The Recall Desk

Archive

February 2019 recalls

610 recalls were announced in February 2019.

What the numbers show

Critical
67
Severe
179
High
200
Moderate
148
Low
16

Of the 610 recalls this month scored against our rubric, 11% are Critical, 29% are Severe.

301–400 of 610

  • SevereFDA (Drugs)·D-0465-2019·2019-02-20

    Promise Pharmacy Recalls Melanotan II Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 43 vials of Melanotan II injections because the product lacks sterility assurance. The affected lots were distributed nationwide.

    Product
    Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0470-2019·2019-02-20

    Promise Pharmacy Recalls Myer's Cocktail Vials Due to Sterility Concerns

    Promise Pharmacy is recalling 5 vials of Myer's Cocktail due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit B1/Leucine/Vit B5/Riboflavin/Ascorbic Acid/Hydroxycobalamin/Magnesium Chloride, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0442-2019·2019-02-20

    Promise Pharmacy Recalls Methylcobalamin Injection Due to Sterility Concerns

    Promise Pharmacy is recalling 252 vials of Methylcobalamin Injection due to a lack of sterility assurance. The product was distributed nationwide.

    Product
    Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0433-2019·2019-02-20

    Promise Pharmacy Recalls Prednisolone and Gatifloxacin Eye Drops for Sterility Concerns

    Promise Pharmacy is recalling 55 bottles of compounded Prednisolone and Gatifloxacin Ophthalmic Solution due to a lack of sterility assurance.

    Product
    Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only, Compounded Prescription, Promise Pharmacy 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0461-2019·2019-02-20

    Promise Pharmacy Recalls HCG Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 2,595 vials of HCG injections nationwide due to a lack of sterility assurance.

    Product
    HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0476-2019·2019-02-20

    Promise Pharmacy Recalls Leucine/Isoleucine/Valine Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling Leucine/Isoleucine/Valine injection vials due to a lack of sterility assurance. The affected products were distributed nationwide.

    Product
    Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0808-2019·2019-02-20

    Medtronic Pacemaker Recall: Circuit Error Affects Dual Chamber Functionality

    Medtronic is recalling 7,469 dual chamber pacemakers worldwide due to a circuit error that may affect device functionality when programmed to specific modes.

    Product
    Medtronic implantable pulse generator: RELIA, Dual chamber pacemaker (VDD): (a) Model Number RED01 (b) Model Number REDR01 (c) Model Number REVDD01
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0832-2019·2019-02-20

    AtriCure COBRA FUSION 150 Ablation System Recalled for Thromboembolism Risk

    AtriCure is recalling 765 units of the COBRA FUSION 150 Ablation System due to a potential elevated risk of thromboembolism during specific off-pump procedures.

    Product
    COBRA FUSION 150 Ablation System (International Only), Catalog # (REF) 700-001MI
    Category
    Medical Device
    Distribution
    37 states
  • SevereFDA (Devices)·Z-0806-2019·2019-02-20

    Medtronic Adapta Dual Chamber Pacemaker Recall for Circuit Error

    Medtronic is recalling specific Adapta, Versa, and Sensia dual chamber pacemakers due to a circuit error that may affect device functionality.

    Product
    Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number ADDR01 (c) Model Number ADDR03 (d) Model Number ADDR06 (e) Model Number ADDRL1 (f) Model Number ADDRS1 (g) Model Number ADVDD01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0892-2019·2019-02-20

    RXBAR Pumpkin Spice Bars Recalled for Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR Pumpkin Spice bars due to undeclared peanut allergen.

    Product
    RXBAR: Pumpkin Spice, single bar, 12-count carton, 4-count carton, 1.83 oz bars
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0894-2019·2019-02-20

    RXBAR Recalls Variety Packs Due to Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR variety packs because they contain undeclared peanut, a major food allergen.

    Product
    RXBAR: 12-Bar Variety Pack (Chocolate Sea Salt, Peanut Butter Chocolate), and 16-Bar Variety Pack (Chocolate Sea Salt, Peanut Butter Chocolate), 1.83 oz. per bar
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0878-2019·2019-02-20

    RXBAR Recalls Coconut Chocolate Bars Due to Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling Coconut Chocolate RXBARs because they contain undeclared peanut, a major food allergen.

    Product
    Coconut Chocolate RXBARs , 1.83 oz., single bar, , 12-count carton, 5-count carton, 4-count carton
    Category
    Food
    Distribution
    43 states
  • HighFDA (Devices)·Z-0811-2019·2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific Versa, Adapta, and Sensia pacemakers distributed worldwide from 2017 to 2019 due to a potential circuit error that may affect device functionality.

    Product
    Medtronic implantable pulse generator: Versa, Dual chamber rate responsive pacemaker (DDDR), Model Number VEDR01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0475-2019·2019-02-20

    Promise Pharmacy Recalls Pyridoxine HCl Injection Due to Sterility Concerns

    Promise Pharmacy, LLC is recalling 8 vials of Pyridoxine HCl Injection due to a lack of sterility assurance. The product was distributed nationwide in the USA.

    Product
    Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0911-2019·2019-02-20

    Thrive Market Sesame Tahini Recalled for Listeria Risk

    Thrive Market is recalling 16 oz. Sesame Tahini due to potential Listeria monocytogenes contamination. The product was sold nationwide via website.

    Product
    Thrive Market Sesame Tahini 16 oz. SKU/UPC 671635704795
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0831-2019·2019-02-20

    AtriCure Recalls COBRA FUSION 150 Ablation System Due to Thromboembolism Risk

    AtriCure is recalling 175 units of the COBRA FUSION 150 Ablation System because patients may face an elevated risk of thromboembolism during specific off-pump procedures.

    Product
    COBRA FUSION 150 Ablation System, Catalog # (REF) 700-001S
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-0835-2019·2019-02-20

    Edwards Commander Delivery System Recalled for Balloon Component Separation

    Edwards Lifesciences is recalling the Edwards Commander Delivery System due to reports of crimp and inflation balloon component separation during TAVR procedures.

    Product
    Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 00690103193954 9600LDS26J 00690103194876 9600LDS29A (US) 00690
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0889-2019·2019-02-20

    RXBAR Recalls Apple Cinnamon Raisin Bars Due to Undeclared Peanut

    Chicago Bar Company LLC is voluntarily recalling RXBAR KIDS Apple Cinnamon Raisin bars because they contain undeclared peanut.

    Product
    RXBAR: KIDS Apple Cinnamon Raisin, 1.16oz bars, single bar, 16-count carton, 5-count carton
    Category
    Food
    Distribution
    43 states
  • HighNHTSA·19V110000·2019-02-20

    Volkswagen Recalls 2019 Jetta Vehicles for Incorrect Driver Airbag

    Volkswagen is recalling 2019 Jetta vehicles because an incorrect driver frontal airbag may have been installed during a service visit, potentially increasing injury risk in a crash.

    Product
    VOLKSWAGEN — VOLKSWAGEN JETTA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V115000·2019-02-20

    Porsche Recalls 14,110 Vehicles for Missing Brake Pad Warning

    Porsche is recalling 14,110 vehicles because the instrument cluster may fail to warn drivers when brake pads are worn out, increasing crash risk.

    Product
    PORSCHE — PORSCHE PANAMERA, PANAMERA 4 HYBRID EXECUTI, PANAMERA TURBO S HYBRID S, PANAMERA 4 HYBRID SPORT T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0807-2019·2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific dual chamber pacemakers distributed worldwide between 2017 and 2019 due to a potential circuit error affecting device functionality.

    Product
    Medtronic implantable pulse generator: ATTESTA L DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number ATDR01 (b) Model Number ATDRL1 (c) Model Number ATDRS1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0824-2019·2019-02-20

    Steris ATLAS Loading Car Recalled for Latch Failure Risk

    Steris Corporation is recalling 129 ATLAS Loading Cars because the latch may fail to engage when empty, causing the unit to slide or fall.

    Product
    ATLAS Loading Car
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0905-2019·2019-02-20

    Thrive Market Organic Almond Butter Recalled for Listeria Risk

    Thrive Market is recalling all varieties of its Organic Almond Butter Creamy 16 oz. due to potential Listeria monocytogenes contamination.

    Product
    Thrive Market Organic Almond Butter Creamy 16 oz. SKU/UPC 671635704757
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0913-2019·2019-02-20

    Thrive Market Organic Coconut Butter Recalled for Listeria Risk

    Thrive Market is recalling Organic Coconut Butter due to potential Listeria monocytogenes contamination. The recall covers all unexpired lots sold nationwide through the company's website.

    Product
    Thrive Market Organic Coconut Butter 16 oz. SKU/UPC 671635704818
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0906-2019·2019-02-20

    Thrive Market Almond Butter Recalled for Listeria Risk

    Thrive Market is recalling Non-GMO Creamy Almond Butter due to potential Listeria monocytogenes contamination. The recall covers all unexpired lots sold nationwide.

    Product
    Thrive Market Non-GMO Creamy Almond Butter 16 oz. SKU/UPC 671635704733
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0825-2019·2019-02-20

    Hemotherm CE Dual Reservoir Cooler/Heater Recalled for Overheating Risk

    Cincinnati Sub-Zero is recalling 396 Hemotherm CE Dual Reservoir Cooler/Heater units because fuse clips may stretch, causing overheating and device shutdown.

    Product
    Hemotherm CE Dual Reservoir Cooler/Heater, Model No. 400CE Product Usage: The HEMOTHERM¿ Model 400CE Dual Reservoir Cooler/Heater is used to lower, maintain, or raise the temperature of the water flowing through a Blood Oxygenator / Heat Exchanger that is used to cool or warm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0916-2019·2019-02-20

    Oskri Tahini Butter Recalled for Potential Listeria Contamination

    Oskri Corp. is recalling specific lots of Tahini Butter due to potential Listeria monocytogenes contamination. Consumers should check their pantry for affected products.

    Product
    Oskri Tahini Butter, Creamy, Net Wt. 16 oz. (453g), UPC 66016-40130. No Refrigeration Required. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551 EXPANDED: Wholesome Pantry branded Organic Tahini Butter in 16 oz. plastic jars UPC 04119005828.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-0836-2019·2019-02-20

    Magstim HORIZON Ez Arm Recalled for Protruding Stainless-Steel Cable Strand

    The Magstim Company Limited is recalling 27 HORIZON Ez Arm units because a stray stainless-steel cable strand may protrude from the heat shrink sleeving on the Balance Cable.

    Product
    HORIZON Ez Arm (Part of the HORIZON TMS Therapy System.)
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0888-2019·2019-02-20

    RXBAR Mixed Berry Bars Recalled for Undeclared Peanut Allergen

    Chicago Bar Company is voluntarily recalling RXBAR Mixed Berry bars due to undeclared peanut. Consumers should stop eating the product and return it to the store.

    Product
    RXBAR: Mixed Berry, single bar, 12-count carton, UPC 57777 00470, 4-count carton
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0870-2019·2019-02-20

    Diamond Crystal Baking Powder Recalled Due to Potential Salmonella Contamination

    Diamond Crystal Brands is recalling specific lots of Chef's Companion and Classic Sysco baking powder because an ingredient may be contaminated with Salmonella.

    Product
    Baking powder in the following ways: 1) Chef's Companion, Baking Powder, Net Wt. 5 lbs, Diamond Crystal Brands, Inc. Savannah, GA, in paper pouches, 6 per case; 2) Classic Sysco, Baking Powder, Net Wt. 5 lbs, Distrbuted by Sysco Corporation, Houston, TX, in paper pouches, 6
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-0893-2019·2019-02-20

    RXBAR Recalls 10-Bar Variety Packs for Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR 10-Bar Variety Packs because they contain undeclared peanut, a major food allergen.

    Product
    RXBAR: 10-Bar Variety Pack (Blueberry, Chocolate Sea Salt, Coconut Chocolate, Peanut Butter Chocolate), 1.83 oz. per bar
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0882-2019·2019-02-20

    RXBAR Chocolate Chip Bars Recalled for Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR Chocolate Chip bars due to undeclared peanut. Consumers should stop eating the product.

    Product
    RXBAR: Chocolate Chip, 1.83oz bars, single bar,, 12-count carton, , 5-count carton,, 4-count carton
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0896-2019·2019-02-20

    RXBAR Recalls 14-Bar Variety Packs Due to Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR 14-Bar Variety Packs because they contain undeclared peanut, a major food allergen.

    Product
    RXBAR: 14-Bar Variety Pack (Chocolate Chip and Chocolate Sea Salt), 1.83 oz. per bar
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0919-2019·2019-02-20

    Oskri Organic Peanut Espresso Cacao Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Organic Peanut Espresso Cacao Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Organic Peanut Espresso Cacao Butter, packaged in pouches UPC 66016-40162. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0883-2019·2019-02-20

    RXBAR Chocolate Hazelnut Bars Recalled for Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR Chocolate Hazelnut bars due to undeclared peanut. Consumers should stop eating these bars.

    Product
    RXBAR: Chocolate Hazelnut, 1.83oz bars single bar, 12-count carton, 4-count carton
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0925-2019·2019-02-20

    Oskri Almond Chia Flax Butter Recalled for Listeria Risk

    Oskri Corp. is recalling Almond Chia Flax Butter due to potential Listeria monocytogenes contamination. The recall was expanded to include all Oskri manufactured butters.

    Product
    Almond Chia Flax Butter, packaged in 16 oz. plastic jars UPC 66016-40112. Oskri, 528 E. Tyranena Park Rd, Lake Mills, WI 53551. .
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0885-2019·2019-02-20

    RXBAR Recalls Mango Pineapple Bars Due to Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR Mango Pineapple bars because they contain undeclared peanut, a major food allergen.

    Product
    RXBAR: Mango Pineapple,1.83oz bars, single bar, 12-count carton, 4- count carton
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0895-2019·2019-02-20

    RXBAR Recalls 12-Bar Variety Packs Due to Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR 12-Bar Variety Packs because they contain undeclared peanut, a major food allergen.

    Product
    RXBAR: 12-Bar Variety Pack (Blueberry, Chocolate Sea Salt, Mixed Berry, Peanut Butter, Peanut Butter Chocolate), See Best By Date on individual bars as noted in other 12-bar pack, 1.83 oz. per bar
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0908-2019·2019-02-20

    Thrive Market Almond Butter Recalled for Potential Listeria Contamination

    Thrive Market is recalling Non-GMO Crunchy Almond Butter due to potential Listeria monocytogenes contamination. The recall covers all unexpired lots sold nationwide.

    Product
    Thrive Market Non-GMO Crunchy Almond Butter 16 oz. SKU/UPC 671635704740
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0612-2019·2019-02-20

    Philips CombiDiagnost R90 X-ray System Recalled for Radiation Dose Risk

    Philips is recalling 146 CombiDiagnost R90 X-ray systems because a software defect may cause patients to receive increased radiation doses.

    Product
    Stationary Fluoroscopic X-ray System CombiDiagnost R90, Model 709030 Stationary Fluoroscopic X-ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0880-2019·2019-02-20

    RXBAR Apple Cinnamon Bars Recalled for Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR Apple Cinnamon bars due to undeclared peanut. Consumers should check Best By dates and stop eating the product.

    Product
    RXBAR: Apple Cinnamon,1.83oz bars, single bar, 12-count carton,
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0881-2019·2019-02-20

    RXBAR Blueberry Bars Recalled for Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR Blueberry bars due to the presence of undeclared peanut, a major food allergen.

    Product
    RXBAR:Blueberry, 1.83oz bars, single bar, 12-count carton, , 10-count carton, , 5-count carton, , 4-count carton
    Category
    Food
    Distribution
    43 states
  • HighFDA (Devices)·Z-0834-2019·2019-02-20

    Signature Orthopedics Recalls Three Genius Knee Cemented CR Femoral Components

    Signature Orthopedics is voluntarily recalling three Genius Knee Cemented CR Femoral Components due to a product mix-up. The devices were distributed in Florida, New York, and Tennessee.

    Product
    Genius Knee Cemented CR Femoral Component Product Usage: Knee replacement component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0859-2019·2019-02-20

    Mylan Recalls DrNatura Probiotics and Detox Kits for Undeclared Soy

    Mylan Pharmaceuticals is recalling DrNatura Flora Protect Probiotics and Toxinout Kits due to an undeclared soy allergen statement.

    Product
    DrNatura Toxinout Kit Broad Spectrum Detoxification Program
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0891-2019·2019-02-20

    RXBAR Recalls Kids Chocolate Chip Bars Due to Undeclared Peanut

    RXBAR is voluntarily recalling Kids Chocolate Chip bars because they contain undeclared peanut, a major food allergen.

    Product
    KIDS Chocolate Chip, 1.16 oz. bars, single bar, 16-count carton, 5-count carton
    Category
    Food
    Distribution
    43 states
  • HighFDA (Devices)·Z-0812-2019·2019-02-20

    Medtronic Pacemaker Recall for Potential Circuit Error in Dual Chamber Mode

    Medtronic is recalling specific dual chamber pacemakers due to a circuit error that may affect device functionality when programmed to atrial-sensing mode.

    Product
    vitatron (implantable pulse generator): (a) A-series, Model Numbers: A30A1, A60A1 (b) E-series, Model Numbers: E50A1, E60A1 (c) G-series, Model Numbers: G70A1, G70A2 (d) Q-series, Model Numbers: Q50A2, Q70A2, Q80A2
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0884-2019·2019-02-20

    RXBAR Coffee Chocolate Bars Recalled for Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR Coffee Chocolate bars due to undeclared peanut. Consumers should check Best By dates and stop eating the product.

    Product
    RXBAR: Coffee Chocolate, 1.83oz bars, single bar, , 12-count carton
    Category
    Food
    Distribution
    43 states
  • HighFDA (Drugs)·D-0456-2019·2019-02-20

    Promise Pharmacy Recalls IGF-1 LR3 Injections Due to Sterility Concerns

    Promise Pharmacy is recalling 59 vials of IGF-1 LR3 injections because they lack sterility assurance. The affected products were distributed nationwide.

    Product
    IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy 19N, Palm Harbor, FL 34684
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0837-2019·2019-02-20

    OMNI K1 Broach Handle Recalled Due to Loose Inner Pin Risk

    OMNIlife science Inc. is recalling seven OMNI K1 Broach Handles because the inner pin may become loose and fall out.

    Product
    OMNI K1 Broach Handle, Product Code HS-10054
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0829-2019·2019-02-20

    AtriCure Recalls COBRA FUSION 50 Ablation Systems Due to Thromboembolism Risk

    AtriCure is recalling 1,288 COBRA FUSION 50 Ablation Systems because patients may face an elevated risk of thromboembolism during specific off-pump procedures.

    Product
    COBRA FUSION 50, Ablation System, Catalog # (REF) 700-002
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Food)·F-0886-2019·2019-02-20

    RXBAR Maple Sea Salt Bars Recalled for Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR Maple Sea Salt bars due to an undeclared peanut allergen.

    Product
    RXBAR: Maple Sea Salt, 1.83 oz bars, single bar, 2-count carton, 4-count carton
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0887-2019·2019-02-20

    RXBAR Mint Chocolate Bars Recalled for Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling RXBAR Mint Chocolate bars due to an undeclared peanut allergen. The recall affects single, 4-count, and 12-count cartons.

    Product
    RXBAR: Mint Chocolate, 1.83 oz. bars, single bar, 12-count carton, 4-count carton
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0879-2019·2019-02-20

    RXBAR Recalls Chocolate Sea Salt Bars Due to Undeclared Peanut

    Chicago Bar Company LLC is voluntarily recalling Chocolate Sea Salt RXBARs because they contain undeclared peanut, a major food allergen.

    Product
    Chocolate Sea Salt RXBARs , 1.83 oz., single bar, , 12-count carton, 10-count carton, , 5-count carton, 4-count carton
    Category
    Food
    Distribution
    43 states
  • HighNHTSA·19V112000·2019-02-20

    Porsche Recalls One 2019 Cayenne Turbo for Shock Absorber Defect

    Porsche is recalling one 2019 Cayenne Turbo because shock absorber forks may allow the shock absorbers to loosen, potentially impairing steering.

    Product
    PORSCHE — PORSCHE CAYENNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2019·2019-02-20

    Medtronic Sphera DR MRI SureScan Pacemakers Recalled for Circuit Error

    Medtronic is recalling specific Sphera DR MRI SureScan pacemakers worldwide due to a circuit error that may affect device functionality when programmed to dual chamber mode.

    Product
    Medtronic implantable pulse generator: Sphera DR MRI SureScan, Dual chamber rate responsive pacemaker (DDDR): (a) Model Number SPDR01 (b) Model Number SPDRL1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-0904-2019·2019-02-20

    Toddler Milk Drink Powder Recalled for Potential Foreign Material

    PBM Nutritionals is recalling specific lots of Parent's Choice and Little Journey toddler milk drink powder because the product may contain foreign material.

    Product
    Parent's Choice Toddler Next Stage¿ Milk Drink Powder Natural Milk Flavor With Other Natural Flavors, Stage 3, 1 Year and Up, NET WT 24 OZ (1.5 LB) 680g, UPC: 0 78742 06717 9 and Little JOURNEY Toddler Next Stage MILK DRINK POWDER, NET WT I PESO NETO 24 OZ I ONZAS (1.5 LB) 680g.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0890-2019·2019-02-20

    RXBAR Recalls KIDS Berry Blast Bars Due to Undeclared Peanut Allergen

    Chicago Bar Company LLC is voluntarily recalling KIDS Berry Blast bars because they contain undeclared peanut, a major food allergen.

    Product
    KIDS Berry Blast, 1.16 oz. bars, single bar, 16-count carton, 5-count carton
    Category
    Food
    Distribution
    43 states
  • HighFDA (Food)·F-0866-2019·2019-02-20

    Diamond Crystal Recalls Vanilla Instant Pudding Due to Salmonella Risk

    Diamond Crystal Brands is recalling specific lots of vanilla instant pudding and pie filling because an ingredient is potentially contaminated with Salmonella.

    Product
    Vanilla instant pudding and pie filling packaged in the following ways: 1) Chef's Companion Vanilla Instant Pudding & Pie Filling, Net Wt. 28 OZ, Distributed By Diamond Crystal Brands, Inc. Savannah, GA in paper pouches 12 per case; 2) Culinary Secrets, Vanilla Instant Pudd
    Category
    Food
    Distribution
    41 states
  • HighFDA (Food)·F-0863-2019·2019-02-20

    Diamond Crystal Recalls Vanilla Pudding Mix Due to Salmonella Risk

    Diamond Crystal Brands is recalling 8,314 cases of vanilla instant pudding and pie filling because an ingredient is potentially contaminated with Salmonella.

    Product
    Vanilla instant pudding and pie filling packaged in the following ways: 1) Classic Sysco Vanilla Instant Pudding & Pie Filling Mix, Net Wt. 24 OZ, Distributed by Sysco Corporation, Houston, TX, in paper pouches, 12 per case; 2) Classic Sysco Vanilla Instant Pudding & Pie Fi
    Category
    Food
    Distribution
    41 states
  • ModerateFDA (Devices)·Z-0828-2019·2019-02-20

    Ottobock MagValve Recall for Prosthetic Socket Air Evacuation Defect

    Ottobock is recalling 110 MagValve units used in prosthetic sockets because some valve inserts have a smaller diameter than specified.

    Product
    21Y15 MagValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0997-2019·2019-02-20

    Avella Recalls Labetalol Syringes Due to Incorrect Barcode Expiration Dates

    Avella of Deer Valley, Inc. is recalling 2,840 syringes of Labetalol 20mg Injectable Solution because the 2D barcodes contain incorrect expiration dates.

    Product
    Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use syringe. Repackaged by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-822-71.
    Category
    Drug
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-1000-2019·2019-02-20

    Avella recalls magnesium sulfate bags with incorrect barcode expiration dates

    Avella of Deer Valley is recalling 8,500 bags of compounded magnesium sulfate because the 2D barcodes contain incorrect expiration dates that do not match the label.

    Product
    MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by Avella Specialty Pharmacy 24416 N 19 th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-907-05.
    Category
    Drug
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0823-2019·2019-02-20

    Philips Ingenuity TF PET/CT Software Update Corrects Multiple Issues

    Philips is issuing a software update for 24 Ingenuity TF PET/CT systems to correct multiple issues identified in the previous software version.

    Product
    Ingenuity TF PET/CT (non-RoHS), Model Number 882456 This device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0486-2019·2019-02-20

    LGM Pharma Recalls Cidofovir Dihydrate Due to CGMP Deviations

    LGM Pharma LLC is recalling Cidofovir Dihydrate because the API manufacturer is on FDA Import Alert for CGMP deviations.

    Product
    CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM BEIJING CO., LTD, 12-2-620, Jia 69, Fushi Rd., Haidian, Beijing 100049, China. Batch Number JD-BP-37-20150801
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0489-2019·2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 390 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, potentially affecting drug release.

    Product
    CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0827-2019·2019-02-20

    Ottobock PushValve Upper Part Recalled for Diameter Specification Defect

    Ottobock is recalling PushValve upper parts because some installed valve inserts have a diameter smaller than the specification.

    Product
    21Y14=S PushValve upper part Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0487-2019·2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 1,023 bottles of Cardizem CD (diltiazem hydrochloride) 120 mg capsules because they failed to meet dissolution specifications.

    Product
    CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0482-2019·2019-02-20

    US Compounding Recalls LET Gel 4% Syringes Due to Missing Lot and Expiration Dates

    US Compounding Inc is recalling 1,931 syringes of LET Gel 4% because the labels are missing specific lot and expiration dates.

    Product
    LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single Use Syringe, Rx only, US Compounding, 1270 Don's Lane, Conway, AR, 800-718-3588, Barcode 62295501303.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0901-2019·2019-02-20

    Bundle Organics Goji-Berry Cashew Snack Bars Recalled for Mold

    1908 Brands is recalling Bundle Organics Goji-Berry Cashew snack bars due to the presence of mold. The recall affects specific lots distributed to one consignee.

    Product
    Bundle Organics Bar Goji-Berry Cashew, 1.9 Oz snack bar, Ambient storage
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0903-2019·2019-02-20

    Bundle Organics Chocolate Chip Snack Bars Recalled for Mold

    1908 Brands is recalling Bundle Organics Chocolate Chip snack bars due to the presence of mold. The recall affects 2,781 bars distributed to one consignee.

    Product
    Bundle Organics Bar Chocolate Chip, 1.9 Oz snack bar, Ambient storage
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0826-2019·2019-02-20

    Ottobock PushValve Recall for Diameter Specification Defect

    Ottobock is recalling 538 PushValve units because some valve inserts have a diameter smaller than the specification. The valve is used for prosthetic fitting of lower limb amputees.

    Product
    21Y14 PushValve Product Usage: The PushValves/ MagValves is intended exclusively for the prosthetic fitting of lower limb amputees. The valve is a threadless one-way valve. It is used to evacuate air from the prosthetic socket.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0490-2019·2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 22 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, potentially affecting drug release.

    Product
    CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0488-2019·2019-02-20

    Valeant Recalls Cardizem CD Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 206 bottles of Cardizem CD capsules because they failed to meet dissolution specifications, meaning the drug may not release properly.

    Product
    CARDIZEM CD — CARDIZEM CD (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0900-2019·2019-02-20

    Bundle Organics Carrot Walnut Snack Bars Recalled for Mold Presence

    1908 Brands is recalling Bundle Organics Carrot Walnut snack bars due to the presence of mold. The recall affects 4,537 bars distributed to one consignee.

    Product
    Bundle Organics Bar Carrot Walnut, 1.9 Oz snack bar, Ambient storage
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0998-2019·2019-02-20

    Avella recalls magnesium sulfate bags with incorrect barcode expiration dates

    Avella of Deer Valley is recalling 250 bags of compounded magnesium sulfate due to incorrect expiration dates in the 2D barcodes.

    Product
    MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-901-05.
    Category
    Drug
    Distribution
    13 states
  • ModerateFDA (Drugs)·D-0999-2019·2019-02-20

    Avella Recalls Magnesium Sulfate Bags Due to Incorrect Barcode Expiration Dates

    Avella of Deer Valley is recalling 4,950 bags of compounded magnesium sulfate because the 2D barcodes contain incorrect expiration dates that do not match the label.

    Product
    MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag, Compounded by Avella Specialty Pharmacy 24416 N 19th Avenue, Phoenix, AZ 85085 (877) 794-0404, NDC 42852-902-05.
    Category
    Drug
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0833-2019·2019-02-20

    Signature Orthopedics Recalls Genius Knee Cemented Tibial Components Due to Product Mix-Up

    Signature Orthopedics is recalling 10 Genius Knee Cemented Tibial Components due to a product mix-up. The recall covers units distributed in Florida, New York, and Tennessee.

    Product
    Genius Knee Cemented Tibial Component Product Usage: Knee replacement component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0898-2019·2019-02-20

    Bundle Organics Salty Nuts and Seeds Bars Recalled for Mold

    1908 Brands is recalling Bundle Organics Salty Nuts and Seeds snack bars due to the presence of mold. The recall affects specific lots distributed to one consignee.

    Product
    Bundle Organics Bar Salty Nuts and Seeds, 1.9 Oz snack bar, Ambient storage
    Category
    Food
    Distribution
    0 states
  • ModerateFDA (Food)·F-0899-2019·2019-02-20

    Bundle Organics Oatmeal Raisin Bars Recalled for Mold Presence

    1908 Brands is recalling Bundle Organics Oatmeal Raisin snack bars due to the presence of mold. The recall affects 3,045 bars distributed to one consignee.

    Product
    Bundle Organics Bar Oatmeal Raisin, 1.9 Oz snack bar, Ambient storage
    Category
    Food
    Distribution
    0 states
  • LowFDA (Devices)·Z-0822-2019·2019-02-20

    Luminex Recalls Verigene BC-GP Utility Kits Due to Labeling Error

    Luminex Corporation is recalling Verigene BC-GP Utility Kits because they were incorrectly labeled with Amplification Tray labels.

    Product
    Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identif
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0491-2019·2019-02-20

    Valeant Recalls Diltiazem HCl Capsules for Dissolution Failures

    Valeant Pharmaceuticals is recalling 23,884 bottles of Diltiazem HCl CD capsules because they failed dissolution specifications, potentially affecting drug release.

    Product
    Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA; By: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada; NDC 68682-
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0483-2019·2019-02-20

    Akorn Recalls COSOPT Ophthalmic Solution Due to Stability Failures

    Akorn Inc. is recalling 30,794 bottles of COSOPT Ophthalmic Solution because the product failed stability specifications for opalescence.

    Product
    COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·016-2019·2019-02-19

    Lean Culinary Services Recalls Chicken Salad Due to Listeria Contamination

    Lean Culinary Services is recalling approximately 223 pounds of ready-to-eat chicken salad products due to possible Listeria monocytogenes contamination. The products were distributed to retail locations in Florida.

    Product
    Lean Culinary Services, LLC — Lean Culinary Services, LLC Recalls Ready To Eat Chicken Salad Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·19V108000·2019-02-19

    Keystone Recalls 2019 Crossroads Redwood Trailers Due to Pin Box Bolt Issue

    Keystone is recalling 2019 Crossroads Redwood recreational trailers because insufficiently tightened pin box mounting bolts could cause the trailer to separate from the tow vehicle.

    Product
    CROSSROADS — CROSSROADS REDWOOD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19067·2019-02-19

    Academy Sports + Outdoors Recalls Outdoor Gourmet Turkey Keg Fryers

    Academy Sports + Outdoors is recalling Outdoor Gourmet Turkey Keg turkey fryers because the spout can leak oil, posing a fire hazard.

    Product
    Outdoor Gourmet Turkey Keg turkey fryers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·19V109000·2019-02-19

    Kia Recalls 2015-2018 Sedona Vehicles Due to Wiring Harness Defect

    Kia is recalling 2015-2018 Sedona vehicles with manual front passenger seats because a wiring harness may break, potentially allowing the airbag to deploy and injure a child.

    Product
    KIA — KIA SEDONA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V102000·2019-02-15

    Goshen Shuttle Buses Recalled for Wheelchair Lift Cam Failure

    Eldorado is recalling 2012-2018 Goshen shuttle buses because a wheelchair lift cam may fail, allowing the platform to rise too high and risk injury.

    Product
    GOSHEN — GOSHEN GCII, IMPULSE, PACER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V100000·2019-02-15

    New Flyer Transit Buses Recalled for Shattering Roof Hatch Glass

    New Flyer is recalling 172 transit buses because the rooftop emergency escape hatch glass may shatter in extreme cold, posing an injury risk to passengers.

    Product
    NEW FLYER — NEW FLYER XN40, XDE60, XD40, XE60
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·19V099000·2019-02-15

    Ford Recalls 2019 Fusion Energi for High Voltage Protection Defect

    Ford is recalling 2019 Fusion Energi Hybrid vehicles because they may not adequately protect against high voltage contact during normal operation.

    Product
    FORD — FORD FUSION ENERGI
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·19V090000·2019-02-14

    Ferrari Recalls 2,150 Vehicles for Fuel Leak Fire Risk

    Ferrari is recalling 2,150 vehicles because a cracked fuel vapor separator may leak fuel, increasing the risk of fire.

    Product
    FERRARI — FERRARI 488 PISTA, 488 SPIDER, GTC4LUSSO, LAFERRARI
    Category
    Vehicle
    Distribution
    Distributed nationwide

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