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.

8801–8825 of 29123

  • SevereFDA (Devices)·Z-0594-2021·2020-12-30

    Cook Inc. Recalls Flexor Check-Flo Introducers Due to Separation Risk

    Cook Inc. is recalling Flexor Check-Flo Introducers because the sheath may separate during use, posing a risk of life-threatening adverse events.

    Product
    Flexor Check-Flo Introducer, RPN KCFW-5.0-35-55-RB-HFANL0-HC, Order Number G56230 Flexor Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·20E094000·2020-12-28

    Summit Racing 6-Ton Jack Stands Recalled Due to Ratchet Bar Failure Risk

    Autosales Inc. is recalling Summit Racing 6-Ton Jack Stands because the ratchet bar may fail, allowing the 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-0131-2021·2020-12-23

    FDA Recalls AOD-9604 Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling AOD-9604 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    AOD-9604, 1200 MCG/ML, 5 ML vial The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0165-2021·2020-12-23

    Cipla Recalls Azacitidine Injection Vials Due to Sterility Concerns

    Cipla is recalling 2,151 vials of Azacitidine for Injection due to potential sterility issues caused by improper sealing.

    Product
    Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa Medicare Limited Jadcherla -509301 INDIA Distributed by: Cipla USA, Inc. 10 Independence Blvd, Suite 300 Warren, NJ 07059 NDC 69097-805-40
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0583-2021·2020-12-23

    DePuy Synthes 16.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 16.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 16.0MM REAMER HEAD FOR RIA 2 STERILE--Orthopedic manual surgical instrument Part Code: 03.404.028S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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
  • 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
  • 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 (Devices)·Z-0575-2021·2020-12-23

    DePuy Synthes 12.0mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 12.0mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 12.0MM REAMER HEAD FOR RIA 2 STERILE -Orthopedic manual surgical instrument Part Code: 03.404.020S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0139-2021·2020-12-23

    FDA Recalls Cerebrolysin Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling Cerebrolysin vials because production processes cannot assure sterility. The product was distributed to seven states.

    Product
    CEREBROLYSIN, 107.5 MG/ML, 10 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0586-2021·2020-12-23

    DePuy Synthes 17.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 17.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue and bone damage.

    Product
    DePuy Synthes 17.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.031S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0133-2021·2020-12-23

    Thymosin Alpha Vials Recalled for Sterility Assurance Concerns

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

    Product
    THYMOSIN ALPHA, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0143-2021·2020-12-23

    Advanced Nutriceuticals Recalls LL-37 Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling LL-37 vials because production processes cannot assure sterility. The product was distributed to seven states.

    Product
    LL-37, 2000 MCG/ML, 2 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0140-2021·2020-12-23

    FDA Recalls Thymosin Beta-4 Vials Due to Sterility Concerns

    Advanced Nutriceuticals, LLC is recalling Thymosin Beta-4 vials because production processes cannot assure sterility. The product was distributed in seven states.

    Product
    THYMOSIN BETA - 4, 2000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Drugs)·D-0144-2021·2020-12-23

    Advanced Nutriceuticals Recalls Pentosan Polysulfate Vials Due to Sterility Concerns

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

    Product
    Pentosan Polysulfate, 300 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-0138-2021·2020-12-23

    Advanced Nutriceuticals Recalls DSIP Vials Due to Sterility Concerns

    Advanced Nutriceuticals is recalling DSIP vials because production processes cannot assure sterility. The product was distributed to specific states.

    Product
    DSIP, 1000 MCG/ML, 5 ML vial, The Guyer Institute of Molecular Medicine, Indianapolis, IN
    Category
    Drug
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0574-2021·2020-12-23

    DePuy Synthes 11.5mm Reamer Head Recalled for Breakage Risk

    Synthes (USA) Products LLC is recalling DePuy Synthes 11.5mm Reamer Heads for RIA 2 due to breakage exceeding expected rates, which can cause tissue or bone damage.

    Product
    DePuy Synthes 11.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.019S
    Category
    Medical Device
    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 (Devices)·Z-0584-2021·2020-12-23

    DePuy Synthes 16.5mm Reamer Head Recalled for Breakage and Tissue Damage

    Synthes (USA) Products LLC is recalling DePuy Synthes 16.5mm reamer heads because breakage exceeds expected rates, causing tissue and bone damage.

    Product
    DePuy Synthes 16.5MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.029S
    Category
    Medical Device
    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
  • 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
  • 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