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.

701–800 of 865

  • ModerateFDA (Food)·F-1992-2018·2018-10-10

    Trader Darwin's Chewable Melatonin Recalled for Misbranding and Wrong Product Contents

    Church & Dwight is recalling Trader Darwin's Chewable Peppermint Flavored Melatonin because bottles contain GABA Calm Sublingual Orange tablets instead.

    Product
    Trader Darwin s Chewable Peppermint Flavored Melatonin Dietary Supplement Number of units per package: 100 tablets Package type: Bottle Units per case: 36
    Category
    Drug
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-0002-2019·2018-10-10

    BioLyte Recalls NeoRelief Topical Gel Due to Ingredient Contamination

    BioLyte Laboratories is recalling NeoRelief topical gel because it contains active ingredients that were previously recalled for water contamination.

    Product
    NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS — NEORELIEF FOR MUSCLE CRAMPLING AND RESTLESSNESS (TOPICAL GEL FOR MUSCLE CRAMPING AND RESTLESSNESS)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0050-2019·2018-10-10

    Oridion Capnostream20 N Bedside Monitors Recalled for Settings Reset

    Oridion Medical is recalling Capnostream20 N bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 N CYVITAL, CS08799
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0037-2019·2018-10-10

    Oridion CAPNOSTREAM 20P Bedside Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 113 CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N, Part Number CS08652-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0001-2019·2018-10-10

    Teva Recalls Clozapine Tablets Due to Failed Disintegration Testing

    Teva Pharmaceuticals is recalling 313 bottles of Clozapine 12.5 mg tablets because routine stability testing showed the tablets failed to disintegrate as required.

    Product
    CLOZAPINE — CLOZAPINE (CLOZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0036-2019·2018-10-10

    Oridion CapnoStream 20 Bedside Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling 245 CapnoStream 20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20 (INTL) N, Part Number CS08652
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0025-2019·2018-10-10

    Oridion Capnostream 20P Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling 2,806 Capnostream 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0054-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling eight refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) M W/PRINTER REFURBISHED, CS78660
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0068-2019·2018-10-10

    Surge Medical Sales Recalls Retrograde Cardioplegia Cannula Due to Stylet Error

    Surge Medical Sales is recalling 35 units of the Retrograde Cardioplegia Cannula because they were built with a rigid stylet instead of a flexible one.

    Product
    Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0030-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M TO MASIMO, Part Number CS08750
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0040-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20 Bedside Monitors Recalled for Settings Reset

    Oridion Medical is recalling 144 CAPNOSTREAM 20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20 (INTL) N W/PRINTER, Part Number CS08658
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0010-2019·2018-10-10

    Radiometer ABL90 FLEX Analyzers Recalled for Fluid Aspiration Error

    Radiometer America Inc. is recalling ABL90 FLEX analyzers with software version 3.3MR1 or below because they may aspirate calibration solution instead of rinse solution.

    Product
    ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0007-2019·2018-10-10

    Dr. Reddy's Recalls Nystatin and Triamcinolone Cream for Stability Failures

    Dr. Reddy's Laboratories is recalling Nystatin and Triamcinolone Acetonide Cream because stability testing showed out-of-specification results for Nystatin composition.

    Product
    Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ -
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0035-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 22 refurbished Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M W/PRINTER REFURBISHED, Part Number CS78659
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0034-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 48 refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) N W/PRINTER REFURBISHED, Part Number CS78657
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0051-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling five refurbished Capnostream20 monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) N REFURBISHED, CS78652
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0041-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P Bedside Patient Monitor Recall

    Oridion Medical is recalling 113 CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N W/PRINTER, Part Number CS08658-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0009-2019·2018-10-10

    Endo Pharmaceuticals Recalls Robaxin-750 Due to Incorrect Dosage Labeling

    Endo Pharmaceuticals is recalling 2,856 bottles of Robaxin-750 (methocarbamol) because the labels contain incorrect dosage instructions.

    Product
    robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0024-2019·2018-10-10

    Oridion CAPNOSTREAM 20 Patient Monitors Recalled for Settings Reset

    Oridion Medical is recalling CAPNOSTREAM 20 patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0029-2019·2018-10-10

    Oridion Capnostream20 Monitors Recalled for Settings Reset Issue

    Oridion Medical is recalling 500 Capnostream20 bedside monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (US) M W/PRINTER, Part Number CS08659
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0044-2019·2018-10-10

    Oridion Capnostream20 Bedside Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling 56 Capnostream20 bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    Capnostream20 (INTL) M, CS08654
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0022-2019·2018-10-10

    Oridion Medical CAPNOSTREAM 20P Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling CAPNOSTREAM 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0061-2019·2018-10-10

    Ortho VITROS TSH Reagent Packs Recalled for Potential Biotin Interference

    Ortho Clinical Diagnostics is recalling VITROS TSH Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated in the instructions.

    Product
    VITROS Immunodiagnostic Products - TSH Reagent Pack (10758750000227) 1912997
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0056-2019·2018-10-10

    Oridion Capnostream 20P Bedside Patient Monitor Recall for Settings Reset

    Oridion Medical is recalling 56 Capnostream 20P bedside patient monitors because date, time, and alarm settings may reset to factory defaults when powered off.

    Product
    CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS, CS051COV-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0060-2019·2018-10-10

    Ortho VITROS Prolactin Reagent Pack Recalled for Biotin Interference

    Ortho Clinical Diagnostics is recalling VITROS Prolactin Reagent Packs because biotin supplements may cause biased test results at lower concentrations than stated in the instructions.

    Product
    VITROS Immunodiagnostic Products - Prolactin Reagent Pack (10758750000111) 1849793
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0017-2019·2018-10-10

    Otsuka Recalls Mislabeled treatNOW Abilify Physician Sample Kits

    Otsuka is recalling 17,325 treatNOW Abilify physician sample kits due to labeling errors, including misspelled product names and missing storage instructions.

    Product
    treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Di
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0075-2019·2018-10-10

    Smiths Medical Portex Nasal Oxygen Cannula Recalled for Labeling Error

    Smiths Medical ASD Inc. is recalling 850 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' dates are transposed, incorrectly suggesting the product expired before it was made.

    Product
    smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0072-2019·2018-10-10

    Smiths Medical Nasal Cannula Recalled for Incorrect Labeling

    Smiths Medical ASD Inc. is recalling 2,550 adult nasal cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expired before it was manufactured.

    Product
    smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0071-2019·2018-10-10

    Smiths Medical Nasal Cannula Recalled for Transposed Date Labels

    Smiths Medical ASD Inc. is recalling 12,000 First Breath Adult Nasal Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.

    Product
    smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0062-2019·2018-10-10

    Dannoritzer Laparoscopy Instruments IFU Recalled for Unvalidated Cleaning Instructions

    Dannoritzer Medizintechnik GmbH & Co. KG is recalling Instructions For Use (IFU) for certain laparoscopy instruments because the manual cleaning process was not validated.

    Product
    Laparoscopy Instruments Instructions For Use (IFU) for the following: 1)Monopolar electrode, 2) Insert, handle and/or shaft component of a modular forceps or scissors for electrosurgical coagulation, 3) One-piece forceps or scissors for electrosurgical coagulation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0073-2019·2018-10-10

    Smiths Medical Portex Nasal Cannula Recalled for Labeling Error

    Smiths Medical ASD Inc. is recalling 3,000 Portex First Breath Adult Nasal Cannulas because the 'Manufactured' and 'Use By' labels are transposed, suggesting the product expires before it was manufactured.

    Product
    smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0018-2019·2018-10-10

    Otsuka Recalls Mislabeled Abilify and Abilify Maintena Physician Sample Kits

    Otsuka is recalling 4,738 physician sample kits of Abilify and Abilify Maintena due to labeling errors, including misspelled product names and missing storage instructions.

    Product
    treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0074-2019·2018-10-10

    Smiths Medical Portex Nasal Oxygen Cannula Recall for Labeling Error

    Smiths Medical ASD Inc. is recalling 13,750 Portex First Breath Nasal Oxygen Cannulas because the 'Manufactured' and 'Use By' labels are transposed, incorrectly suggesting the product expired before it was manufactured.

    Product
    smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxygen Adapter. Product Usage: For the administration of nasal oxygen and humidity to patients.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V708000·2018-10-09

    Altec Recalls 2014-2018 Cranes Due to Incorrect Load Chart Display

    Altec is recalling 2014-2018 AC40-152S cranes because the electronic load protection screen may display incorrect values, risking unit instability or loss of load control.

    Product
    ALTEC — ALTEC CRANE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·19006·2018-10-09

    Marker Recalls Kingpin Ski Bindings Due to Fall Hazard

    Marker is recalling Kingpin 10 and 13 ski bindings because steel pins can break, reducing release force and causing a fall hazard. No injuries have been reported.

    Product
    Kingpin 10 and Kingpin 13 alpine touring ski bindings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V705000·2018-10-09

    Thor Motor Coach Recalls 2013 Motorhomes Due to Wiper Defect

    Thor Motor Coach is recalling 2,854 specific 2013 motorhome models because incorrectly installed windshield wipers may fail, reducing driver visibility and increasing crash risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH PALAZZO, WINDSPORT, HURRICANE, CHALLENGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V706000·2018-10-09

    Altec Recalls Aerial Devices and Digger Derricks Due to Step Defect

    Altec is recalling 2017-2018 aerial devices and digger derricks because a step on the fiberglass platform can break off, increasing injury risk.

    Product
    ALTEC — ALTEC AERIAL DEVICE, DIGGER DERRICK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·086-2018·2018-10-05

    Canteen Recalls Breaded Chicken Tenders for Undeclared Milk Allergen

    Canteen is recalling ready-to-eat breaded chicken tenders because they contain undeclared milk (whey), a known allergen.

    Product
    Compass Group/Canteen — Canteen/Covenco Recalls Ready-To-Eat Breaded Chicken Products Due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    4 states
  • CriticalUSDA FSIS·087-2018·2018-10-05

    Ukrop's Recalls Deli Meat and Poultry Due to Possible Listeria

    Ukrop's Homestyle Foods is recalling ready-to-eat meat and poultry products due to possible Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Ukrop's Homestyle Foods — Ukrop's Homestyle Foods Recalls Ready-To-Eat Meat and Poultry Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    5 states
  • SevereNHTSA·18V703000·2018-10-05

    Daimler Trucks Recalls 2018-2019 Models for Loose Brake Caliper Bolts

    Daimler Trucks North America is recalling 2018-2019 Freightliner, Western Star, and FCCC trucks because brake caliper mounting bolts may be insufficiently tightened, increasing crash risk.

    Product
    FREIGHTLINER — FREIGHTLINER, FCCC, WESTERN STAR 114SD, XBS, XCM, XCP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V704000·2018-10-05

    Hyundai Recalls Ioniq Hybrids for Potential Fire Risk

    Hyundai is recalling 2017-2018 Ioniq Hybrid and 2018 Plug-In Hybrid vehicles because a faulty relay may overheat the rear seat, increasing the risk of a fire.

    Product
    HYUNDAI — HYUNDAI IONIQ HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V702000·2018-10-05

    Thomas Built Buses Recalls 2018-2019 Models Due to Brake Caliper Bolts

    Daimler Trucks North America is recalling 2018-2019 Thomas Built school buses because brake caliper mounting bolts may be insufficiently tightened, increasing crash risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER EFX, SAF-T-LINER HDX, SAF-T-LINER C2
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18E094000·2018-10-05

    Truck-Lite Recalls Right-Hand Headlights for International LT Trucks

    Truck-Lite is recalling right-hand headlights for 2016-2019 International LT trucks due to incorrect markings that may lead to improper aiming and reduced visibility.

    Product
    INTERNATIONAL — INTERNATIONAL LT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V698000·2018-10-05

    Thomas Built Buses Minotour Recalled for Rear Emergency Exit Door Defect

    Daimler Trucks North America is recalling 2016-2019 Thomas Built Buses Minotour school buses because the rear emergency exit door may not open wide enough to meet federal safety standards.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V684000·2018-10-04

    Toyota Recalls Prius and Prius V for Hybrid System Shutdown Risk

    Toyota is recalling 2010-2014 Prius and 2012-2014 Prius V vehicles because excessive voltage may cause the hybrid system to shut down, increasing crash risk.

    Product
    TOYOTA — TOYOTA PRIUS, PRIUS V
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V685000·2018-10-04

    Toyota Recalls 2018-2019 Models for Air Bag Software Defect

    Toyota is recalling specific 2018-2019 Avalon, Sequoia, Tundra, and Avalon Hybrid vehicles because the air bag software may prevent deployment in a crash.

    Product
    TOYOTA — TOYOTA AVALON, SEQUOIA, TUNDRA, AVALON HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V694000·2018-10-04

    Suzuki Recalls 2017-2018 Motorcycles for Fuel Pump O-Ring Defect

    Suzuki is recalling 2017-2018 DL650, GSX-R1000, and GSX-S750 motorcycles because a twisted fuel pump O-ring may cause a fuel leak, increasing fire risk.

    Product
    SUZUKI — SUZUKI DL650, GSX-R1000, GSX-S750
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·085-2018·2018-10-04

    JBS Tolleson Recalls Raw Beef Products Due to Salmonella Newport Contamination

    JBS Tolleson is recalling approximately 6.9 million pounds of raw beef products potentially contaminated with Salmonella Newport. The recall follows an investigation linking the bacteria to 57 reported illnesses.

    Product
    JBS Tolleson Inc. — JBS Tolleson, Inc. Recalls Raw Beef Products Due to Possible Salmonella Newport Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • HighNHTSA·18V695000·2018-10-04

    Yamaha Recalls 2012-2013 XTZ12 Super Tenere Motorcycles for Wiring Defect

    Yamaha is recalling 2012-2013 XTZ12 Super Tenere motorcycles because a gap in protective sealant may cause wire corrosion, preventing the engine from returning to idle and increasing crash risk.

    Product
    YAMAHA — YAMAHA XTZ12
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V693000·2018-10-04

    Altec Recalls 2017 Aerial Devices Due to Electrical Shock Risk

    Altec is recalling 2017 AT37, AT41, and AT48 aerial devices because an incorrectly installed hose sock may cause electrical shock.

    Product
    ALTEC — ALTEC AERIAL DEVICE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1983-2018·2018-10-03

    Zakah Life Recalls Kratom Supplements Due to Salmonella Contamination Risk

    Zakah Life LLC is recalling Super Green Maeng Da Premium Kratom supplements because FDA samples tested positive for Salmonella.

    Product
    Super Green Maeng Da Premium Kratom, Zakah Life Dietary Supplement, Mitragyn Speciosa, packaged in 1) 90 capsules, 500 mg per capsules bottles, or 2) 3.52 oz // 100 grams of Kratom bags. Distributed by Zakah Life LLC Ankeny IA.
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-0028-2019·2018-10-03

    Gravel Ridge Farms Eggs Recalled for Salmonella Contamination

    Gravel Ridge Farms is recalling approximately 55,000 dozen shelled eggs due to Salmonella contamination. The products were distributed in Alabama, Georgia, and Tennessee.

    Product
    Shelled eggs in blank cardboard cases at 2.5 dozen a case. Shelled eggs in dozen cartons labeled as "Gravel Ridge Farms Cullman County, Alabama***CAGE FREE***Free Range***ANTIBIOTIC FREE***One Dozen Grade A***Large Eggs".
    Category
    Food
    Distribution
    3 states
  • CriticalUSDA FSIS·084-2018·2018-10-03

    Johnston County Hams Recalls Ready-to-Eat Ham Products Due to Listeria Risk

    Johnston County Hams is recalling approximately 89,096 pounds of ready-to-eat ham products due to possible Listeria monocytogenes contamination. The recall affects products distributed in five states.

    Product
    Johnston County Hams Recalls Ready-To-Eat Ham Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Drugs)·D-0081-2019·2018-10-03

    Hetero Labs Recalls Montelukast Sodium Tablets Due to Labeling Error

    Hetero Labs Limited is recalling 98,016 bottles of Montelukast Sodium 10 mg tablets because one lot may contain Losartan Potassium 50 mg tablets.

    Product
    MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1982-2018·2018-10-03

    Zakah Life Recalls Kratom Supplements Due to Salmonella Contamination

    Zakah Life LLC is recalling specific batches of Powerful Red Vein Bali Premium Kratom supplements because FDA testing found potential Salmonella contamination.

    Product
    Powerful Red Vein Bali Premium Kratom, Zakah Life Dietary Supplement, Mitragyn Speciosa, packaged in 1) 90 capsules, 500 mg per capsules bottles, or 2) 3.52 oz // 100 grams of Kratom bags. Distributed by Zakah Life LLC Ankeny IA.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-1984-2018·2018-10-03

    Zakah Life Recalls Kratom Supplements Due to Salmonella Contamination Risk

    Zakah Life LLC is recalling Top Shelf White Maeng Da Premium Kratom supplements because the ingredient lacks safety assurance and red/green strains are potentially contaminated with Salmonella.

    Product
    Top Shelf White Maeng Da Premium Kratom, Zakah Life Dietary Supplement, Mitragyn Speciosa, packaged in 1) 90 capsules, 500 mg per capsules bottles, or 2) 3.52 oz // 100 grams of Kratom bags. Distributed by Zakah Life LLC Ankeny IA.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-3245-2018·2018-10-03

    Agfa DX-D 600 X-Ray System Recalled for Potential Cable Failure

    Agfa N.V. is recalling 108 DX-D 600 X-ray systems because support cables may break, posing a risk of the equipment falling.

    Product
    DX-D 600 Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray radiographic images of the skeleton
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1972-2018·2018-10-03

    Men's Health Supplement Recalled for Undeclared Ingredients

    Confidence Inc. is recalling For-Men-10 dietary supplements because they contain undeclared ingredients, including HPMC and artificial colors.

    Product
    FP0392, For-Men-10, All Natural Formula to Overall Men's Health, A Dietary Supplement, 60 Tablets, UPC: 8 92483 00139 7
    Category
    Food
    Distribution
    20 states
  • SevereFDA (Drugs)·D-1209-2018·2018-10-03

    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
  • SevereFDA (Devices)·Z-3265-2018·2018-10-03

    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 body of the device.

    Product
    Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • SevereFDA (Devices)·Z-3279-2018·2018-10-03

    GE Medical Systems Recalls Discovery MR750w MRI Systems Due to Burn Risk

    GE Medical Systems is recalling 516 Discovery MR750w MRI systems because a small area on the bore surface can become warm enough to cause a serious burn if a patient touches it without proper padding.

    Product
    Discovery MR750w Nuclear Magnetic Resonance Imaging System labeled as the following product name sold under: Product Name (Model Number): A. 3.0T MR750 32CH (911000-3); B. 3.0T MR750W (5911000-3, 5481490-2, 5499460-7, 5499460-10, 5373011-3, 5352293, 5911000-3); C. 3.0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3255-2018·2018-10-03

    Boston Scientific Recalls ESSENTIO Pacemakers Due to Battery Depletion

    Boston Scientific is recalling ESSENTIO pacemakers and CRT-P systems due to an elevated potential for early replacement caused by hydrogen-induced accelerated battery depletion.

    Product
    ESSENTIO Pacemaker
    Category
    Medical Device
    Distribution
    48 states
  • SevereFDA (Devices)·Z-3257-2018·2018-10-03

    Boston Scientific Recalls ACCOLADE Pacemakers Due to Battery Depletion Risk

    Boston Scientific is recalling specific ACCOLADE pacemakers and CRT-P systems due to an elevated potential for early replacement caused by hydrogen-induced accelerated battery depletion.

    Product
    ACCOLADE Pacemaker
    Category
    Medical Device
    Distribution
    48 states
  • SevereFDA (Devices)·Z-3261-2018·2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates

    Biomet UK Ltd. is recalling specific 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 130¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-130-004 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
  • SevereFDA (Food)·F-1985-2018·2018-10-03

    Swanson Himalayan Crystal Salt Recalled for Metal Wire Contamination

    Swanson Health Products is recalling Himalayan Crystal Salt because it may contain metal wire pieces. The product was distributed nationwide and in Canada and Switzerland.

    Product
    Swanson Ultra, Himalayan Crystal Salt, #SWU403, Net Wt. 35.27 oz. (2.2 lbs) (1,000 grams). Product of Pakistan. Distributed by Swanson Health Products, Fargo, ND 58104.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V692000·2018-10-03

    MCI Recalls 2018-2019 J4500 Motorcoaches for Emergency Exit Window Defect

    Motor Coach Industries is recalling 2018-2019 MCI J4500 motorcoaches with 60-passenger seating due to insufficient emergency egress windows, which may delay passenger exit during an emergency.

    Product
    MCI — MCI J4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3268-2018·2018-10-03

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

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

    Product
    Bausch + Lomb Stellaris Elite 23 GA Vit Cutter, Model BL5627, 7500 cpm, packaged in sterile pouches, 6/shipper.
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-3247-2018·2018-10-03

    Shockwave S4 IVL Catheters Recalled for Inflation Pressure Failure

    Shockwave Medical is recalling 612 Shockwave S4 IVL Catheters because they may fail to maintain required inflation pressure during treatment.

    Product
    The Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Shockwave S4, Peripheral In
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-3248-2018·2018-10-03

    Swissray Medical Recalls ddR Formula B X-ray Systems for Movement and Calibration Issues

    Swissray Medical is recalling 26 ddR Formula B X-ray systems in the U.S. due to potential arm movement, calibration loss, and communication loss that could cause injury.

    Product
    ddR Formula B X-ray System, ddR Formula B Product Usage: X-ray system used for imaging
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·18V691000·2018-10-03

    Spartan Emergency Vehicles Recalled for Loose EMS Cabinet Fasteners

    Spartan Motors is recalling 2001-2019 MetroStar and Gladiator emergency vehicles because EMS cabinet fasteners may be the wrong size, posing a crash injury risk.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3239-2018·2018-10-03

    Philips Medical Monitor Ceiling Suspension Recall Due to Detachment Risk

    Philips is recalling 5,115 medical monitor ceiling suspensions because the monitor may detach and fall, posing an injury risk to patients and users.

    Product
    Cesar Powerpack-Visub(V3000), System Code 72243 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3232-2018·2018-10-03

    Philips Allura Xper F020 DR Table Recall for Monitor Suspension Defect

    Philips is recalling 5,115 Allura Xper F020 DR Tables because the ceiling monitor suspension may detach, posing a risk of injury from falling equipment.

    Product
    Allura Xper F020 DR Table, System Code 722023 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3263-2018·2018-10-03

    Biomet Recalls HipLOC Hip Fracture Fixation System Plates

    Biomet UK Ltd. is recalling 44 units of the HipLOC Hip Fracture Fixation System due to an undersized bore that may prevent the lag screw from fitting.

    Product
    HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 4 Hole Plate Item Number: 2110-135-004 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fix
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3233-2018·2018-10-03

    Philips Allura Xper F010 DR Table Recall for Monitor Detachment Risk

    Philips is recalling 5,115 Allura Xper F010 DR Tables because the ceiling monitor suspension may detach, posing a risk of injury from falling equipment.

    Product
    Allura Xper F010 DR Table, System Code 722014 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3236-2018·2018-10-03

    Philips Allura Xper F020 Biplane DR Table Recall for Monitor Suspension Defect

    Philips is recalling 5,115 Allura Xper F020 Biplane 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 Biplane DR Table, System Code 722020 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3214-2018·2018-10-03

    Philips INTEGRIS Allura 9 Biplane Recall for Monitor Suspension Defect

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

    Product
    INTEGRIS Allura 9 (biplane), System Code 722021 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·19003·2018-10-03

    Walmart Recalls Ozark Trail Camp Axes Due to Injury Hazard

    Walmart is recalling Ozark Trail camp axes because the axe head can detach from the handle, posing an injury hazard.

    Product
    Ozark Trail camp axes
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·19701·2018-10-03

    Yamaha Recalls Golf Cars and Specialty Vehicles Due to Crash Hazard

    Yamaha is recalling 145,000 golf cars and specialty vehicles because a broken accelerator pedal return spring can cause a crash.

    Product
    Yamaha golf cars, personal transportation and specialty vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3216-2018·2018-10-03

    Philips INTEGRIS Allura Monitor Ceiling Suspension Recall for Detachment Risk

    Philips is recalling INTEGRIS Allura 15-12 systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    INTEGRIS Allura 15-12 (mono), System Code 722043 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3277-2018·2018-10-03

    Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall

    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. Combined Wide-Field Elite Pack, REF SE5525WV (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-3278-2018·2018-10-03

    CooperSurgical Retractor System Elastic Stays Recalled for Potential Seal Compromise

    CooperSurgical is recalling 18,000 units of Retractor System Elastic Stays because the sterile pouch seal may be compromised, increasing the risk of infection.

    Product
    Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) Product Usage: The Retractor System Elastic Stays (Part 3314-lG; 3316-lG; 3550-lG) are a sterile single-use medical device providing retraction to achieve and maintain optimal visualization throughout a variety o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3229-2018·2018-10-03

    Philips FlexVision Monitor Ceiling Suspension Recall for 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, System Code 722010 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3231-2018·2018-10-03

    Philips AIIura Xper F010 DR Table Recall for Monitor Detachment Risk

    Philips is recalling AIIura Xper F010 DR Tables because the ceiling monitor suspension may detach, posing a risk of injury to patients and staff.

    Product
    AIIura Xper F010 DR Table, System Code 722022 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3217-2018·2018-10-03

    Philips INTEGRIS Allura 15-12 Biplane Monitor Suspension Recall

    Philips is recalling INTEGRIS Allura 15-12 biplane systems because the monitor ceiling suspension may detach, causing the monitor to fall and potentially injure patients, users, or bystanders.

    Product
    INTEGRIS Allura 15-12 (biplane), System Code 722044 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3270-2018·2018-10-03

    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. Posterior Wide-Field Elite Pack, REF SE5423WV (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-3251-2018·2018-10-03

    Medtronic Visualase Thermal Therapy System Recalled for MR Thermometry Inaccuracy

    Medtronic is recalling Visualase Thermal Therapy System software due to potential MR thermometry inaccuracies that may cause unaccounted thermal energy spread during laser ablation.

    Product
    Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
    Category
    Medical Device
    Distribution
    35 states

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