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.

3676–3700 of 4878

  • SevereFDA (Devices)·Z-1076-2022·2022-05-25

    Atrium Advanta V12 Covered Stent System Recalled for Delivery Catheter Separation

    Atrium Medical is recalling the Advanta V12 Covered Stent System worldwide for potential separation of the balloon or catheter hub during withdrawal, which may cause procedural delays and serious complications including embolism and organ infarction.

    Product
    Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part Number: 85320 85321 85322 85323 85324 85325 85326 85327 85328 85329 85330 85331 85332 85333 85334 85335 85336 85337 85338 85339 85340 85341 85342 85343 85344 85345 85350 85351 85352 85353 85354 85355 85360
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0867-2022·2022-05-25

    Milk of Magnesia USP Recalled for Microbial Contamination

    Plastikon Healthcare LLC is recalling Milk of Magnesia USP (2400 mg/30 mL) distributed in Indiana due to microbial contamination in this non-sterile product. The FDA classified this as a Class I recall.

    Product
    MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Food)·F-1060-2022·2022-05-25

    Doux South Pickles Curry Cauliflower Recalled for Listeria Contamination

    Doux South Specialties LLC has recalled Bakkavor Curry Cauliflower pickles due to positive Listeria monocytogenes test results. The recall affects 145 five-gallon pails distributed to California and North Carolina.

    Product
    DOUX SOUTH PICKLES EAT WITH A SOUTHERN ACCENT BAKKAVOR CURRY CAULIFLOWER 5 GALLON
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1069-2022·2022-05-25

    Yes! Enoki Mushrooms recalled due to Listeria monocytogenes contamination

    Yes! Enoki Mushrooms (Lot 6021053, UPC 825382736947) distributed to CA, FL, TX, and NY are being recalled because Listeria monocytogenes was detected in the product. Consumers should not consume the product and should discard it.

    Product
    Yes! Enoki Mushrooms; Pesticide Free Produce: Vacuumed packed. Product of China UPC: 825382736947 Net Wt 200g/7.05 oz Distributed by YES Produce City of Industry, CA 91746
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0868-2022·2022-05-25

    Antacid suspension product recalled due to microbial contamination

    Plastikon Healthcare LLC is recalling 23,300 antacid suspension cups due to microbial contamination. The product was distributed in Indiana for institutional use.

    Product
    Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distribute by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6838-73.
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1044-2022·2022-05-18

    COVID-19 Rapid Antigen Test Kits Recalled for Unauthorized Distribution

    Woodside Acquisitions Inc. recalled 34,240 Oral Rapid SARS-CoV-2 Antigen Test Kits distributed in Alabama and Georgia. The tests were distributed without FDA clearance or authorization for marketing.

    Product
    Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1045-2022·2022-05-18

    COVID-19 Antigen Test Kit Distributed Without FDA Authorization or Clearance

    The FDA is recalling 17,000 units of Joysbio SARS-CoV-2 Antigen Rapid Test Kits distributed in Alabama and Georgia. The tests were sold without FDA clearance or authorization for marketing in the United States.

    Product
    Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1009-2022·2022-05-18

    FDA Recalls Accula SARS-CoV-2 Test for False Positive Risk

    Mesa Biotech is recalling approximately 6,162 units of the Accula SARS-CoV-2 Test due to an increased risk of false positive results, which could delay correct diagnosis and treatment.

    Product
    Accula SARS-CoV-2 Test, REF: COV4100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0856-2022·2022-05-18

    SyrSpend SF Suspending Base Recalled for Burkholderia Contamination

    Fagron is recalling SyrSpend SF Suspending Base, Cherry Flavored (NDC 51552-1123-5 and 51552-1123-9) due to contamination with Burkholderia gladioli. This FDA Class I recall affects medication used in compounding.

    Product
    SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (NDC 51552-1123-5) and b) 4L bottles (NDC 51552-1123-9), Rx Only, Manufactured for Fagron, Inc., St. Paul, MN 55120.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1057-2022·2022-05-18

    Ramen Hero vegan shoyu ramen recalled for undeclared egg allergen

    Ramen Hero is recalling certain lots of its Vegan Shoyu Ramen meal kits because they contain egg noodles despite egg not being listed on the label, posing a risk to people with egg allergies.

    Product
    Ramen Hero - Vegan Shoyu ramen (Hippie Van) Ramen noodles in a soy sauce infused vegan broth with a vegan meat ragu, roasted tomato, bell pepper and zucchini blend, and seaweed. Kits are in a frosted meal kit stand up pouch. Net Wt. 20.05 oz. (1.25 lb.) 568 g UPC: 60003
    Category
    Food
    Distribution
    2 states
  • SevereNHTSA·21V990000·2022-05-12

    2020 Mercedes-Benz A220 suspension recall due to corroding axle carrier

    Mercedes-Benz is recalling certain 2019-2020 A220 and other model vehicles because the front axle carrier may corrode and fail, potentially causing loss of steering control. Dealers will inspect and replace the carrier for free.

    Product
    MERCEDES-BENZ — 2020 MERCEDES-BENZ A220
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V893000·2022-05-11

    Motorhome seat belt retractor defect affects child restraint systems

    Jayco recalls certain 2021-2022 motorhomes with defective seat belt retractors that may fail to secure child restraint systems during crashes. Dealers will replace the retractors free of charge.

    Product
    ENTEGRA — 2021 ENTEGRA ETHOS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0944-2022·2022-05-11

    COVID-19 Rapid Test Kits Recalled for Lacking FDA Authorization

    SML Distribution is recalling 209,450 units of Skippack COVID-19 rapid test kits that were distributed without FDA authorization or clearance. The kits were distributed nationwide across Alabama, Florida, Georgia, Missouri, New York, Texas, and Wyoming.

    Product
    Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1043-2022·2022-05-11

    Whole Foods red lentil dal recalled for possible Listeria contamination

    Whole Foods Market red lentil dal (12 oz) may contain Listeria monocytogenes. The affected product was distributed to nine states. Consumers should not consume the product.

    Product
    WHOLE FOODS MARKET red lentil dal NET WT. 12 OZ (340g) DISTRIBUTED BY: WHOLE FOODS MARKET AUSTIN, TX 78703 UPC 1 95515 02394 8
    Category
    Food
    Distribution
    9 states
  • SevereNHTSA·21V892000·2022-05-11

    2021 Volkswagen Atlas and 2020-2021 Cross Sport recalled for air bag water damage

    Volkswagen is recalling certain 2021 Atlas and 2020-2021 Cross Sport vehicles whose air conditioning drain tube can become blocked, allowing water to damage the air bag control module and potentially trigger inadvertent air bag deployment.

    Product
    VOLKSWAGEN — 2021 VOLKSWAGEN ATLAS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1068-2022·2022-05-11

    Salsa Texan tortillas recalled for undeclared wheat and whey allergens

    The Salsa Texan tortillas (coconut flour and blended flour varieties) are being recalled for potentially containing undeclared wheat and whey. Products were distributed online and at farmers markets.

    Product
    The Salsa Texan Coconut Flour Tortilla regular and burrito size packaged in clear flexible plastic; The Salsa Texan Blended Flour Tortilla regular and burrito size packaged in clear flexible plastic; Unlabeled tortillas sold at farmer's market in Dallas, TX area
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0876-2022·2022-05-11

    Hand Sanitizer Product Recalled for Methanol Chemical Contamination

    Mickey Mouse Hand Sanitizer (ethyl alcohol 68%, 2.11 oz. bottles) is being recalled nationwide by Best Brands Consumer Products, Inc. due to methanol contamination in Lot #20D21 (expiration 06/30/2022).

    Product
    Mickey Mouse Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./to mL bottle, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-013-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0877-2022·2022-05-11

    The Mandalorian Hand Sanitizer Recalled Nationwide for Benzene Contamination

    The Mandalorian Hand Sanitizer has been recalled nationwide due to FDA-detected benzene contamination. The recall affects 346,320 bottles with lot number 20E21.

    Product
    The Mandalorian Hand Sanitizer, ethyl alcohol 68%, 2.11 oz./60 mL bottles, Best Brands Consumer Products, Inc., c/o Best Brands Sales Company LLC, New York, NY NDC 74530-012-02
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V589000·2022-05-08

    Tiffin motorhomes recalled for electrical fuse defect causing engine stall

    Tiffin Motorhomes is recalling 2022 Zephyr and related motorhomes equipped with a Powerglide chassis. A defective fuse can overheat while driving, causing the engine to stall and increasing crash risk.

    Product
    TIFFIN — 2022 TIFFIN ZEPHYR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V461000·2022-05-06

    2020-2021 Nissan Sentra Vehicles Recalled for Bent Tie Rod Defects

    Nissan is recalling 2020-2021 Sentra vehicles because the left or right tie rod may be bent. A bent tie rod can break, causing loss of steering control and increasing crash risk.

    Product
    NISSAN — 2021 NISSAN SENTRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V304000·2022-05-05

    2021-2022 Kia Rio and Forte steering column bolt failure

    A bolt in the steering column may not be secured properly in certain 2021-2022 Kia Rio and Forte vehicles, potentially causing the steering column to detach from the steering rack and result in loss of steering control.

    Product
    KIA — 2022 KIA RIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0953-2022·2022-05-04

    Celltrion DiaTrust COVID-19 Rapid Test distributed to unqualified facilities

    Celltrion USA Inc. is recalling Celltrion DiaTrust COVID-19 Ag Rapid Test kits distributed to facilities without valid CLIA certification. The tests were distributed nationwide from December 2021 through February 2022.

    Product
    Celltrion DiaTrust COVID-19 Ag Rapid Test, Reference No. CT-P60 D-2 02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0999-2022·2022-05-04

    Surgical Stapler: da Vinci SureForm Recalled for Tissue Pushout and Bleeding

    Intuitive Surgical recalled SureForm surgical staplers after tissue pushout events caused unexpected bleeding during procedures. The actual harm rate exceeded safety predictions.

    Product
    da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da Vinici X da Vinci Xi Sureform 60 REF 480460
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1047-2022·2022-05-04

    Organic Marketside Zucchini Recalled Due to Salmonella Contamination Risk

    World Variety Produce Inc is recalling Organic Marketside Zucchini sold at Walmart due to potential Salmonella contamination. The product was distributed to Walmart distribution centers in 18 states.

    Product
    Organic Marketside Zucchini 2 Count packages/8 per case Ingredients: Organic Zucchini New WT. 6 oz. (170g) UPC: 6-81131-22105-4 Perishable Keep Refrigerated Clear plastic overwrap tray Use within 2-3 days of opening Distributed by Walmart, Inc. Bentonville, AR 72716 Pro
    Category
    Food
    Distribution
    1 state