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.

Which agencies issued them

801–865 of 865

  • HighFDA (Devices)·Z-3224-2018·2018-10-03

    Philips Allura Xper FD2O Biplane Recall for Monitor Suspension Detachment Risk

    Philips is recalling 5,115 Allura Xper FD2O Biplane systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper FD2O Biplane, System Code 722008 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3223-2018·2018-10-03

    Philips Allura Xper FD2O Biplane Recall for Monitor Suspension Defect

    Philips is recalling 5,115 Allura Xper FD2O Biplane systems because the monitor ceiling suspension may detach, causing the monitor to fall and risk injury.

    Product
    Allura Xper FD2O Biplane, System Code 722013 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3260-2018·2018-10-03

    Boston Scientific LATITUDE Programming System Recalled for Stimulation Risk

    Boston Scientific is recalling 74 LATITUDE Programming Systems due to a potential for unintended cross-chamber stimulation in pacing devices.

    Product
    Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston Scientific LATITUDE Programming System is intended for use in hospital and clinical environments to communicate with Boston Scientific implantable systems. The software in use controls all communication fun
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3266-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation

    Bausch & Lomb is recalling Stellaris Elite Vit Cutters because the back cap may separate from the cutter body.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Mid-Field Elite Pack, REF SE5420M (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-3242-2018·2018-10-03

    Terumo Advanced Perfusion System Recalled for Potential Electrical Short

    Terumo is recalling 47 Advanced Perfusion System units because improperly torqued screws may cause an electrical short.

    Product
    Terumo 100/120V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801763
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3269-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Recall for Cap Separation

    Bausch & Lomb is recalling Stellaris Elite Vit Cutters because the back cap may separate from the cutter body during use.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Posterior Mid-Field Elite Pack, REF SE5423MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-3272-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Recall for Back Cap Separation

    Bausch & Lomb is recalling Stellaris Elite Vit Cutters because the back cap may separate from the cutter body.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Mid-Field Elite Pack, REF SE5425MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Food)·F-1986-2018·2018-10-03

    Gotham Greens Classic Pesto Recalled for Incorrect Ingredient Labeling

    Brett Anthony Foods is recalling Gotham Greens Classic Pesto because the ingredient list incorrectly omits milk (parmigiano).

    Product
    Gotham Greens Classic Pesto 6.5 oz. plastic cup, 12 cups per case. Refrigerated. UPC 85392700334
    Category
    Food
    Distribution
    8 states
  • HighFDA (Devices)·Z-3238-2018·2018-10-03

    Philips Medical Monitor Ceiling Suspension Recall for Detachment Risk

    Philips is recalling 5,115 medical monitor ceiling suspensions because the monitor may detach from the actuator, posing a risk of injury to patients and users.

    Product
    Cesar-DMCP-Visub(HM2000/3000), System Code 72239 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3273-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation

    Bausch & Lomb is recalling Stellaris Elite 25 GA Vit Cutters because the back cap may separate from the cutter body.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Posterior Wide-Field Elite Pack, REF SE5425WV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-3215-2018·2018-10-03

    Philips INTEGRIS CV Ceiling Monitor Suspension Recall for Detachment Risk

    Philips is recalling INTEGRIS CV systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    INTEGRIS CV, System Code 722030 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3275-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall

    Bausch + Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the cutter body.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Wide-Field Elite Pack, REF SE5523WV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-3221-2018·2018-10-03

    Philips Allura Xper FD2O Ceiling Monitor Suspension Recall

    Philips is recalling 5,115 Allura Xper FD2O systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper FD2O, System Code 722006 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3226-2018·2018-10-03

    Philips AlIura Xper F010 F Monitor Ceiling Suspension Recall

    Philips is recalling AlIura Xper F010 F systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    AlIura Xper F010 F, System Code 722002 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3254-2018·2018-10-03

    Intuitive Surgical Recalls da Vinci Redundant Medical Grade Power Supply Units

    Intuitive Surgical is recalling specific da Vinci Surgical System power supply units that were manufactured incorrectly and may fail during use.

    Product
    da Vinci Si/X/Xi Surgical System Redundant Medical Grade Power Supply (RMGPS) Units The da Vinci System consists of a Surgeon Console, a Patient Cart, and a Vision Cart and is used with an endoscope, da Vinci EndoWrist instruments, and accessories to perform minimally invasiv
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1987-2018·2018-10-03

    Love Corn Sea Salt Recall Issued for Undeclared Peanuts

    Love Corn Inc. is voluntarily recalling 1,404 cases of 1.6 oz. Sea Salt Love Corn due to undeclared peanuts.

    Product
    Love Corn, Sea Salt , Net WT. 1.6 Oz. Bags of 10 per cases
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-3262-2018·2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates Due to Fit Issues

    Biomet UK Ltd. is recalling 10 units of HipLOC Hip Fracture Fixation System plates due to an undersized bore that prevents the lag screw from fitting.

    Product
    HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3237-2018·2018-10-03

    Philips Medical Monitor Ceiling Suspension Recall Due to Detachment Risk

    Philips is recalling 5,115 medical monitor ceiling suspensions because the monitor may detach from the actuator rotor shaft and fall, posing a risk of injury to patients, users, and bystanders.

    Product
    Poly C- DMCP-Visub(H3000), System Code 72238 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3267-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall

    Bausch + Lomb is recalling Stellaris Elite 20 GA Vit Cutters because the back cap may separate from the cutter body.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 20 ga. Posterior Wide-Field Elite Pack, REF SE5420W (containing the Stellaris Elite 20 GA Vit Cutter, Model BL5626), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-3274-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall

    Bausch & Lomb is recalling Stellaris Elite 23 GA Vit Cutters because the back cap may separate from the cutter body during use.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 23 ga. Combined Mid-Field Elite Pack, REF SE5523MV (containing the Stellaris Elite 23 GA Vit Cutter, Model BL5627), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-3219-2018·2018-10-03

    Philips INTEGRIS Allura 9 F FDXD Monitor Suspension Recall

    Philips is recalling INTEGRIS Allura 9 F FDXD systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    INTEGRIS Allura 9 F FDXD, System Code 722497 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3240-2018·2018-10-03

    Stryker Recalls Hoffmann LRF Hexapod Software Due to Calculation Error

    Stryker GmbH is recalling 233 units of Hoffmann LRF Hexapod Software because it may compute erroneously accelerated correction plans under specific settings.

    Product
    Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3222-2018·2018-10-03

    Philips Allura Xper FD2O Monitor Ceiling Suspension Recall

    Philips is recalling Allura Xper FD2O systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper FD2O, System Code 722012 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3234-2018·2018-10-03

    Philips Allura Xper F020 DR Table Recall for Monitor Suspension Defect

    Philips is recalling 5,115 Allura Xper F020 DR Tables because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper F020 DR Table, System Code 722015 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3213-2018·2018-10-03

    Philips INTEGRIS Allura 9 Monitor Ceiling Suspension Recall

    Philips is recalling INTEGRIS Allura 9 systems because the monitor ceiling suspension may detach, causing the monitor to fall and risk injury.

    Product
    INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3271-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Recall for Cap Separation

    Bausch & Lomb is recalling Stellaris Elite vit cutters because the back cap may separate from the body. The defect poses a risk of harm during use.

    Product
    Bausch + Lomb Stellaris Elite 25 GA Vit Cutter, Model BL5628, 7500 cpm, packaged in sterile pouches, 6/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-3276-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Recall for Back Cap Separation

    Bausch + Lomb is recalling Stellaris Elite Vit Cutters because the back cap can separate from the cutter body.

    Product
    Bausch + Lomb Stellaris Elite Vision Enhancement System, 25 ga. Combined Mid-Field Elite Pack, REF SE5525MV (containing the Stellaris Elite 25 GA Vit Cutter, Model BL5628), packaged in sterile trays, 6 trays/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-3264-2018·2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates

    Biomet UK Ltd. is recalling 6 units of HipLOC System 140° Plates due to an undersized bore that prevents the lag screw from fitting through the barrel.

    Product
    HipLOC Hip Fracture Fixation System-Hiploc System 140¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-140-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3225-2018·2018-10-03

    Philips Allura Xper FD1O C Ceiling Monitor Recall for Detachment Risk

    Philips is recalling 5,115 Allura Xper FD1O C systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper FD1O C, System Code 722001 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3243-2018·2018-10-03

    Terumo Advanced Perfusion System Power Manager Board Recall

    Terumo is recalling 10 Advanced Perfusion System units due to improperly torqued screws on the Power Manager Board, which may cause electrical shorts.

    Product
    Terumo 220/240V AC, Advanced Perfusion System Platform (APS) for use in cardiopulmonary bypass procedures. Catalog Number 801764
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3230-2018·2018-10-03

    Philips FlexVision Monitor Ceiling Suspension Recall Due to Detachment Risk

    Philips is recalling FlexVision Monitor Ceiling Suspensions because the monitor may detach from the actuator rotor shaft, posing a risk of injury to patients, users, and bystanders.

    Product
    AIIuraXperFDlO/10, System Code 722011 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3228-2018·2018-10-03

    Philips AlluraXperFOlO/lO Ceiling Monitor Suspension Recall

    Philips is recalling 5,115 AlluraXperFOlO/lO systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients or users.

    Product
    AlluraXperFOlO/lO, System Code 722005 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3218-2018·2018-10-03

    Philips INTEGRIS SUITE Ceiling Monitor Suspension Recall

    Philips is recalling INTEGRIS SUITE systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients or users.

    Product
    INTEGRIS SUITE, System Code 722199 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3227-2018·2018-10-03

    Philips Allura Xper F010 Ceiling Monitor Suspension Recall

    Philips is recalling Allura Xper F010 systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients or users.

    Product
    Allura Xper F010, System Code 722003 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3220-2018·2018-10-03

    Philips NTEGRIS Allura 9 0 FDXD Ceiling Monitor Recall

    Philips is recalling NTEGRIS Allura 9 0 FDXD systems because the ceiling monitor suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    NTEGRIS Allura 9 0 FDXD, System Code 722498 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3241-2018·2018-10-03

    Durex Real Feel Polyisoprene Condoms Recalled for Burst Pressure Failure

    Reckitt Benckiser is recalling Durex Real Feel Polyisoprene Condoms because they failed to meet the required burst pressure specification.

    Product
    Durex Real Feel Polyisoprene Condoms, 10 count and 24 count, SKU Numbers 02340-89456-14 and 02340-89457-00 Product Usage: The Durex Synthetic polyisoprene male condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of se
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3212-2018·2018-10-03

    Medtronic Clip Gun Magazines Recalled for Packaging Sterility Defect

    Medtronic Neurosurgery is recalling Clip Gun Magazines because the packaging sterile barrier may be compromised without visible signs.

    Product
    Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5 individually pouched Clip Gun Magazine. REF CM8902, Medtronic Clip Gun Magazine, Rx only, CE 0344, STERILE EO, Rx only, Single Use
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-3235-2018·2018-10-03

    Philips Allura Xper F010/10 DRTable Recall for Monitor Suspension Defect

    Philips is recalling 5,115 Allura Xper F010/10 DRTables because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    Allura Xper F010/10 DRTable, System Code 722019 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1213-2018·2018-10-03

    Hetero Recalls Montelukast Sodium Tablets Due to Blue Specks

    Hetero Labs Limited is recalling 98,016 bottles of Montelukast Sodium 10 mg tablets because a pharmacist reported blue specks on the tablets.

    Product
    MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3249-2018·2018-10-03

    Zimmer Biomet Recalls Vanguard 360 Knee Augments Due to Missing Bolt

    Zimmer Biomet is recalling 16 Vanguard 360 Revision Knee System tibial block augments because the sterile packages contained only one bolt instead of the required two.

    Product
    Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1989-2018·2018-10-03

    Trader Joe's Cinnamon Coffee Cake Recalled for Undeclared Soy

    Pin Hsiao & Associates, LLC dba Zen Bakery is recalling Trader Joe's Cinnamon Coffee Cake because it contains undeclared soy lecithin.

    Product
    TRADER JOE'S Cinnamon Coffee Cake; NET WT. 16 OZ (1 LB) 454g; SKU# 94235; UPC: 00942355
    Category
    Food
    Distribution
    8 states
  • ModerateFDA (Devices)·Z-3250-2018·2018-10-03

    Zimmer Biomet Recalls Vanguard 360 Knee Augments Due to Missing Bolt

    Zimmer Biomet is recalling 16 Vanguard 360 Revision Knee System tibial block augments because the sterile packages contained one bolt instead of the required two.

    Product
    Vanguard 360 Revision Knee System 75x 5mm Universal Tibial Block Augment, Model Number 185224 Intended for use in Total Knee Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3246-2018·2018-10-03

    Zimmer Biomet Recalls Mislabelled Tibial Nail Due to Size Discrepancy

    Zimmer Biomet is recalling a specific lot of 8.3mm tibial nails that are actually 12mm. The product was distributed only in the Netherlands.

    Product
    Zimmer Natural Nail Tibial Nail - Yellow 8.3mm, Model Number 47249534008 Product Usage - The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone. Indications for the Tibial nails include the following in the tibia: Compound an
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1971-2018·2018-10-03

    Confidence Bone-Lock Dietary Supplement Recalled for Undeclared Ingredients

    Confidence Inc. is recalling Bone-Lock dietary supplements containing undeclared ingredients, including Hydroxypropyl Methylcellulose, Titanium Dioxide, and Polyethylene Glycol.

    Product
    FP0191, Confidence, Bone-Lock WITHGENISTEIN AND CHLOROPHYLL, A Dietary Supplement, 60 tablets per bottle, UPC: 8 92483 00145 8
    Category
    Food
    Distribution
    20 states
  • ModerateFDA (Drugs)·D-1210-2018·2018-10-03

    Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defects

    Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.

    Product
    MINIVELLE — MINIVELLE (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1207-2018·2018-10-03

    Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defect

    Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.

    Product
    MINIVELLE — MINIVELLE (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1215-2018·2018-10-03

    Baxter Recalls Levofloxacin Injection Bags Due to High Potency

    Baxter Healthcare is recalling 523,896 bags of Levofloxacin Injection in 5% Dextrose because the drug concentration was higher than specified.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-3244-2018·2018-10-03

    Tosoh G8 Automated HPLC Analyzer Recalled for Missing 510(k) Software

    Tosoh Bioscience Inc is recalling eight G8 Automated HPLC Analyzers because they were distributed with software that lacks a 510(k).

    Product
    G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diagnosis of diabetes and as an aid in identifying patients who may be at risk for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1208-2018·2018-10-03

    Noven Recalls Minivelle Estradiol Patches Due to Adhesive Defect

    Noven Pharmaceuticals is recalling Minivelle (estradiol) transdermal patches because the adhesive delivery system failed to meet specification standards for shear.

    Product
    MINIVELLE — MINIVELLE (ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1988-2018·2018-10-03

    Caffeine-Free Barq's Root Beer Recalled for Mislabeling

    Swire Coca Cola USA is recalling Caffeine-Free Barq's Root Beer 12 Packs due to mislabeling. The recall covers 2,945 cases distributed nationwide.

    Product
    Caffeine-Free Barq s Root Beer 12 Pack, 12 oz cans
    Category
    Food
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-3252-2018·2018-10-03

    Biomet Sports Medicine Drill Bit Recalled for Incorrect Expiration Date Labeling

    Zimmer Biomet is recalling 217 units of Biomet Sports Medicine Juggerknot Long Flex Drill Bits because the expiration date is incorrectly listed on the label.

    Product
    Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992
    Category
    Medical Device
    Distribution
    10 states
  • LowFDA (Drugs)·D-0103-2019·2018-10-03

    Dr. Reddy's Recalls Zoledronic Acid Injection Due to Unknown Impurities

    Dr. Reddy's Laboratories is recalling Zoledronic Acid Injection vials because they failed impurity specifications with out-of-specification unknown impurities.

    Product
    ZOLEDRONIC ACID — ZOLEDRONIC ACID (ZOLEDRONIC ACID)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Devices)·Z-3253-2018·2018-10-03

    Medtronic Diagnostic Catheter Recalled for Incorrect French Size Labeling

    Medtronic is recalling 250 units of DxTerity TRA 5F Diagnostic Catheters because the inner pouch may incorrectly display a 6 French size indicator instead of the correct 5 French size.

    Product
    Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
    Category
    Medical Device
    Distribution
    7 states
  • HighNHTSA·18V686000·2018-10-02

    Jayco Recalls 2019 Jay Flight Trailers Due to Wiring Defect

    Jayco is recalling 2019 Jay Flight travel trailers because incorrectly wired turn signal and brake lights may fail to operate, increasing crash risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V687000·2018-10-02

    Entegra Recalls 2019 Motorhomes Due to Park Brake Defect

    Entegra is recalling 2019 Aspire, Anthem, and Insignia motorhomes because the park brake may fail to hold the vehicle on a grade.

    Product
    ENTEGRA — ENTEGRA INSIGNIA, ASPIRE, ANTHEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V688000·2018-10-02

    Entegra Recalls 2019 Motorhomes Due to Door Latch Adjustment Issue

    Entegra is recalling 2019 Anthem, Aspire, Cornerstone, and Insignia motorhomes because improperly adjusted entry door latch rods may allow the door to open during transit.

    Product
    ENTEGRA — ENTEGRA ASPIRE, ANTHEM, CORNERSTONE, INSIGNIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V689000·2018-10-02

    Jayco Recalls 2019 Precept Motorhomes Due to Wheel Stud Defect

    Jayco is recalling 2019 Precept and Precept Prestige motorhomes because improperly heat-treated front wheel studs may break, increasing crash risk.

    Product
    JAYCO — JAYCO PRECEPT, PRECEPT PRESTIGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V682000·2018-10-01

    Winnebago Recalls Minnie Drop Trailers Due to Propane Line Fire Risk

    Winnebago is recalling 2017-2019 Minnie Drop trailers because a missing clamp may allow the propane line to contact the refrigerator burner, posing a fire risk.

    Product
    WINNEBAGO — WINNEBAGO MINNIE
    Category
    Vehicle
    Distribution
    Distributed nationwide

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