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.

14076–14100 of 29192

  • SevereFDA (Drugs)·D-0911-2018·2018-07-11

    Fagron Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error

    Fagron Compounding Services is recalling 390 prefilled syringes of Neostigmine Methylsulfate Injection Solution because some may be incorrectly labeled with the wrong strength.

    Product
    Neostigmine Methylsulfate Injection Solution, 3 mg per 3 mL, 1 mg per mL, 3 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0910-2018·2018-07-11

    Fagron Recalls Neostigmine Methylsulfate Syringes Due to Labeling Error

    Fagron Sterile Services is recalling 840 prefilled syringes of Neostigmine Methylsulfate Injection Solution because they may be incorrectly labeled with the wrong strength.

    Product
    Neostigmine Methylsulfate Injection Solution, 5 mg per 5 mL, 1 mg per mL, 5 mL prefilled syringe, 5 syringes per package, Rx only, Fagron Sterile Services, ICB Laboratories, 8710 E 34th St. N., Wichita, KS 67205, NDC 71266-2003-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2345-2018·2018-07-11

    FHC microTargeting Drive System Recalled for Lead Damage Risk

    FHC, Inc. is recalling 2,952 microTargeting Drive Systems because over-tightening the depth stop screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Drive System, Product Number MT-DS
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Food)·F-1647-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products for Salmonella Risk

    Caito Foods Service, Inc. is recalling mixed melon products, including Whole Foods Market brand, due to potential Salmonella contamination.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Whole Foods/ Amazon Melon Combo 20 oz., UPC: 826766811205, Whole Foods Market label
    Category
    Food
    Distribution
    23 states
  • SevereFDA (Drugs)·D-0898-2018·2018-07-11

    SCA Pharmaceuticals Recalls Norepinephrine Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling specific lots of Norepinephrine Bitartrate bags due to a potential for leakage that compromises sterility.

    Product
    Norepinephrine Bitartrate 4 mg (16 mcg/mL) in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2293-2018·2018-07-11

    Howmedica Recalls LFIT Anatomic CoCr Femoral Heads Due to Disassociation

    Howmedica Osteonics Corp. is recalling specific LFIT Anatomic CoCr Femoral Heads because of a higher than expected number of complaints regarding disassociation from the hip stem.

    Product
    LFIT Anatomic CoCr Femoral Heads, Catalog No. 6260-9-040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2358-2018·2018-07-11

    FHC Depth Stop Adapter Recall Due to Lead Damage Risk

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring surgical replacement.

    Product
    microTargeting" STar" Drive System (Motorized) Distributed by Medtronic, Product Number FC8002
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2355-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the microTargeting Drive System Depth Stop Adapter because over-tightening the screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Drive System Distributed by Medtronic, Product Number FC1006
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2354-2018·2018-07-11

    FHC Depth Stop Adapter Recall for Potential Lead Damage

    FHC, Inc. is recalling microTargeting Lead Adapters because over-tightening the depth stop screw can damage implanted leads, requiring replacement.

    Product
    microTargeting" Lead Adapter for STar" Drive, Product Number 70-CN-DB
    Category
    Medical Device
    Distribution
    46 states
  • SevereNHTSA·18V463000·2018-07-11

    Pierce Emergency Vehicles Recalled for Aerial Bracket Detachment Risk

    Pierce is recalling 2007-2017 emergency vehicles because an aerial device bracket may detach and fall, potentially striking a person below.

    Product
    PIERCE — PIERCE QUANTUM, IMPEL, VELOCITY, ARROW XT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0905-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine Bags Due to Leakage Risk

    SCA Pharmaceuticals is voluntarily recalling 196 bags of Phenylephrine HCL 80mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 80mg in 0.9% Sodium Chloride 250 mL Bag (320 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0890-2018·2018-07-11

    Ingenus Recalls Irinotecan Hydrochloride Injection Due to Potency Issues

    Ingenus Pharmaceuticals is recalling specific lots of Irinotecan Hydrochloride Injection because they had high out-of-specification assay values for potency.

    Product
    IRINOTECAN HYDROCHLORIDE — IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0895-2018·2018-07-11

    SCA Pharmaceuticals Recalls Fentanyl Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling 492 bags of Fentanyl admixture due to a potential for leakage that compromises sterility.

    Product
    Fentanyl (as citrate) 10 mcg/mL in 0.9% Sodium Chloride 250 mL bag, SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2351-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage the implanted lead, requiring removal and replacement.

    Product
    microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Drugs)·D-0903-2018·2018-07-11

    SCA Pharmaceuticals Recalls Phenylephrine HCL Bags Due to Sterility Concerns

    SCA Pharmaceuticals is voluntarily recalling 400 bags of Phenylephrine HCL 20 mg in 0.9% Sodium Chloride due to a potential for leakage that compromises sterility.

    Product
    Phenylephrine HCL 20 mg in 0.9% Sodium Chloride 250 mL Bag (160 mcg/mL), SCA Pharmaceuticals, LLC, Windsor, CT
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·18V461000·2018-07-11

    Lamborghini Recalls 2015-2016 Aventador Models for Wheel Detachment Risk

    Lamborghini is recalling 2015-2016 Aventador SV vehicles because loose brake disc bolts may cause wheels to detach, increasing crash risk.

    Product
    LAMBORGHINI — LAMBORGHINI AVENTADOR, AVENTADOR ROADSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1642-2018·2018-07-11

    Caito Foods Recalls Mixed Melon Products for Salmonella Risk

    Caito Foods Service, Inc. is recalling multiple brands of mixed melon products due to potential Salmonella contamination. The recall affects approximately 3.16 million pounds of product distributed across 23 states.

    Product
    Multiple Brands Mixed Melon: Customer Product Description Pack Weight UPC Label Description/Brand Walmart SALAD SEASONAL FRUIT 4/10Z 13 oz., UPC: 826766254262 Freshness Guaranteed label
    Category
    Food
    Distribution
    23 states
  • SevereNHTSA·18V458000·2018-07-10

    MV Agusta Recalls 2018 Motorcycles Due to Fork Axle Thread Damage

    MV Agusta is recalling 2018 Brutale 800 Dragster RC, F3 800, and F3 800 RC motorcycles because damaged fork axle threads may cause wheel clamping screw play and loss of control.

    Product
    MV AGUSTA — MV AGUSTA BRUTALE 800 DRAGSTER RC, F3 800, F3 800 RC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·18V457000·2018-07-10

    Mercedes-Benz Recalls 2017 AMG G65 for Reverse Speed Software Defect

    Mercedes-Benz is recalling 2017 AMG G65 vehicles because incorrect reverse speed limitation software may cause instability and rollover risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG G65
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·060-2018·2018-07-09

    Afandina Halal Recalls Raw Chicken Produced Without Federal Inspection

    Afandina Halal is recalling raw chicken products produced and distributed without federal inspection. No adverse reactions have been reported.

    Product
    Afandina Halal — Afandina Halal Recalls Raw Chicken Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·18V453000·2018-07-06

    BMW Recalls 2018-2019 X3 and X4 Models for Brake Caliper Defect

    BMW is recalling 2018-2019 X3 and 2019 X4 vehicles because insufficient coating on rear brake caliper pistons may reduce braking performance.

    Product
    BMW — BMW X3, X4
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2301-2018·2018-07-04

    Philips OmniDiagnost X-ray System Recalled for Tilt Actuator Failure Risk

    Philips is recalling 477 OmniDiagnost Classic X-ray systems because a broken tilt actuator could cause the table to rotate uncontrollably, posing a risk of injury.

    Product
    OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. 70859, 708023, 708024, 708025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0889-2018·2018-07-04

    Advanced Pharma Recalls Subpotent Fentanyl Citrate Prefilled Syringes

    Advanced Pharma Inc. is recalling 100 prefilled syringes of fentanyl citrate because the final drug concentration is subpotent compared to the label.

    Product
    fentanyl Citrate USP 5 mcg in 0.9% Sodium Chloride USP 0.5 mL, 10 mcg per mL prefilled syringe, Rx only, Advanced Pharma an FDA Regulated 503B Outsourcing Facility 9265 Kirby Dr., Houston, TX 77054, NDC 15082-210-72.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2281-2018·2018-07-04

    Konica Minolta CS-7 Medical Device Recall Due to Laptop Fire Risk

    Konica Minolta is recalling CS-7 medical devices because the Panasonic Toughbook laptops used in some configurations have a potential battery ignition risk.

    Product
    CS-7, Model No. A4C1
    Category
    Medical Device
    Distribution
    Distributed nationwide