The Recall Desk

Archive

October 2018 recalls

865 recalls were announced in October 2018.

What the numbers show

Critical
24
Severe
111
High
490
Moderate
214
Low
26

Of the 865 recalls this month scored against our rubric, 3% are Critical, 13% are Severe.

201–300 of 865

  • HighNHTSA·18V764000·2018-10-30

    Grand Design Recalls 2018-2019 Reflection Trailers Due to Fire Risk

    Grand Design RV is recalling 2018-2019 Reflection fifth wheel trailers because the power converter circuit lacks over-current protection, increasing the risk of fire.

    Product
    GRAND DESIGN — GRAND DESIGN REFLECTION
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V766000·2018-10-30

    Volvo Recalls VHD Trucks for Snow Plow Lighting Defect

    Volvo is recalling 2004-2019 VHD trucks with snow plow kits because the headlights can operate without other exterior lights, reducing visibility.

    Product
    VOLVO — VOLVO VHD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V765000·2018-10-30

    Mack Recalls 2019 Granite Trucks Due to Snow Plow Lighting Defect

    Mack is recalling 2019 Granite trucks with snow plow kits because the headlights can operate without other exterior lights, reducing visibility.

    Product
    MACK — MACK GRANITE (GU)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V763000·2018-10-30

    Thor Motor Coach Recalls 2017-2019 Models for Lighting Defect

    Thor Motor Coach is recalling 1,769 motorhomes because a damaged power distribution module may cause rear lights or turn signals to fail, increasing crash risk.

    Product
    THOR — THOR, THOR MOTOR COACH ARIA, PALAZZO, TUSCANY, VENETIAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V759000·2018-10-29

    2018 Jeep Grand Cherokee SRT and Trackhawk Floor Mat Recall

    Chrysler is recalling 2018 Jeep Grand Cherokee SRT and Trackhawk vehicles because the driver's floor mat may prevent the accelerator pedal from returning to idle, increasing crash risk.

    Product
    JEEP — JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V761000·2018-10-29

    Mercedes-Benz Recalls 2019 Models Due to Potential Engine Stall Risk

    Mercedes-Benz is recalling 119 specific 2019 models because a software defect may cause the engine to stall while driving, increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ CLS 450, C 300, E 450, AMG C43
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V760000·2018-10-29

    Heartland Recalls 2019 Pioneer Trailers Due to Fire Risk

    Heartland is recalling 2019 Pioneer recreational trailers because a flexible propane hose may overheat and cause a fire.

    Product
    HEARTLAND — HEARTLAND PIONEER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18E097000·2018-10-29

    Chrysler Recalls Mopar Floor Mats for 2018 Jeep Grand Cherokee SRT

    Chrysler is recalling specific Mopar floor mats for 2018 Jeep Grand Cherokee SRT and Trackhawk models because they may interfere with the accelerator pedal, increasing crash risk.

    Product
    JEEP — JEEP GRAND CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·106-2018·2018-10-27

    Red Square Foods Recalls Frozen Meat and Poultry Products for Undeclared Allergens

    Red Square Foods is recalling frozen meat and poultry ravioli and blintzes because they contain undeclared eggs, milk, and wheat.

    Product
    Red Square Foods, Inc., Recalls Frozen Not-Ready-To-Eat Meat and Poultry Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·18V757000·2018-10-26

    Altec Recalls 2018 Digger Derricks and Aerial Devices for Fastener Failure

    Altec is recalling 2018 Digger Derricks and Aerial Devices because high-strength fasteners may fail, causing the pedestal to separate from the turn table and increasing injury risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE, DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V758000·2018-10-26

    Isuzu and Chevrolet Trucks Recalled for Cab Tilt-Lock Warning Defect

    Isuzu is recalling 2018-2019 Chevrolet Low Cab Forward 6500 and Isuzu FTR trucks because the cab tilt-lock may not provide an adequate warning after servicing.

    Product
    ISUZU — ISUZU, CHEVROLET FTR, LOW CAB FORWARD 6500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V756000·2018-10-26

    Pierce Fire Trucks Recalled for Whelen Brake Light Wiring Defect

    Pierce is recalling 2017-2018 vehicles equipped with Whelen accessory brake lights that may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    PIERCE — PIERCE SABER, VELOCITY, ARROW XT, ENFORCER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·105-2018·2018-10-26

    Suzanna's Kitchen Recalls Grilled Chicken Strips Due to Unapproved Thallium

    Suzanna's Kitchen is recalling approximately 15,408 pounds of grilled chicken breast strips because they contain unapproved concentrations of thallium. No illnesses have been reported.

    Product
    Suzanna's Kitchen Inc. — Suzanna's Kitchen, Inc., Recalls Poultry Products due to an Unapproved Substance
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V754000·2018-10-25

    Kia Recalls 2018 Stinger Vehicles Due to Wiring Fire Risk

    Kia is recalling 2018 Stinger vehicles because a front wiring harness may be damaged by a burr, increasing the risk of a fire.

    Product
    KIA — KIA STINGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·19015·2018-10-25

    Haier Top-Mount Refrigerators Recalled Due to Fire Hazard

    Haier America is recalling about 137,000 top-mount refrigerators because an electrical component can short circuit, posing a fire hazard.

    Product
    Haier Top-Mount Refrigerators
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V755000·2018-10-25

    BMW Recalls Diesel Vehicles Due to EGR Cooler Leak Fire Risk

    BMW is recalling specific 2013-2018 diesel models because a leaking EGR cooler can cause the intake manifold to melt, increasing the risk of a fire.

    Product
    BMW — BMW 328D, X5, 535D, X3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V752000·2018-10-25

    Forest River Cherokee Recalled for Insufficient Awning Fasteners

    Forest River is recalling 2018-2019 Cherokee Alpha Wolf and 2019 Arctic Wolf trailers because awning fasteners may be insufficient, risking arm detachment.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19023·2018-10-25

    CB2 Recalls Pendant Lights Due to Fire and Shock Hazards

    CB2 is recalling Colby pendant lights because loose electrical wiring insulation poses fire and shock risks. No injuries have been reported.

    Product
    Pendant lights
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19019·2018-10-25

    Pacific Cycle Recalls Schwinn Abbott Mountain Bicycles Due to Fall Hazard

    Pacific Cycle is recalling 2018 Schwinn Abbott mountain bicycles because the downtube can crack, posing a fall hazard. One injury involving cuts and abrasions has been reported.

    Product
    2018 Schwinn Abbott Adult Men's Full Suspension Mountain Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19021·2018-10-25

    Shimano Recalls Lazer Bicycle Helmets Due to Head Injury Risk

    Shimano is recalling specific Lazer bicycle helmet models because they do not comply with federal safety standards, posing a risk of head injury.

    Product
    Lazer bicycle helmets
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V753000·2018-10-25

    Toyota Recalls 4Runners With Incorrect Weight Rating Labels

    Southeast Toyota Distributors is recalling 2017-2019 Toyota 4Runners with TRD wheel packages because incorrect weight labels may lead to vehicle overloading.

    Product
    TOYOTA — TOYOTA 4RUNNER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • LowUSDA FSIS·104-2018·2018-10-25

    All Peoples Food Recalls Smoked Whole Chicken for Undeclared MSG

    All Peoples Food is recalling approximately 3,904 pounds of smoked whole chicken products because they contain monosodium glutamate (MSG) that is not declared on the label.

    Product
    Recall Notification Report 104-2018 (Smoked Whole Chicken Products)
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0422-2019·2018-10-24

    La Mexicana Cantina Salsa Recalled for Potential Listeria Contamination

    La Mexicana LLC is recalling specific sizes of Cantina Salsa due to potential Listeria monocytogenes contamination. The product was distributed in 22 U.S. states.

    Product
    La Mexicana Cantina Salsa 14 oz., 24 oz., and 64 oz.
    Category
    Food
    Distribution
    22 states
  • CriticalFDA (Drugs)·D-0074-2019·2018-10-24

    CVS Sinus Relief Nasal Spray Recalled for Pseudomonas Contamination

    Product Quest Manufacturing LLC is recalling CVS-branded Sinus Relief nasal spray due to failed microbiological testing for Pseudomonas aeruginosa.

    Product
    Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 43236 5.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-0418-2019·2018-10-24

    La Mexicana Mild Salsa Recalled for Potential Listeria Contamination

    La Mexicana LLC is recalling various sizes of Mild Salsa due to potential Listeria monocytogenes contamination. The product was distributed across 22 U.S. states.

    Product
    La Mexicana Mild Salsa 16 oz., 24 oz., 48 oz., 64 oz., and 128 oz. Gourmet Style Mild Salsa 16 oz. and 24 oz.
    Category
    Food
    Distribution
    22 states
  • CriticalFDA (Food)·F-0420-2019·2018-10-24

    La Mexicana Peach Mango Salsa Recalled for Listeria Risk

    La Mexicana LLC is recalling Peach Mango Salsa in 16, 24, and 64 oz. sizes due to potential Listeria monocytogenes contamination.

    Product
    La Mexicana Peach Mango Salsa 16 oz., 24 oz., and 64 oz.
    Category
    Food
    Distribution
    22 states
  • CriticalFDA (Food)·F-0421-2019·2018-10-24

    La Mexicana Garlic Salsa Recalled for Potential Listeria Contamination

    La Mexicana LLC is recalling 780,000 units of Garlic Salsa due to potential Listeria monocytogenes contamination. The product was distributed across 22 U.S. states.

    Product
    La Mexicana Garlic Salsa 16 oz. Gourmet Style Garlic 16 oz.
    Category
    Food
    Distribution
    22 states
  • CriticalFDA (Food)·F-0417-2019·2018-10-24

    La Mexicana Hot Salsa Recalled for Potential Listeria Contamination

    La Mexicana LLC is recalling various sizes of Hot Salsa due to potential Listeria monocytogenes contamination. The product was distributed in 22 U.S. states.

    Product
    La Mexicana Hot Salsa 16 oz., 24 oz., 48 oz., 64 oz., and 128 oz. Gourmet Style Hot Salsa 16 oz.
    Category
    Food
    Distribution
    22 states
  • CriticalFDA (Food)·F-0419-2019·2018-10-24

    La Mexicana Medium Salsa Recalled for Potential Listeria Contamination

    La Mexicana LLC is recalling various sizes of Medium Salsa due to potential Listeria monocytogenes contamination. The product was distributed in 22 U.S. states.

    Product
    La Mexicana Medium Salsa 16 oz., 24 oz., 48 oz., 64 oz., and 128 oz. Gourmet Style Medium Salsa 16 oz.
    Category
    Food
    Distribution
    22 states
  • SevereFDA (Drugs)·D-0027-2019·2018-10-24

    Dermatone Sunscreen Stick Recalled for Staphylococcus Aureus Contamination

    Product Quest Manufacturing LLC is recalling Dermatone No-Touch Sunscreen Sticks because samples tested positive for Staphylococcus aureus.

    Product
    DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0071-2019·2018-10-24

    CeraVe Healing Lip Balm Recalled for Staphylococcus Aureus Contamination

    Product Quest Manufacturing LLC is recalling CeraVe Healing Lip Balm/SPF 30 due to failed microbiological testing for Staphylococcus aureus.

    Product
    CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0.15 oz. (4.25 g) stick, CeraVe LLC., New York, NY 10001, UPC 3 01872 49201 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0063-2019·2018-10-24

    Walgreens Anefrin Nasal Spray Recalled for Manufacturing Quality Issues

    Product Quest Manufacturing LLC is recalling 355,056 bottles of Walgreens Anefrin Nasal Spray due to manufacturing conditions that could impact product quality.

    Product
    Walgreens, NO DRIP, Anefrin Nasal Spray (Oxymetazoline HCl 0.05%), Nasal Decongestant, Original, 12 Hour, Maximum Strength, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015,NDC 0363-7005-01, UPC 3 11917 18537 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0181-2019·2018-10-24

    OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Deficiencies

    OriGen Biomedical is recalling 435 Reinforced Dual Lumen Cannulas because they may lack barium sulfate and have tips shorter than labeled.

    Product
    Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support proced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0050-2019·2018-10-24

    Sweet Me Creamery Brookie Dough Ice Cream Recalled for Undeclared Peanuts

    Kemps, LLC is recalling Sweet Me Creamery Brookie Dough ice cream because it may contain undeclared peanuts. The product was distributed in Illinois, Minnesota, North Dakota, and Wisconsin.

    Product
    Sweet Me Creamery Brookie Dough ice cream, packaged in following configuration: 1 Pint (473 ML), UPC: 41483-04219 or 4-Pack of 1 Pint (473 ML) containers Net Half Gallon (1.89L), UPC 41483-04241. Vanilla ice cream swirled with sea salt fudge and pieces of cookie dough and brown
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0072-2019·2018-10-24

    Mushatt's No. 9 PsoriWash Medicated Wash Recalled for Microbial Contamination

    Product Quest Manufacturing LLC is recalling Mushatt's No. 9 PsoriWash Medicated Wash due to microbial contamination and low salicylic acid levels.

    Product
    Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. Box 372476, Satellite Beach, FL 32937, UPC 8 58245 00203 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0103-2019·2018-10-24

    Thoratec CentriMag Motor Recall Due to Electrical Cable Failure

    Thoratec is recalling CentriMag Motors because a wire break or short circuit in the cable can cause the motor to stop.

    Product
    Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
    Category
    Medical Device
    Distribution
    43 states
  • SevereFDA (Drugs)·D-0066-2019·2018-10-24

    Freeze It Spray Recalled for High Camphor Levels

    Product Quest Manufacturing LLC is recalling Freeze It spray cans due to high out-of-specification camphor levels.

    Product
    FREEZE IT (camphor 0.2% and menthol 3.5%) spray, 118.29 mL (4 fl. oz.) can, Distributed by: Expedite Products, Inc., Tampa, FL 33619 USA, UPC 8 56569 00203 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0178-2019·2018-10-24

    Siemens Biograph mCT PET/CT Scanners Recalled for Plug Overheating Risk

    Siemens Medical Solutions is recalling 890 Biograph mCT PET/CT scanners because plug terminals may become loose and overheat.

    Product
    Biograph mCT: a) S(64)-3R, Material Number 10248669 b) S (20) -3R, Material Number 10507786 c) Flow 20-4R, Material Number 10528958 d) m Flow 64-4R, Material Number 10529161 e) mCT S(40)-4R, Material Number 10248671 f) mCT S(64)-4R, Material Number 0248672 g) mCT S(20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0062-2019·2018-10-24

    Product Quest Recalls Well at Walgreens Sinus Relief Mist for Quality Issues

    Product Quest Manufacturing LLC is recalling Well at Walgreens ULTRA FINE Sinus Relief Mist due to manufacturing deviations that could impact product quality.

    Product
    Well at Walgreens, ULTRA FINE Sinus Relief Mist (Oxymetazoline HCl 0.05%) bottle, Sinus Reliever, Nasal Decongestant, 12 Hour Pump Mist, 0.5 FL OZ (15 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-7000-01, UPC 3 11917 18535 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0039-2019·2018-10-24

    Harmon Face Values Saline Nasal Gel Recalled for Quality Deviations

    Product Quest Manufacturing LLC is recalling Harmon Face Values Saline Nasal Gel with Soothing Aloe due to manufacturing deviations that could impact product quality.

    Product
    Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Union, NJ 07083 USA, UPC 7 27510 00474 7 .
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0029-2019·2018-10-24

    Product Quest Recalls CareOne Saline Nasal Gel Due to Quality Concerns

    Product Quest Manufacturing LLC is recalling CareOne Saline Nasal Gel With Soothing Aloe because it was manufactured under conditions that could impact product quality.

    Product
    CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Landover, MD 20785, 1-877-846-9949, UPC 3 41520 00175 8.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0171-2019·2018-10-24

    Life Technologies Recalls Gibco MEM Non-Essential Amino Acids Solution

    Life Technologies is recalling Gibco MEM Non-Essential Amino Acids Solution (100X) because defective bottle caps may compromise sterility.

    Product
    Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0164-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 19 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number 814609360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0423-2019·2018-10-24

    La Mexicana Guacamole Recalled for Potential Listeria Contamination

    La Mexicana LLC is recalling 10-ounce guacamole products due to potential Listeria monocytogenes contamination. The recall covers units distributed across 22 U.S. states.

    Product
    La Mexicana (Pico with) Guacamole 10 oz..
    Category
    Food
    Distribution
    22 states
  • HighFDA (Devices)·Z-0105-2019·2018-10-24

    Liko Multirall 200Liko Strap Gripper Overhead Lift Recall

    Liko AB is recalling two Multirall 200Liko Strap Gripper overhead lifts due to potential assembly errors that could cause patient falls.

    Product
    Multirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer situations.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0131-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 153 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail 125 11mm x 180mm, Item Number 814311180 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2019·2018-10-24

    OriGen Biomedical Recalls 13Fr Reinforced Dual Lumen Cannulas

    OriGen Biomedical is recalling 1,517 units of 13Fr Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length markings.

    Product
    Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0152-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 60 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail - Left 125 11mm x 340mm, Item Number 814411340 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0149-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 30 Affixus Hip Fracture Nails because sterile packaging was found open during surgery, posing a risk of infection.

    Product
    Affixus Hip Fracture Nail Left 125 9 mm x 460 mm, Item Number 814409460 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0155-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 31 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Left 125 13 mm x 340 mm, Item Number 814413340 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0134-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 20 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Right 125 11 mm x 380 mm, Item Number 814311380 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2019·2018-10-24

    OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Endotoxin Failure

    OriGen Biomedical is recalling 106 units of Reinforced Dual Lumen Cannulas because they failed endotoxin testing. The devices were distributed in 25 US states and four foreign countries.

    Product
    Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0160-2019·2018-10-24

    Recall of Affixus Hip Fracture Nail Over Sterility Issue

    Zimmer Biomet is recalling the Affixus Hip Fracture Nail because sterile packaging was found already open during surgery. The affected lot was distributed in the US and internationally.

    Product
    Affixus Hip Fracture Nail Right 130 11 mm x 340 mm, Item Number 814511340 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0122-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 153 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail 125 9 mm x 180 mm, Item Number 814309180 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0174-2019·2018-10-24

    Life Technologies Recalls Gibco GlutaMAX Supplement Due to Leaky Bottles

    Life Technologies is recalling 1,912 units of Gibco GlutaMAX Supplement because defective bottle caps may compromise the product's sterility.

    Product
    Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0184-2019·2018-10-24

    OriGen Reinforced Dual Lumen Cannula Recalled for Manufacturing Deficiencies

    OriGen Biomedical is recalling 73 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length labeling.

    Product
    Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support proced
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0037-2019·2018-10-24

    Lidl Recalls Bellona Chocolate Wafers Due to Missing Wheat Allergen Labeling

    Lidl US is voluntarily recalling Bellona brand chocolate wafers because the packaging fails to list wheat as an allergen.

    Product
    Bellona brand Milk Chocolate Flavored Coated Wafer with Hazelnut Cr¿me Filling and White Chocolate Flavor, 5.3 oz. (150g) package containing 7 single-serving, foil-wrapped chocolate wafers on a cardboard tray with foil overwrap.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-0154-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 16 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.

    Product
    Affixus Hip Fracture Nail Left 125 13 mm x 260 mm, Item Number 814413260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0031-2019·2018-10-24

    CVS Health Saline Nasal Spray Recalled for Manufacturing Deviations

    Product Quest Manufacturing LLC is recalling 552 bottles of CVS Health Saline Nasal Spray due to CGMP deviations that could impact product quality.

    Product
    CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Benzalkonium Chloride as Preservatives, 1.5 FL OZ (44 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 40814 8 Product #8914
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2019·2018-10-24

    Siemens Biograph Horizon PET/CT Scanners Recalled for Plug Overheating Risk

    Siemens Medical Solutions is recalling 78 Biograph Horizon PET/CT scanners because loose plug terminals may overheat.

    Product
    Biograph Horizon a) 3R, Material Number 10532746 b) 4R, Material Number 10532748 The Siemens Biograph Horizon and Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high res
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0183-2019·2018-10-24

    OriGen ECMO Reinforced Dual Lumen Cannula Recalled for Manufacturing Deficiencies

    OriGen Biomedical is recalling 241 units of ECMO Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length labeling.

    Product
    ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support pr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0053-2019·2018-10-24

    Thayers Saline Nasal Spray Recalled for Manufacturing Quality Deviations

    Product Quest Manufacturing is recalling Thayers Saline Nasal Spray due to manufacturing conditions that could impact product quality.

    Product
    Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00660 4.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0125-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 38 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers units distributed in the US and two foreign countries.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 320 mm, Item Number 814309320 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0052-2019·2018-10-24

    Taylor Farms Recalls Macaroni Salad Labeled as Potato Salad Due to Allergen Mislabeling

    Taylor Farms Pacific Inc. is recalling Raley's Country Macaroni Salad because it was labeled as potato salad and failed to declare wheat as an allergen.

    Product
    Raley's Country Macaroni Salad labeled as Raley's Country Potato Salad; 32 oz. (907g) clear plastic containers; UPC 4656768934 Ingredients: Ditalini Macaroni, Mayonnaise, Dijon Mustard, Red Onions, Eggs, Celery, Black Olives, Salt & Pepper. Some containers have a Raley's
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0173-2019·2018-10-24

    Life Technologies Recalls Gibco Sodium Pyruvate Due to Leaky Bottle Caps

    Life Technologies is recalling 41 units of Gibco Sodium Pyruvate (100 mM) because defective bottle caps may compromise product sterility.

    Product
    Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0116-2019·2018-10-24

    Siemens Atellica IM CKMB Calibrator Recalled for Potential Bias

    Siemens Healthcare Diagnostics is recalling 97 kits of Atellica IM CKMB Calibrator due to a potential bias compared to internal standards.

    Product
    Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0193-2019·2018-10-24

    Siemens Recalls Atellica IM 1600 Analyzer Software Due to Behavioral Issues

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer software version 1.13 and lower due to five identified behavioral issues affecting reagent locking, barcode reading, and result reporting.

    Product
    Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0120-2019·2018-10-24

    A M Systems Recalls Disposable Smooth Interior Tubing for Pulmonary Equipment

    A M Systems Inc is recalling 610 units of Disposable Smooth Interior Tubing because the tubing may pull apart when stretched.

    Product
    Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0157-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 22 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 130 9 mm x 320 mm, Item Number 814509320 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 29 Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The devices were distributed in the US and abroad.

    Product
    Affixus Hip Fracture Nail Left 125 9 mm x 440 mm, Item Number 814409440 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0129-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defect

    Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because sterile packaging was found open during surgery, posing a contamination risk.

    Product
    Affixus Hip Fracture Nail Right 125 9 mm x 440 mm, Item Number 814309440 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0159-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 39 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Right 130 11 mm x 320 mm, Item Number 814511320 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V743000·2018-10-24

    Daimler Recalls 2018 Sprinter Vans Due to Door Latch Defect

    Daimler Vans USA is recalling 2018 Freightliner and Mercedes-Benz Sprinter vans because right-side door latches may fail to open, increasing injury risk in crashes.

    Product
    FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500, SPRINTER 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0156-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 32 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the product was opened in surgery.

    Product
    Affixus Hip Fracture Nail Left 125 13 mm x 360 mm, Item Number 814413360 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0029-2019·2018-10-24

    Harris Teeter Frozen Yogurt Recalled for Unlabeled Peanut and Coconut Oil

    Harris Teeter is recalling Low Fat Frozen Yogurt (Cookies & Cream) because it contains peanuts and coconut oil not listed on the label.

    Product
    Harris Teeter Low Fat FROZEN YOGURT cookies & cream 1.5 QUART (1.42l) CONTAINS: MILK, WHEAT, SOY PROUDLY DISTRIBUTED BY: HARRIS TEETER, LLC MATTHEWS, NC 28105 UPC 0 72036 98182 0
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-0038-2019·2018-10-24

    Frozen Sweet Corn Recalled Due to Bacteria Detection

    Iowa Choice Harvest is recalling 200 containers of frozen sweet corn after sample analysis detected fecal coliform bacteria and generic E. coli.

    Product
    Sweet corn, Net weight 20 pounds, Marshalltown IA
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-0166-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Defects

    Zimmer Biomet is recalling 41 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number 814611380 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0135-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 51 Affixus Hip Fracture Nails because complaints indicated the sterile packaging was already open when the products were opened in surgery.

    Product
    Affixus Hip Fracture Nail Right 125 11 mm x 420 mm, Item Number 814311420 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0175-2019·2018-10-24

    Philips HeartStart FR3 Defibrillators Recalled for Water Ingress Risk

    Philips is recalling 432 HeartStart FR3 defibrillators because they may not meet water resistance specifications, potentially causing device failure if water enters.

    Product
    Philips HeartStart FR3 Defibrillator, Model: 861388, 861389 Product Usage: The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0045-2019·2018-10-24

    FDA Recalls Premier Value Nasal Decongestant Due to Manufacturing Deviations

    Product Quest Manufacturing LLC is recalling Premier Value Nasal Decongestant due to CGMP deviations that could impact product quality.

    Product
    Premier Value, Nasal Decongestant, No Drip Nasal Spray (oxymetazoline HCl) Nasal Solution, 12 Hour Pump Mist, Maximum Strength, 1 FL OZ (30 mL) bottle, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431, NDC 68016-308-03, UPC 8 40986 01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighCPSC·19707·2018-10-24

    Cub Cadet Recalls Challenger 400 Utility Vehicles Due to Fire Hazard

    Cub Cadet is recalling about 350 Challenger 400 utility vehicles because a cracked fuel tank neck can leak fuel, posing a fire hazard. No injuries have been reported.

    Product
    Cub Cadet Challenger 400 utility vehicles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0170-2019·2018-10-24

    Mindray BeneVision Distributed Monitoring System Recalled for ECG Display Anomalies

    Mindray is recalling five BeneVision Distributed Monitoring Systems due to a software issue that can cause ECG waveforms to display as a flat line when more than 64 telemetry transmitters are connected.

    Product
    Mindray BeneVision Distributed Monitoring System (DMS), Part No. 115-034413-00
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0111-2019·2018-10-24

    GE Healthcare MRI Systems Software Recall - On-Site Software Not Reinstalled

    GE Medical Systems is recalling MRI systems because the latest software version was not properly reinstalled after service, potentially causing image flipping and patient data mismatch.

    Product
    GE Healthcare MRI Systems, Software Version 12.x, sold under the following product names: SIGNA MR/I ECHOSPD W/ EXCITE, 1.5 HISPEED HD 8-CH 400-AP, MR GOLDSEAL 1.5T HD 8CH USED, UPGRADE 1.5 EXC-II TO EXC-III HD, SIGNA MR/I HISPD W/ EXCITE, 1.5 ECHOSPEED HD 16-CH 800-AP, 1.5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0042-2019·2018-10-24

    Meijer Sterile Saline Nasal Mist Recalled for Quality Control Issues

    Product Quest Manufacturing LLC is recalling Meijer Sterile Saline Nasal Mist cans due to manufacturing deviations that could impact product quality.

    Product
    Meijer, Sterile Saline Nasal Mist (0.9% Sodium Chloride Solution), 4.25 OZ (120 g) can, Dist. By Meijer Distribution, Inc., 2929 Walker Ave. NW, Grand Rapids, MI 49544, UPC 7 13733 27615 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0195-2019·2018-10-24

    GE Healthcare Recalls Centricity Universal Viewer Due to Patient Data Error

    GE Healthcare is recalling Centricity Universal Viewer software because remote comparison studies may display incorrect patient data without a warning icon.

    Product
    Centricity Universal Viewer with Cross Enterprise Display This impacts product versions 6.0 SP1 and higher.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0139-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 24 units of Affixus Hip Fracture Nails because sterile packaging was found open during surgery. The recall covers US and foreign distribution.

    Product
    Affixus Hip Fracture Nail Right 125 13 mm x 260 mm, Item Number 814313260 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0112-2019·2018-10-24

    GE Healthcare MRI Systems Recalled for Potential Image Flipping and Data Mismatch

    GE Medical Systems is recalling 5,200 MRI systems worldwide because software issues may cause flipped images or patient data mismatches.

    Product
    GE Healthcare MRI Systems, Software Version 15.x or HD 16 sold under the following product names: *ER*15T HDXT ECHOSPEED 16 CHANNEL, *OC*1.5T HDX ECHOSPEED 8 CHANNEL, *SC*1.5T HD TO HDX UPGRADE, *TR*15T HDXT 16CH, *TR*3.0T HDX TWINSPEED 16 CHANNEL, 1,5T HDXT, 1.5 HD TO HDX U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0147-2019·2018-10-24

    Zimmer Biomet Recalls Affixus Hip Fracture Nails Due to Packaging Issues

    Zimmer Biomet is recalling 14 Affixus Hip Fracture Nails because sterile packaging was found open during surgery.

    Product
    Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number 814409320 Product Usage: Intended for the fixation of fractures
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0108-2019·2018-10-24

    Carl Zeiss IOLMaster 700 Recalled for Incorrect Calibration Settings

    Carl Zeiss Meditec AG is recalling one IOLMaster 700 system because a manufacturing error caused incorrect calibration, leading to inaccurate eye images.

    Product
    Carl Zeiss Meditec AG, Goeschwitzer Strasse 51-52 07745 Jena, Germany, IOLMaster 700, REF 1932-169 SN 1185393 2017-09-01
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-0058-2019·2018-10-24

    Tarry Medical Recalls DandleLION KISSES Due to Microorganism Contamination

    Tarry Medical Products is recalling DandleLION KISSES oral sucrose solution because a microorganism was found inside the vials. The recall affects 46 cases distributed to six states.

    Product
    Product comes in a plastic bag which is labeled as follows: DandleLION MEDICAL DandleLION KISSES ORAL USE ONLY SINGLE PATIENT USE SINGLE APPLICATION 24% ORGANIC SUCROSE, D-12442 2mL; The Product Case Labeling is as follows: DandleLION MEDICAL D 12242 C384 DandleLION KISSES (2ML)
    Category
    Drug
    Distribution
    6 states

Looking for a different month? Back to 2018.