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.

4301–4325 of 4878

  • SevereFDA (Drugs)·D-0251-2022·2021-11-24

    Tinactin Tolnaftate Liquid Spray Recalled for Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) liquid spray due to the presence of benzene chemical contamination. The product was distributed nationwide through retail channels.

    Product
    TINACTIN — TINACTIN (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0189-2022·2021-11-24

    HelloFresh Meal Kit Recalled for Salmonella-Contaminated Onions

    HelloFresh is recalling meal kits containing onions from ProSource that may be contaminated with Salmonella Oranienburg. The affected product is from Production Week 28 (starting July 7, 2021) and was distributed nationwide.

    Product
    HelloFresh Meal Kit Product Code 2-7-17-19-21-25-AB from Production Week 28 (production week start date: 07/07/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0175-2022·2021-11-24

    Sysco Onion Products Recalled for Potential Salmonella Contamination

    Sysco Merchandising and Supply is recalling whole yellow and Spanish onions, and pre-cut yellow colossal onions, because they may be contaminated with Salmonella.

    Product
    Whole Yellow and Spanish onions packed in 5 pound bag, 10 pound bag; Pre cut yellow colossal onions
    Category
    Food
    Distribution
    15 states
  • SevereFDA (Food)·F-0209-2022·2021-11-24

    Kroger Garden Salad Recalled Due to Listeria Contamination

    Kroger Garden Salad has been recalled because the Georgia Department of Agriculture detected Listeria monocytogenes in the product. The recall affects specific lot codes distributed to multiple states.

    Product
    Kroger Garden Salad; iceberg lettuce, shredded carrots, red cabbage; Net Wt. 12 oz. (340g) UPC: 0-11110-91036-3 Distributed by The Kroger Company, Cincinnati, OH
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Drugs)·D-0244-2022·2021-11-24

    Tinactin Jock Itch Powder Spray Recall Due to Benzene Contamination

    Bayer Healthcare is recalling 592,416 cans of Tinactin (Tolnaftate 1%) Jock Itch Powder Spray distributed nationwide due to potential benzene contamination. The product was manufactured at a facility where other lots were found to be contaminated with benzene.

    Product
    Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Ireland 86951967, UPC 3 11017 41007 3, NDC 11523-0072-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0170-2022·2021-11-24

    Whole Raw Red Onions from Mexico Recalled for Salmonella Risk

    Keeler Family Farms is recalling whole raw red onions imported from Chihuahua, Mexico due to potential contamination with Salmonella Oranienburg. The affected onions were shipped between July 1 and August 25, 2021, and distributed nationwide and to Ontario, Canada.

    Product
    Whole raw onions - RED - imported from Chihuahua, Mexico and shipped from July 1, 2021 through August 25, 2021. Products are packaged in 25 lb. and 50 lb. mesh bags. One pallet contains 42 bags. Store in cool dry place off the ground. Labeling will state product of Mexico on bill
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0198-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination Risk

    HELLOFRESH US is recalling specific EveryPlate meal kits from production week 07/07/2021 due to onions contaminated with Salmonella Oranienburg. The affected products were distributed nationwide.

    Product
    EveryPlate Meal Kit Product Codes 82-83-86-88-89-91-92-94-95-96-97-99-100 from Production Week 28 (production week start date: 07/07/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0210-2022·2021-11-24

    Dole Garden Salad Recalled for Listeria monocytogenes

    Dole Fresh Vegetables Inc is recalling Salad Classics Garden Salad (12 oz) due to Listeria monocytogenes contamination found by the Georgia Department of Agriculture. The product was distributed across multiple states.

    Product
    Salad Classics Garden Salad; iceberg lettuce, shredded carrots, red cabbage; Net Wt. 12 oz. (340g) UPC: 6-88267-18443-7 Packaged by Dole Distributed by F-------Old USA, Landover, MD
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Food)·F-0184-2022·2021-11-24

    Green Giant Fresh Whole White Onions Recalled for Salmonella

    Green Giant Fresh brand whole white onions in 2 lb. bags are being recalled due to potential Salmonella Oranienburg contamination. The affected onions were distributed in Minnesota and North Dakota.

    Product
    Green Giant Fresh brand, Whole WHITE Onions packaged in 2 lb. flexible mesh bags, UPC 60580600218-2.
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-0185-2022·2021-11-24

    Red Onions Recalled for Potential Salmonella Contamination

    Hardies Fruit & Vegetable Co., LP is recalling red onions (Jumbo and Medium sizes) due to potential Salmonella contamination. Affected products were distributed in Texas.

    Product
    Onion Red Jumbo packed in a 5 pound cardboard box Product Code 2307, Onion Red Medium packed in a 5 pound cardboard box Product Code 2308
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0196-2022·2021-11-24

    HelloFresh Meal Kit Recalled for Salmonella Oranienburg Contamination

    HelloFresh has recalled meal kits containing onions from ProSource that are associated with a Salmonella Oranienburg outbreak. The affected products were produced in Week 35 (starting August 25, 2021) and distributed nationwide.

    Product
    HelloFresh Meal Kit Product Code 4-12-14-18-23-25-AA from Production Week 35 (production week start date: 8/25/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0177-2022·2021-11-24

    Pier-C Produce White Onions Recalled for Salmonella Contamination

    Pier-C Produce, Inc. is recalling white onions that may be contaminated with Salmonella. The recalled onions were distributed in Florida. Consumers should not eat the affected product.

    Product
    Pier-C Produce, Inc., White Onions Grade No 1, Net Wt 2 lbs (0.907 KG), Distributed by Pier C Produce, Leamington, Ontario, Produce of Mexico
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0252-2022·2021-11-24

    Tinactin Tolnaftate Jock Itch Powder Spray Recall Due to Benzene Contamination

    Bayer Healthcare is recalling Tinactin Tolnaftate 1% Jock Itch Powder Spray due to the presence of benzene contamination. The product was distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

    Product
    Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Finland 20066104 UPC 3 11017 41007 3, NDC 11523-0072-5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0202-2022·2021-11-24

    EveryPlate Meal Kits Recalled for Salmonella Contamination Risk

    EveryPlate meal kits from production week 08/04/2021 are being recalled because they contain onions contaminated with Salmonella Oranienburg. The onions were purchased from ProSource.

    Product
    EveryPlate Meal Kit Product Codes 81-82-84-90-92-95-98-99 from Production Week 32 (production week start date: 08/04/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0231-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device Inner Lumen Detachment Recall

    The inner lumen of Arrow-Trerotola Over-The-Wire PTD catheters (7FR) can detach from the device, causing an embolism. This requires additional medical intervention and delays treatment.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-12709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0250-2022·2021-11-24

    Tinactin Tolnaftate Deodorant Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Tinactin (Tolnaftate 1%) Deodorant Powder Spray due to the presence of benzene chemical contamination. The recall affects 738,432 cans distributed nationwide and internationally.

    Product
    TINACTIN — TINACTIN (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0192-2022·2021-11-24

    HelloFresh Meal Kit Recalled for Salmonella-Contaminated Onions

    HelloFresh is recalling certain meal kits from Production Week 31 (starting 07/28/2021) due to onions contaminated with Salmonella Oranienburg. The affected products were distributed nationwide.

    Product
    HelloFresh Meal Kit Product Code 2-4-5-8-15-19-20-22-24-AA from Production Week 31 (production week start date: 07/28/2021)
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0224-2022·2021-11-24

    FDA Recalls Scrip Ultrasound Gel for Potential Bacterial Contamination

    Scrip Inc is recalling Scrip Ultrasound Gel Clear (5L) nationwide due to potential bacterial contamination. Affected units may cause harm if contaminated product contacts patients during ultrasound procedures.

    Product
    Scrip Ultrasound Gel Clear, 5L Intended for use in acoustic coupling of ultrasound transducer to tissue
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0176-2022·2021-11-24

    Greenhead Lobster Frozen Cooked Meat Recalled for Listeria Contamination

    Greenhead Lobster brand frozen cooked lobster meat products may be contaminated with Listeria monocytogenes. The recall affects multiple lobster meat products sold in six states.

    Product
    Greenhead Lobster brand Frozen Cooked Claw and Knuckle Meat - 2lbs; Greenhead Lobster brand Frozen Cooked Claw and Knuckle Meat - 1lb; Greenhead Lobster brand Frozen Cooked Broken Meat - 2lbs; Greenhead Lobster brand Frozen Cooked Tail Meat - 2lbs; Greenhead Lobster brand Fro
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0182-2022·2021-11-24

    Yellow onions recalled for potential Salmonella contamination

    Brothers Produce of Dallas Inc is recalling 5 lb. boxes of yellow onions due to potential Salmonella contamination. The affected product was distributed in Texas.

    Product
    5 lb. boxes of yellow onions packaged in cardboard boxes
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Food)·F-0186-2022·2021-11-24

    Hardies Onion Yellow Jumbo Recalled for Salmonella Contamination Risk

    Hardies Fruit & Vegetable Co., LP is recalling Onion Yellow Jumbo packed in 5-pound boxes due to potential Salmonella contamination. Consumers should not consume the affected product.

    Product
    Onion Yellow Jumbo packed in a 5 pound cardboard box Product Code 2377
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0249-2022·2021-11-24

    Lotrimin Daily Prevention Deo Tolnaftate Spray Recalled for Benzene Contamination

    Bayer Healthcare Pharmaceuticals is recalling Lotrimin Daily Prevention Deo (Tolnaftate 1%) spray powder due to the presence of benzene contamination. The recall affects 579,456 cans distributed nationwide.

    Product
    LOTRIMIN DAILY PREVENTION DEO — LOTRIMIN DAILY PREVENTION DEO (TOLNAFTATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0236-2022·2021-11-24

    LOTRIMIN AF Miconazole Nitrate Powder Spray Recalled for Benzene Contamination

    Bayer is recalling LOTRIMIN AF Deodorant Powder Spray due to potential benzene contamination from manufacturing deviations at a facility where other lots were found contaminated. The recall affects 2,817,468 cans distributed nationwide in the US, Puerto Rico, Canada, and Mexico.

    Product
    LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-1272-2 UPC 3 11017 41023 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0234-2022·2021-11-24

    Arrow-Trerotola Percutaneous Thrombolytic Device: Inner Lumen Detachment Risk

    Arrow International is recalling 1918 units of the Arrow-Trerotola Percutaneous Thrombolytic Device due to inner lumen detachment that can cause embolization, requiring emergency retrieval and delaying treatment.

    Product
    Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-WC The Arrow-Trerotola" Percutaneous Thrombolytic Device (PTDTM) Catheter, in conjunction with the Arrow Rotator Drive Unit, permits mechanical declotting of native arterio-venous
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0248-2022·2021-11-24

    Lotrimin AF Powder Spray Recalled for Benzene Contamination

    Bayer Healthcare is recalling Lotrimin AF miconazole nitrate 2% powder spray due to the presence of benzene chemical contamination. The recall affects approximately 3.8 million cans distributed nationwide.

    Product
    LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can, Dist by: Bayer Healthcare LLC, Whippany, NJ 07981, Product of Spain, NDC 11523-0544-2 UPC 3 11017 41025 7
    Category
    Drug
    Distribution
    Distributed nationwide