The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

What “severe” means here

Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

13951–13975 of 29188

  • 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·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·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
  • 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 (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 (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-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-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 (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 (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 (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-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-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 (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-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-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 (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
  • 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 LEGACY, CONCORDE II, COMMUTE, APOLLO
    Category
    Vehicle
    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 (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…
    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-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 (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-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 (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