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.

3351–3375 of 4878

  • SevereFDA (Devices)·Z-1525-2022·2022-08-31

    Intensive care ventilator status board may loosen, causing water damage and malfunction

    Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.

    Product
    HAMILTON-C6 Intensive Care Ventilator, REF: 160021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·22210·2022-08-25

    Stand-up Paddleboard Paddles Recalled for Puncture and Laceration Risk

    Agit Global stand-up paddleboard paddles can suddenly break mid-shaft during use, exposing sharp edges. About 124,000 units sold nationwide from 2015–2020 pose a risk of serious puncture or laceration injuries.

    Product
    Paddles sold with stand-up paddleboards
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1589-2022·2022-08-24

    Kingdom Creamery of Vermont Maple Soft Serve Mix Recalled for Listeria

    Kingdom Creamery of Vermont's 10% Maple Soft Serve Mix is being recalled due to potential Listeria monocytogenes contamination. The affected product was distributed in Vermont, Maine, and Massachusetts.

    Product
    Kingdom Creamery of Vermont 10% Maple Soft Serve Mix
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1594-2022·2022-08-24

    14% Chocolate Base Mix recalled for potential Listeria monocytogenes contamination

    Kingdom Creamery of Vermont is recalling 1,623 cases of 14% Chocolate Base Mix (Lot 220724, Best By Date 8/11/22) distributed in VT, ME, and MA due to potential Listeria monocytogenes contamination.

    Product
    14% Chocolate Base Mix; Kingdom Creamery of Vermont
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1558-2022·2022-08-24

    Albertsons Ready Meals Crab & Shrimp recalled for undeclared allergens

    Albertsons ready-to-eat meals may contain undeclared fish, shellfish, egg, wheat, and soy allergens. Consumers with allergies should not consume and should return the product.

    Product
    Ready Meals Crab & Shrimp w/Ccktl SCE NET WT 12 OZ CAL 310 NET WT. 0lb 12oz (340g) ready2eat UPC 23253500000 Store Banners: ACME, Albertsons, Andronico s Community Markets, Balducci s, Carrs-Safeway, Eagle, Jewel-Osco, King s, Pak N Save, Safeway, Shaw s, Star Market, Vons
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Food)·F-1586-2022·2022-08-24

    FDA Recalls Kingdom Creamery Vanilla Soft Serve Mix for Listeria Risk

    Kingdom Creamery of Vermont is recalling 5% Vanilla Soft Serve Mix due to potential Listeria monocytogenes contamination. The affected product was distributed in Vermont, Maine, and Massachusetts.

    Product
    Kingdom Creamery of Vermont 5% Vanilla Soft Serve Mix
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1593-2022·2022-08-24

    Kingdom Creamery Vermont 14% Base Mix Recalled for Listeria Contamination

    Kingdom Creamery of Vermont's 14% Base Mix is being recalled due to potential Listeria monocytogenes contamination. The product was distributed in Vermont, Maine, and Massachusetts.

    Product
    14% Base Mix; Kingdom Creamery of Vermont
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1587-2022·2022-08-24

    Maple Soft Serve Mix Recalled Due to Potential Listeria Contamination

    Kingdom Creamery of Vermont is recalling its 5% Maple Soft Serve Mix due to potential Listeria monocytogenes contamination. The affected product was distributed in Vermont, Maine, and Massachusetts.

    Product
    Kingdom Creamery of Vermont 5% Maple Soft Serve Mix
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1557-2022·2022-08-24

    Albertsons Ready Meals Snow Crab Legs Imitation Surimi Recalled for Undeclared Allergens

    Albertsons Companies LLC is recalling Ready Meals Snow Crab Legs Imitation Surimi (UPC 23463900000) for undeclared fish, shellfish, egg, and wheat allergens. Affected products have sell-through dates up to July 18.

    Product
    Ready Meals Snow Crab Legs Imitation Surimi SCE NET WT 12 OZ CAL 300 NET WT. 0lb 12oz (340g) ready2eat Tomato paste, water, high fructose corn syrup, distilled vinegar, horseradish, salt, lemon juice concentrate, soybean oil, beet powder, natural and artificial flavor, zanthan g
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Food)·F-1555-2022·2022-08-24

    Marutomo Dashi Soup Base Recalled Due to Undeclared Wheat and Soy Allergens

    Wismettac Asian Foods recalls Marutomo Dashi Soup Base due to undeclared wheat and soy allergens. The product may pose serious allergic reaction risk to sensitive consumers.

    Product
    Marutomo Dashi Soup Base, Item # #37402 Ingredients: Dried Shaved Skipjack Tuna, Fish Extract (Dried Skipjack Tuna, Salt, Sea Bream Bone, Yeast Extract), Kelp Extract (Kelp Extract, Sorbitol, Maltitol, Hydrogenated Starch Hydrolysate (Cassava), Salt, Ethyl Alcohol, Kelp Product
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1598-2022·2022-08-24

    Philip R's Sorbet Recalled Due to Possible Listeria Contamination

    Philip R's Sorbet Co. Inc. sorbet products are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Vermont, Maine, and Massachusetts.

    Product
    Philip R's Sorbet Co. Inc.; 16% base mix; the label also lists Kingdom Creamery of Vermont
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1597-2022·2022-08-24

    Rococo Ice Cream Base Mix Recalled Due to Listeria Contamination Risk

    Kingdom Creamery of Vermont LLC is recalling Rococo Ice Cream 15% base mix due to potential Listeria monocytogenes contamination. The recalled product was distributed in Vermont, Maine, and Massachusetts.

    Product
    Rococo Ice Cream 15% base mix; list Kingdom Creamery of Vermont on the product label
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1588-2022·2022-08-24

    Kingdom Creamery Vanilla Soft Serve Mix Recalled for Listeria Contamination

    Kingdom Creamery of Vermont is recalling 10% Vanilla Soft Serve Mix in specific lots due to potential Listeria monocytogenes contamination. The affected product was distributed in Vermont, Maine, and Massachusetts.

    Product
    Kingdom Creamery of Vermont 10% Vanilla Soft Serve Mix
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1592-2022·2022-08-24

    Vermont creamery recalls ice cream base mix due to Listeria contamination

    Kingdom Creamery of Vermont is recalling 14% Base Mix and Archie Case Mix ice cream base products due to Listeria monocytogenes contamination. A Class I FDA recall affects 1,623 cases distributed to Vermont, Maine, and Massachusetts.

    Product
    14% Base Mix Case:14% Archie Case Mix
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1591-2022·2022-08-24

    Kingdom Creamery Vermont Chocolate Soft Serve Mix Recalled for Listeria

    Kingdom Creamery of Vermont 10% Chocolate Soft Serve Mix is being recalled due to potential Listeria monocytogenes contamination. The product was distributed in Vermont, Maine, and Massachusetts.

    Product
    Kingdom Creamery of Vermont 10% Chocolate Soft Serve Mix
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1512-2022·2022-08-24

    HeartWare HVAD System Batteries Recalled for Critical Electrical Faults

    HeartWare HVAD System Batteries are being recalled due to electrical faults that may prevent the battery from powering the device controller, accepting charges, or maintaining charge. Approximately 19,616 batteries distributed worldwide are affected.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1556-2022·2022-08-24

    Albertsons Ready Meals Shrimp recalled for undeclared fish and shellfish allergens

    Albertsons Companies recalled Ready Meals Shrimp Cooked with Cocktail Sauce for undeclared fish and shellfish allergens. The product was distributed across 24 US states.

    Product
    Ready Meals Shrimp Cooked with Cocktail Sauce SCE NET WT 12 OZ CAL 330 NET WT. 0lb 12oz (340g) ready2eat Tomato paste, water, high fructose corn syrup, distilled vinegar, horseradish, salt, lemon juice concentrate, soybean oil, beet powder, natural and artificial flavor, zanthan
    Category
    Food
    Distribution
    25 states
  • SevereFDA (Food)·F-1595-2022·2022-08-24

    Lake Champlain Chocolates 14% base mix recalled for Listeria monocytogenes

    Kingdom Creamery of Vermont LLC is recalling Lake Champlain Chocolates 14% base mix due to potential Listeria monocytogenes contamination. The product was distributed in Vermont, Maine, and Massachusetts.

    Product
    Lake Champlain Chocolates 14% base mix
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-1599-2022·2022-08-24

    Ice cream base mix recalled due to listeria monocytogenes contamination

    SOCO Creamery ice cream base mix is being recalled due to potential Listeria monocytogenes contamination. Affected consumers in Vermont, Maine, and Massachusetts should discard the product.

    Product
    SOCO Creamery 15% Base Mix; the label also lists Kingdom Creamery of Vermont
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1488-2022·2022-08-17

    Cobalt Implantable Defibrillators May Deliver Reduced Shock Energy

    Medtronic Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. The reduced energy could affect device performance in patients requiring defibrillation.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1490-2022·2022-08-17

    Crome Implantable Cardioverter Defibrillators may deliver reduced shock energy

    Medtronic recalls 866 Crome implantable defibrillators due to potential reduced shock energy delivery during high-voltage therapy, affecting devices worldwide. Patients should contact their physician to determine if their device is affected.

    Product
    Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1489-2022·2022-08-17

    Crome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy

    Medtronic is recalling 1,657 Crome implantable cardioverter defibrillators due to potential reduced shock energy during high-voltage therapy. Affected devices may deliver only 79% of programmed energy.

    Product
    Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1399-2022·2022-08-17

    FDA Recalls 3.95 Million Viral Transport Containers Distributed Without Clearance

    The FDA recalled 3.95 million viral transport containers distributed without FDA clearance and in violation of established guidance. The containers were distributed worldwide, including to facilities in California, Florida, Illinois, and New York.

    Product
    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
    Category
    Medical Device
    Distribution
    Distributed nationwide