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.

3701–3725 of 4878

  • SevereFDA (Food)·F-1015-2022·2022-05-04

    Produce Packaging Spicy Southwest Grain Bowl recalled for undeclared wheat

    Produce Packaging Inc.'s Spicy Southwest Grain Bowl is recalled for failing to declare wheat on the product label. Products were distributed to Illinois and Ohio.

    Product
    Produce Packaging Inc. brand Spicy Southwest Grain Bowl in a 11.75oz plastic bowl with a plastic lid. One bowl per case.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1014-2022·2022-05-04

    Red Curry Grain Bowl Recalled for Undeclared Wheat Allergen

    Produce Packaging Inc. is recalling 57 cases of Red Curry Grain Bowls distributed to IL and OH due to undeclared wheat on the product label. The FDA issued a Class I classification for this recall.

    Product
    Produce Packaging Inc. brand Red Curry Grain Bowl in a 10.5oz plastic bowl with a plastic lid. Four bowls per case.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Devices)·Z-0966-2022·2022-05-04

    Ventilator Audible and Visual Alarms May Not Activate During Alarm States

    The Puritan Bennett 980 Series Ventilator may fail to sound its audible alarm or display its visual alarm during critical alarm states, potentially delaying treatment response.

    Product
    Puritan Bennett 980 Series Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1016-2022·2022-05-04

    Groundwork MIND-FULL Bar Snacks Recalled for Undeclared Allergens

    Groundwork Coffee LLC recalled MIND-FULL Bar snacks distributed in California and Oregon because allergens were not properly declared on the product. The bars contain peanut butter and should not be consumed by those with nut allergies.

    Product
    groundwork MIND-FULL Bar. Ingredients: Gluten-free oats, Flax seed, Chocolate chips, Brown sugar, Chia seeds, peanut butter, salt, cinnamon, coconut oil, agave, vanilla. Vegan, Gluten Free. Contains Nuts 671 Rose Ave. Venice, CA 90291
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·21V182000·2022-05-03

    2021 Newmar Motorhomes Recalled for Missing Brake Pedal Return Spring

    Newmar is recalling 2021 New Aire, Dutch Star, and Ventana motorhomes because the brake pedal assembly may be missing a return spring. This can cause brake lights to stay on and brakes to remain engaged, increasing crash risk.

    Product
    NEWMAR — 2021 NEWMAR NEW AIRE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V082000·2022-05-02

    Newmar motorhome brake light switches may fail to illuminate

    Newmar is recalling 2017–2021 Dutch Star and 2021 Kountry Star motorhomes because the brake light switch may chafe against the windshield wiper mechanism, preventing brake lights from illuminating. This increases crash risk.

    Product
    NEWMAR — 2017 NEWMAR DUTCH STAR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0909-2022·2022-04-27

    Philips Respironics V680 Ventilator May Stop Operating Due to Electrical Fault

    Philips Respironics V680 Ventilators may stop operating due to an internal electrical circuit fault. Units were distributed worldwide and across the United States.

    Product
    Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1009-2022·2022-04-27

    Enoki Mushrooms Recalled Due to Listeria Monocytogenes Contamination

    Wisetrade Corporation is recalling Global Fresh Marketing Enoki Mushrooms because the California Department of Public Health detected Listeria monocytogenes contamination during product sampling. Consumers should not consume the product.

    Product
    Global Fresh Marketing Enoki Mushrooms Champignons d'Enoki Net Wt/Poids 200g/7.05 oz. Vacuumed Plastic bag UPC: 809728-95012 Wisetrade Corporation, Irvine, CA 92618
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0908-2022·2022-04-27

    Philips Respironics V60 Plus Ventilator Recalled for Electrical Circuit Failure Risk

    Philips Respironics V60 Plus Ventilators are recalled for an internal electrical circuit defect that could cause the device to stop operating. Approximately 12,145 units were affected worldwide.

    Product
    Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0782-2022·2022-04-27

    artnaturals Hand Sanitizer Recalled for Benzene and Chemical Contamination

    artnaturals ethyl alcohol hand sanitizer (8 fl oz bottles, lot G20127E and G20128A, exp. 5/1/2022) is recalled nationwide due to chemical contamination including benzene, acetaldehyde, and acetal.

    Product
    artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0907-2022·2022-04-27

    Philips Respironics V60 Ventilator Recalled Due to Electrical Circuit Defect

    Philips Respironics V60 ventilators are recalled due to an internal electrical circuit defect that may cause the device to stop operating. Approximately 87,138 units worldwide are affected.

    Product
    Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0785-2022·2022-04-27

    FDA Recalls Pink Pussycat Sensual Enhancement Capsules for Undeclared Sildenafil

    Pink Pussycat Sensual Enhancement capsules are being recalled nationwide. The FDA found they contain undeclared sildenafil and were marketed without FDA approval.

    Product
    Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1004-2022·2022-04-27

    Carol's Cuts Fresh-Cut Cantaloupe Fruit Medley Recalled for Salmonella

    Carol's Cuts Fruit Medley is recalled due to fresh-cut cantaloupe testing positive for Salmonella. The affected product was distributed to retail, military, food service, and schools in Kansas, Missouri, Iowa, and Nebraska.

    Product
    Carol's Cuts Fruit Medley Ingredients may include Honey, cantaloupe, pine, and grape Prepared: Carols Cuts 1247 Argentine Blvd, KC KS 66105 Net Weight 8oz, Net Weight 16oz UPC: 852193001087, 852193900458 Best If Used By: 03/21/22, 03/23/22, 03/27/22, 03/26/22, 03/24/22 Product of
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0927-2022·2022-04-27

    Medtronic Harmony Delivery Catheter System Recalled Over Equipment Failure Risk

    Medtronic is recalling 1,483 Harmony Delivery Catheter Systems due to potential capsule bond failure during pulmonary valve replacement procedures. The FDA has classified this as a Class I recall affecting devices distributed in the US and Canada.

    Product
    Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1002-2022·2022-04-27

    Fresh-cut Hawaiian blend fruit recalled due to Salmonella

    Carol's Cuts Hawaiian Blend is being recalled due to Salmonella in fresh-cut cantaloupe. The product was distributed to retail stores, military facilities, food service, and schools in Kansas, Missouri, Iowa, and Nebraska.

    Product
    Carol's Cuts Hawaiian Blend Ingredients may include Honeydew, cantaloupe, pineapple, strawberries and blueberries Prepared: Carols Cuts 1247 Argentine Blvd, KC KS 66105 Net Weight 32 oz UPC: 852193321086 Best If Used By: 03/21/22, 03/23/22, 03/24/22, 03/26/22 Product of: USA. CRI
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-1008-2022·2022-04-27

    Super Twa Mushroom Mixed Mushrooms Recalled Due to Listeria Monocytogenes

    Farm Fresh Produce LLC is recalling Super Twa Mushroom Mixed Mushrooms (14.11 oz) due to Listeria monocytogenes contamination identified in California. The recall affects 160 cases distributed in California only.

    Product
    Super Twa Mushroom Mixed Mushrooms; New Wt/When Packed) 14.11 oz. (400g) Keep refrigerated. UPC: 6957937481850
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-1006-2022·2022-04-27

    WFM 365 Organic Creamy Caesar Dressing Recalled for Undeclared Wheat and Soy

    Whole Foods Market is recalling WFM 365 Organic Creamy Caesar dressing due to undeclared wheat and soy allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    WFM 365 Organic Creamy Caesar, 12oz, UPC#99482490290, Keep Refrigerated. Bottled in USA. Distributed by: Whole Foods Market Austin, TX
    Category
    Food
    Distribution
    3 states
  • SevereCPSC·22125·2022-04-21

    Insignia Air Fryers and Air Fryer Ovens Recalled for Fire and Burn Hazards

    About 635,000 Insignia air fryers and air fryer ovens can overheat, posing fire and burn hazards. Best Buy is offering refunds or store credit for affected units sold between November 2018 and February 2022.

    Product
    Insignia Air Fryers and Air Fryer Ovens
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0999-2022·2022-04-20

    Giant Eagle Happy Face Cookies Recalled for Undeclared Milk Allergen

    Giant Eagle recalled Happy Face Cookies from two Ohio stores due to undeclared milk allergen. Consumers with milk allergies should not consume these products.

    Product
    Giant Eagle, Happy Face Cookie Single 25065900000
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0998-2022·2022-04-20

    Giant Eagle Happy Face Cookies recalled for undeclared milk allergen

    Giant Eagle is recalling Happy Face Cookie 4-packs due to undeclared milk allergen. Consumers with milk allergies should avoid this product.

    Product
    Giant Eagle, Happy Face Cookie 4 Pack 25051900000, 11 oz, Clam Shell
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0765-2022·2022-04-20

    FDA Recalls IDArubicin Injection for Particulate Matter Contamination

    Teva Pharmaceuticals is recalling IDArubicin Hydrochloride Injection vials due to the presence of silica and iron oxide particulate matter. The recall affects nationwide distribution within the United States.

    Product
    IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1005-2022·2022-04-20

    Back to Nature Cheese Crackers Recalled Due to Undeclared Egg and Milk Allergens

    B&G Foods is recalling Back to Nature Cheddalicious Cheese Flavored Crackers due to undeclared egg and milk allergens caused by mispackaging. Consumers with egg or milk allergies should discard the product or return it.

    Product
    Back to Nature Cheddalicious Cheese Flavored Crackers 6 oz.. UPC: 8-19898-01491-0 6 cartons per case
    Category
    Food
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0918-2022·2022-04-20

    Cub 2 Enclosed Bed Canopy System Recalled Due to Potential Misuse

    Sensory Medical Inc recalled 225 units of the Cub 2 Enclosed Bed Canopy System for potential misuse risk. The firm is updating product warnings and precautions for devices distributed before December 16, 2021.

    Product
    Cub 2 Enclosed Bed Canopy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·22117·2022-04-14

    GE French Door Refrigerators Recalled for Detachable Freezer Handle

    GE Appliances is recalling about 155,000 French door refrigerators because the freezer handle can detach when opened, posing a fall hazard. The company has received 71 reports of handle detachment resulting in 37 injuries, including three serious falls.

    Product
    GE-brand Free-Standing French Door Refrigerators in Fingerprint Resistant Stainless Steel
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0971-2022·2022-04-13

    Multiple Brands of Pineapple Spears and Chunks Recalled for Listeria Contamination

    Fruit Fresh Up is recalling multiple pineapple products sold under various store brands due to potential Listeria monocytogenes contamination. Affected products were distributed in New York, Massachusetts, and Pennsylvania with best-by dates from March 5 to March 23, 2022.

    Product
    1. Wegmans 32oz Pineapple Spears 2. Fresh Harvest 18oz Pineapple Spears 3. Fresh Harvest 6# Pine Bucket 4. Tops Small Pineapple 5. Lexington Co-op 10oz Pineapple chunks 6. Lexington Co-op 32oz Pineapple Spears 7. EDU Kids 2 oz. Pineapple tidbits
    Category
    Food
    Distribution
    3 states