The Recall Desk

Severity 4 of 5

Severe recalls

Illness, injury, or structural failure has been reported. 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.

8826–8850 of 29123

  • SevereFDA (Devices)·Z-0572-2021·2020-12-23

    DePuy Synthes 10.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 10.5mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 10.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.017S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0573-2021·2020-12-23

    DePuy Synthes 11.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 11.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 11.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.018S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0149-2021·2020-12-23

    BASF Recalls Crospovidone Excipient Due to Theophylline Contamination

    BASF Corporation is recalling 4,560 kg of Kollidon CL-M Crospovidone excipient because it was found to be cross-contaminated with theophylline.

    Product
    Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in 30 kg plastic drums, Manufacturer: BASF SE, Carl-Bosch-Strabe 38, 67056 Ludwigshafen, Germany, Co-Manufactured by Siegfried PharmaChemikalien Minden GmbH, D-32423 Minden
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0587-2021·2020-12-23

    DePuy Synthes 18.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 18.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·031-2020·2020-12-23

    CLS Gourmet Recalls Meat Products Produced Without Federal Inspection

    CLS Gourmet CL Saigon Food Company is recalling approximately 128,841 pounds of raw and cooked meat products produced without federal inspection.

    Product
    CLS Gourmet CL Saigon Food Company Recalls Meat Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0614-2021·2020-12-23

    Carl Zeiss Meditec VISUREF 150 Recalled for Electrical Shock Risk

    Carl Zeiss Meditec is recalling 132 VISUREF 150 diagnostic instruments due to an incorrect component that may cause electrical shocks to users.

    Product
    Carl Zeiss Meditec AG VISUREF150 REF 2227-967 - Product Usage: is a diagnostic instrument used to determine the objective refractive values and keratometric characteristics of the human eye. The results are used to assist the process of prescribing optical aids such as eyeglasses
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0141-2021·2020-12-23

    Advanced Nutriceuticals Recalls GHK-CU Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling GHK-CU vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    GHK-CU, 10 MG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0134-2021·2020-12-23

    Advanced Nutriceuticals Recalls IPAMORELIN Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling IPAMORELIN vials because production processes cannot assure the sterility of the product.

    Product
    IPAMORELIN, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0129-2021·2020-12-23

    Advanced Nutriceuticals Recalls FGL Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling FGL 10 mg/ml vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    FGL, 10 MG/ML, 3 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereCPSC·21059·2020-12-23

    Hampton Bay Mara Ceiling Fans Recalled for Blade Detachment Hazard

    King of Fans is recalling Hampton Bay 54-inch Mara ceiling fans because blades can detach while in use, posing an injury hazard.

    Product
    Hampton Bay 54-inch Mara Indoor/Outdoor Ceiling Fans
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0135-2021·2020-12-23

    Advanced Nutriceuticals Recalls GHRP Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling GHRP vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    GHRP, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0142-2021·2020-12-23

    High Dose B12 Injection Recalled for Sterility Assurance Concerns

    Advanced Nutriceuticals is recalling High Dose B12 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    HIGH DOSE B12, 10 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0128-2021·2020-12-23

    FDA Recalls CJC-1295 Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling CJC-1295 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    CJC-1295, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0578-2021·2020-12-23

    DePuy Synthes 13.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 13.5mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 13.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.023S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0571-2021·2020-12-23

    DePuy Synthes 10.0MM Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 10.0MM Reamer Heads for RIA 2 because breakage exceeds expected rates, causing potential tissue or bone damage.

    Product
    DePuy Synthes 10.0MM REAMER HEAD FOR RIA 2, STERILE-Orthopedic manual surgical instrument Part Code: 03.404.016S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0585-2021·2020-12-23

    DePuy Synthes 17.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 17.0mm Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 17.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.030S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E093000·2020-12-23

    Autosales Recalls Summit Racing 3-Ton Jack Stands Due to Ratchet Bar Failure

    Autosales is recalling Summit Racing 3-Ton Jack Stands because the ratchet bar may fail, allowing a vehicle to fall. Owners should stop using the stands and contact Autosales for a refund.

    Product
    EQUIPMENT:MECHANICAL:ACCESSORY SCISSOR/SCREW/BOTTLE JACK/LIFT:STAND recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0130-2021·2020-12-23

    PT-141 Injection Recalled Due to Sterility Assurance Concerns

    Advanced Nutriceuticals is recalling PT-141 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    PT-141, 10 MG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0137-2021·2020-12-23

    Advanced Nutriceuticals Recalls B12 Injection Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling B12 for Injection vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    B12 for Injection, 2 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0582-2021·2020-12-23

    DePuy Synthes 15.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 15.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 15.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.027S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0579-2021·2020-12-23

    DePuy Synthes 14.0MM Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 14.0MM Reamer Heads for RIA 2 due to breakage rates exceeding expectations, which can cause tissue and bone damage.

    Product
    DePuy Synthes 14.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.024S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V808000·2020-12-22

    GM Recalls 2020 Chevrolet Bolt EV for Brake Caliper Fracture Risk

    General Motors is recalling 2020 Chevrolet Bolt EV vehicles because a front left brake caliper may fracture, potentially reducing brake performance and increasing crash risk.

    Product
    CHEVROLET — CHEVROLET BOLT EV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V764000·2020-12-21

    GM Recalls 2010-2013 Buick and Chevrolet Models for Rear Suspension Defect

    General Motors is recalling specific Buick and Chevrolet vehicles because excessive corrosion protection on rear toe links may cause them to fracture, increasing crash risk.

    Product
    BUICK — BUICK, CHEVROLET LACROSSE, REGAL, MALIBU
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V804000·2020-12-21

    Thor Motor Coach Recalls 2018-2019 Hurricane and Windsport Motorhomes

    Thor Motor Coach is recalling 2018-2019 Hurricane and Windsport motorhomes because overhead cabinets may detach and fall on occupants.

    Product
    THOR MOTOR COACH — THOR MOTOR COACH HURRICANE, WINDSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V802000·2020-12-21

    Mercedes-Benz and Freightliner Sprinter Vehicles Recalled for Brake Fluid Leak

    Daimler Vans USA is recalling 2019-2020 Mercedes-Benz and Freightliner Sprinter vans because rear brake calipers may leak fluid, allowing air into the hydraulic brake system.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ, FREIGHTLINER SPRINTER 3500, SPRINTER 2500, SPRINTER 4500, SPRINTER 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide