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.

6651–6675 of 29119

  • 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 (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-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
    1 state
  • SevereFDA (Devices)·Z-1095-2022·2022-05-25

    Dragonfly OpStar Imaging Catheter Recall Due to Proximal Marker Separation Risk

    Abbott Vascular recalls 14,544 Dragonfly OpStar Imaging Catheters due to potential separation of the proximal marker. The affected devices were distributed throughout the US and internationally.

    Product
    Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
    Category
    Medical Device
    Distribution
    44 states
  • SevereNHTSA·22V371000·2022-05-24

    Cross Country Recalls 2022 Trailers Due to Improperly Welded Couplers

    Cross Country is recalling 2022 trailers because improperly welded couplers may cause the trailer to separate from the tow vehicle, increasing crash risk.

    Product
    CROSS COUNTRY — CROSS COUNTRY CROSS COUNTRY TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V370000·2022-05-24

    Braun Ambulances Recall 2020-2021 Models Due to Lighting Failure Risk

    Braun Ambulances is recalling 2020-2021 models because a defective circuit board can cause vehicle lighting to fail, increasing crash risk.

    Product
    BRAUN — BRAUN, BRAUN AMBULANCES TLC, EXPRESS PLUS TYPE I, CHIEF XL TYPE I
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V367000·2022-05-23

    School buses recalled for steering wheels that may loosen and detach

    Navistar is recalling certain 2022-2023 IC BUS school buses. The steering wheel retaining nut may have been tightened incorrectly, allowing the steering wheel to loosen or detach. Owners should not drive their vehicles until repaired.

    Product
    IC BUS — IC BUS CE, RESB, RE, CESB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V369000·2022-05-23

    Navistar Recalls 2022-2023 IC Buses Due to Steering Wheel Defect

    Navistar is recalling 2022-2023 IC CE, RE, and 1300 FBC buses because the steering wheel retaining nut may be tightened incorrectly, allowing the wheel to detach.

    Product
    IC BUS — IC BUS RE, 1300 FBC, CE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V362000·2022-05-20

    Isuzu Recalls 2022 FTR and FVR Trucks for Fuel Leak Risk

    Isuzu is recalling 2022 FTR and FVR trucks because a fuel system component may leak, increasing fire risk, or allow air intake, causing engine stalling.

    Product
    ISUZU — ISUZU FVR, FTR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V366000·2022-05-20

    Great Lakes Tandem Trailers Recalled for Improperly Welded Couplers

    Joe's Trailer Mfg. is recalling 2021-2022 Great Lakes Tandem 16', 18', and 20' trailers because improperly welded couplers may cause the trailer to separate from the tow vehicle.

    Product
    GREAT LAKES — GREAT LAKES TANDEM 16', TANDEM 18', TANDEM 20'
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V363000·2022-05-20

    Bravo Recalls 2021 Trailers Due to Improperly Welded Couplers

    Bravo Trailers is recalling 2021 Hero, Scout, and Star models because improperly welded couplers may cause the trailer to separate from the tow vehicle.

    Product
    BRAVO — BRAVO STAR, HERO, SCOUT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V357000·2022-05-19

    Bigfoot Recalls 2022 Travel Trailers Due to Gas Leak Risk

    Bigfoot is recalling 2022 25B17FB travel trailers because damaged burner control valves may cause a gas leak, increasing the risk of fire.

    Product
    BIGFOOT — BIGFOOT 25B17FB
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V355000·2022-05-19

    2022 International CV Vehicles Brake Sensor Fitting May Cause Brake Failure

    Navistar is recalling certain 2022 International CV vehicles because the pressure sensor fitting on the brake line assembly may not be tightened correctly, potentially causing brake fluid loss and brake failure.

    Product
    INTERNATIONAL — INTERNATIONAL CV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V354000·2022-05-19

    Hyundai Elantra and Accent seat belt pretensioners may explode in crash

    Hyundai is recalling certain 2020-2022 Accent and 2021-2022 Elantra models due to seat belt pretensioners that may explode during a crash, potentially projecting metal fragments and injuring occupants. Dealers will secure them with a cap at no charge.

    Product
    HYUNDAI — HYUNDAI ELANTRA HYBRID, ELANTRA, ACCENT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V356000·2022-05-19

    Reiser Recalls 2022 Trailers Due to Improperly Welded Couplers

    Reiser is recalling 2022 WCH, LSA, LTA, L, SBS, and LATV trailers because improperly welded couplers may cause the trailer to separate from the tow vehicle.

    Product
    REISER — REISER LTA, LSA, L, LATV
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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 (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 (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
  • SevereNHTSA·22V350000·2022-05-18

    Oliver Travel Trailers Recall Elite Models Due to Gas Leak Risk

    Oliver Travel Trailers is recalling 2021-2022 Legacy Elite models because damaged burner control valves may cause a gas leak, increasing fire risk.

    Product
    OLIVER TRAVEL TRAILERS — OLIVER TRAVEL TRAILERS LEGACY ELITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • 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 (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
  • SevereUSDA FSIS·016-2022·2022-05-18

    USDA Recalls Ready-to-Eat Pork Sausage Due to Metal Contamination

    America New York Ri Wang Food Group is recalling ready-to-eat pork sausage products nationwide due to possible metal contamination.

    Product
    America New York Ri Wang Food Group Co., Ltd. — America New York Ri Wang Food Group Co., Ltd Recalls Ready to Eat Pork Sausage Products due to Possible Foreign Matter Contamination
    Category
    Food
    Distribution
    Distributed nationwide