The Recall Desk

Archive

February 2017 recalls

436 recalls were announced in February 2017.

What the numbers show

Critical
36
Severe
125
High
176
Moderate
78
Low
21

Of the 436 recalls this month scored against our rubric, 8% are Critical, 29% are Severe.

1–100 of 436

  • SevereCPSC·17098·2017-02-28

    S.R. Smith Recalls Helix Pool Slides Due to Fall Hazard

    S.R. Smith is recalling Helix pool slides because children can fall off the side before reaching the pool, posing a risk of serious injury.

    Product
    Helix pool slides
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·017-2017·2017-02-28

    Wayne Farms Recalls Ready-to-Eat Chicken Bites Due to Processing Defect

    Wayne Farms is recalling approximately 12,610 pounds of ready-to-eat chicken bites due to a potential processing defect that may allow bacterial pathogens to survive.

    Product
    Wayne Farms LLC — Wayne Farms, LLC Recalls Ready-To-Eat Chicken Products Due To Potential Processing Deviation
    Category
    Food
    Distribution
    10 states
  • SevereUSDA FSIS·016-2017·2017-02-28

    Gourmet Classic Salads Recalls Ready-To-Eat Meat and Poultry Products

    Gourmet Classic Salads is recalling approximately 3,236 pounds of ready-to-eat meat and poultry products due to possible Listeria monocytogenes contamination.

    Product
    Gourmet Classic Salads, Inc Recalls Ready-To-Eat Meat and Poultry Products Due To Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • HighCPSC·17099·2017-02-28

    Dillard's Recalls Baby Faux-Fur Coats Due to Choking Hazard

    Dillard's is recalling about 1,800 baby faux-fur coats because metal snaps can detach, posing a choking hazard to children.

    Product
    Faux-Fur Hooded Bear Coats
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V125000·2017-02-27

    Thomas Built Buses Recalls 2017-2018 Saf-T-Liner HDX School Buses

    Daimler Trucks North America is recalling 2017-2018 Thomas Built Buses Saf-T-Liner HDX school buses because a loose steering bolt may cause loss of vehicle control.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V123000·2017-02-27

    Ford Recalls 2016-2017 Edge, MKX, Continental for Air Bag Defect

    Ford is recalling 2016-2017 Edge, MKX, and Continental vehicles because the driver's air bag may not fully inflate or detach during a crash.

    Product
    LINCOLN — LINCOLN, FORD MKX, CONTINENTAL, EDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V126000·2017-02-27

    Thomas Built Buses Recalls Saf-T-Liner HDX for Steering Defect

    Daimler Trucks North America is recalling 2017-2018 Thomas Built Buses Saf-T-Liner HDX transit buses because a loose steering pinch bolt may cause loss of vehicle control.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES SAF-T-LINER HDX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V124000·2017-02-27

    Western Star 4900 Trucks Recalled for Air Tank Weld Defects

    Daimler Trucks North America is recalling 2015-2018 Western Star 4900 trucks because aluminum air tanks may have improper welds, risking rapid air pressure loss.

    Product
    WESTERN STAR — WESTERN STAR 4900
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V122000·2017-02-27

    Horton Ambulances Recalled for Rear Brake Bolt Torque Issue

    Halcore Group is recalling 2017 Horton ambulances because overtightened rear brake bolts may cause loss of braking power, increasing crash risk.

    Product
    HORTON AMBULANCE — HORTON AMBULANCE CCO, 453, 623, 457
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V121000·2017-02-27

    Tiffin Recalls 2012 Phaeton Motorhomes Due to Exhaust Fire Risk

    Tiffin is recalling 35 model-year 2012 Phaeton motorhomes because the exhaust pipe is mounted too close to the floor, creating a fire hazard.

    Product
    TIFFIN — TIFFIN PHAETON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V117000·2017-02-24

    Forest River Recalls 2017 Sandstorm and Stealth RVs for Propane Leak Risk

    Forest River is recalling 2017 Sandstorm and Stealth recreational vehicles because the liquid propane line may be damaged by the axle, creating a fire or explosion hazard.

    Product
    FOREST RIVER — FOREST RIVER SANDSTORM, STEALTH
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V118000·2017-02-24

    Forest River Recalls 2017 Wildwood and Salem Trailers Due to Propane Leak Risk

    Forest River is recalling 2017 Wildwood and Salem recreational trailers because an improperly installed refrigerator vent allows propane gas to enter the vehicle, increasing the risk of fire or explosion.

    Product
    FOREST RIVER — FOREST RIVER WILDWOOD, SALEM
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-022417·2017-02-24

    PREMO Meat and Poultry Wraps Alerted for Possible Listeria Contamination

    USDA FSIS issued a public health alert for PREMO Brand wraps due to possible Listeria contamination from a cheese ingredient. No illnesses have been reported.

    Product
    JLM Manufacturing — Fsis Issues Public Health Alert for Meat and Poultry Wraps Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    10 states
  • SevereCPSC·17094·2017-02-23

    Carrier Recalls Packaged Terminal Air Conditioners and Heat Pumps Due to Fire Hazard

    Carrier is expanding a recall for about 94,000 packaged terminal air conditioners and heat pumps because the power cord plug can overheat, posing a fire hazard.

    Product
    Packaged Terminal Air Conditioners (PTAC) and Packaged Terminal Heat Pumps (PTHP)
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereCPSC·17096·2017-02-23

    Little Tikes Recalls Toddler Swings Due to Fall Hazard

    Little Tikes is recalling about 540,000 2-in-1 Snug 'n Secure Pink toddler swings because the plastic seat can crack or break, posing a fall hazard.

    Product
    Little Tikes™ 2-in-1 Snug 'n Secure Pink toddler swings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·17V116000·2017-02-23

    GM Recalls 2017 Buick LaCrosse for Power Steering Seal Defect

    General Motors is recalling 2017 Buick LaCrosse vehicles because water may enter the electric power steering connectors, potentially causing a loss of power steering.

    Product
    BUICK — BUICK LACROSSE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·17V115000·2017-02-23

    BMW and Rolls-Royce Recall Vehicles for Air Bag Initiator Defect

    BMW is recalling 2017 430i, 440i, M4, and Rolls-Royce Dawn vehicles because seat-mounted air bag inflator initiators may fail to ignite during a crash.

    Product
    BMW — BMW, ROLLS-ROYCE 430I, 440I, M4, DAWN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17095·2017-02-23

    STIHL Recalls Gas-Powered Chain Saws Due to Fire and Burn Hazards

    STIHL is recalling about 100,000 gas-powered chain saws because a leaking fuel line can cause fire and burn hazards. Consumers should stop using the saws and return them for a free repair.

    Product
    STIHL gas-powered chain saws
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1486-2017·2017-02-22

    Giant Eagle Apple Pistachio Salad Recalled for Listeria Risk

    Giant Eagle is recalling Apple Pistachio Salad due to potential Listeria monocytogenes contamination. Consumers in Ohio and Pennsylvania should not eat the product.

    Product
    Giant Eagle Apple Pistachio Salad, NET WT 13 oz.
    Category
    Food
    Distribution
    2 states
  • CriticalUSDA FSIS·015-2017·2017-02-22

    Ready Pac Foods Recalls Chicken Salad Due to Possible Listeria Contamination

    Ready Pac Foods is recalling approximately 59,225 pounds of Puro Picante Blazin Hot chicken salad due to possible Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Ready Pac Produce, Inc. — Ready Pac Foods Inc. Recalls Chicken Salad Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0472-2017·2017-02-22

    MS Bionic Recalls MegaJex Herbal Supplement Containing Unapproved ED Drugs

    MS Bionic is recalling MegaJex Herbal Supplement because it contains sildenafil and tadalafil, active ingredients in approved erectile dysfunction drugs, without FDA approval.

    Product
    MegaJex Herbal Supplement, Maximum Formula for Men, Fast acting, Increase Stamina, 20 capsules, MS Bionics, Gardena, CA
    Category
    Drug
    Distribution
    1 state
  • CriticalFDA (Food)·F-1485-2017·2017-02-22

    Giant Eagle Apple Pistachio Salad Recalled for Listeria Risk

    Giant Eagle is recalling Apple Pistachio Salad with Chicken due to potential Listeria monocytogenes contamination. The product was sold in Ohio and Pennsylvania.

    Product
    Giant Eagle Apple Pistachio Salad with Chicken, NET WT 15 oz.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1193-2017·2017-02-22

    Stryker Restoris RIO Reamer Handle Recalled for Engagement Failure

    Mako Surgical Corporation is recalling 595 Stryker Restoris RIO Reamer Handles because they may fail to engage mating components during surgery.

    Product
    Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1188-2017·2017-02-22

    GE Healthcare Recalls Discovery MR450 MRI Scanners Due to Burn Risk

    GE Healthcare is recalling 60 Discovery MR450 MRI scanners because a component failure can cause the patient bore to heat up, potentially leading to serious burns.

    Product
    Discovery MR450 The systems are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectro
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1103-2017·2017-02-22

    Zimmer Biomet Recalls Reverse Shoulder Humeral Trays Due to Fracture Risk

    Zimmer Biomet is recalling 4,388 Comprehensive Reverse Shoulder System Humeral Trays because they are fracturing at higher-than-anticipated rates, posing a risk of revision surgery.

    Product
    Comprehensive Reverse Shoulder System Humeral Tray Model 115340
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1192-2017·2017-02-22

    Integra Cadence Total Ankle System Recalled Due to Tibial Fractures

    Integra LifeSciences Corp. is recalling 944 units of the Cadence Total Ankle System because posterior tibial fractures have been reported.

    Product
    Integra Cadence Total Ankle System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·014-2017·2017-02-22

    Fratelli Beretta Recalls Mortadella Due to Undeclared Pistachio Allergens

    Fratelli Beretta USA is recalling approximately 468 pounds of Deli Thin Dietz & Watson Mortadella because the product contains undeclared pistachio nuts, a known allergen.

    Product
    Fratelli Beretta USA, Inc. — Fratelli Beretta USA, Inc. Recalls Mortadella Product Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-1215-2017·2017-02-22

    Siemens PRIMUS Radiation Therapy Systems Recalled for Collimator and Weld Defects

    Siemens is recalling 194 PRIMUS radiation therapy systems due to incorrect collimator position displays and improper weld seams at the overhead suspension.

    Product
    PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1203-2017·2017-02-22

    Merge Healthcare Recalls Schiller PB 1000 Blood Pressure Pumps

    Merge Healthcare is recalling Schiller PB 1000 blood pressure pumps because insufficient voltage causes them to fail before reaching adequate pressure.

    Product
    The Schiller PB 1000, also known as: Merge Hemo Patient Data Module (PDM), V2 model, a major component of the Merge Hemo software.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1207-2017·2017-02-22

    Atrium Medical Recalls Maquet Oasis Chest Drains Due to Valve Defect

    Atrium Medical is recalling Maquet Oasis chest drains because the manual vent valve may fail to re-seal after use.

    Product
    Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative colle
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1194-2017·2017-02-22

    Argon Medical Devices Recalls Bone Marrow Aspiration Needles Due to Sterility Risk

    Argon Medical Devices is recalling specific bone marrow aspiration needles because a potential defect in the blister packaging may compromise the sterility of the product.

    Product
    BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1197-2017·2017-02-22

    Advanced Sterilization Products Recalls STERRAD NX Sterilization Systems

    Advanced Sterilization Products is recalling STERRAD NX Sterilization Systems because the door interlock may disengage for 20 seconds after a power outage.

    Product
    STERRAD NX Sterilization System, Product Code: 10033, 10033-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1210-2017·2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction OCEAN DRAIN Chest Drains

    Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction OCEAN DRAIN chest drains because the manual vent valve may fail to re-seal after use.

    Product
    Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE Reference: 2002-400 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2017·2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction OASIS Drain

    Atrium Medical Corporation is recalling 18 units of Maquet Express Dry Seal Suction OASIS Drain because the manual vent valve may fail to re-seal.

    Product
    Maquet Express Dry Seal Suction OASIS DRAIN, DRY PEDI W/AC Reference: 3612-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and re
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1474-2017·2017-02-22

    Whole Foods Market Tarts Recalled for Missing Almond Allergen Labeling

    Whole Foods Market is recalling specific tart products because almond flour is not listed on the scale label, posing a risk to consumers with nut allergies.

    Product
    Whole Foods Market, SMALLTART FRESH BERRY SMALL, TART FRESH BERRY LARGE
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1513-2017·2017-02-22

    Pier Fish Company Recalls Frozen Ground Tuna Due to Elevated Histamine Levels

    Pier Fish Company is recalling 34 cases of frozen ground tuna in Massachusetts and Ohio due to elevated histamine levels.

    Product
    Frozen Ground Tuna. Product is labeled in part: "PIER FISH CO. 68 CONWAY ST NEW BEDFORD, MA 02740 COLUMBUS FISH & SFD TUNA GRIND LOT# 16185 PRODUCT OF : USA HARVESTED: WILD CAUGHT NET WT: 20 LBS
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1218-2017·2017-02-22

    Aesculap GN200 Caiman HF Generators Recalled for Faulty Component

    Aesculap Implant Systems LLC is recalling 24 GN200 Caiman HF generators due to a faulty component that may impact proper device functioning.

    Product
    GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2017·2017-02-22

    Siemens Recalls ONCOR Radiation Therapy Systems Due to Collimator and Weld Defects

    Siemens is recalling 194 ONCOR radiation therapy systems in the US due to incorrect collimator position displays and improper weld seams.

    Product
    ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cance
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1202-2017·2017-02-22

    Abbott StarClose SE Vascular Closure System Recall for Deployment Failure

    Abbott Vascular is recalling the StarClose SE Vascular Closure System because the device may fail to deploy the clip.

    Product
    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. The UDI is 08717648079467. The GMDN is 47411.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Food)·F-1468-2017·2017-02-22

    Pictsweet Farms Breaded Okra Recalled for Potential Glass Fragments

    The Pictsweet Company is recalling Southern Classics Crunchy Breaded Okra because the product may contain glass fragments.

    Product
    PICTSWEET(R) FARMS, Southern Classics, Crunchy Breaded Okra, NET WT 12 OZ (340g), UPC 7056098377
    Category
    Food
    Distribution
    15 states
  • HighFDA (Food)·F-1472-2017·2017-02-22

    Whole Foods Key Lime Tarts Recalled for Undeclared Almond Flour

    Whole Foods Market is recalling specific Key Lime Tarts because they contain almond flour, a tree nut, which is not listed on the store scale label.

    Product
    Whole Foods Market, TART KEY LIME 4IN TART KEY LIME 4IN,TART KEY LIME 9IN
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1470-2017·2017-02-22

    Whole Foods Tart Crusts Recalled for Unlabeled Almond Flour

    Whole Foods Market is recalling tart crusts because almond flour is missing from the scale label, posing a risk to people with nut allergies.

    Product
    Whole Foods Market, TART FRESH FRUIT AMERO SHELL LARGE
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1212-2017·2017-02-22

    Siemens ARTISTE MV System Recalled for Collimator and Weld Defects

    Siemens is recalling 194 ARTISTE MV radiation therapy systems due to incorrect collimator position displays and improper weld seams.

    Product
    ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1123-2017·2017-02-22

    Physio-Control Recalls LIFEPAK 15 Defibrillators Due to Relay Failure

    Physio-Control is recalling 338 LIFEPAK 15 defibrillators because an internal relay may fail, preventing the device from delivering defibrillation energy.

    Product
    LIFEPAK 15 Monitor, Automated External Defibrillator (AED), Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1480-2017·2017-02-22

    Joe Chips Potato Chips Recalled for Potential Salmonella Contamination

    The Two Little Guys Company is recalling Joe Chips Sour Cream & Toasted Onion potato chips because a milk powder ingredient may be contaminated with Salmonella.

    Product
    Joe Chips Retro Potato Chips Sour Cream & Toasted Onion Distributed by: The Joe Tea Company, Upper Montclair, NJ 07043-0255 (973)744-7502 Net Wt. 2 OZ UPC 743234001725 Net Wt. 5 OZ UPC 743234001800
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1473-2017·2017-02-22

    Whole Foods Market Tart Chocolate Ganache Recalled for Allergen Mislabeling

    Whole Foods Market is recalling Tart Chocolate Ganache products because almond flour is missing from the scale label, posing a risk to consumers with nut allergies.

    Product
    Whole Foods Market, TART CHOCOLATE GANACHE SMALL, TART CHOCOLATE GANACHE LARGE
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1481-2017·2017-02-22

    BWI Inc Recalls Burt's British Potato Chips Due to Gluten Mislabeling

    BWI Inc is recalling Burt's British Hand Cooked Potato Chips because they are labeled gluten-free but contain gluten. The recall covers 653 cases distributed in 24 U.S. states and the Grand Cayman.

    Product
    Burts British Hand Cooked Potato Chips Sea Salt & Malted Vinegar 150gx10 and 40gx20
    Category
    Food
    Distribution
    24 states
  • HighCPSC·17093·2017-02-22

    Moose Toys Recalls Little Live Pets Lil Frog Toys Due to Battery Hazards

    Moose Toys is recalling Little Live Pets Lil Frog toys because the battery cap can become a projectile and chemicals can leak, causing eye irritation.

    Product
    Little Live Pets Lil Frog and Lil Frog Lily Pad toys
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1219-2017·2017-02-22

    Zimmer Biomet Recalls Vanguard Total Knee Plates Due to Material Inclusions

    Zimmer Biomet is recalling Vanguard Total Knee punch-through trial plates due to potential alumina inclusions in the raw material that could cause the instruments to crack or separate.

    Product
    Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1191-2017·2017-02-22

    Encore Medical Recalls LIMA Modular Revision Hip Stems Due to Sterilization Error

    Encore Medical is recalling 13 LIMA Modular Revision Hip Stems because they were inadvertently re-sterilized, which may compromise the integrity of the safety screw.

    Product
    LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1477-2017·2017-02-22

    Whole Foods Market Tart Lemon Small Recalled for Allergen Mislabeling

    Whole Foods Market is recalling Tart Lemon Small products because almond flour is not listed on the scale label, posing a risk to consumers with nut allergies.

    Product
    Whole Foods Market, TART LEMON SMALL
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1205-2017·2017-02-22

    Atrium Medical Recalls Maquet Ocean Water Seal Chest Drains

    Atrium Medical is recalling Maquet Ocean Water Seal Chest Drains because the manual vent valve may fail to re-seal after being depressed.

    Product
    Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and r
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1199-2017·2017-02-22

    Acumed Recalls 6-Hole Pubic Symphysis Plates Due to Material Error

    Acumed LLC is recalling 15 units of 6-hole Pubic Symphysis plates because they were manufactured with the wrong titanium alloy.

    Product
    6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured wher
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1206-2017·2017-02-22

    Atrium Medical Recalls Maquet Ocean Water Seal Chest Drains

    Atrium Medical Corporation is recalling Maquet Ocean Water Seal Chest Drains because the manual vent valve may fail to re-seal after use.

    Product
    Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1208-2017·2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction Chest Drains

    Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction Chest Drains because the manual vent valve may fail to re-seal after being depressed.

    Product
    Maquet Express Dry Seal Suction Chest Drain, Single Collection w/AC Reference: 4000-100N Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collecti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1201-2017·2017-02-22

    Terumo Recalls Hercules 360 Universal Stabilizing Arms Due to Pin Separation

    Terumo CVS is recalling Hercules 360 Universal Stabilizing Arms because pins may come loose and fall into the surgical site.

    Product
    Hercules 360 Universal Stabilizing Arm, top mount, 360-degree rotation, reusable stainless steel
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1209-2017·2017-02-22

    Atrium Medical Recalls Maquet Express Dry Seal Suction Chest Drains

    Atrium Medical Corporation is recalling Maquet Express Dry Seal Suction chest drains because the manual vent valve may fail to re-seal after being depressed.

    Product
    Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1213-2017·2017-02-22

    Siemens Oncor Avant-garde Radiation Therapy Systems Recalled for Sensor Defects

    Siemens is recalling 194 Oncor Avant-garde radiation therapy systems due to incorrect collimator position displays and improper weld seams.

    Product
    ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1195-2017·2017-02-22

    Argon Medical Devices Recalls T-LOK Bone Marrow Biopsy Needles

    Argon Medical Devices is recalling T-LOK bone marrow biopsy needles due to a potential defect in the blister packaging that may compromise sterility.

    Product
    T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1196-2017·2017-02-22

    Argon Medical Devices Recalls Harvest Needles Due to Sterility Concerns

    Argon Medical Devices is recalling 15 boxes of Harvest Needles because a potential defect in the blister packaging may compromise the sterility of the product.

    Product
    HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or bone marrow specimens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1478-2017·2017-02-22

    Pizza Hut Creamy Alfredo Sauce Recalled for Foreign Object

    Yum Restaurants International is recalling Pizza Hut Creamy Alfredo sauce due to a likely flexible plastic foreign object.

    Product
    Pizza Hut Creamy Alfredo sauce, case size 40 lbs. 8 bags per case. Bags are each 80 oz (5 lbs) of sauce
    Category
    Food
    Distribution
    17 states
  • ModerateFDA (Drugs)·D-0476-2017·2017-02-22

    Actavis Recalls Glipizide Extended-Release Tablets Due to Dissolution Failure

    Actavis Inc is recalling specific lots of Glipizide extended-release tablets because they failed to meet dissolution specifications at the 10-hour testing point.

    Product
    Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufactured By Patheon Pharmaceuticals Inc Cincinnati OH 45237 USA, NDC 0591-0900-30, UPC 3-0591090030-4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1198-2017·2017-02-22

    Arthrex Shoulder Suspension Tower Recalled for Loose Screw Risk

    Allen Medical Systems is recalling 112 Arthrex Shoulder Suspension Towers because fastening screws may come loose and enter the sterile field.

    Product
    Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1217-2017·2017-02-22

    Siemens Enzyme II Calibrator Recalled for ALTI Result Shifts

    Siemens Healthcare Diagnostics is recalling Enzyme II Calibrators because they may cause patient and QC results to shift by up to 10% on the Dimension clinical chemistry system.

    Product
    The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Food)·F-1483-2017·2017-02-22

    Crystal Geyser Sparkling Mineral Water Recalled for Missing Plastic Piece

    Crystal Geyser is recalling specific lots of sparkling mineral water because a piece of orange plastic from the filler tube was found missing.

    Product
    Crystal Geyser Sparkling Mineral Water, Original; 18 oz. (53 ml) plastic bottles sold in 28 pack wrapped tray. UPC codes: Bottle Label  6 54871 18001 1 Case  6 54871 18249 7
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1200-2017·2017-02-22

    BioMerieux Recalls VIDAS 3 Software Version 1.1.4 Due to Anomalies

    BioMerieux SA is recalling 1,161 units of VIDAS 3 software version 1.1.4 in the U.S. because anomalies identified during the development of version 1.2 were found to be present in the current field version.

    Product
    VIDAS 3 software v. 1.1.4
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1222-2017·2017-02-22

    Atrium Thoracic Catheter Recall Due to Incorrect Labeling Icon

    Atrium Medical Corporation is recalling 1,394 cases of 10 Fr Straight Thoracic Catheters because the label icon incorrectly depicts six eyelets instead of two.

    Product
    Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1189-2017·2017-02-22

    BD Vacutainer Blood Collection Tubes Recalled for Excess Anticoagulant

    Becton Dickinson is recalling specific lots of BD Vacutainer blood collection tubes because they contain approximately twice the expected amount of buffered sodium citrate additive.

    Product
    BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x 13 x 75 mm) Catalog Number: 369714 Product Usage: The BD Vacutainer Safety Coagulation tube is an evacuated blood collection tube that provides means of collecting, transporting and processing bloo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0479-2017·2017-02-22

    Teva Recalls Mimvey Lo Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals USA is recalling specific lots of Mimvey Lo tablets because they failed impurity specifications for norethindrone.

    Product
    Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharm
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0478-2017·2017-02-22

    Accord Healthcare Recalls Lisinopril Tablets Due to Missing Break Line

    Accord Healthcare is recalling 12,896 bottles of 5 mg Lisinopril tablets because the tablets are missing a break line. The recall covers the U.S. and Puerto Rico.

    Product
    Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-376-17
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0474-2017·2017-02-22

    Aurobindo Recalls Venlafaxine Hydrochloride Capsules Due to Physical Defects

    Aurobindo Pharma USA Inc is recalling 47,040 bottles of Venlafaxine Hydrochloride extended-release capsules because some contain punctured or clumped capsules.

    Product
    VENLAFAXINE HYDROCHLORIDE — VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1221-2017·2017-02-22

    Atrium Medical Recalls 8 Fr Thoracic Catheters Due to Labeling Error

    Atrium Medical Corporation is recalling 8 Fr Straight Thoracic Catheters because the label depicts six eyelets instead of the correct two.

    Product
    Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1204-2017·2017-02-22

    Siemens CentraLink Software Recalled for Potential Sample Type Omission

    Siemens is recalling CentraLink Data Management System software versions v13x, v14x, and v15x because the system may download orders to the ADVIA Automation System without specifying the sample type.

    Product
    CentraLink¿ Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software is a network solution provider and multi-system data manager for the instruments and lab automation systems (LAS) within the lab. The CentraLink software consolidates data from
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1190-2017·2017-02-22

    Greatbatch Recalls T5766 Offset Reamer Handles Due to Drive Chain Seizure

    Greatbatch Medical is recalling 1,441 T5766 Offset Reamer Handles because the drive chain U-joints may seize during hip surgery, rendering the device non-functional.

    Product
    Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1216-2017·2017-02-22

    Siemens Enzyme 2 Calibrator Recalled for Positive Result Shifts

    Siemens Healthcare Diagnostics is recalling Enzyme 2 Calibrators because they may cause patient and QC results to shift up to 10% when used with the Dimension Vista System.

    Product
    The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransferase (ALTI and ALTI) and Aspartate Aminotransferase (AST) methods on the Dimension Vista System. For prescription use only.
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Drugs)·D-0477-2017·2017-02-22

    Taclonex Topical Suspension Recalled for Outdated Package Insert

    LEO Pharma Inc. is recalling Taclonex topical suspension because it was packaged with an out-of-date package insert.

    Product
    TACLONEX — TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Food)·F-1484-2017·2017-02-22

    NOW Foods Recalls Multi-Food 1 Tablets Due to Labeling Error

    NOW Foods is recalling Multi-Food 1 Tablets because the label incorrectly states the molybdenum content is 75 mg instead of 75 mcg.

    Product
    NOW¿ Multi-Food 1 Tablets, One Tablet Daily, 90 tablets, A Dietary Supplement
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V111000·2017-02-21

    Yamaha Recalls 2015-2016 YZF-R3 Motorcycles for Fuel Tank Leak Risk

    Yamaha is recalling 2015-2016 YZF-R3 motorcycles because engine vibration may cause the fuel tank bracket to contact the tank, potentially leading to a fuel leak and fire risk.

    Product
    YAMAHA — YAMAHA YZF-R3
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17E012000·2017-02-21

    LiquidSpring Recalls Suspension Systems Due to Brake Bolt Tightening Defect

    LiquidSpring is recalling certain Compressible Liquid Adaptive Suspension Systems because overtightened rear brake banjo bolts may cause loss of rear brakes, increasing crash risk.

    Product
    SERVICE BRAKES, HYDRAULIC:FOUNDATION COMPONENTS:HOSES, LINES/PIPING, AND FITTINGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·17090·2017-02-21

    Yamaha Recalls Grand Piano Benches Due to Lead Paint Violation

    Yamaha Corporation of America is recalling about 900 piano benches sold with grand pianos because the interior paint contains excessive lead, violating federal standards.

    Product
    Piano benches sold with Yamaha grand piano
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·17E011000·2017-02-20

    Roush Propane Conversion Kits Recalled for Potential Fuel Leak

    Roush CleanTech is recalling propane conversion kits for Ford F-250 trucks because worn fittings may cause a propane leak, increasing fire risk.

    Product
    FUEL SYSTEM, OTHER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17E010000·2017-02-20

    Autoliv Recalls AI2 Air Bag Initiators Due to Deployment Failure Risk

    Autoliv is recalling AI2 Air Bag Initiators manufactured between June 2016 and November 2016 because an improper chemical mix may prevent air bags from deploying properly in a crash.

    Product
    AIR BAGS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V108000·2017-02-20

    Winnebago Recalls 2016-2017 Travato RVs Due to Propane Hose Hazard

    Winnebago is recalling 2016-2017 Travato recreational vehicles because the liquid propane hose may contact the emergency brake cable, potentially causing a propane leak that increases the risk of fire or explosion.

    Product
    WINNEBAGO — WINNEBAGO TRAVATO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·17V105000·2017-02-17

    Isuzu Recalls 2015-2017 Trucks Due to Frame Crossmember Burrs

    Isuzu is recalling 2015-2017 NPR HD, NPR XD, NQR, and NRR trucks because burrs on the frame crossmember may cause transmission mounting studs to break, increasing crash risk.

    Product
    ISUZU — ISUZU NRR, NQR, NPR XD, NPR HD
    Category
    Vehicle
    Distribution
    Distributed nationwide

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