloody Mary Concentrate Due to Undeclared Anchovies

    Damon Industries is recalling Bloody Mary Premium Beverage Concentrate because it contains undeclared anchovies, a major allergen.

    Product
    Fruitful Juice Product Bloody Mary Premium, Beverage Concentrate; Contains 54% Juice; 2 + 1 packed in 3 gal Bag in Box. UPC - 7 0073 08203 2; Manufactured by Damon Industries, Sparks, NV
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1067-2015·2015-02-18

    Mt. Rose Bloody Mary Mix Recalled for Undeclared Anchovy Allergen

    Mt. Rose Drinks is recalling Bloody Mary mixes because Worcestershire sauce contains anchovies not listed on the label.

    Product
    Mt. Rose Drinks Bloody Mary and Mt. Rose The Lakes Country Club Bloody Mary; 32 oz. glass bottles, 12 per case packed in 3 gal Bag in Box. UPC - Mt. Rose Drinks 7 0073 85212 3; UPC Mt. Rose The Lakes 7 00073 85275 8 Manufactured and distributed by Mt. Rose Drinks, S
    Category
    Food
    Distribution
    5 states
  • HighNHTSA·15V093000·2015-02-18

    Land Rover Recalls Range Rovers Due to Passenger Air Bag Software Issue

    Jaguar Land Rover is recalling 2013-2015 Range Rovers and 2014-2015 Range Rover Sports because the occupant classification system may incorrectly disable the front passenger air bag.

    Product
    LAND ROVER — LAND ROVER RANGE ROVER, RANGE ROVER SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15E010000·2015-02-18

    Gillig Recalls S5510 Wheelchair Lifts Due to Platform Cracking Risk

    Gillig LLC is recalling S5510 series wheelchair lifts manufactured by Ricon Corporation between November 2010 and February 2011. The platform side plates may crack, posing a risk of injury if the platform falls.

    Product
    EQUIPMENT ADAPTIVE/MOBILITY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1109-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain black particles. The recall covers 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor pac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1197-2015·2015-02-18

    Amana Dinner Rolls Recalled for Undeclared Milk Allergens

    The Jefferson Street Bakery Inc. is recalling Amana Dinner Rolls due to undeclared milk allergens. The product was distributed in five states.

    Product
    Amana Dinner Rolls, packaged in 1 lb 2 oz plastic bags
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1068-2015·2015-02-18

    Fruitful Juice Bloody Mary Beverage Recalled for Undeclared Anchovy Allergen

    Damon Industries is recalling Fruitful Juice Bloody Mary Beverage because Worcestershire sauce contains anchovies that were not declared on the label.

    Product
    Fruitful Juice Products Bloody Mary Beverage, contains 56% Juice. Ready to Use Packed in 5 gal Bag in Box and 36 FL oz. bottles, 12 to a case. glass bottles, 12 per case packed in 3 gal Bag in Box. UPC - 5 gallon bag in box 7 0073 87405 7; UPC Mt. Rose The Lakes 7 00073
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1030-2015·2015-02-18

    MorningStar Farms Chipotle Black Bean Burgers Recalled for Undeclared Peanut

    Kellogg USA Inc is recalling MorningStar Farms Chipotle Black Bean Burgers because they contain undeclared peanut protein.

    Product
    MorningStar Farms Chipotle Black Bean Burger, 38.10 oz (9 ct) - UPC 2898971674; 50.80 oz (12 ct) - UPC 2898940864;
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2015·2015-02-18

    Teleflex Medical Recalls Aquapak Sterile Water Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak sterile water humidifier adaptors because packages may contain black foreign particles.

    Product
    AQUAPAK SW/EAU STERILE, 340 ML W/ADAPTOR Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1097-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340 ML W/404 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2015·2015-02-18

    Teleflex Medical Recalls Aqua 540 Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aqua 540 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUA 540 SW, 540 W/040 ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1107-2015·2015-02-18

    Teleflex Medical Recalls 040 Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling 040 Humidifier Adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    ADAPTOR, 040 HUM, INTL. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the wate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·15E009000·2015-02-18

    Gillig Recalls S26 Eaton Hydraulic Pumps for Steering Effort Changes

    Gillig LLC is recalling 177 S26 Eaton-brand hydraulic pumps sold between 2011 and 2014. The pumps may have manufacturing inconsistencies causing unexpected steering effort changes.

    Product
    STEERING:HYDRAULIC POWER ASSIST:PUMP recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1027-2015·2015-02-18

    Chicken of the Sea Recalls Chunk Light Tuna Due to Metal Pieces

    Chicken of the Sea is recalling Chunk Light Tuna in Water 12oz cans because they may contain metal pieces from broken equipment.

    Product
    Chicken of the Sea brand Chunk Light Tuna, Case UPC is 4800001164 and the Label UPC is 0 4800001164 0. 100 cases (24 cans/case)
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1029-2015·2015-02-18

    MorningStar Farms Spicy Black Bean Burgers Recalled for Undeclared Peanut

    Kellogg USA Inc is recalling MorningStar Farms Spicy Black Bean Burgers because they contain undeclared peanut protein.

    Product
    MorningStar Farms Spicy Black Bean Burger: 9.50 oz (4 ct) - UPC 2898939207; 18.90 oz (8 ct): UPC 2898971750; 8.7 lb case (48 ct): UPC 2898949938; 9.75 lb case (4 sleeve): UPC 2898997765; 12.75 lb case (4 sleeve): UPC 2898931651
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1035-2015·2015-02-18

    Whole Foods Recalls Raw Sheep Milk Cheese for Listeria Risk

    Whole Foods Market is recalling Shepherdista Bleating Heart cheese due to potential Listeria monocytogenes contamination. The product was sold in California, Arizona, and Hawaii.

    Product
    Cheese sold under the brand name, Sheperdista Bleating Heart, Ingredients: Raw sheep milk, cultures, salt. Contains Milk: 080414. Sold with a Whole Foods Market scale label in clear plastic wrap. Variable weight item.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1098-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors Due to Foreign Material

    Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor pac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2015·2015-02-18

    Arrow International Recalls Two-Lumen CVC Kits Due to Foreign Material

    Arrow International Inc is recalling 1,195 ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kits because visible foreign material was found inside the kits.

    Product
    ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1200-2015·2015-02-18

    El Campestre Seasoning Products Recalled for Undeclared Dyes

    El Campestre, Inc. is recalling Chicken Sasonador, Beef Sasonador, and Adobo Mix due to undeclared Yellow #5 and Yellow #6 dyes.

    Product
    El Campestre Beef Sasonador NET WT. 1 GAL. (3.79L) After Opening Keep Refrigerated Ingredients: Water, Salt, Orange Juice Concentrate, Lemon Juice Concentrate, Vinegar, Paprika, Garlic, Onion, Spices, Sugar, 0.1% Sodium Benozoate, and Potassium Sorbate. 0 89239 30026
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1065-2015·2015-02-18

    SCC Soft Computer Recalls SoftPath Laboratory Information System Versions

    SCC Soft Computer is recalling specific versions of the SoftPath Laboratory Information System because diagnostic text modifications may not be saved or displayed correctly.

    Product
    SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1083-2015·2015-02-18

    MedComp Recalls Hemodialysis Catheters and PICCs Due to Sterilization Error

    Medical Components, Inc dba MedComp is recalling 243 hemodialysis catheters and PICCs because a duplicate sterilization process may have rendered included drug products ineffective.

    Product
    Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO-PICC NURSING TRAY), MRCTP52010 (5F DUAL PRO-PICC MAX BARR TRAY), MR81013106M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1040-2015·2015-02-18

    Son In Law Products Recalls BBQ Sauces for Undeclared Anchovies

    Son In Law Products is recalling Hot & Medium Smoking BBQ, Garlic & Honey horseradish BBQ, and Cherry BBQ Sauces because they contain anchovies not declared on the labeling.

    Product
    Hot Smoking BBQ Sauce
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1043-2015·2015-02-18

    Son In Law BBQ Sauces Recalled for Undeclared Anchovies

    Son In Law Products is recalling three varieties of BBQ sauce because they contain anchovies that are not listed on the label.

    Product
    Honey Horseradish BBQ Sauce
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1066-2015·2015-02-18

    Damon Industries Recalls Bloody Mary Concentrate Due to Undeclared Anchovies

    Damon Industries is recalling 87 gallons of Southern Supreme Spicy Tabasco Bloody Mary Beverage Concentrate because it contains undeclared anchovies.

    Product
    Southern Supreme Spicy Tabasco Bloody Mary Beverage Concentrate; 2 + 1 packed in 3 gal Bag in Box. UPC - 7 0073 22603 0; Manufactured by Damon Industries, Sparks, NV
    Category
    Food
    Distribution
    5 states
  • HighFDA (Food)·F-1201-2015·2015-02-18

    El Campestre Seasoning Mixes Recalled for Undeclared Dyes

    El Campestre, Inc. is recalling Chicken Sasonador, Beef Sasonador, and Adobo Mix due to undeclared Yellow #5 and Yellow #6.

    Product
    El Campestre Adobo Mix Ingredients: Red Chile, Paprika, Water, Vinegar, Orange Juice, Garlic, Salt, & Spices NET WT. 28 LBS. Keep Refrigerated Manufactured by: El Campestre Inc. 1400 S. Santa Fe Avenue Compton, CA 90221 (310) 764-2461
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1063-2015·2015-02-18

    Siemens ACUSON S2000 Breast Scanner Recall for Detachment Risk

    Siemens is recalling 24 ACUSON S2000 breast scanners because the scanner arm may detach from the column.

    Product
    ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. The affected sub-components are #10434968 - Boom Welding and 10434969 - Arm Welding. The S2000 ABVS ultrasound System for imaging the breast allows volumetric acquisition of the breast image.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1104-2015·2015-02-18

    Teleflex Medical Recalls Aquapak Sterile Water Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak sterile water humidifier adaptors because packages may contain black particles.

    Product
    AQUAPAK SW/EAU STERILE, 650 ML W/ADAPTOR. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1100-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 340 SW Humidifier Adaptors for Foreign Material

    Teleflex Medical is recalling Aquapak 340 SW humidifier adaptors because the packages may contain black particles. The recall affects 15,779,607 units distributed worldwide.

    Product
    AQUAPAK 340 SW, 340 ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor pa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1084-2015·2015-02-18

    Integra Recalls Mayfield Ultra 360 Base Units Due to Locking Handle Failure

    Integra LifeSciences is recalling 1,053 Mayfield Ultra 360 Base Units because the locking handle mechanism may fail during use, posing a risk to patients.

    Product
    The MAYFIELD¿ Ultra 360 Base Unit for head positioner, one unit per package. Product Usage: This product provides the ability to position and hold a patient head while the patient is in the prone, supine, lateral or park-bench and sitting positions. It is intended to be u
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1114-2015·2015-02-18

    Arthrosurface Shoulder Prosthesis Components Recalled for Lack of US Clearance

    Arthrosurface, Inc. is recalling 187 units of the HHXL (OVO) 15.6x32mm Taper Post Fixation Component because the product was not cleared for marketing in the US with its current indications.

    Product
    Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1105-2015·2015-02-18

    Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors

    Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain foreign material, specifically black particles.

    Product
    AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor pac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1069-2015·2015-02-18

    Biomet Spine Recalls Timberline Cranial Caudal and Posterior Blades

    Biomet Spine, LLC is recalling Timberline Cranial Caudal and Posterior Blades due to an oversize set screw hex feature.

    Product
    Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used with
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1068-2015·2015-02-18

    Natus Medical Recalls EPWorks Software Due to Remote Monitoring Error

    Natus Medical is recalling EPWorks software versions prior to 6.0 used in the Xltek Protektor Stimulator. A software error prevents remote users from stopping free run waveform groups.

    Product
    EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1070-2015·2015-02-18

    TeraRecon Recalls Aquarius iNtuition Client Viewer Software Due to Anomaly

    TeraRecon is recalling 91 units of the Aquarius iNtuition Client Viewer due to a software anomaly in the RECIST 1.1 evaluation criteria.

    Product
    Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and vi
    Category
    Medical Device
    Distribution
    Distributed nationwide

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