The Recall Desk

Archive

September 2018 recalls

633 recalls were announced in September 2018.

What the numbers show

Critical
19
Severe
188
High
305
Moderate
102
Low
19

Of the 633 recalls this month scored against our rubric, 3% are Critical, 30% are Severe.

Which agencies issued them

401–500 of 633

  • SevereFDA (Devices)·Z-2961-2018·2018-09-12

    Bayer Overhead Counterpoise Systems Recalled for Potential Structural Failure

    Bayer Medical Care is recalling one Overhead Counterpoise System unit due to potential overtightening of bolts that could compromise structural integrity.

    Product
    Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with Bayer injector systems as a support for an injector head. , SHORT CEIL MNT, STD HORZ ARM, Catalog # OCS 115AS, Material Number 59880288
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Food)·F-1931-2018·2018-09-12

    El Guapo Jamaica Hibiscus Flowers Recalled for Undeclared Allergen

    Mojave Foods Corp. is recalling El Guapo Jamaica Hibiscus Flowers in various pouch sizes due to an undeclared allergen.

    Product
    El Guapo Jamaica Hibiscus Flowers in flexible pouches , 1 oz., 2 oz., 8 oz., 16 oz., and 10 lb. box .
    Category
    Food
    Distribution
    13 states
  • HighFDA (Food)·F-1949-2018·2018-09-12

    Sammy Salsa Recalled for Potential Cyclospora Contamination

    Sammy Food Products LLC is recalling Sammy Salsa Happy Medium due to potential Cyclospora contamination from cilantro.

    Product
    Sammy Salsa Happy Medium, packaged in 14 oz. plastic container, 6 units per case. UPC # 00868422000110. The label is read in parts: "***INGREDIENTS: Fresh Tomatoes, Fresh Onions, Fresh Chili Peppers, Fresh Cilantro, Fresh Garlic, Fresh Lime, Vinegar, Whole Peeled Tomatoes (ca
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1935-2018·2018-09-12

    Caito Foods Recalls Small Garden Salad Due to Cyclospora Contamination

    Caito Foods LLC is recalling Small Garden Salad because an ingredient tested positive for Cyclospora. The product was distributed in Michigan, Indiana, and California.

    Product
    Small Garden Salad, 9.3 oz. UPC 0081851402182
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1944-2018·2018-09-12

    Caito Foods Recalls Greek Salad with Greek Feta Dressing Due to Cyclospora

    Caito Foods LLC is recalling 11 oz. Greek Salad with Greek Feta Dressing because an ingredient tested positive for Cyclospora. The product was distributed in Michigan, Indiana, and California.

    Product
    Greek Salad with Greek Feta Dressing, 11 oz. UPC 0826766141081
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1939-2018·2018-09-12

    Caito Foods Recalls Small Caesar Salad Due to Cyclospora Contamination

    Caito Foods LLC is recalling Small Caesar Salad because an ingredient tested positive for Cyclospora. The product was distributed in Michigan, Indiana, and California.

    Product
    Small Caesar Salad, 7.6 oz. UPC 0081851402243
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2992-2018·2018-09-12

    Hitachi VidiStar PACS Software Recalled for Potential Image Mix-Up

    Hitachi is recalling VidiStar PACS software versions 3.10.5 and 3.10.6 because a defect may cause images from multiple patients to appear in a single study.

    Product
    VidiStar(TM) PACS & DICOM Viewer Software system
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-1934-2018·2018-09-12

    Caito Foods Recalls Garden Highway Greek Salad Due to Cyclospora

    Caito Foods LLC is recalling Garden Highway Mt. Olympus Greek Salad because an ingredient tested positive for Cyclospora.

    Product
    Garden Highway Mt. Olympus Greek Salad, 8 oz. UPC 0826766009374
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2984-2018·2018-09-12

    GE LOGIQ 9 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling 12,426 LOGIQ 9 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.

    Product
    GE LOGIQ 9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1942-2018·2018-09-12

    Caito Foods Recalls Vegetable Garden Salad Due to Cyclospora Contamination

    Caito Foods LLC is recalling Delish Vegetable Garden Salad because an ingredient tested positive for Cyclospora. The product was distributed in Michigan, Indiana, and California.

    Product
    Delish Vegetable Garden Salad, 10.5 oz. UPC 49022542426
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1952-2018·2018-09-12

    Sammy Salsa Roasted Cabo Verde Recalled for Potential Cyclospora Contamination

    Sammy Food Products LLC is recalling 10 cases of Roasted Cabo Verde salsa due to potential Cyclospora contamination from cilantro. The product was distributed in Oregon and Washington.

    Product
    Sammy Salsa Roasted Cabo Verde, packaged in 14 oz. plastic container, 6 units per case. UPC # 00868422000141. The label is read in parts: "***Roasted Tomatillos, Roasted Onion, Roasted Chile Peppers, Roasted Garlic, Fresh Cilantro, Fresh Lime, Water, Organic Vegetable Stock (w
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1937-2018·2018-09-12

    Caito Foods Recalls Large Caesar Salad Due to Cyclospora Ingredient

    Caito Foods LLC is recalling Large Caesar Salad because an ingredient tested positive for Cyclospora. The product was distributed in Michigan, Indiana, and California.

    Product
    Large Caesar Salad, 11.2 oz. UPC 0081851402199
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2987-2018·2018-09-12

    GE Vivid E90 Ultrasound System Recalled for Electrical Shock Risk

    GE Medical Systems is recalling Vivid E90 ultrasound systems because the power cord may break and expose electrical conductors, posing a risk of shock.

    Product
    GE Vivid E90 ultrasound system Product Usage: Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1943-2018·2018-09-12

    Caito Foods Recalls Delish Greek Salad Due to Cyclospora Contamination

    Caito Foods LLC is recalling Delish Greek Salad because an ingredient tested positive for Cyclospora. The product was distributed in Michigan, Indiana, and California.

    Product
    Delish Greek Salad, 10.5 oz. UPC 0049022549296
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1938-2018·2018-09-12

    Caito Foods Recalls Large Garden Salad Due to Cyclospora Ingredient

    Caito Foods LLC is recalling Large Garden Salad because an ingredient tested positive for Cyclospora. The product was distributed in Michigan, Indiana, and California.

    Product
    Large Garden Salad, 14.1 oz. UPC 0081851402229
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2988-2018·2018-09-12

    GE Vivid E95 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling 12,426 Vivid E95 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.

    Product
    GE Vivid E95 ultrasound system Product The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pedia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1951-2018·2018-09-12

    Sammy Salsa Smok'n Chipotle Recalled for Potential Cyclospora Contamination

    Sammy Food Products LLC is recalling 17 cases of Smok'n Chipotle salsa due to potential Cyclospora contamination from cilantro.

    Product
    Sammy Salsa Smok'n Chipotle, packaged in 14 oz. plastic container, 6 units per case. UPC # 00868422000134. The label is read in parts: "***INGREDIENTS: ***Fresh Tomatoes, Fresh Onions, Fresh Chile Peppers, Fresh Cilantro, Fresh Garlic, Fresh Lime, Whole Peeped Tomatoes (calciu
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1950-2018·2018-09-12

    Sammy Salsa Pleasantly Mild Recalled for Potential Cyclospora Contamination

    Sammy Food Products LLC is recalling 36 cases of Sammy Salsa Pleasantly Mild due to potential Cyclospora contamination from cilantro.

    Product
    Sammy Salsa Pleasantly Mild, packaged in 14 oz. plastic container, 6 units per case. UPC 00868422000127. The label is read in parts: "***INGREDIENTS: Fresh Tomatoes, Fresh Onioins, Fresh Chile Peppers, Fresh Cilantro, Fresh Lime, Whole Peeled Tomatoes (Calcium Chloride, citri
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-2976-2018·2018-09-12

    Medline Recalls Art-Line Surgery Packs Due to Non-Sterile Component

    Medline is recalling 3,000 Art-Line Surgery Packs because a non-sterile CHG disk was attached to the outside of the sterile packaging, posing a potential infection risk.

    Product
    Art-Line Surgery Pack-LF, STERILE, 40 packs each per case.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2983-2018·2018-09-12

    GE LOGIQ E9 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling 12,426 LOGIQ E9 ultrasound systems because the power cord side may break, exposing electrical conductors and creating a risk of electric shock.

    Product
    GE LOGIQ E9 ultrasound system Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral V
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2977-2018·2018-09-12

    Medline Recalls Sterile PICC Trays Due to Non-Sterile Component

    Medline Industries is recalling sterile PICC trays because a non-sterile component was attached to the outside of the packaging, posing a potential infection risk.

    Product
    PICC Tray, STERILE, 12 packs each per case.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2989-2018·2018-09-12

    GE Vivid 7 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling 12,426 Vivid 7 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.

    Product
    GE Vivid 7 ultrasound system Product Usage: Vivid E7 is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal/Obstetrics; Abdominal (i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2986-2018·2018-09-12

    GE Vivid E80 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling Vivid E80, E90, and E95 ultrasound systems because the power cord may break and expose electrical conductors, creating a shock hazard.

    Product
    GE Vivid E80 ultrasound system Vivid E80 / E90 / E95 ultrasound system is general-purpose ultrasound systems, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of fetal/Obstetr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2959-2018·2018-09-12

    Steris Recalls V-PRO Low Temperature Sterilization Systems Due to Sterilant Expiration Defect

    Steris Corporation is recalling 2,889 V-PRO low temperature sterilization systems because they may fail to detect expired sterilant cups after a power cycle.

    Product
    AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems The V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Systems, using VAPROX HC Sterilant, are intended for use in the terminal Sterilization of properly prepared (cleaned, rinsed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2985-2018·2018-09-12

    GE Vivid E9 Ultrasound System Recalled for Power Cord Shock Risk

    GE Medical Systems is recalling 12,426 Vivid E9 ultrasound systems because the power cord may break and expose electrical conductors, posing a risk of electric shock.

    Product
    GE Vivid E9 ultrasound system Product Usage: GE Vivid E9 ultrasound system is a general purpose ultrasound system for use in cardiac imaging. It is intended for use by, or under direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1945-2018·2018-09-12

    Caito Foods Recalls deLish Garden Side Salad Due to Cyclospora

    Caito Foods LLC is recalling deLish Garden side salad because an ingredient tested positive for Cyclospora. The product was distributed in Michigan, Indiana, and California.

    Product
    deLish Garden side salad NET WT. 10.5 oz (298g), UPC: 0049022650619
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1940-2018·2018-09-12

    Caito Foods Recalls Vegetable Garden Salad Due to Cyclospora Contamination

    Caito Foods LLC is recalling 8 oz Vegetable Garden Salad because an ingredient tested positive for Cyclospora. The product was distributed in Michigan, Indiana, and California.

    Product
    Vegetable Garden Salad, 8 oz. UPC 0081851223497
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2968-2018·2018-09-12

    McKesson Cardiology Hemo Software Recalled for Signal Display Issues

    McKesson Israel Ltd. is recalling McKesson Cardiology Hemo software version 13.0 because the Real Time Monitor may fail to display physiological signals under certain circumstances.

    Product
    McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytic
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2982-2018·2018-09-12

    Alden Optical Recalls Zen RC Toric Contact Lenses with Incorrect Contents

    Alden Optical is recalling Zen RC Toric contact lenses because vials labeled for specific prescriptions contained incorrect lenses.

    Product
    Zen RC Toric-Gas permeable contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx)as follows: Zen RC TPC (Toric Peripheral Curve) Zen RC FT (Front Toric Optics) Catalog Number: AOZNT Zenlens Toric - Zenlens contact lenses are indicated for daily wear for the corr
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Food)·F-1932-2018·2018-09-12

    Virtus Pharmaceuticals Recalls Virt-Nate and Virt Gard Tablets for Labeling Error

    Virtus Pharmaceuticals is recalling Virt-Nate and Virt Gard Tablets because the labels do not reflect the correct amount of Dietary Folate Equivalents.

    Product
    Virt-Nate Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
    Category
    Drug
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2966-2018·2018-09-12

    Exactech Recalls Tibial Alignment Guides Due to Incorrect GTIN Labeling

    Exactech is recalling 7 Tibial Alignment Guides because the Global Trade Item Number (GTIN) printed on the devices is incorrect.

    Product
    Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Drugs)·D-1183-2018·2018-09-12

    Akorn Recalls Ethosuximide Capsules Due to Impurity Failures

    Akorn, Inc. is recalling Ethosuximide Capsules, 250 mg, due to out-of-specification results for an unspecified impurity.

    Product
    Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2969-2018·2018-09-12

    Inspire II Implantable Pulse Generator Recalled for Incorrect Use-By Date

    Inspire Medical Systems is recalling 93 Inspire II Implantable Pulse Generators because the device registration labels contain an incorrect use-by date.

    Product
    Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients wit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2967-2018·2018-09-12

    Encore Medical Recalls Foundation Modular Femoral Stem for Lack of Clearance

    Encore Medical is recalling 12 units of the Foundation Modular Femoral Stem because the device lacks FDA clearance.

    Product
    Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.
    Category
    Medical Device
    Distribution
    6 states
  • ModerateFDA (Devices)·Z-2974-2018·2018-09-12

    Quasar MD Plus Light Therapy System Recalled for Uncleared Claims

    Quasar Bio-Tech, Inc. is recalling the Quasar MD Plus Light Therapy System because the packaging and user manuals contain claims for collagen and elastin production that were not cleared by the FDA.

    Product
    Quasar MD Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2965-2018·2018-09-12

    Zimmer Biomet Recalls 2.5mm Orthopedic Pegs Due to Packaging Error

    Zimmer Biomet is recalling 2.5mm orthopedic pegs because a larger 22mm peg was found in the package. The error affects 25 units distributed to Japan and the Netherlands.

    Product
    Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstruct
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2981-2018·2018-09-12

    Alden Optical Recalls Zenlens Toric Contact Lenses Due to Labeling Errors

    Alden Optical is recalling 36 vials of Zenlens Toric-Gas Permeable Contact Lenses because the vials contained incorrect lenses for the prescriptions labeled on them.

    Product
    Zenlens Toric-Gas Permeable Contact lenses for Daily Wear in a 10-cc polycarbonate vial (Rx) as follows: Zenlens FT(Front Toric); Zenlens Toric-Zenlens FT + MV (Front Toric+Microvault); Zenlens TPC-(Toric Peripheral Curve); Zenlens TPC + FT- (Toric Peripheral Curve + FrontTor
    Category
    Medical Device
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-2975-2018·2018-09-12

    Quasar Pure Rayz Light Therapy System Recalled for Uncleared Claims

    Quasar Bio-Tech is recalling 6,783 Pure Rayz Light Therapy Systems because the packaging and manuals make claims about collagen and elastin production that were not cleared by the FDA.

    Product
    Pure Rayz, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-1933-2018·2018-09-12

    Virtus Pharmaceuticals Recalls Virt-Nate and Virt Gard Tablets for Labeling Error

    Virtus Pharmaceuticals is recalling Virt-Nate and Virt Gard tablets because the labels do not reflect the correct amount of Dietary Folate Equivalents.

    Product
    Virt Gard Tablets, Number of units per package: 100 Tablets Package Type: 100 Tablets/Bottle
    Category
    Food
    Distribution
    26 states
  • ModerateFDA (Devices)·Z-2973-2018·2018-09-12

    Quasar Bio-Tech Recalls Baby Quasar Plus Light Therapy System

    Quasar Bio-Tech is recalling the Baby Quasar Plus Light Therapy System because it lacks FDA clearance for specific collagen and elastin claims.

    Product
    Baby Quasar Plus, Light Therapy System, packaging, box, sleeve and user manual. Handheld Wrinkles Reduction Device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1220-2018·2018-09-12

    AutoDELFIA Neonatal IRT Kit Recalled for Missing Quality Control Certificate Information

    PerkinElmer is recalling AutoDELFIA Neonatal IRT kits because missing quality control certificate information may delay reporting of IRT results.

    Product
    AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-2963-2018·2018-09-12

    Zimmer Dental Implants Recalled for Incorrect Inner Package Labeling

    Zimmer Dental Inc. is recalling 299 units of Tapered Screw-Vent Implants because the inner package labels display incorrect item, lot, and size information.

    Product
    Outer Package Label: Tapered Screw-Vent Implant System, 4.1mm X 10mm, 3.5mm, REF:TSVM4B10, Sterile:R, Rx Only; Inner Package Label: Implant, MTX, 3.7mm x 10mm,3.5mm, REF: TSVB10. Zimmer Dental Implants are designed for use in the maxilla or mandible for immediate loading or
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·078-2018·2018-09-11

    CTI Foods Recalls Ready-to-Eat Philly Beef Steak for Listeria Risk

    CTI Foods LLC is recalling approximately 6,720 pounds of ready-to-eat Philly Beef Steak products due to possible Listeria monocytogenes contamination.

    Product
    CTI Foods LLC. — CTI Foods LLC Recalls Ready-To-Eat Philly Steak Products Due to Possible Listeria Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V608000·2018-09-11

    Mercedes-Benz Recalls 2018 C-Class Models Due to Rear Window Bonding Defect

    Mercedes-Benz is recalling 2018 C300, C300 4MATIC, C63 AMG, and C63S AMG vehicles because incorrect rear window bonding may cause the glass to detach, creating a road hazard.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, MERCEDES BENZ AMG C63S, C 300 4MATIC, C 300, AMG C63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V612000·2018-09-11

    Ford Recalls 2018 Edge and Lincoln MKX for Door Striker Bolt Defect

    Ford is recalling 2018 Ford Edge and Lincoln MKX vehicles because shorter-than-intended door striker bolts may cause doors to open in a crash, increasing injury risk.

    Product
    FORD — FORD, LINCOLN EDGE, MKX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18219·2018-09-11

    Jimco Recalls Bistro Chairs Due to Seat Breakage and Fall Hazard

    Jimco is recalling about 16,000 outdoor folding bistro chairs because the seats can break, posing a fall hazard. Consumers should stop using the chairs and contact the company for a refund.

    Product
    Bistro chairs
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V613000·2018-09-11

    Ferrara Recalls 2017-2019 Emergency Vehicles for Brake Light Defect

    Ferrara is recalling 2017-2019 emergency vehicles because Whelen accessory brake lights may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    FERRARA — FERRARA INTRUDER, CINDER, ULTRA, IGNITER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V607000·2018-09-11

    Mercedes-Benz Recalls 2018 AMG S63 and S65 for Lane Keeping Software Defect

    Mercedes-Benz is recalling 2018 AMG S63 and S65 vehicles because the Active Lane Keeping Assist software may fail to intervene during unintended lane departures above 65 mph.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG S63, AMG S65
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V606000·2018-09-11

    E-One Recalls 2017-2019 Emergency Vehicles Due to Brake Light Wiring Defect

    E-One is recalling 2017-2019 Typhoon, Cyclone II, and Quest II emergency vehicles because Whelen accessory brake lights may illuminate without the brake pedal being pressed.

    Product
    E-ONE — E-ONE TYPHOON, QUEST II, CYCLONE II
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V610000·2018-09-11

    Mercedes-Benz Recalls 2018 GLC Models for Incorrect Turn Signal Color

    Mercedes-Benz is recalling 2018 GLC models because the front turn signals may be pink or violet instead of the required color, potentially reducing visibility to other drivers.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLC 350 E, GLC 300, AMG GLC43
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18E089000·2018-09-11

    Sunright Recalls Rodia Motorcycle Helmets Due to Chin Strap Defect

    Sunright is recalling Rodia RHD200 and RHD200V motorcycle helmets because the chin strap may stretch in a crash, allowing the helmet to separate from the rider's head.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V611000·2018-09-11

    Coach and Equipment Transit Buses Recalled for Wheelchair Lift Defect

    Coach and Equipment is recalling certain transit buses because a wheelchair lift component may fail, allowing the platform to rise too high and increasing injury risk.

    Product
    COACH AND EQUIPMENT — COACH AND EQUIPMENT PHOENIX, METRO LITE, CONDOR LT, PEGASUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V609000·2018-09-11

    Mercedes-Benz Recalls 2018 AMG E63S Due to Seat Adjustment Defect

    Mercedes-Benz is recalling 2018 AMG E63S vehicles because the front passenger seat may adjust beyond its intended limit, increasing injury risk in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG E63S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18218·2018-09-11

    BlueStar and Big Chill Gas Ranges Recalled for Burn Hazard

    Prizer-Painter Stove Works is recalling BlueStar and Big Chill gas ranges and wall ovens because the convection fan can cause gas ignition and burns.

    Product
    BlueStar and Big Chill gas ranges and wall ovens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18220·2018-09-11

    Emerson Recalls RIDGID Wet/Dry Vacuums Due to Shock Hazard

    Emerson Tool Company is recalling RIDGID wet/dry vacuums because the on/off switch can dislodge, exposing energized wiring and posing a shock hazard.

    Product
    RIDGID® NXT HD06000 and HD09000 wet/dry vacuums
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18766·2018-09-11

    John Deere Recalls Gator Utility Vehicles Due to Throttle Crash Hazard

    John Deere is recalling about 4,700 Gator utility vehicles because powertrain hardware can come loose, causing the throttle to stick and preventing the operator from stopping the vehicle.

    Product
    John Deere XUV590 and XUV590 S4 Gator™ utility vehicles
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V603000·2018-09-10

    Turtle Top Transit Buses Recalled for Wheelchair Lift Cam Failure

    Turtle Top is recalling 2013-2018 Odyssey, VanTerra, and Terra Transit buses because a wheelchair lift cam may fail, allowing the platform to rise too high.

    Product
    TURTLE TOP — TURTLE TOP VANTERRA, ODYSSEY, TERRA TRANSIT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V592000·2018-09-10

    Ford Recalls 120V Charge Cords for Fire Risk

    Ford is recalling 120V convenience charge cords for 2012-2015 C-Max, Fusion, and Focus Electric vehicles because they lack thermistors, creating a fire risk.

    Product
    FORD — FORD FUSION HYBRID, FOCUS ELECTRIC, C-MAX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V585000·2018-09-08

    Trailstar Recalls 2019 Dump Trailers Due to Wheel Separation Risk

    Trailstar is recalling 2019 Dump trailers because improperly installed wheel end nuts may cause the wheel to separate from the axle, increasing crash risk.

    Product
    TRAILSTAR — TRAILSTAR DUMP TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V602000·2018-09-08

    REV Recalls 2017-2018 Ambulances with Whelen Brake Light Wiring Defect

    REV Ambulance Group is recalling 2017-2018 ambulances equipped with Whelen accessory brake lights that may illuminate without the brake pedal being pressed.

    Product
    ROAD RESCUE — ROAD RESCUE, MARQUE, MCCOY MILLER TYPE III, TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V601000·2018-09-07

    Nissan Recalls Murano, Maxima, Pathfinder, and QX60 for Brake Fire Risk

    Nissan is recalling specific 2015-2018 Murano, Maxima, Pathfinder, and 2017 QX60 vehicles because brake fluid leaks may cause electrical shorts and fires.

    Product
    NISSAN — NISSAN, INFINITI MURANO, QX60, MAXIMA, PATHFINDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V598000·2018-09-07

    Navistar Recalls 2019 IC Bus School Buses Due to Brake Defect

    Navistar is recalling 2019 IC Bus CE and RE school buses because a parking brake component may be improperly crimped, causing air leaks and increased stopping distances.

    Product
    IC BUS — IC BUS CESB, RESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V599000·2018-09-07

    Honda Recalls 2017 Acura NSX for Brake Light Circuit Defect

    Honda is recalling 793 2017 Acura NSX vehicles because road vibrations may loosen screws, causing the center brake light to fail and increasing crash risk.

    Product
    ACURA — ACURA NSX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V597000·2018-09-07

    Navistar Recalls 2019 International and IC Bus Vehicles for Brake Defect

    Navistar is recalling 2,089 2019 International and IC Bus vehicles because a brake chamber defect may cause air leaks, increasing stopping distance and crash risk.

    Product
    INTERNATIONAL — INTERNATIONAL, IC BUS LT, HX, WORKSTAR, DURASTAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V595000·2018-09-07

    GM Recalls 2014-2016 Cadillac CTS for Seat Heater Fire Risk

    General Motors is recalling 2014-2016 Cadillac CTS vehicles because damaged front seat heaters may overheat and cause a fire when the car is remotely started.

    Product
    CADILLAC — CADILLAC CTS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V594000·2018-09-07

    AEV Traumahawk Ambulances Recalled for Brake Light Wiring Defect

    Halcore Group is recalling 2017-2018 AEV Traumahawk ambulances because Whelen accessory brake lights may illuminate without the brake pedal being pressed, potentially confusing other drivers.

    Product
    AEV — AEV TRAUMAHAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V586000·2018-09-07

    GM Recalls 2015 SUVs and Trucks for Electric Power Steering Software Issue

    General Motors is recalling 2015 Chevrolet, GMC, and Cadillac vehicles because electric power steering assist may momentarily be lost and then suddenly return, increasing crash risk.

    Product
    GMC — GMC, CADILLAC, CHEVROLET SIERRA 1500, ESCALADE, TAHOE, SUBURBAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateNHTSA·18V596000·2018-09-07

    Micro Bird Recalls 2018 School Buses for Missing Seat Warning Labels

    Micro Bird is recalling 252 2018 MB II school buses because certain child restraint seats are missing warning labels, which may lead to improper use and injury.

    Product
    MICRO BIRD — MICRO BIRD MB II SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V593000·2018-09-06

    Nissan Recalls 2019 Infiniti QX50 for Knee Air Bag Cover Defect

    Nissan is recalling 2019 Infiniti QX50 vehicles because the passenger-side knee air bag cover may separate unexpectedly in cold crashes, increasing injury risk.

    Product
    INFINITI — INFINITI QX50
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1853-2018·2018-09-05

    Marsee Foods Recalls Cafe YUMM! Ginger Spice Cookies for Undeclared Peanuts

    Marsee Foods Inc is recalling Cafe YUMM! Ginger Spice Cookies because they may contain undeclared peanuts. The affected cookies were sold in Oregon and Washington.

    Product
    Ginger Spice Cookies, brand Cafe YUMM! Product is packaged in shrink wrapped master case. Each master case contains two boxes and each box contains 24 cookies. The master case is taped shut and labeled with the contents and production date, along with a lot code. The label
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Food)·F-1854-2018·2018-09-05

    Marsee Foods Recalls Oatmeal Raisin Cookies for Undeclared Peanuts

    Marsee Foods is recalling Oatmeal Raisin Cookies sold at Cafe YUMM! restaurants in Oregon and Washington because they may contain undeclared peanuts.

    Product
    Oatmeal Raisin Cookies, brand Cafe YUMM! Product is packaged in shrink wrapped master case. Each master case contains two boxes and each box contains 24 cookies. The master case is taped shut and labeled with the contents and production date, along with a lot code. The lab
    Category
    Food
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-0004-2019·2018-09-05

    Living Well Remedies Weight Away Remedy Recalled for Microbial Contamination

    Living Well Remedies is recalling Weight Away Remedy spray bottles due to out-of-specification microbial results.

    Product
    Living Well Remedies Weight Away Remedy, 2 fl oz (59 mL) Distributed by Living Well Remedies, LLC P.O. Box 704, Franklin Lakes, NJ 07417 www.LivingWellRemedies.com. Made in the USA
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1145-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active ingredient.

    Product
    Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2878-2018·2018-09-05

    Biosense Webster Recalls WaveCrest Left Atrial Appendage Occlusion System Devices

    Biosense Webster is recalling 25 units of the WaveCrest Left Atrial Appendage Occlusion System (32 mm) because the delivery sheath may buckle during recapture.

    Product
    WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numbers WCR1523 and WCR2523.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1167-2018·2018-09-05

    Auro Pharmacies Recalls Methyl-Cobalamin Injectable Due to Sterility Concerns

    Auro Pharmacies is recalling 74 vials of Methyl-Cobalamin injectable because the manufacturer could not assure the sterility of the product.

    Product
    Methyl-Cobalamin injectable, 2 mg/mL, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1149-2018·2018-09-05

    Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 355 vials of Human Chorionic Gonadotropin 20000 IU due to a lack of assurance of sterility.

    Product
    Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1136-2018·2018-09-05

    Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity

    Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 320mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets USP, 320mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-070-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1150-2018·2018-09-05

    Pharmcore Recalls Human Chorionic Gonadotropin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 3,070 vials of Human Chorionic Gonadotropin 2500 IU due to a lack of assurance of sterility. The recall is nationwide.

    Product
    Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1137-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine and Valsartan Tablets Due to Carcinogen Impurity

    Torrent Pharma Inc. is recalling Amlodipine and Valsartan Tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-204-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1153-2018·2018-09-05

    Pharmcore Recalls Ipamorelin Vials Due to Sterility Assurance Concerns

    Pharmcore Inc. is recalling Ipamorelin 3 mg vials because the company cannot ensure the product is sterile.

    Product
    Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1132-2018·2018-09-05

    AvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    AvKARE, Inc. is recalling specific lots of Valsartan Tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient used to manufacture the drug.

    Product
    Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-785-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·075-2018·2018-09-05

    Caito Foods Recalls Chicken Salad for Undeclared Walnut Allergen

    Caito Foods is recalling 242 pounds of chicken salad containing undeclared walnuts. The products were distributed to retail locations in four states.

    Product
    Caito Foods, LLC — Caito Foods, LLC Recalls Chicken Salad Products due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-1155-2018·2018-09-05

    Pharmcore Recalls Ipamorelin Vials Due to Sterility Assurance Concerns

    Pharmcore Inc. is recalling 599 vials of Ipamorelin 9 mg because the company cannot assure the sterility of the product.

    Product
    Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1135-2018·2018-09-05

    Torrent Pharma Recalls Valsartan Tablets Due to Carcinogen Impurity

    Torrent Pharma Inc. is recalling specific batches of Valsartan Tablets USP, 160mg, because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets USP, 160mg, 90 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-069-90
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1142-2018·2018-09-05

    Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity

    Torrent Pharma Inc. is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1154-2018·2018-09-05

    Pharmcore Recalls Methylcobalamin Vials Due to Sterility Concerns

    Pharmcore Inc. is recalling 1,115 vials of Methylcobalamin 10 mg due to a lack of assurance of sterility. The product was distributed nationwide.

    Product
    Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach, FL 33009
    Category
    Drug
    Distribution
    Distributed nationwide

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