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.

4576–4600 of 4878

  • SevereFDA (Devices)·Z-2433-2021·2021-09-22

    AMSORB PLUS Anesthesia Canisters Recalled for Gas Flow Obstruction Risk

    Armstrong Medical Services Limited is recalling AMSORB PLUS PREFILLED anesthesia canisters due to risk of high resistance to gas flow that could prevent adequate ventilation. Not all defective units will be detected by standard pre-use testing.

    Product
    AMSORB PLUS PREFILLED G-CAN 1.0L; Carbon dioxide absorbent canister; Product codes AMAB3801 and AMAB3801GE. Used in anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0796-2021·2021-09-22

    Florance Morris ANTISEPTIC Hand Sanitizer Recalled for Methanol Contamination

    Florance Morris ANTISEPTIC Hand Sanitizer (70% ethyl alcohol) in 8.45 fl oz and 33.81 fl oz bottles is being recalled due to methanol contamination found in some lots. All lots are affected due to manufacturing under the same conditions as contaminated products.

    Product
    Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0804-2021·2021-09-22

    Spironolactone Ophthalmic Solution Recalled for Lack of Sterility Assurance

    Greenpark Compounding Pharmacy is recalling Spironolactone Ophthalmic Solution 0.005 mg/mL due to lack of assurance of sterility. The 15 mL bottles were distributed nationwide.

    Product
    Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2428-2021·2021-09-22

    Angiographic Catheter Recall: Cordis SUPER TORQUE Entrapment and Dislodgement Risk

    Cordis is recalling its SUPER TORQUE MB Angiographic Catheter worldwide because it may become entrapped between endovascular devices and the vessel wall. This entrapment can cause marker band movement or dislodgement.

    Product
    Cordis 5F UNIVERSAL FLUSH F4 SUPER TORQUE MB, SPECIAL, Angiographic Catheter, REF SRD6785MB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0795-2021·2021-09-22

    Florance Morris Hand Sanitizer Recalled for Methanol Contamination

    Florance Morris ANTISEPTIC Hand Sanitizer (70% ethyl alcohol) distributed nationwide is recalled due to FDA-detected methanol contamination and insufficient ethanol content. The product was distributed by Asimex International LLC in Florida.

    Product
    Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0805-2021·2021-09-22

    AMINOSYN II 15% Amino Acid Injection Recalled for Particulate Matter

    ICU Medical Inc is recalling AMINOSYN II 15% An Amino Acid Injection due to the presence of particulate matter including fibers, hair, and proteinaceous material found in retained samples.

    Product
    AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2432-2021·2021-09-22

    Cordis SUPER TORQUE MB Angiographic Catheter Recalled for Device Entrapment Risk

    Cordis Corporation recalls SUPER TORQUE MB angiographic catheters worldwide due to risk of entrapment between endovascular devices and vessel wall, potentially causing marker band dislodgement.

    Product
    Cordis SUPER TORQUE MB 5F PIG, Angiographic Catheter, REF 532-598C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0965-2021·2021-09-22

    Full Tilt Dark Chocolate Ice Cream Recall for Inadequate Pasteurization

    Full Tilt Ice Cream, LLC is recalling Dark Chocolate ice cream in 16oz pints and 3-gallon tubs because the ice cream mix did not meet pasteurization specifications. The product was distributed in Washington.

    Product
    Dark Chocolate, Full Tilt Ice Cream brand, packaged in 16oz pre packed pints and 3 gallon tubs. UPC on pint container only: 00856962005276.
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0975-2021·2021-09-22

    Purim Health Products EpiGenius Kids Creamy Chocolate Recalled for Undeclared Milk

    Purim Health Products EpiGenius Kids Creamy Chocolate powder is recalled due to undeclared milk in an MCT powder ingredient. The product was not labeled to indicate the presence of milk, which is a common allergen.

    Product
    Purim Health Products: EpiGenius Kids Creamy Chocolate; 630 Grams, individually packed pouches. Daily Superfoods. This high protein, whole-food blend is an excellent source of vitamins A, C, D and E and contains superfruits and superveggies, along with healthy fat, fiber and
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0960-2021·2021-09-22

    Weis Markets Crab Cake Meal Recalled for Undeclared Milk Allergen

    Weis Markets is recalling $7 Crab Cake Meals because they contain undeclared milk, a common allergen. The product was distributed to retail locations in Maryland, Pennsylvania, New Jersey, and West Virginia.

    Product
    $7 Crab Cake Meal packaged in a 3 compartment plastic container. 14oz, UPC 2 07879400700 8. Refrigerated product.
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2403-2021·2021-09-15

    EV3 Pipeline Flex Embolization Device Recalled for Push Wire Fracture Risk

    Micro Therapeutics Inc. is recalling 16,169 EV3 Pipeline Flex Embolization Devices due to potential push wire fractures in the delivery system during use.

    Product
    EV3 Pipeline Flex Embolization Device with Flex Shield Technology
    Category
    Medical Device
    Distribution
    48 states
  • SevereFDA (Devices)·Z-2377-2021·2021-09-15

    NORMOFLO Irrigation Warming Sets Recalled for Aluminum Leaching Risk

    Smiths Medical is recalling NORMOFLO Irrigation Warming sets (Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700) due to potential aluminum leaching when used at lower flow rates with certain solutions and blood products. No illnesses have been reported.

    Product
    NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2391-2021·2021-09-15

    FDA Recalls Ultrasound Gel for Risk of Bacterial Contamination

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. are being recalled due to the risk of bacterial contamination. Healthcare providers and consumers should stop using affected products.

    Product
    LiquaSonic Ultrasound Gel 250mL, Model No. 001205
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2376-2021·2021-09-15

    NORMOFLO Irrigation Fluid Warmer Recalled for Risk of Aluminum Leaching

    Smiths Medical recalls NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 (913 units) due to potential harmful aluminum leaching when used at lower flow rates with certain solutions and blood products.

    Product
    NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·21780·2021-09-09

    Teak shower benches recalled due to fall hazard and collapse risk

    Ivena teak shower benches sold at Costco can collapse during use, posing a fall hazard. Consumers have reported 81 incidents of collapse or breakage, including four injuries.

    Product
    Teak shower benches
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0780-2021·2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel recalled for methanol contamination

    The FDA found one lot of MEDICALLY MINDED Hand Sanitizer Gel to contain methanol and fall below the labeled ethanol content. The product was distributed nationwide.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200, Distributed by SBL Brands, LLC. Las Vegas, NV 89119. Made i
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0781-2021·2021-09-08

    Hand Sanitizer Gel Recalled for Methanol Contamination and Low Ethanol

    MEDICALLY MINDED Hand Sanitizer Gel (Ethyl Alcohol 70%) distributed nationwide has been recalled after FDA testing found methanol contamination and ethanol content below label claims. Consumers should stop using the product.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0895-2021·2021-09-08

    BrightFarms Nutrigreens Recalled for Potential Salmonella Contamination

    BrightFarms Nutrigreens 3oz packages may be contaminated with Salmonella. The product was grown at the company's Rochelle, Illinois indoor farm and distributed across Illinois, Wisconsin, Iowa, Indiana, and Michigan with best-by dates through July 29, 2021.

    Product
    BrightFarms Nutrigreens; packaged in clear, plastic clamshells; 3oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0897-2021·2021-09-08

    BrightFarms Spinach Recall Due to Potential Salmonella Contamination

    BrightFarms Spinach packaged in 4oz and 8oz clamshells may be contaminated with Salmonella. The affected product was grown at the company's Rochelle, Illinois indoor farm and distributed across multiple Midwest states.

    Product
    BrightFarms Spinach; packaged in clear, plastic clamshells; 4oz and 8oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0902-2021·2021-09-08

    Cahill Whiskey Cheddar Cheese Recalled for Potential Listeria Contamination

    Whole Foods Market is recalling Cahill Whiskey Cheddar Cheese due to potential contamination with Listeria monocytogenes. The cheese was distributed to stores across multiple states from May to July 2021.

    Product
    Cahill Whiskey Cheddar Cheese packaged in clear plastic PLU 5478494884
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0894-2021·2021-09-08

    BrightFarms Butter Crisp Lettuce Recalled for Salmonella Risk

    BrightFarms Butter Crisp lettuce packaged in 4-oz clear plastic clamshells is being recalled due to potential Salmonella contamination. The product was distributed in Illinois, Wisconsin, Iowa, Indiana, and Michigan with best-by dates through July 29, 2021.

    Product
    BrightFarms Butter Crisp; packaged in clear, plastic clamshells; 4oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0901-2021·2021-09-08

    Cahill Cheddar with Porter Cheese Recalled for Listeria Contamination Risk

    Whole Foods Market is recalling Cahill Cheddar with Porter cheese (PLU 93579) sold in clear plastic packaging due to potential contamination with Listeria monocytogenes, a serious foodborne pathogen.

    Product
    Cahill Cheddar with Porter PLU 93579 packaged in clear plastic
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0893-2021·2021-09-08

    BrightFarms Spring Crunch Lettuce Recall Due to Salmonella Risk

    BrightFarms Spring Crunch lettuce packaged in 4oz clear plastic clamshells may be contaminated with Salmonella. The recall affects products distributed in Illinois, Wisconsin, Iowa, Indiana, and Michigan with best-by dates through July 29, 2021.

    Product
    BrightFarms Spring Crunch; packaged in clear, plastic clamshells; 4oz; grown at the company's Rochelle, Illinois indoor farm
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Drugs)·D-0782-2021·2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel Recalled for Methanol Contamination

    Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (Ethyl Alcohol 70% v/v, 8.5 FL OZ / 250 mL) distributed nationwide due to manufacturing conditions that led to methanol contamination in product lots.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle, Made in Mexico, Distributed by SBL Brands, LLC Las Vegas, NV 89119. UPC: 6 76753 00359 1 ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0783-2021·2021-09-08

    MEDICALLY MINDED Hand Sanitizer Gel Recalled for Manufacturing Deviations

    Global Sanitizers LLC is recalling MEDICALLY MINDED Hand Sanitizer Gel (70% ethyl alcohol, 8 fl oz bottles) distributed nationwide due to manufacturing deviations under conditions that produced a methanol-contaminated product lot.

    Product
    MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ (236 mL) bottle, Manufactured by Asiaticon, S.A. de C.V. Conkal 62, Jardines del Ajusco, Tlalpan, Ciudad de Mexico, C.P. 14200. Distributed by SBL Brands, LLC Las Vegas, NV 89119 UPC: 6
    Category
    Drug
    Distribution
    Distributed nationwide