The Recall Desk

Archive

July 2018 recalls

502 recalls were announced in July 2018.

What the numbers show

Critical
34
Severe
167
High
225
Moderate
62
Low
14

Of the 502 recalls this month scored against our rubric, 7% are Critical, 33% are Severe.

1–100 of 502

  • SevereCPSC·18755·2018-07-31

    Matrix Fitness Ascent Trainers and Ellipticals Recalled for Fire Hazard

    Johnson Health Tech is reannouncing a recall of Matrix fitness machines due to a fire hazard caused by moisture buildup in the power socket.

    Product
    Ascent Trainer® by Matrix and Matrix fitness elliptical
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18V504000·2018-07-31

    Cummins Recalls 2015-2018 Generator Sets Due to Wiring Defect

    Cummins is recalling 2015-2018 generator sets because incorrect wiring may prevent the remote emergency stop from functioning, increasing injury risk.

    Product
    CUMMINS POWER GENERATION — CUMMINS POWER GENERATION GENERATOR SET
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V510000·2018-07-31

    Heartland Sundance XLT TT Recalled for Incorrect Tire Load Rating

    Heartland is recalling 2018 Sundance XLT TT trailers equipped with incorrect Load Range C tires. Owners should contact dealers to replace them with correct Load Range D tires.

    Product
    HEARTLAND — HEARTLAND SUNDANCE XLT TT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V498000·2018-07-30

    Thor Motor Coach Recalls 2018 Ace RVs Due to LP Hose Fire Risk

    Thor Motor Coach is recalling 167 2018 Ace recreational vehicles because a rubber liquid propane hose may sag and contact the tire, creating a fire risk.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH ACE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V499000·2018-07-30

    Keystone Recalls 2019 Summerland Trailers Due to Propane Bracket Defect

    Keystone is recalling 2019 Summerland recreational trailers because the propane bottle brackets may break, allowing the cylinder to detach and increasing the risk of injury or crash.

    Product
    KEYSTONE — KEYSTONE SUMMERLAND
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E070000·2018-07-30

    TAP Recalls G2 Axle Housings Due to Potential Weld Failure

    TAP Worldwide is recalling G2 Axle and Gear aftermarket axle housings because weak welds may allow the axle tube to rotate, increasing crash risk.

    Product
    POWER TRAIN:AXLE ASSEMBLY recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E066000·2018-07-30

    TAP Pro Comp Aftermarket Control Arms Recalled for Detachment Risk

    TAP Worldwide is recalling specific Pro Comp aftermarket control arms that may detach due to missing or improperly seated circlips, increasing crash risk.

    Product
    SUSPENSION:FRONT:CONTROL ARM:LOWER ARM recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E067000·2018-07-30

    TAP Recalls G2 Axle and Gear Wheel Spacers for Missing Hub Rings

    TAP Worldwide is recalling G2 Axle and Gear aftermarket wheel spacers that may lack hub-centering rings, potentially causing wheels to wobble or loosen.

    Product
    WHEELS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V500000·2018-07-30

    Forest River Cherokee Wolf Pup Recalled for Propane Bracket Defect

    NHTSA is recalling 2019 Forest River Cherokee Wolf Pup trailers because a propane bracket may break, causing the cylinder to detach and increasing crash risk.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE WOLF PUP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E064000·2018-07-30

    TAP Recalls Pro Comp Steering Knuckles for Nissan Titan Vehicles

    TAP Worldwide LLC is recalling Pro Comp aftermarket steering knuckles for Nissan Titan vehicles because they may deform or fracture under high loads, potentially causing loss of control.

    Product
    STEERING recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E068000·2018-07-30

    TAP Recalls LRG Rims 8-Lug Aftermarket Wheel Center Caps

    TAP Worldwide is recalling LRG Rims 8-Lug aftermarket wheel center caps that may not seat properly, potentially causing wheels to loosen and increasing crash risk.

    Product
    WHEELS:HUB recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E065000·2018-07-30

    TAP Recalls Pro Comp Extended Thread Lug Nuts for Seating Issues

    TAP Worldwide is recalling specific Pro Comp Extended Thread Lug Nuts that may not seat properly, potentially causing wheel detachment and loss of vehicle control.

    Product
    WHEELS:LUGS/NUTS/BOLTS/STUDS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18E073000·2018-07-30

    TAP Pro Comp Shock Absorbers Recalled for Mounting Defect

    TAP Worldwide is recalling Pro Comp aftermarket shock absorbers because an incorrect lower mount may cause them to detach, affecting vehicle handling and increasing crash risk.

    Product
    SUSPENSION:REAR:SHOCK ABSORBER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighUSDA FSIS·pha-07302018-1·2018-07-30

    Caito Foods Recalls Beef, Pork, and Poultry Salad and Wrap Products

    Caito Foods LLC is recalling beef, pork, and poultry salad and wrap products due to concerns about Cyclospora contamination. The products were distributed nationwide.

    Product
    Caito Foods, LLC — FSIS Issues Public Health Alert for Beef, Pork and Poultry Salad and Wrap Products due to Concerns about Contamination with Cyclospora
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V497000·2018-07-29

    Mercedes-Benz Metris Recall: Driveshaft Bolts May Loosen

    Daimler Vans USA is recalling 2017-2018 Mercedes-Benz Metris vehicles because driveshaft securing bolts may loosen, potentially causing loss of drive and increasing crash risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ METRIS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V495000·2018-07-27

    Trail King Recalls 2016-2018 Dolly Trailers Due to Frame Crack Risk

    Trail King is recalling 2016-2018 Dolly trailers because the frame channel may crack, potentially causing the frame rail to separate and increasing crash risk.

    Product
    TRAIL KING — TRAIL KING DOLLY TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V486000·2018-07-27

    RAM Pickup Trucks Recalled for Tailgate Latch Fracture Risk

    Chrysler is recalling 2015-2017 RAM 1500, 2500, and 3500 trucks because the tailgate latch may fracture and open while driving, potentially causing cargo to fall out.

    Product
    RAM — RAM 1500, 3500, 2500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V496000·2018-07-27

    Hyundai Recalls 2018 Genesis G80 for Passenger Air Bag Sensor Defect

    Hyundai is recalling 2018 Genesis G80 vehicles because the occupant classification system may fail to deactivate the front passenger air bag, increasing injury risk for children.

    Product
    GENESIS — GENESIS G80
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18195·2018-07-27

    Hirsch Gift Recalls CloudCharge Wireless Charging Pads Due to Burn Hazard

    Hirsch Gift is recalling about 21,000 CloudCharge Qi Wireless Charging Pads because they can overheat and cause burns. Consumers should stop using the pads and contact the company for a free replacement.

    Product
    CloudCharge Qi Wireless Charging Pads
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·18E062000·2018-07-27

    PTL Recalls Recreational Vehicle Doors Due to Latch Adjustment Defect

    PTL Engineering is recalling 3000 and 7000 Series RV entry doors because the latch rod may be improperly adjusted, allowing the door to open while the vehicle is moving.

    Product
    EQUIPMENT:RECREATIONAL VEHICLE/TRAILER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V493000·2018-07-26

    Chrysler Recalls 2018 Pacifica Vehicles Due to Axle Assembly Defect

    Chrysler is recalling 2018 Pacifica vehicles because front axle halfshafts may be incorrectly assembled. This defect could cause loss of drive or movement in Park, increasing crash risk.

    Product
    CHRYSLER — CHRYSLER PACIFICA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V492000·2018-07-26

    Chrysler Recalls 2018 Pacifica and 2019 Jeep Cherokee for Transmission Weld Defect

    Chrysler is recalling 2018 Chrysler Pacifica non-hybrid and 2019 Jeep Cherokee vehicles because a transmission component may not be welded properly, which could cause the vehicle to stop moving.

    Product
    JEEP — JEEP, CHRYSLER CHEROKEE, PACIFICA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V494000·2018-07-26

    2018 Jeep Cherokee Recall for Potential Front Halfshaft Bearing Failure

    Chrysler is recalling 2018 Jeep Cherokee all-wheel-drive vehicles because the right front halfshaft bearing cage may break, potentially causing loss of drive or movement in Park.

    Product
    JEEP — JEEP CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·18V490000·2018-07-26

    Forest River Recalls 2019 Prime Time Crusader Trailers for Incorrect Placard

    Forest River is recalling 2019 Prime Time Crusader fifth-wheel trailers because the Federal Placard lists an incorrect axle weight capacity, which could lead to axle overload and loss of control.

    Product
    PRIME TIME — PRIME TIME CRUSADER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighCPSC·18194·2018-07-26

    Jimmy Hack Golf Recalls Orange Whip Swing Trainers Due to Injury Hazard

    Jimmy Hack Golf is recalling Orange Whip swing trainers because the weighted orange ball can detach during use, posing an injury risk to users and bystanders.

    Product
    Orange Whip golf swing trainers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·18193·2018-07-26

    Trek Recalls Bontrager Line Pro Bicycle Pedals Due to Fall Hazard

    Trek is recalling Bontrager Line Pro flat bicycle pedals because the spindle can break, posing a fall hazard. No injuries have been reported.

    Product
    Bontrager Line Pro flat bicycle pedals
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0962-2018·2018-07-25

    Avella Recalls Phenylephrine IV Bags Due to Sterility Concerns

    Avella of Deer Valley is recalling 120 bags of Phenylephrine 20 mg IV solution due to potential bag leakage and lack of sterility assurance.

    Product
    PHENYLephrine 20 mg (PHENYLephrine HCL (USP) 20 mg, 5% Dextrose (USP) 250 mL) Volume: 252 mL. Single dose bag. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-894-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0928-2018·2018-07-25

    Avella Recalls Ropivacaine Pumps Due to Potential Sterility Compromise

    Avella of Deer Valley is recalling 40 Ropivacaine OnQ pumps due to potential bag leakage that compromises sterility.

    Product
    0.2% ROPivacaine - OnQ Pump, (ROPivacaine HCL (USP) 1100mg, 0.9% Sodium Chloride (USP) QS 550 ml, single dose pump. For: Vidant Medical Center, By: Avella of Houston, 9265 Kirby Dr., Houston, TX 77056. NDC: 42852-661-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2514-2018·2018-07-25

    Medtronic Recalls Tri-Staple 2.0 Curved Tip Intelligent Reloads

    Medtronic is recalling specific Tri-Staple 2.0 Curved Tip Intelligent Reloads because a missing sled component may prevent staple formation, potentially leading to bleeding or leakage.

    Product
    Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30ACTAVM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0964-2018·2018-07-25

    Avella Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 225 syringes of ePHEDrine Sulfate due to potential bag leakage and lack of sterility assurance.

    Product
    ePHEDrine Sulfate, USP 50 mg in 0.9% Sodium Chloride, USP QS 10mL. 50 mg/10 mL (5 mg per mL). Volume 10 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-895-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0960-2018·2018-07-25

    Avella Recalls Norepinephrine Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 2,280 bags of Norepinephrine Bitartrate in 5% Dextrose due to potential bag leakage and lack of sterility assurance.

    Product
    NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 5% Dextrose Inj. (USP) 250 mL (Concentration 16 mcg/mL) Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0945-2018·2018-07-25

    Avella Recalls Fentanyl Syringes Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 100 fentanyl syringes due to potential bag leakage and lack of sterility assurance.

    Product
    fentaNYL 5 mcg Citrate, USP 5 mcg in 0.9% Sodium Chloride, USP QS 0.5mL. (10 mcg per mL) 5 mcg in 0.5 mL. Volume: 0.5 mL. Single dose syringe. For Cook Children's Med Ctr. By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-210-72
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0943-2018·2018-07-25

    Avella Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    Avella of Deer Valley is recalling 500 syringes of ephedrine sulfate due to potential bag leakage and lack of sterility assurance.

    Product
    ePHEDrine Sulfate, USP 50mg in 0.9% Sodium Chloride USP QS 10mL. 50 mg/10 mL (5 mg/mL). Volume: 10 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-891-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2443-2018·2018-07-25

    NewDeal UNI-CP Medical Devices Recalled Due to Infection Risk

    NewDeal SA is recalling specific UNI-CP medical devices because their use may cause superficial or deep infections requiring antibiotic treatment or device removal.

    Product
    UNI-CP, Model Numbers: 330021S, 330023S, 330025S, 330030S, 330025S, 30030S, 330217S, 330220S, 330225S, 330230S, 330420S, 330425S, & 330430S
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Drugs)·D-0957-2018·2018-07-25

    Avella Recalls Midazolam Syringes Due to Sterility Assurance Concerns

    Avella of Deer Valley, Inc. is recalling 110 syringes of Midazolam 1 mg/mL due to a lack of assurance of sterility and potential bag leakage.

    Product
    Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe. Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-76
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0956-2018·2018-07-25

    Avella Recalls Midazolam Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 220 bags of Midazolam 0.5mg/mL due to potential bag leakage and lack of assurance of sterility.

    Product
    Midazolam 0.5mg/mL (Midazolam HCL (USP) 50 mg, 0.9% Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. For: Coral Gables Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-408-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2504-2018·2018-07-25

    Medtronic Endo GIA Reloads Recalled for Missing Sled Component

    Medtronic is recalling specific Endo GIA 60 mm reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Endo GIA 60 mm Articulating Medium/Thick Reload with Tri-StapleTechnology, Item Code EGIA60AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2508-2018·2018-07-25

    Medtronic Tri-Staple 2.0 Intelligent Reloads Recalled for Missing Sled Component

    Medtronic is recalling Tri-Staple 2.0 Intelligent Reloads because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Vascular/Medium, Item Code SIG30AVM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2445-2018·2018-07-25

    NewDeal SA Recalls ADVANSYS MLP/DLP Medical Devices Due to Infection Risk

    NewDeal SA is recalling specific ADVANSYS MLP/DLP models because their use may cause superficial or deep infections requiring medical treatment.

    Product
    ADVANSYS MLP/DLP, Model Numbers: 181051S, 181052S, 181041S, 181042S, 181031S, 181032S, 181033S, 181021S, 181022S & 181023S
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2503-2018·2018-07-25

    Endo GIA 45 mm Articulating Medium/Thick Reload Recalled for Missing Sled Component

    COVIDIEN MEDTRONIC is recalling Endo GIA 45 mm Articulating Medium/Thick Reloads because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Endo GIA 45 mm Articulating Medium/Thick Reload with Tri-Staple Technology, Item Code EGIA45AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2516-2018·2018-07-25

    Medtronic Tri-Staple 2.0 Curved Tip Reloads Recalled for Missing Sled Component

    Medtronic is recalling Tri-Staple 2.0 Curved Tip Intelligent Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system , Item Code EGIA30CTAV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0959-2018·2018-07-25

    Avella Recalls Norepinephrine Syringes Due to Potential Sterility Compromise

    Avella of Deer Valley, Inc. is recalling 850 single-dose norepinephrine syringes nationwide due to potential bag leakage that may compromise sterility.

    Product
    NORepiNEPHrine Bitartrate, USP 160 mcg in 5% Dextrose, USP QS 10mL. Volume 10mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-807-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0929-2018·2018-07-25

    Avella Recalls CeFAZolin Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 2,500 bags of ceFAZolin 2 gm in NS 100mL due to potential bag leakage that compromises sterility.

    Product
    ceFAZolin 2 gm in NS 100mL. ceFAZolin Sodium (USP) 2gm, 0.9% Sodium Chloride (USP) 100mL. Volume 110 mL. Single dose bag. Avella of Houston 9265 Kirby Dr., Houston, TX 77054 NDC: 42852-604-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0941-2018·2018-07-25

    Avella Recalls Vancomycin Bags Due to Potential Leakage

    Avella of Deer Valley is recalling 1,352 bags of Vancomycin 1.25gm in D5W 250 mL due to potential leakage that compromises sterility.

    Product
    Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0951-2018·2018-07-25

    Avella Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 25 bags of Magnesium Sulfate in Sodium Chloride due to potential leakage and lack of sterility assurance.

    Product
    MAGnesium 1gm in NS 100 mL (MAGnesium SULfate (USP) 1 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 102 mL. Single dose bag. For: Salt Lake Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-906-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2497-2018·2018-07-25

    RayStation Software Recalled for Potential Radiation Overdose Risk

    RaySearch Laboratories is recalling RayStation treatment planning software versions 4.5 through 8A because a calculation error could lead to significant radiation overdosage during therapy.

    Product
    RayStation stand-alone software treatment planning system, RayStation 4.5, RayStation 4.7, RayStation 4.9 (RayPlan 1), RayStation 5, RayStation 6 (RayPlan 2), RayStation 7 (RayPlan 7) and RayStation 8A (RayPlan 8A) Product Usage: RayStation is a software system designed for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0965-2018·2018-07-25

    Avella Recalls Phenylephrine Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 40 bags of Phenylephrine 10 mg due to potential leakage that compromises sterility. The product was distributed nationwide.

    Product
    PHENYLephrine 10 mg (PHENYLephrine HCL (USP) 10mg, 0.9% Sodium Chloride (USP) 250 mL. Volume: 251 mL Single dose bag. For: Redlands Community Hospital Pharmacy. BY: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 NDC 15082-856-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0923-2018·2018-07-25

    La Vita Compounding Pharmacy Recalls Glutathione Injection Due to Sterility Concerns

    La Vita Compounding Pharmacy is recalling 191 vials of Glutathione 200mg/mL Injection because production methods raised questions about the sterility of the drug product.

    Product
    Glutathione 200mg/mL Injection w/Pres. (Benzyl Alcohol 1.5% in Sterile Water), 30 mL vial, Rx only, la VITA Compounding Pharmacy, 858.453.2500
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0936-2018·2018-07-25

    Avella Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    Avella of Deer Valley is recalling 100 bags of Magnesium Sulfate in Sodium Chloride due to potential bag leakage and lack of sterility assurance.

    Product
    MAGnesium 4gm in NS 100 mL (MAGnesium SULfate (USP) 4 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 108 mL. Single dose bag. For: Gaston Memorial Hospital By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-905-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2511-2018·2018-07-25

    Medtronic Endo GIA Stapler Recall Due to Missing Sled Component

    Medtronic is recalling Endo GIA staplers that may be missing a sled component, which could cause staple line failure, bleeding, or leakage during surgery.

    Product
    Endo GIA 45 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA454AVM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0939-2018·2018-07-25

    Avella Recalls Norepinephrine Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 4,280 bags of Norepinephrine 8 mg due to potential bag leakage and lack of assurance of sterility.

    Product
    NORepiNEPHrine 8 mg (norepinephrine Bitartrate (USP) 8 mg added to 5% Dextrose Inj. (USP) 250 mL. (Concentration 32 mcg/mL) Volume: 258 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-815-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0952-2018·2018-07-25

    Avella Recalls Magnesium Sulfate Bags Due to Sterility Concerns

    Avella of Deer Valley is recalling 175 bags of Magnesium Sulfate in Sodium Chloride due to potential bag leakage and lack of sterility assurance.

    Product
    MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single dose bag. For: Desert Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-907-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0946-2018·2018-07-25

    Avella Recalls Fentanyl and Ropivacaine Cassettes Due to Sterility Concerns

    Avella of Deer Valley is recalling 100 fentanyl and ropivacaine cassettes due to potential bag leakage and lack of sterility assurance.

    Product
    fentaNYL 2 mcg/mL, 0.125% ROPivacaine, Fentanyl Citrate, USP 300 mcg, Ropivacaine HCL PF, USP 187.5 mg, 0.9% Sodium Chloride, USP QS 150 mL. Volume: 150 mL. Single dose cassette For: Methodist Dallas Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 150
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2505-2018·2018-07-25

    Medtronic Endo GIA Reloads Recalled for Missing Sled Component

    Medtronic is recalling specific Endo GIA 60 mm reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Endo GIA 60 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA60AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2509-2018·2018-07-25

    Medtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component

    Medtronic is recalling specific Endo GIA 45mm Vascular Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Endo GIA 45mm Gray Articulating Vascular Reload with Tri-Staple Technology, Item Code EGIA45AV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0935-2018·2018-07-25

    Avella Recalls Hydromorphone Syringes Due to Sterility Assurance Concerns

    Avella of Deer Valley, Inc. is recalling 275 single-dose hydromorphone syringes nationwide due to a lack of assurance of sterility caused by potential bag leakage.

    Product
    HYDROmorphone 1 mg/mL (HYDROmorphone HCL (USP) 50 mg, 0.9% Sodium Chloride (USP) QS 50 mL) Volume: 50mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX. NDC 42852-222-65
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0937-2018·2018-07-25

    Avella Recalls Midazolam Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 1,860 bags of Midazolam 1 mg/mL due to potential bag leakage and lack of assurance of sterility.

    Product
    Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0922-2018·2018-07-25

    La Vita Compounding Pharmacy Recalls Methyl Folate Injection Due to Sterility Concerns

    La Vita Compounding Pharmacy is recalling Methyl Folate CA+ 1mg/ml Injection vials because production methods raised questions about the sterility of the drug product.

    Product
    Methyl Folate CA+ 1mg/ml Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2512-2018·2018-07-25

    Medtronic Endo GIA Reloads Recalled for Missing Sled Component

    Medtronic is recalling specific Endo GIA 45mm reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Endo GIA 45mm Curved Tip Articulating Vascular/Medium Reload with Tri-Staple Technology, Item Code EGIA45CTAVM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0950-2018·2018-07-25

    Avella Recalls Hydromorphone Injection Bags Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 660 bags of Hydromorphone injection due to potential leakage that compromises sterility.

    Product
    HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100 mL) Volume: 100mL. Single dose bag. Advanced Pharma, 9265 Kirby Dr., Houston,077054 TX. NDC 15082-221-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0933-2018·2018-07-25

    Avella Recalls Fentanyl Syringes Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 120 fentanyl syringes due to potential bag leakage and lack of assurance of sterility.

    Product
    fentaNYL (10 mcg per mL) in 0.95 Sodium Chloride, USP QS 1mL. Volume 1mL. Single dose Syringe. For: Hunt Regional Medical Center, By: Advanced Pharma, 9265 Kirby Dr,., Houston, TX 77054. NDC 15082-210-70
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0947-2018·2018-07-25

    Avella Recalls Heparin Bags Due to Potential Sterility Issues

    Avella of Deer Valley is recalling 900 bags of Heparin 12,500 Units in 5% Dextrose due to potential bag leakage and lack of sterility assurance.

    Product
    HEPARIN 12,500 Units in 5% Dextrose. (Heparin Sodium, USP 12,500 Units, 5% Dextrose Inj., USP 250 mL) Volume: 252.5 mL. Single dose bag. Avella Specialty Pharmacy, 24416 N 19th Avenue Phoenix, AZ 85085. NDC 42852-745-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0938-2018·2018-07-25

    Avella Recalls Morphine Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 1,500 bags of Morphine 1 mg/mL due to potential bag leakage and lack of assurance of sterility.

    Product
    MORphine 1 mg/mL (Morphine Sulfate, USP 100mg, 0.9% Sodium Chloride, USP QS 100 mL). Volume 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0953-2018·2018-07-25

    Avella Recalls Morphine Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 130 bags of Morphine 1 mg/mL due to potential bag leakage and lack of assurance of sterility.

    Product
    MORphine 1 mg/mL (Morphine Sulfate, USP 250mg, 0.9% Sodium Chloride, USP 250 mL). Volume 255 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-241-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0931-2018·2018-07-25

    Avella Recalls Epinephrine Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley is recalling 420 bags of Epinephrine 4 mg in 5% Dextrose due to potential leakage that compromises sterility.

    Product
    EPINEPHrine (USP) 4 mg, 5% Dextrose For Inj. (USP) 250 mL Volume: 254 mL single dose bag. For: Peninsular Regional Medical Center. By: Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054. NDC 15082-855-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V481000·2018-07-25

    Forest River Recalls 2017-2018 Glaval Transit Buses for Seat Belt Defect

    Forest River is recalling 2017-2018 Glaval transit buses because a washer in the seat belt assembly may break, allowing the belt to separate from the vehicle.

    Product
    GLAVAL BUS — GLAVAL BUS CONCORDE II, COMMUTE, APOLLO, UNIVERSAL
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0954-2018·2018-07-25

    Avella Recalls Morphine Syringes Due to Potential Sterility Compromise

    Avella of Deer Valley, Inc. is recalling 740 single-dose Morphine 150 mg syringes due to a lack of assurance of sterility caused by potential bag leakage.

    Product
    MORphine 150 mg (Morphine Sulfate, USP 150mg in 0.9% Sodium Chloride, USP QS 30mL). Volume 30 mL. Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-243-63
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2502-2018·2018-07-25

    Maquet VOLISTA StandOP Surgical Light Recall for Detachment Risk

    Maquet is recalling 151 VOLISTA StandOP surgical lights due to a potential light head detachment issue that could cause serious injury.

    Product
    VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM STP Product Usage: The Maquet VOLISTA surgic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0940-2018·2018-07-25

    Avella Recalls Phenylephrine Bags Due to Potential Leakage

    Avella of Deer Valley is recalling 200 bags of Phenylephrine 40 mg due to potential leakage that compromises sterility.

    Product
    PHENYLephrine 40 mg (PHENYLephrine HCL (USP) 40 mg, 5%Dextrose Inj., USP 250 mL) Volume: 254 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-893-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2513-2018·2018-07-25

    Medtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component

    Medtronic is recalling Tri-Staple 2.0 Intelligent Reloads because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Tri-Staple 2.0 Intelligent Reload for use with Signia stapling system 30 mm Medium/Thick, Item Code SIG30AMT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2506-2018·2018-07-25

    Endo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled

    COVIDIEN MEDTRONIC is recalling Endo GIA 60 mm Articulating Vascular/Medium Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.

    Product
    Endo GIA 60 mm Articulating Vascular/Medium Loading Unit with Tri-Staple Technology, Item Code EGIA60AVM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0958-2018·2018-07-25

    Avella Recalls NORepiNEPHrine 16 Bags Due to Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 520 bags of NORepiNEPHrine 16 injection due to potential bag leakage and lack of assurance of sterility.

    Product
    NORepiNEPHrine 16 (NORepiNEPHrine Bitartrate (USP) 16 mg, 5% Dextrose Inj. (USP) 250 mL. Volume: 266 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-834-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0963-2018·2018-07-25

    Avella Recalls Ephedrine Sulfate Syringes Due to Sterility Concerns

    Avella of Deer Valley is recalling 10,500 ephedrine sulfate syringes nationwide due to potential bag leakage and lack of sterility assurance.

    Product
    ePHEDrine Sulfate, USP 25 mg in 0.9% Sodium Chloride, USP QS 5mL. Volume 5 mL Single dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-67
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2515-2018·2018-07-25

    Medtronic Tri-Staple 2.0 Curved Tip Intelligent Reload Recall for Missing Sled

    Medtronic is recalling Tri-Staple 2.0 Curved Tip Intelligent Reloads because a missing sled component may prevent staple formation, potentially causing bleeding or leakage.

    Product
    Tri-Staple 2.0 Curved Tip Intelligent Reload for use with Signia stapling system 45 mm Vascular/Medium, Item Code SIG45ACTAVM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0961-2018·2018-07-25

    Avella Recalls Norepinephrine Bags Due to Potential Leakage

    Avella of Deer Valley is recalling 1,290 bags of Norepinephrine Bitartrate 4 mg due to potential leakage and lack of sterility assurance.

    Product
    NORepiNEPHrine4mg (Norepinephrine Bitartrate (USP) 4 mg added to 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL Single dose bag. Avella of Houston, 9265 Kirby Dr. Houston, TX 77054. NDC 42852-860-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0921-2018·2018-07-25

    La Vita Compounding Pharmacy Recalls Methylcobalamin Injections Due to Sterility Concerns

    La Vita Compounding Pharmacy is recalling Methylcobalamin 1mg/mL Injection vials because production methods raised questions about the sterility of the drug product.

    Product
    Methylcobalamin 1mg/mL Injection w/Pres. (Benzyl Alcohol 1% in Sterile Water), packaged in 10 mL and 30 mL vials, Rx only, la VITA Compounding Pharmacy, 858.453.2500
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0932-2018·2018-07-25

    Avella Recalls Epinephrine Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 700 bags of Epinephrine (USP) 4 mg due to potential leakage that compromises sterility.

    Product
    EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-823-25.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0955-2018·2018-07-25

    Avella Recalls Midazolam Syringes Due to Potential Sterility Issues

    Avella of Deer Valley, Inc. is recalling specific lots of Midazolam 1 mg/mL syringes due to a lack of assurance of sterility and potential bag leakage.

    Product
    Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willowbrook Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-63
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2470-2018·2018-07-25

    Ion Beam Applications Recalls Proteus 235 Nozzles Due to Crushing Risk

    Ion Beam Applications is recalling 14 Proteus 235 nozzles because they may allow gantry rotation or proton irradiation when accessories are not correctly positioned, posing a risk of crushing or mistreatment.

    Product
    Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS ma
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2444-2018·2018-07-25

    NewDeal ADVANSYS TTC Medical Devices Recalled for Infection Risk

    NewDeal SA is recalling ADVANSYS TTC medical devices because they may cause superficial or deep infections requiring antibiotic treatment or device removal.

    Product
    ADVANSYS TTC, Model Numbers: 181011S, 181012S, 181013S, 181014S, 181001S, 181002S, 181003S & 181004S
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2510-2018·2018-07-25

    Medtronic Endo GIA Reloads Recalled for Missing Sled Component

    Medtronic is recalling specific Endo GIA 45 mm Extra Thick Black Articulating Reloads because a missing sled component may prevent staple formation, potentially leading to bleeding or leakage.

    Product
    Endo GIA 45 mm Extra Thick Black Articulating Reload with Tri-Staple Technology, Item Code EGIA45AXT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2467-2018·2018-07-25

    GE Medical Systems Recalls T2100 Microflex Drive Treadmill Units

    GE Medical Systems is recalling T2100 Microflex Drive Treadmills because unaddressed spare parts may cause uncontrolled walking belt motion during stress tests.

    Product
    T2100 Micro flex Drive Treadmill, powered Product Usage: Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Specifically the T210 Treadm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2434-2018·2018-07-25

    AesDex Cardica C-Port Flex-A PLUS Distal Anastomosis System Recalled for Handle Damage

    AesDex is recalling the Cardica C-Port Flex-A PLUS Distal Anastomosis System because the handle mechanism may be damaged during use, potentially causing plastic fragments to disperse.

    Product
    AesDex, LLC Cardica C-Port Flex-A PLUS Distal Anastomosis System, Catalog Number: FG-000150 The Cardica C-Port Flex-A PLUS Distal Anastomosis System, delivers a series of clips that create an anastomosis between a small target vessel and conduit. The stainless steel clips cr
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2441-2018·2018-07-25

    Zeiss UV Disinfection Unit Recalled for Potential Radiation Exposure

    Zeiss is recalling 8 UV disinfection units for the Celldiscoverer 7 microscope because a firmware issue may allow the unit to activate outside its housing, exposing users to harmful UV radiation.

    Product
    Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2437-2018·2018-07-25

    Siemens Dimension Vista MULTI 1 SDIL Diluent Recall for Defective Septum

    Siemens is recalling 197 units of Dimension Vista MULTI 1 SDIL diluent due to a potential defect in the vial cap septum that may cause inaccurate test results.

    Product
    Dimension Vista¿ MULTI 1 SDIL, KD693, SMN# 10469971
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-2464-2018·2018-07-25

    Ethicon Recalls Proline Sutures Due to Packaging Perforation Risk

    Ethicon is recalling 372 units of Proline Suture Blue 18" 7-0 because the needle may perforate the packaging, posing a risk of soft tissue injury or infection.

    Product
    PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631
    Category
    Medical Device
    Distribution
    25 states
  • HighFDA (Drugs)·D-0930-2018·2018-07-25

    Avella Recalls Ephedrine Syringes Due to Potential Sterility Issues

    Avella of Deer Valley is recalling specific lots of ePHEDrine 50mg syringes because bags may leak, compromising sterility.

    Product
    ePHEDrine 50mg, 50 mg/10 mL (5 mg per mL) (Ephedrine Sulfate, USP 50mg in 0.9% Sodium Chloride, USPQS 10mL. 10 mL-Sterile use dose syringe. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054 NDC 42852-805-61
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2018·2018-07-25

    Hitachi Oasis MRI Systems Recalled for Exposed Belt Hazard

    Hitachi Medical Systems America Inc is recalling 264 Oasis MRI systems because an exposed stainless steel belt can cause finger cuts.

    Product
    Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The Oasis system produces transverse, corona
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2018·2018-07-25

    Cardinal Health Recalls Hydroline Trumpet Valves Due to Suction Defect

    Cardinal Health 200, LLC is recalling Hydroline Trumpet Valves because the suction valve may not close properly, potentially causing continuous suction.

    Product
    Hydroline Trumpet Valve with Pulse Wave Cassette, Trumpet Valve with Double Spike and no Probe, Ref ASC1221, packaged 1/box, 12 boxes/case, single use, RX, Sterile.
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2447-2018·2018-07-25

    NewDeal TIBIAXYS Medical Device Recalled Due to Infection Risk

    NewDeal SA is recalling TIBIAXYS devices because use may cause superficial or deep infections requiring antibiotic treatment or device removal.

    Product
    TIBIAXYS, Model Numbers: 150010S, 150020S, 150030S, 150040S, 150120S, 150110S, 150130S, 150200S, 150240S, 150242S, 150246S, 150250S, 150255S, 150260S, 150265S, 150270S, 150275S, 150280S, 150285S, 150290S, 150514S & 150516S
    Category
    Medical Device
    Distribution
    19 states
  • HighFDA (Food)·F-1651-2018·2018-07-25

    TR Toppers Chopped Chocolate Pretzel Pieces Recalled for Peanut Contamination

    T R Toppers, Inc. is recalling Chopped Chocolate Pretzel Pieces due to potential peanut contamination. Consumers should check for Lot 10481 and stop using the product.

    Product
    TR Toppers Brand Chopped Chocolate Pretzel Pieces. Item number B160-075 GTIN 0 06 51844 10599 6, 7.5 Lbs. (3 x 2.5 Lbs. Bags), Best Kept Between 34¿F and 40¿F <50% Relative Humidity
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0948-2018·2018-07-25

    Avella Recalls Heparin Bags Due to Potential Leakage and Sterility Concerns

    Avella of Deer Valley, Inc. is recalling 40 bags of Heparin 1,000 Units in NS 250mL due to potential leakage that compromises sterility.

    Product
    HEPARIN 1,000 Units in NS 250mL. (Heparin Sodium, USP 1,000 Units, 0.9% Sodium Chloride, USP 250 mL) Volume: 251 mL. Single dose bag. For: Adventist Medical Center Hanford. By: Avella of Huston, 9265 Kirby Dr., Houston TX, 77054. NDC 42852-747-25
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2018·2018-07-25

    Ethicon Recalls PRONOVA Suture Needles Due to Packaging Perforation Risk

    Ethicon is recalling specific PRONOVA suture needles because a packaging design issue may allow the needle to perforate the package, posing injury or infection risks.

    Product
    PRONOVA SUTURE BLUE MONO POLY - SH-1 Taperpoint 1/2C, D10027
    Category
    Medical Device
    Distribution
    25 states

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