The Recall Desk

Archive

November 2015 recalls

745 recalls were announced in November 2015.

What the numbers show

Critical
22
Severe
397
High
235
Moderate
76
Low
15

Of the 745 recalls this month scored against our rubric, 3% are Critical, 53% are Severe.

Which agencies issued them

701–745 of 745

  • HighFDA (Devices)·Z-0183-2016·2015-11-04

    Siemens ADVIA Chemistry XPT Systems Recalled for Unflagged Electrode Errors

    Siemens is recalling ADVIA Chemistry XPT systems because unplugged electrodes may cause unflagged errors in sodium, potassium, or chloride results.

    Product
    ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0101-2016·2015-11-04

    Kermit's Key Lime Cocktail Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 12-ounce bottles of Key Lime Cocktail Sauce due to undeclared soy on the label.

    Product
    Kermit's Key Lime Cocktail Sauce, 12 oz, Key West, FL, UPC 007172006076 & 0802468905503
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0105-2016·2015-11-04

    Kermit's Hot & Spicy Key Lime Barbecue Sauce Recalled for Undeclared Soy

    Kermit, Inc. is recalling 16 oz bottles of Hot & Spicy Key Lime Barbecue Sauce due to undeclared soy on the label.

    Product
    Kermit's Hot & Spicy Key Lime Barbecue Sauce, 16 oz, Key West, FL, UPC 116601501423 & 802468905312
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·15V730000·2015-11-04

    Blue Bird School Bus Wheelchair Lift Recall for Bearing Defects

    Blue Bird is recalling certain school buses with Ricon wheelchair lifts where pivot holes may allow bearings to move, risking platform failure.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN, MICRO BIRD, CONVENTIONAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V731000·2015-11-04

    Blue Bird Transit Buses Recalled for Wheelchair Lift Bearing Defect

    Blue Bird is recalling 2007-2015 transit buses with Ricon wheelchair lifts where pivot holes may allow bearings to shift, risking platform failure.

    Product
    BLUE BIRD — BLUE BIRD VISION, ALL AMERICAN, MICRO BIRD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0121-2016·2015-11-04

    American Pure Whey Protein Recalled for Undeclared Soy and Milk Allergens

    American Pure Whey is recalling Whey Protein Matrix Vanilla flavor due to undeclared soy and milk allergens.

    Product
    American Pure Whey, Whey Protein Matrix Vanilla flavor, 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC.
    Category
    Food
    Distribution
    28 states
  • HighFDA (Food)·F-0118-2016·2015-11-04

    American Pure Whey Protein Isolate Recalled for Undeclared Soy and Milk

    American Pure Whey is recalling Whey Protein Isolate (Chocolate flavor) in 2 lb. and 5 lb. containers due to undeclared soy and milk allergens.

    Product
    American Pure Whey, Whey Protein Isolate (Chocolate flavor), 2 lb. and 5 lb. containers, Manufactured by American Pure Whey, Vanceboro, NC.
    Category
    Food
    Distribution
    28 states
  • HighFDA (Devices)·Z-0166-2016·2015-11-04

    Perkin Elmer Specimen Gate Software Recall for Incorrect Result Interpretation

    Perkin Elmer is recalling Specimen Gate software because abnormal newborn screening test results may be incorrectly interpreted as normal.

    Product
    Perkin Elmer Specimen Gate, Screening Center. Data management of neonatal screening test results and demographics by qualified laboratory personnel in newborn screening programs.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0187-2016·2015-11-04

    FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns

    Resource Optimization & Innovation LLC is recalling 153 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.

    Product
    Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Food)·F-0098-2016·2015-11-04

    Goya Mojo Criollo Marinade Recalled for Undeclared Peanut

    Goya Foods is recalling Mojo Criollo Marinade because an ingredient supplier reported that cumin used in the product may contain undeclared peanut protein.

    Product
    Goya Mojo Criollo Marinade for Chicken, Pork & Beef (a) 12 ounce (b) 24.5 oz and (c) 1 Gallon containers; Goya Foods, Inc., Secaucus, NJ 07096 USA Distributor. Product of Dominican Republic
    Category
    Food
    Distribution
    27 states
  • HighFDA (Devices)·Z-0193-2016·2015-11-04

    Integra Bone Marrow Biopsy Trays Recalled Due to Lidocaine Particulate

    Integra is recalling Bone Marrow Biopsy Trays because they contain Hospira Lidocaine vials with visible particulate matter.

    Product
    Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and d
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0180-2016·2015-11-04

    Encore Medical Recalls Reverse Shoulder Prosthesis Stem Impaction Fixtures

    Encore Medical is recalling 634 units of Reverse Shoulder Prosthesis Stem Impaction Fixtures because polymer wear from the fixtures can damage the titanium coating on humeral stems during assembly.

    Product
    Reverse Shoulder Prosthesis Stem Impaction Fixture REF 804-03-053 The Turon and RSP Impaction Fixtures are used in the operating room on the back table to assemble the shoulder systems for implant. The Turon Fixture is used to connect the Humeral Head to the Humeral Neck, then s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0170-2016·2015-11-04

    Varian ARIA Radiation Oncology Software Recall for Printing Anomaly

    Varian Medical Systems is recalling ARIA Radiation Oncology software versions 10, 11, 13.0, and 13.5 because admin instructions may fail to print or transmit.

    Product
    ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0192-2016·2015-11-04

    Synthes Threaded Plate Holder Recalled for Incorrect Part Number Etching

    Synthes (USA) Products LLC is recalling 25 units of Threaded Plate Holders that are incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.

    Product
    Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0173-2016·2015-11-04

    Philips Recalls Brilliance 16-Slice CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 323 Brilliance 16-Slice CT systems worldwide due to X-ray measurement errors causing Ring/Dot artifacts.

    Product
    Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0176-2016·2015-11-04

    Philips Ingenuity Core 128 CT Systems Recalled for X-ray Measurement Error

    Philips Medical Systems is recalling 109 Ingenuity Core 128 CT systems due to X-ray measurement errors causing image artifacts.

    Product
    Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0110-2016·2015-11-04

    Sobisk Lemon Cream Cookies Recalled for Undeclared Color Additive

    Sobisk Foods LLC is recalling Lemon Cream Cookies imported from India because they contain undeclared FD & C Yellow #5.

    Product
    Sobisk Lemon Cream Cookies; Imported Exclusively by: Sobisk Foods, LLC, 110 W Baltimore Ave, Clifton heights, PA 19018; Product of India;;; BEST BY: 1/31/2017 Net Wt: 11.04 oz package 10 Packs and/or Net Wt: 9.1 oz. 8 Packs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0111-2016·2015-11-04

    Sobisk Orange Cream Cookies Recalled for Undeclared Food Dyes

    Sobisk Foods LLC is recalling Orange Cream Cookies imported from India because they contain undeclared food dyes, including FD & C Red #3, Yellow #5, and #6.

    Product
    Sobisk Orange Cream Cookies; Imported Exclusively by: Sobisk Foods, LLC, 110 W Baltimore Ave, Clifton heights, PA 19018; Product of India;;; BEST BY: 03/31/2017 Net Wt: 11.04 oz package 10 Packs and/or Net Wt: 9.1 oz. 8 Packs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Food)·F-0112-2016·2015-11-04

    Sobisk Strawberry Cream Cookies Recalled for Undeclared Food Dyes

    Sobisk Foods LLC is recalling Strawberry Cream Cookies from India because they contain undeclared food dyes, including FD & C Red #3 and Yellow #6.

    Product
    Sobisk Strawberry Cream Cookies; Imported Exclusively by: Sobisk Foods, LLC, 110 W Baltimore Ave, Clifton heights, PA 19018; Product of India;;; BEST BY: 01/31/2017 Net Wt: 11.04 oz package 10 Packs and/or Net Wt: 9.1 oz. 8 Packs.
    Category
    Food
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-0172-2016·2015-11-04

    Spacelabs CardioCall ECG Event Recorders Recalled for Battery Defect

    Spacelabs Healthcare is recalling CardioCall ECG Event Recorders because a battery defect causes continuous ringing and prevents normal operation.

    Product
    Spacelabs Healthcare CardioCall ECG Event Recorder, Models VS20, VS20x4, ST80, ST80x4, PCBAs PN # 670-1670-00 Product Usage: The CardioCall event recorder is worn by the patient to record a short period of electrocardiogram which can be sent to his physician.
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0165-2016·2015-11-04

    Encore Medical Recalls Exprt Precision System Knee Implants for Missing Labeling

    Encore Medical is recalling 209 Exprt Precision System Revision Knee implants because the labeling is missing size and diameter information.

    Product
    Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0164-2016·2015-11-04

    Sentinel Ammonia Reagent Recalled for Inaccurate Results in Heparin Tubes

    Sentinel CH SpA is recalling 765 kits of Sentinel MULTIGENT Ammonia Ultra Reagent because results may be below the linear range for samples collected in heparin tubes.

    Product
    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0161-2016·2015-11-04

    Nipro Safe Touch TULIP Safety Fistula Needle Packaging Error Recall

    Nipro Medical Corporation is recalling 50,000 fistula needles because some 1 1/4-inch needles were packaged in 1-inch blister packs.

    Product
    Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0175-2016·2015-11-04

    Philips Ingenuity Core CT Systems Recalled for X-ray Measurement Error

    Philips is recalling 36 Ingenuity Core CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

    Product
    Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0167-2016·2015-11-04

    Synthes 2.7 mm Locking Screws Recalled for Mislabeling as 2.4 mm

    Synthes (USA) Products LLC is recalling 98 units of 2.7 mm locking screws that were mislabeled as 2.4 mm. The units were distributed to Tennessee.

    Product
    2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0182-2016·2015-11-04

    Siemens ACUSON SC2000 Ultrasound Systems Recalled for Hardware Defects

    Siemens is recalling 2,099 ACUSON SC2000 ultrasound systems due to hardware defects involving wheel lock disconnection and system lockups.

    Product
    ACUSON SC2000 ultrasound systems model 10433816 Imaging system that provides the ability to measure anatomical structures and calculation packages that provide info for clinical diagnosis purposes.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0174-2016·2015-11-04

    Philips Recalls Brilliance 64 CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 108 Brilliance 64 CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts.

    Product
    Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0178-2016·2015-11-04

    Philips Recalls Ingenuity Flex CT Systems Due to X-ray Measurement Error

    Philips Medical Systems is recalling 67 Ingenuity Flex CT systems worldwide due to an X-ray measurement error that causes Ring/Dot artifacts in images.

    Product
    Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0171-2016·2015-11-04

    BD CD3 FITC Recalled for Spanish Labeling Error

    Becton, Dickinson and Company is recalling two lots of BD CD3 (SK7) FITC in vitro diagnostic reagents due to an error in the Spanish small text on the label.

    Product
    BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the epsilon chain of the CD3 antigen/T-cell antigen receptor (TCR) complex. In vitro diagnostic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·16025·2015-11-03

    GE Recalls Zoneline Air Conditioners and Heating Units Due to Fire Risk

    GE is recalling about 33,500 Zoneline air conditioning and heating units due to a risk of fire caused by moisture accumulation and electrical arcing.

    Product
    GE Zoneline® Air Conditioners and Heating Units
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V725000·2015-11-03

    Prevost Recalls 2016 Coaches Due to Front Suspension Stud Failure Risk

    Prevost is recalling 2016 H3-45 and X3-45 VIP coaches because front suspension studs may fail, allowing a wheel to turn unexpectedly and increasing crash risk.

    Product
    PREVOST — PREVOST H3-45 VIP, H3-45, X3-45 VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V728000·2015-11-03

    Toyota Recalls 2013-2015 Avalon and Lexus ES for Braking Defect

    Toyota is recalling 2013-2015 Avalon and Lexus ES vehicles because the Pre-Collision System may unexpectedly brake when detecting steel road objects.

    Product
    LEXUS — LEXUS, TOYOTA ES HYBRID, ES350, AVALON HYBRID, AVALON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·16705·2015-11-03

    Carra Imports Recalls Window Shades Due to Strangulation Hazard

    Carra Imports is recalling about 55,500 custom window shades due to a strangulation hazard involving continuous loop cords or exposed inner cords.

    Product
    Window shades
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·15V724000·2015-11-03

    Diamond Coach Recalls 2006-2011 Buses with Defective Wheelchair Lifts

    Diamond Coach is recalling 49 model year 2006-2011 PT and VIP transit buses equipped with certain Ricon wheelchair lifts. The lifts may have oversized pivot holes that allow bearings to move, potentially causing the platform to fall out of the vehicle.

    Product
    DIAMOND COACH — DIAMOND COACH PT, VIP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V726000·2015-11-03

    Forest River Recalls 2016 Recreational Vehicles Due to Shift Cable Defect

    Forest River is recalling 217 model year 2016 recreational vehicles because an incorrect shift cable bracket allows the vehicle to be shifted out of park without applying the brakes.

    Product
    FOREST RIVER — FOREST RIVER, COACHMEN FR3, GEORGETOWN, MIRADA, PURSUIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V721000·2015-11-02

    Indian Motorcycle Recalls 2015-2016 Models Due to Rear Brake Failure

    Indian Motorcycle is recalling 7,614 motorcycles from 2015-2016 because a rear brake master cylinder defect may cause a loss of braking power.

    Product
    INDIAN — INDIAN CHIEF CLASSIC, CHIEF VINTAGE, CHIEFTAIN, ROADMASTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V722000·2015-11-02

    Trans Tech School Buses Recalled for Wheelchair Lift Bearing Defect

    Transportation Collaborative is recalling 188 Trans Tech school buses equipped with certain Ricon wheelchair lifts. Defective pivot holes may allow bearings to shift, causing the lift platform to fall and injure operators.

    Product
    TRANS TECH BUS — TRANS TECH BUS, TRANS TECH STUDENT SAFETY TRANSPORT, ROADSTER, ST AERO, ROADSTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·15V723000·2015-11-02

    KME Recalls 2016 Predator and Severe Service Vehicles for Axle Defect

    KME is recalling 2016 Predator and Severe Service vehicles because improperly tightened axle hex nuts may cause the driveshaft to disconnect, increasing crash risk.

    Product
    KME — KME SEVERE SERVICE, PREDATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·15V720000·2015-11-02

    McNeilus Front Loader Trucks Recalled for Hydraulic Fire Risk

    McNeilus is recalling 2012-2015 front loader trucks because a hydraulic test port tube may crack, allowing fluid to contact hot exhaust components and increase fire risk.

    Product
    MCNEILUS — MCNEILUS ATLANTIC FRONT LOADER, PACIFIC FRONT LOADER, CONTENDER FRONT LOADER, ULTRA FRONT LOADER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·136-2015·2015-11-01

    Ready Pac Foods Recalls Salad Kits Due to Undeclared Allergens

    Ready Pac Foods is recalling approximately 265 pounds of Bistro Salad Kits with Grilled Chicken because the products contain undeclared eggs and anchovies.

    Product
    Ready Pac Produce, Inc. — Ready Pac Foods, Inc. Recalls Salad Kit Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    1 state
  • HighUSDA FSIS·135-2015·2015-11-01

    All American Meats Recalls Ground Beef Due to E. Coli O157:H7 Risk

    All American Meats is recalling approximately 167,427 pounds of ground beef products due to possible E. coli O157:H7 contamination. No illnesses have been reported.

    Product
    All American Meats, Inc. — All American Meats, Inc. Recalls Ground Beef Products Due to Possible E. Coli O157:H7 Contamination
    Category
    Food
    Distribution
    Distributed nationwide

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