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.

7751–7775 of 29121

  • SevereFDA (Devices)·Z-2577-2021·2021-10-06

    Reperfusion Catheter Recalled Due to Risk of Distal End Fracture

    Imperative Care ZOOM 71 Reperfusion Catheters are recalled due to potential for distal end fracture and detachment. This FDA Class I recall affects units distributed nationwide.

    Product
    Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0896-2021·2021-10-06

    ceFAZolin Injectable Recalled for Lack of Sterility Assurance

    IntegraDose Compounding Services LLC is recalling ceFAZolin 2 G/20 mL sterile syringes for injection due to lack of sterility assurance. Approximately 2,614 syringes distributed in NH, MA, and MN are affected.

    Product
    ceFAZolin, 2 G/20 mL in Sterile Water, 20 mL Sterile Syringe for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-7087-1
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0897-2021·2021-10-06

    ceFAZolin Injectable Drug Bags Recalled for Lack of Sterility Assurance

    IntegraDose Compounding Services is recalling ceFAZolin 3 G in 0.9% Sodium Chloride injectable bags due to lack of sterility assurance. The recall affects 589 bags distributed to New Hampshire, Massachusetts, and Minnesota.

    Product
    ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave SE, Minneapolis, MN. NDC: 71139-7153-1
    Category
    Drug
    Distribution
    3 states
  • SevereFDA (Drugs)·D-0844-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recalled for Benzene Contamination

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 50) due to the presence of benzene contamination. The recall affects 1,437,804 aerosol cans distributed nationwide.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2499-2021·2021-10-06

    DeRoyal Procedure Packs with NORMOFLO Warming Sets Recalled for Aluminum Leaching

    DeRoyal procedure packs containing Smiths Medical NORMOFLO warming systems are recalled due to potential aluminum ion leaching into warming fluids. The FDA classified this Class I recall affecting 2880 units distributed in Florida and South Carolina.

    Product
    DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
    Category
    Medical Device
    Distribution
    2 states
  • SevereNHTSA·21V779000·2021-10-06

    Mercedes-Benz Recalls 2021 Sprinter Vans for Electrical Fire Risk

    Daimler Vans USA is recalling 2021 Mercedes-Benz Sprinter vans because a cable duct defect may cause an electrical short, increasing the risk of a fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ SPRINTER 1500, SPRINTER 2500, SPRINTER 3500, SPRINTER 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0856-2021·2021-10-06

    Morphine Sulfate Injection Recalled Due to Defective Vials

    Fresenius Kabi USA LLC is recalling 963,000 vials of Morphine Sulfate Injection because some vials are cracked, which compromises sterility assurance. The affected product was distributed nationwide.

    Product
    MORPHINE SULFATE — MORPHINE SULFATE (MORPHINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2587-2021·2021-10-06

    GENOSYL DS vasodilator console recalled for reversed gas lines defect

    Vero Biotech recalled 3 GENOSYL DS consoles for a manufacturing defect that reverses gas inlet and outlet lines, causing delivery of toxic nitrogen dioxide instead of therapeutic nitric oxide.

    Product
    GENOSYL DS (Delivery System) console, for use as a vasodilator.
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2518-2021·2021-10-06

    FDA Recalls Ultrasound Gels for Bacterial Contamination Risk

    Omnisound Gel and EcoGel 200 ultrasound gels distributed nationwide from January 2018 to August 2021 may contain bacterial contamination. The FDA issued a Class I recall; health care providers should immediately stop using these products.

    Product
    Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0899-2021·2021-10-06

    Testosterone Cypionate/Propionate Injection Recalled for Sterility Assurance

    New Vitalis Pharmacy is recalling Testosterone Cypionate and Testosterone Propionate injections nationwide due to lack of assurance of sterility. The recall affects 1,347 vials distributed across multiple lots.

    Product
    Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy 4139 Cadillac Ct # 201 Louisville, KY 40213
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1028-2021·2021-10-06

    Chocolate Flavor Recalled for Undeclared Egg Allergen

    Medina Baking and Powder Products, Inc. is recalling Chocolate Flavor (1 QT) distributed domestically because it contains egg that was not declared on the label. Consumers with egg allergies face a serious health risk.

    Product
    Chocolate Flavor, 1 QT
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1027-2021·2021-10-06

    Vanilla Flavor Imitation recalled for undeclared allergens and food dyes

    Medina Baking and Powder Products, Inc. is recalling Vanilla Flavor Imitation (White) in 128 fl. oz. gallons due to undeclared egg, Yellow #5, Red #40, and Blue #1. Consumers with allergies or sensitivities to these ingredients face potential health risks.

    Product
    Vanilla Flavor Imitation (White), Net Contents 128 FL. OZS. (1 Gallon)
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0845-2021·2021-10-06

    Neutrogena Beach Defense Sunscreen Spray Recalled for Benzene Contamination

    Johnson & Johnson Consumer, Inc. is recalling Neutrogena Beach Defense water+sun protection sunscreen spray (SPF 60+) in 8.5 oz aerosol cans due to the presence of benzene contamination.

    Product
    Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0008-2022·2021-10-06

    Ruzurgi (amifampridine) Tablets Recalled for Microbial Contamination

    Jacobus Pharmaceutical Company is recalling Ruzurgi (amifampridine) 10 mg tablets due to microbial contamination. Testing found that certain lots exceeded acceptable limits for aerobic bacteria, yeast, and mold.

    Product
    Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.
    Category
    Drug
    Distribution
    0 states
  • SevereNHTSA·21V774000·2021-10-04

    Nissan Recalls Hybrid SUVs for Software-Related Loss of Drive Power

    Nissan is recalling certain 2014-2017 hybrid SUVs because software may shut down the engine, causing a loss of drive power and increasing crash risk.

    Product
    NISSAN — NISSAN, INFINITI PATHFINDER HYBRID, QX60 HYBRID, MURANO HYBRID
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V770000·2021-10-01

    2021 Ford Bronco Passenger Air Bag Vent Deployment Defect

    Ford is recalling certain 2021 Bronco vehicles because the passenger air bag vent may open prematurely during deployment, increasing the risk of injury during a crash.

    Product
    FORD — FORD BRONCO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E087000·2021-10-01

    Arcimoto Recalls TRiO Conversion Kits Due to Bolt Failure Risk

    Arcimoto is recalling TRiO conversion kits because a connecting bolt may fail, causing immediate loss of traction power and increasing crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V762000·2021-09-30

    Jayco Recalls 2021-2022 Flight SLX Trailers Due to Fire Risk

    Jayco is recalling 2021-2022 Flight SLX travel trailers because the cooktop may not be sealed from the furnace, creating a fire risk.

    Product
    JAYCO TRAVEL TRAILER — JAYCO TRAVEL TRAILER JAY FLIGHT SLX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V764000·2021-09-30

    Highland Ridge RV Recalls 2021 Open Range Trailers Due to Fire Risk

    Highland Ridge RV is recalling 2021 Open Range recreational trailers because the cooktop cabinet may not be sealed from the furnace, creating a fire risk.

    Product
    HIGHLAND RIDGE TT — HIGHLAND RIDGE TT OPEN RANGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0830-2021·2021-09-29

    Avicel RC-591 NF Bulk Powder Recalled for Microbial Contamination

    DuPont Nutrition USA is recalling Avicel RC-591 NF bulk powder (lot #2173766940) due to out-of-specification microbial contamination. The product was distributed as a component in finished drug formulations nationwide.

    Product
    Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1009-2021·2021-09-29

    Banquet Cut European Style Cold Smoked Salmon Recalled for Botulinum Risk

    Seabear Company is recalling Banquet Cut European Style Cold Smoked Salmon due to potential for growth of Clostridium botulinum. The affected product was distributed in Arizona, California, and Georgia.

    Product
    Banquet Cut European Style Cold Smoked Salmon, Item Number 2-92845, brand Gerard and Dominique Seafoods, packaged in pouch, net wt. per pouch is random, frozen, UPC of pouch: 2 92845 00250 3. The storage/thawing instructions on the pouch is read in parts: "***KEEP FROZEN UNTIL
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1008-2021·2021-09-29

    Kroger Kale Bags Recalled for Potential Listeria Contamination

    The Kroger Co. is recalling Kroger Kale Bags (16 oz) due to potential contamination with Listeria Monocytogenes. The affected product was distributed to retail locations in seven states.

    Product
    Kroger Kale Bag 16oz plastic bag 8 packages per case
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-2480-2021·2021-09-29

    Ultrasound Gels and Lotions Recalled Due to Bacterial Contamination

    Eco-Med Pharmaceutical, Inc. is recalling ultrasound gels and lotions that may contain bacterial contamination. Products were distributed nationally and internationally.

    Product
    EcoGel 100 Imaging Gel, EcoGel 200 MultiPurpose Gel (Blue), EcoGel 200 MultiPurpose Gel (CLEAR), and EcoLotion Transmission Lotion 1) 100, 200 gel Intended for use in acoustic coupling of ultrasound transducer to tissue 2) Lotion Ecolotion transmission and massage lotion is in
    Category
    Medical Device
    Distribution
    Distributed nationwide