January 2018 recalls

494 recalls were announced in January 2018.

What the numbers show

Critical: 39
Severe: 121
High: 177
Moderate: 138
Low: 19

Of the 494 recalls this month scored against our rubric, 8% are Critical, 24% are Severe.

Which agencies issued them

401–494 of 494

HighFDA (Devices)·Z-0313-2018·2018-01-10
Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Mechanism Defect
Smiths Medical ASD Inc. is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.
Product
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood p
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0519-2018·2018-01-10
New Seasons Market Recalls Buttermilk Herb Side Salad for Undeclared Wheat
New Seasons Market is recalling Buttermilk Herb Side Salad because the croutons contain wheat, which is not declared on the label.
Product
Buttermilk Herb Side Salad, prepacked in a clear plastic container, sold by the unit for $2.99, UPC 252326-602998.
Category
Food
Distribution
3 states
HighFDA (Devices)·Z-0315-2018·2018-01-10
Centurion Recalls Convenience Kits Contaminated with Particulate Matter
Centurion Medical Products is recalling specific lots of convenience kits containing BD SafetyGlide needles due to particulate contamination.
Product
SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0305-2018·2018-01-10
Zimmer Biomet Recalls Distal Femoral Knee Implant Due to Labeling Error
Zimmer Biomet is recalling a specific lot of distal femoral knee implant assemblies because the internal patient label may be incorrect, although the product itself is correctly identified.
Product
RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0301-2018·2018-01-10
Zimmer Biomet Recalls CER OPTION TYPE 1 TPR SLEVE -6 Due to Labeling Error
Zimmer Biomet is recalling CER OPTION TYPE 1 TPR SLEVE -6 devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Product
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0297-2018·2018-01-10
Zimmer Biomet Recalls Lateral Troch Plate Due to Labeling Error
Zimmer Biomet is recalling Lateral Troch Plate Full Crimp devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Product
Lateral Troch Plate Full Crimp - 254mm, model # 350838
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0296-2018·2018-01-10
Zimmer Biomet Recalls Lateral Troch Plate Due to Labeling Error
Zimmer Biomet is recalling Lateral Troch Plate Full Crimp units because the internal patient label may be incorrect, though the product itself is correct.
Product
Lateral Troch Plate Full Crimp - 254mm, model # 350837
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0304-2018·2018-01-10
Zimmer Biomet Recalls Femoral Distal Assembly Due to Internal Labeling Error
Zimmer Biomet is recalling specific femoral distal assemblies because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Product
RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0314-2018·2018-01-10
Smiths Medical Medfusion Syringe Infusion Pump Recall for Clamp Loosening
Smiths Medical is recalling Medfusion Syringe Infusion Pumps because a loose clamp mechanism may cause the device to incorrectly alarm for invalid syringe sizes.
Product
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0307-2018·2018-01-10
Smiths Medical CADD-Legacy 1 Pumps Recalled for Serial Number Mismatch
Smiths Medical ASD Inc. is recalling 58 CADD-Legacy 1 Ambulatory Infusion Pumps because the physical label may not match the serial number programmed into the device software.
Product
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0306-2018·2018-01-10
Euro Diagnostica Recalls DIASTAT ANA ELISA Kits Due to Performance Deviation
Euro Diagnostica is recalling 534 DIASTAT ANA ELISA kits (Lot TS 2076) distributed in Minnesota, Nebraska, and Texas because a component deviation may cause false positive results.
Product
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0303-2018·2018-01-10
Zimmer Biomet Recalls OSS Cemented IM Stem Due to Labeling Error
Zimmer Biomet is recalling specific OSS Cemented IM Stem units because the internal patient label may be incorrect, although the outer box and product itself are correctly identified.
Product
OSS CEMENTED IM STEM 12X150, model # 150366
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0299-2018·2018-01-10
Zimmer Biomet Recalls COMP Primary Stem Due to Labeling Error
Zimmer Biomet is recalling COMP Primary Stem 8MM MINI devices because the internal patient label may be incorrect, although the product itself is correctly identified.
Product
COMP PRIMARY STEM 8MM MINI, model # 113628
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0302-2018·2018-01-10
Zimmer Biomet Recalls CER BIOLOXD OPTION HD 32MM Due to Labeling Error
Zimmer Biomet is recalling CER BIOLOXD OPTION HD 32MM implants because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Product
CER BIOLOXD OPTION HD 32MM, model # 650-1056
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0298-2018·2018-01-10
Zimmer Biomet Recalls Hip Fracture Stem Due to Internal Label Error
Zimmer Biomet is recalling specific hip fracture stems because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Product
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0524-2018·2018-01-10
Rapunzel Vegetable Bouillon Recalled for Misleading No Added Salt Label
World Finer Foods is recalling Rapunzel Vegetable Bouillon because the front label claims no added salt, but sea salt is listed in the ingredients.
Product
Rapunzel Vegetable Bouillon ( no added salt ), 2.4 oz. net weight, in a thick paper sleeve containing 8 foil-wrapped bouillon cubes, 12 units per case .
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0300-2018·2018-01-10
Zimmer Biomet Recalls ECHO POR FMRL NC 9X125 Due to Labeling Error
Zimmer Biomet is recalling ECHO POR FMRL NC 9X125 medical devices because the internal patient label may be incorrect, although the outer box and product are correctly identified.
Product
ECHO POR FMRL NC 9X125, model # 192009
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0312-2018·2018-01-10
Zimmer Biomet Recalls PPS RingLoc+ Acetabular Shells Due to Missing Etching
Zimmer Biomet is recalling 15 units of PPS RingLoc+ Acetabular Shells because the product was distributed with missing etching.
Product
PPS RingLoc+ Acetabular Shell, RNGLC+ LTD HOLE SHELL SZ62 The Porous Plasma Spray (PPS) Ringloc¿+ Acetabular System is intended to replace the natural acetabulurn damaged by disease, trauma or revision of previous arthroplasty. The Porous Plasma Spray (PPS) Ringloc¿+ Acetabul
Category
Medical Device
Distribution
3 states
LowFDA (Devices)·Z-0309-2018·2018-01-10
Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk
Beckman Coulter is recalling three Access 2 Immunoassay Systems due to a potential risk of minor skin burns during pipettor alignment.
Product
Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0310-2018·2018-01-10
Beckman Coulter Recalls UniCel DxC 600i Systems Due to Burn Risk
Beckman Coulter is recalling two UniCel DxC 600i SYNCHRON Access Clinical Systems because a tool may contact a board and cause minor skin burns during alignment.
Product
UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
1 state
LowFDA (Devices)·Z-0308-2018·2018-01-10
Beckman Coulter Access 2 Immunoassay System Recalled for Burn Risk
Beckman Coulter is recalling Access 2 Immunoassay Systems due to a potential for minor skin burns if the tool contacts the reagent storage interface board during pipettor alignment.
Product
Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
1 state
SevereNHTSA·18V025000·2018-01-09
Toyota Recalls Yaris, Vibe, and Corolla Matrix for Air Bag Defect
Toyota is recalling 116,126 vehicles due to a defect in passenger frontal air bag inflators that may explode during deployment, posing a risk of serious injury or death.
Product
TOYOTA — TOYOTA, PONTIAC COROLLA MATRIX, VIBE, YARIS
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V016000·2018-01-09
Mazda Recalls 2009 B-Series Trucks Due to Air Bag Inflator Defect
Mazda is recalling 2009 B-Series trucks because the passenger air bag inflator may explode during deployment, posing a risk of serious injury or death.
Product
MAZDA — MAZDA B-SERIES TRUCK
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V032000·2018-01-09
2013 Freightliner and Mercedes-Benz Sprinter Passenger Air Bag Recall
Daimler Vans USA is recalling 2013 Sprinter vans because the passenger air bag inflator may explode during deployment, posing a risk of serious injury or death.
Product
FREIGHTLINER — FREIGHTLINER, MERCEDES-BENZ SPRINTER 3500, SPRINTER 2500
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V012000·2018-01-09
Subaru Recalls Vehicles Due to Passenger Air Bag Inflator Explosion Risk
Subaru is recalling specific 2009-2013 models because passenger air bag inflators may explode during deployment, potentially causing serious injury or death.
Product
SUBARU — SUBARU FORESTER, LEGACY, IMPREZA, TRIBECA
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V014000·2018-01-09
Subaru Recalls 2009 Models Due to Air Bag Inflator Explosion Risk
Subaru is recalling 2009 Forester, Legacy, Impreza, Tribeca, WRX, and Outback vehicles because the passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.
Product
SUBARU — SUBARU FORESTER, LEGACY, IMPREZA, TRIBECA
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V026000·2018-01-09
Hyundai Recalls Sonata and Azera Vehicles for Brake Module Fire Risk
Hyundai is recalling 2006-2011 Azera and 2006 Sonata vehicles because water in the ABS module can cause an electrical short and engine fire.
Product
HYUNDAI — HYUNDAI AZERA, SONATA
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V018000·2018-01-09
Mazda Recalls CX-7, Mazda6, and CX-9 for Air Bag Inflator Defect
Mazda is recalling 2009-2013 CX-7, Mazda6, and CX-9 vehicles because the front passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.
Product
MAZDA — MAZDA CX-7, MAZDA6, CX-9
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V041000·2018-01-09
Honda Recalls Acura RL, Element, and Ridgeline for Air Bag Defect
Honda is recalling specific 2009-2013 Acura RL, Honda Element, and Ridgeline vehicles because the passenger air bag inflator may explode, posing a risk of serious injury or death.
Product
ACURA — ACURA, HONDA RL, RIDGELINE, ELEMENT
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V031000·2018-01-09
Tesla Recalls 2013 Model S Vehicles Due to Air Bag Inflator Defect
Tesla is recalling 17,846 2013 Model S vehicles because the passenger frontal air bag inflators may explode during deployment, posing a risk of serious injury or death.
Product
TESLA — TESLA MODEL S
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V056000·2018-01-09
E-One Emergency Vehicles Recalled for Electrical Fire Risk
E-One is recalling 2005-2010 emergency vehicles because loose electrical connections at the transfer switch may cause excessive heat and increase the risk of a fire.
Product
E-ONE — E-ONE I440, I740, CYCLONE III, CYCLONE II
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V024000·2018-01-09
Toyota Recalls Lexus, Scion, and Toyota Vehicles for Airbag Defect
Toyota is recalling specific 2009-2013 Lexus, Scion, Toyota, and Pontiac vehicles because the passenger airbag inflator may explode during deployment, posing a risk of serious injury or death.
Product
LEXUS — LEXUS, SCION, TOYOTA IS 350C, IS 350, IS 250C, IS 250
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V013000·2018-01-09
Subaru Recalls 2009-2010 Models for Air Bag Inflator Defect
Subaru is recalling 2009-2010 vehicles in 22 states because passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.
Product
SUBARU — SUBARU FORESTER, LEGACY, IMPREZA, TRIBECA
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V042000·2018-01-09
Honda Recalls Vehicles for Air Bag Inflator Explosion Risk
Honda is recalling specific 2009-2013 models because the passenger air bag inflator may explode, potentially causing serious injury or death.
Product
HONDA — HONDA, ACURA PILOT, TSX, TSX SPORT WAGON, ACCORD
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V040000·2018-01-09
Ferrari Recalls 2013 Models Due to Air Bag Inflator Explosion Risk
Ferrari is recalling 1,899 2013 models because passenger air bag inflators may explode during deployment, potentially causing serious injury or death.
Product
FERRARI — FERRARI 458, CALIFORNIA, FF, F12 BERLINETTA
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V045000·2018-01-09
Honda Recalls GL1800 Gold Wing Motorcycles Due to Air Bag Inflator Defect
Honda is recalling 2009-2010 and 2012-2016 GL1800 Gold Wing motorcycles because air bag inflators may explode. Dealers will replace the air bag module free of charge.
Product
HONDA — HONDA GL1800
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V021000·2018-01-09
Chrysler, Dodge, and Ram Vehicles Recalled for Air Bag Inflator Defect
Chrysler is recalling specific 2009-2013 vehicles because the passenger air bag inflator may explode during deployment, posing a risk of serious injury or death.
Product
CHRYSLER — CHRYSLER, DODGE, RAM 300, CHARGER, CHALLENGER, RAM 3500
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V030000·2018-01-09
BMW Recalls X5 and X6 Models Due to Air Bag Inflator Defect
BMW is recalling 2007-2013 X5 and 2009-2013 X6 vehicles because the passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.
Product
BMW — BMW X5, X6
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V020000·2018-01-09
New Flyer Transit Buses Recalled for Air Brake Hose Tightness Issue
New Flyer is recalling 283 transit buses because improperly tightened air brake hoses may disconnect, increasing braking distance and crash risk.
Product
NEW FLYER — NEW FLYER XT60, XN40, XDE60, XDE40
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·18V019000·2018-01-09
E-One Recalls 2013-2017 Emergency Vehicles Due to Starter Defect
E-One is recalling 2013-2017 Quest II, Cyclone II, and Typhoon emergency vehicles because a missing diode may damage the starter lock-out relay, preventing the vehicle from starting.
Product
E-ONE — E-ONE CYCLONE II, QUEST II, TYPHOON
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·18V057000·2018-01-09
E-One Recalls 2001-2002 X-036 and X-113 Emergency Vehicles for Pump Defect
E-One is recalling 2001-2002 X-036 and X-113 emergency vehicles because fire pump manifold end caps may fail, causing sudden water discharge or pressure loss.
Product
E-ONE — E-ONE X-036, X-113
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·18078·2018-01-09
Skip Hop Recalls Tuo Convertible High Chairs Due to Fall Hazard
Skip Hop is recalling Tuo convertible high chairs because the front legs can detach, posing a fall hazard to children.
Product
Tuo Convertible High Chairs
Category
Consumer Product
Distribution
Distributed nationwide
CriticalNHTSA·18V011000·2018-01-08
Land Rover Range Rover Recall for Exploding Passenger Air Bag Inflators
Jaguar Land Rover is recalling 2009-2010 Range Rovers because the passenger air bag inflator may explode during deployment, potentially causing serious injury or death.
Product
LAND ROVER — LAND ROVER RANGE ROVER
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V015000·2018-01-08
Land Rover Recalls Range Rovers for Air Bag Inflator Explosion Risk
Jaguar Land Rover is recalling 2010-2012 Range Rovers because passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.
Product
LAND ROVER — LAND ROVER RANGE ROVER
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V009000·2018-01-08
Jaguar Recalls 2009-2013 XF Models for Air Bag Inflator Defect
Jaguar is recalling 2009-2013 XF vehicles because the front passenger air bag inflators may explode during a crash, potentially causing serious injury or death.
Product
JAGUAR — JAGUAR XF
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V010000·2018-01-08
Jaguar Recalls XF Vehicles Due to Air Bag Inflator Explosion Risk
Jaguar is recalling 2010-2015 XF vehicles because the front passenger air bag inflator may explode during deployment, potentially causing serious injury or death.
Product
JAGUAR — JAGUAR XF
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·18V008000·2018-01-08
Terex Recalls 2015-2017 XT Pro Aerial Devices for Control Defect
Terex is recalling 2015-2017 XT Pro 56 and 60 aerial devices because the platform control enable system may be adjusted incorrectly, increasing injury risk.
Product
TEREX — TEREX XT PRO 60, XT PRO 56
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V007000·2018-01-05
McLaren Recalls 2013 MP4-12C Vehicles Due to Air Bag Inflator Defect
McLaren is recalling 371 2013 MP4-12C vehicles because the passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.
Product
MCLAREN — MCLAREN MP4-12C
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·002-2018·2018-01-05
Crescent City Meats Recalls Underprocessed Ready-to-Eat Tasso Ham Products
Crescent City Meats is recalling approximately 430 pounds of ready-to-eat Tasso Cajun Spicy Ham because the product may be underprocessed and undercooked.
Product
Crescent City Meats — Crescent City Meats Recalls Ready-To-Eat Tasso Ham Products due to Underprocessing
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·18V004000·2018-01-04
Audi Recalls Vehicles Due to Passenger Air Bag Inflator Explosion Risk
Volkswagen Group of America is recalling specific Audi models because passenger air bag inflators may explode during deployment, posing a risk of serious injury or death.
Product
AUDI — AUDI S6, S4 CABRIOLET, A4 CABRIOLET, A6
Category
Vehicle
Distribution
Distributed nationwide
SevereCPSC·18077·2018-01-04
HP Recalls Lithium-Ion Batteries for Notebook Computers and Mobile Workstations
HP is recalling about 50,000 lithium-ion batteries for notebook computers and mobile workstations because they can overheat, posing fire and burn hazards.
Product
Lithium-ion batteries for HP notebook computers and mobile workstations
Category
Consumer Product
Distribution
Distributed nationwide
SevereUSDA FSIS·001-2018·2018-01-04
Hempler Foods Recalls Pepperoni Sticks Due to Possible Metal Contamination
Hempler Foods Group is recalling approximately 4,068 pounds of pepperoni sticks that may contain metal. The recall covers products distributed in Eastern Washington.
Product
Hempler Foods Group LLC — Hempler Foods Group, LLC Recalls Pepperoni Products due to Possible Extraneous Material Contamination
Category
Food
Distribution
1 state
HighNHTSA·18V006000·2018-01-04
Altec Recalls 2010-2011 Knuckle Boom Cranes Due to Bearing Fastener Failure
Altec Industries is recalling 2010-2011 Effer 440 and 470 Knuckle Boom Cranes because rotation bearing fasteners may fail, causing the pedestal to crack and increasing injury risk.
Product
ALTEC — ALTEC 470 KNUCKLE BOOM CRANE, EFFER 440
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·18V005000·2018-01-04
Gulf Stream Recalls 2011-2012 Trailers Due to Fire Extinguisher Defect
Gulf Stream is recalling 2011-2012 recreational trailers because the installed fire extinguishers may clog or detach, potentially failing to discharge or causing injury.
Product
GULF STREAM — GULF STREAM EXECUTIVE RIDGELINE, MAKO, MATRIX, RIDGELINE
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·18713·2018-01-04
SureFit Recalls Riding Lawn Mower Blade Spindle Shafts Due to Impact Hazard
SureFit is recalling about 900 riding lawn mower blade spindle shafts and assemblies because they can break and become projectiles, posing an impact injury risk.
Product
SureFit™ riding lawn mower blade spindle shafts and assemblies
Category
Consumer Product
Distribution
Distributed nationwide
SevereFDA (Food)·F-0528-2018·2018-01-03
Farrell Farms Dark Chocolate Almonds Recalled for Undeclared Milk Allergen
Farrell Farms is recalling Dark Chocolate Almonds due to an undeclared milk allergen. The product was sold online in North Carolina.
Product
Dark Chocolate Almonds, Net Wt.7 oz, Farrell Farms, 200 Gin Road, Goldsboro, NC
Category
Food
Distribution
1 state
SevereFDA (Devices)·Z-0286-2018·2018-01-03
Accuray Hi-Art System Recalled for Uncontrolled Couch Movement
Accuray Incorporated is recalling 250 Hi-Art(R) Systems due to uncontrolled couch Z-axis movement (descent). The affected units are distributed worldwide.
Product
Hi-Art(R) System, Model Number H-000-0003 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other tar
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0143-2018·2018-01-03
SSM St. Clare Recalls Oxytocin IV Bags Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Oxytocin IV bags due to a lack of sterility assurance. No distributed product has been identified as actually containing microorganisms.
Product
Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0903-01
Category
Drug
Distribution
1 state
SevereFDA (Drugs)·D-0144-2018·2018-01-03
SSM St. Clare Recalls Phenylephrine Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling compounded phenylephrine syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.
Product
Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentration: 100 mcg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0104-01
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-0289-2018·2018-01-03
Accuray TomoHDA System Recalled for Uncontrolled Couch Movement
Accuray is recalling 87 TomoHDA radiation therapy systems worldwide due to a defect causing uncontrolled couch descent.
Product
TomoHDA(R) System, Model Number 1018286 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targe
Category
Medical Device
Distribution
0 states
SevereFDA (Drugs)·D-0134-2018·2018-01-03
Simple Diagnostics Recalls Alcohol Prep Pads Due to Sterility Concerns
Simple Diagnostics is recalling 150,250 alcohol prep pads because the company cannot ensure they are sterile and due to cGMP deviations.
Product
Alcohol Prep Pads (Isopropyl Alcohol USP 70% v/v), 100 Individual Pads, Sterile, Distributed by Simple Diagnostics, Winston Park, NY NDC 98302-0001-05
Category
Medical Device
Distribution
0 states
SevereNHTSA·18V003000·2018-01-03
Forest River Recalls 2018 Glaval Legacy Buses for Brake Caliper Defect
Forest River is recalling 2018 Glaval Legacy buses because improperly tightened brake caliper bolts may cause the calipers to detach, reducing braking power and increasing crash risk.
Product
GLAVAL BUS — GLAVAL BUS LEGACY
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0288-2018·2018-01-03
Accuray TomoH System Recalled for Uncontrolled Couch Movement
Accuray is recalling 29 TomoH Systems due to a defect causing uncontrolled couch descent, posing a risk of injury to patients.
Product
TomoH(R) System, Model Number 1018284 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targete
Category
Medical Device
Distribution
0 states
HighFDA (Drugs)·D-0138-2018·2018-01-03
SSM St. Clare Recalls Compounded Fentanyl and Ropivacaine Injectable Bags
SSM St. Clare Health Center is recalling compounded fentanyl and ropivacaine injectable bags due to a lack of sterility assurance. Microbial growth was detected during a routine simulation, though no distributed product was found to contain microorganisms.
Product
Fentanyl 2 mcg/mL and ropivacaine 0.2% in 0.9% Sodium Chloride 150 mL, 150 mL bag, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-4272-01
Category
Drug
Distribution
1 state
HighFDA (Food)·F-0526-2018·2018-01-03
Farrell Farms Dark Chocolate Pecans Recalled for Undeclared Milk Allergen
Farrell Farms is recalling Dark Chocolate Pecans because they contain an undeclared milk allergen. The product was sold online in North Carolina.
Product
Dark Chocolate Pecans Net Wt. 7 oz, Farrell Farms, 200 Gin Road, Goldsboro, NC
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0213-2018·2018-01-03
Sterilmed recalls reprocessed St. Jude Medical Agilis NxT Steerable Introducers
Sterilmed Inc is recalling 112 reprocessed St. Jude Medical Agilis NxT Steerable Introducers due to inadequate seals caused by missing adhesive glue.
Product
St. Jude Medical. Agilis NxT Steerable Introducer: B1-Directional, Medium Curl 22.4 mm, 71 cm, 6.5 F ID; Dilator: 94 cm, 8.5 F; Super Stiff, Guidewire: 180 cm, 0.032". Reprocessed device for single use only, sterile. Product Usage: The reprocessed steerable introducer sheath
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0527-2018·2018-01-03
Farrell Farms Recalls Dark Chocolate Cashews Due to Undeclared Milk Allergen
Farrell Farms is recalling Dark Chocolate Cashews because the product contains milk, which is not declared on the label.
Product
Dark Chocolate Cashews, Net Wt.7 oz, Farrell Farms, 200 Gin Road, Goldsboro, NC
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0142-2018·2018-01-03
SSM St. Clare Recalls Norepinephrine IV Bags Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Norepinephrine IV bags in Missouri due to microbial growth detected during a routine manufacturing simulation.
Product
Norepinephrine 8 mg in dextrose 5% 250 mL, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, , Fenton, MO --- NDC: 88890-0334-01
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-0287-2018·2018-01-03
Accuray TomoHD System Recalled for Uncontrolled Couch Movement
Accuray is recalling 118 TomoHD radiation therapy systems worldwide due to uncontrolled couch descent.
Product
TomoHD(R) System, Model Number 1018283 Product Usage: The TomoTherapy treatment system is intended to be used as an integrated system for t he planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other target
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0291-2018·2018-01-03
Orthofix Power Drill Torque Limiter Recalled Due to Breakage Risk
Orthofix Srl is recalling 416 units of Power Drill Torque Limiters because they may break during surgical use. The devices are used for temporary bone stabilization in lower limb procedures.
Product
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box
Category
Medical Device
Distribution
3 states
HighFDA (Food)·F-0517-2018·2018-01-03
Lovejoy Bakers Rosemary Poppyseed Crackers Recalled for Undeclared Wheat
Lovejoy Bakers Inc. is recalling 6 oz. bags of Rosemary Poppyseed crackers because the ingredients list declares flour but fails to declare wheat.
Product
Rosemary Poppyseed crackers, net wt. 6 oz., packaged in clear poly bag with a twist tie. No UPC code. The label is read in parts: "***Ingredients: Flour, Baking Powder, Salt, Extra Virgin Olive Oil, Fresh Rosemary, Poppyseeds. This bag may contain one or more of the following
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0292-2018·2018-01-03
Philips IntelliVue Patient Monitors Recalled for Distorted ST-Segment Display
Philips is recalling specific IntelliVue patient monitors and measurement servers because they may display distorted ST-segments during 12-lead ECG monitoring.
Product
IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the phys
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0141-2018·2018-01-03
SSM St. Clare Recalls Neostigmine Methylsulfate Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling compounded Neostigmine Methylsulfate syringes because microbial growth was detected during a routine manufacturing simulation. No distributed product has been confirmed to contain microorganisms.
Product
Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-0329-01
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-0295-2018·2018-01-03
Medline Recalls Sterile Elastic Esmark Bandages Due to Sterilization Failure
Medline Industries is recalling 5,722 units of sterile elastic bandages because they may not have been properly sterilized.
Product
Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0270-2018·2018-01-03
L3 Security Cabinet X-ray System Recalled for Shielding Gaps
L3 Security & Detection is recalling 471 Examiner 3DX 6000 cabinet X-ray systems used for airline baggage screening due to shielding gaps that may cause excessive X-ray emissions.
Product
L3 Security & Detection System Cabinet X-ray system used for security screening of checked airline baggage.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0145-2018·2018-01-03
SSM St. Clare Recalls Succinylcholine Chloride Syringes Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded succinylcholine chloride syringes because microbial growth was detected during a routine manufacturing simulation.
Product
Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO --- NDC: 88890-7536-01
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0135-2018·2018-01-03
Bayer Chewable Low Dose Aspirin Recalled for Failed Stability Specifications
Bayer HealthCare Pharmaceuticals is recalling 104,128 bottles of Chewable Low Dose Aspirin 81 mg due to failed stability specifications.
Product
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets, Made in Spain, Distributed by: Bayer Healthcare LLC Morristown, NJ 07962 NDC 0280-2160-36 UPC 3128431310577
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-0290-2018·2018-01-03
Remel Shigella sonnei Agglutinating Serum Recalled for Failure to Agglutinate
Remel Inc is recalling Shigella sonnei Agglutinating Serum because it may fail to agglutinate within the specified minimum reaction time.
Product
Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagnostic purposes.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0137-2018·2018-01-03
SSM St. Clare Recalls Amiodarone Injectable Due to Sterility Concerns
SSM St. Clare Health Center is recalling a specific lot of compounded Amiodarone injectable bags due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.
Product
Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-0333-01
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0136-2018·2018-01-03
SSM St. Clare Recalls Fentanyl Vials Due to Sterility Assurance Concerns
SSM St. Clare Health Center is recalling Fentanyl 10 mcg vials because microbial growth was detected during a routine manufacturing simulation. No distributed product has been identified as containing microorganisms.
Product
Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mcg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88890-9010-81
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0140-2018·2018-01-03
SSM St. Clare Recalls Morphine PCA Cartridges Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Morphine PCA cartridges due to a lack of sterility assurance detected during routine testing.
Product
Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentration: 1 mg/mL, This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88887-6795-01
Category
Drug
Distribution
1 state
ModerateFDA (Drugs)·D-0139-2018·2018-01-03
SSM St. Clare Recalls Hydromorphone PCA Cartridges Due to Sterility Concerns
SSM St. Clare Health Center is recalling specific lots of compounded Hydromorphone PCA cartridges due to a lack of sterility assurance. No distributed product has been confirmed to contain microorganisms.
Product
HYDROmorphone 10 mg in 0.9% Sodium Chloride 50 mL PCA, 50 mL Cartridge, Concentration: 0.2 mg/mL., This is a compounded injectable drug; Rx only; Hospital/office use only. SSM St. Clare Outsourcing Facility, Fenton, MO. --- NDC: 88883-0600-01
Category
Drug
Distribution
1 state
ModerateFDA (Devices)·Z-0285-2018·2018-01-03
Randox HbA1c Reagent Recalled for Low Calibration Absorbance
Randox Laboratories is recalling 90 kits of HbA1c reagent (Batch 414553) due to low calibration absorbance that may affect performance.
Product
Rx series HbA1c REF/Catalog Number HA3830, GTIN 05055273203561, IVD; -- RANDOX LABORATORIES LTD. , This product is suitable for use on RX series instruments which includes the RX Daytona and RX Imola analysers. Packaging Format: HbA1c R1: Antibody Reagent - 3 x 14 ml
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0273-2018·2018-01-03
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides because they may produce biased results when used with citrate plasma specimens.
Product
VITROS Chemistry Products PHYT Slides, REF/CATALOG 829 8671, Rx ONLY, IVD; Ortho-Clinical Diagnostics, Inc. For in vitro diagnostic use only. VITROS Chemistry Products PHYT Slides quantitatively measure phenytoin (PHYT) concentration in serum and plasma using VITROS 250/350/95
Category
Medical Device
Distribution
1 state
LowFDA (Drugs)·D-0131-2018·2018-01-03
Pharmedium Recalls Morphine Sulfate Injection Due to Labeling Errors
Pharmedium Services LLC is recalling specific lots of compounded morphine sulfate injection because the labels may have incorrect or missing lot and expiration dates.
Product
morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL , For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-455-78
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0133-2018·2018-01-03
Auryxia Ferric Citrate Tablets Recalled for Damaged Desiccant Packets
Keryx Biopharmaceuticals is recalling Auryxia (ferric citrate) tablets because damaged silica gel packets may allow desiccant granules to contact the medication.
Product
AURYXIA — AURYXIA (FERRIC CITRATE)
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0130-2018·2018-01-03
Pharmedium Recalls Morphine Sulfate Injection Due to Labeling Errors
Pharmedium Services LLC is recalling morphine sulfate injection due to incorrect or missing lot and expiration dates on the labels.
Product
morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL (2 mg per 2 mL), For IV Use, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-259-28
Category
Drug
Distribution
Distributed nationwide
LowFDA (Drugs)·D-0132-2018·2018-01-03
Pharmedium Recalls Hydromorphone Injection Due to Labeling Errors
Pharmedium Services LLC is recalling Hydromorphone HCl Injection due to incorrect or missing lot and expiration dates.
Product
HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78
Category
Drug
Distribution
Distributed nationwide
CriticalNHTSA·18E003000·2018-01-02
Takata Frontal Passenger Air Bag Inflator Recall for 2009 Vehicles
Takata is recalling specific 2009 model year air bag inflators that may explode due to propellant degradation. This affects vehicles registered in 22 specific states.
Product
AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE recall
Category
Vehicle
Distribution
Distributed nationwide
CriticalNHTSA·18E002000·2018-01-02
Takata Frontal Passenger Air Bag Inflator Recall for 2010 Vehicles
Takata is recalling specific frontal passenger air bag inflators in 2010 vehicles registered in 22 states and D.C. due to a risk of explosion causing serious injury or death.
Product
AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18E001000·2018-01-02
Takata Frontal Passenger Air Bag Inflator Recall for 2013 Vehicles
Takata is recalling specific 2013 model year air bag inflators in 13 states and territories due to a risk of explosion from propellant degradation.
Product
AIR BAGS:FRONTAL:PASSENGER SIDE:INFLATOR MODULE recall
Category
Vehicle
Distribution
Distributed nationwide
SevereNHTSA·18V002000·2018-01-02
Forest River Recalls 2018 Surveyor Trailers Due to Fire Risk
Forest River is recalling 2018 Surveyor recreational trailers because an incorrect circuit breaker can cause wiring to melt, increasing the risk of a fire.
Product
FOREST RIVER — FOREST RIVER SURVEYOR
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·18V001000·2018-01-02
Erwin Hymer Recalls Motorhomes With Defective Fire Extinguishers
Erwin Hymer is recalling 2012-2018 motorhomes because the installed fire extinguishers may clog and fail to discharge properly.
Product
ROADTREK — ROADTREK, CARADO, SUNLIGHT ZION, RS ADVENTUROUS, BANFF, AXION
Category
Vehicle
Distribution
Distributed nationwide
HighCPSC·18076·2018-01-02
Comfort Research Recalls Ultra Lounge Bean Bag Chair Covers
Comfort Research is recalling about 1,200 Ultra Lounge bean bag chair covers due to risks of entrapment and suffocation to children.
Product
Ultra Lounge bean bag chair covers
Category
Consumer Product
Distribution
Distributed nationwide

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