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.

9326–9350 of 29156

  • SevereFDA (Drugs)·D-1486-2020·2020-08-12

    Yusef Tropical Lip Moisturizer Recalled for Superpotent Meradimate Ingredient

    Yusef Manufacturing Laboratories is recalling Tropical Lip Moisturizer, SPF 30, because the beginning of the batch is approximately 25% superpotent for the active ingredient Meradimate.

    Product
    Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1489-2020·2020-08-12

    Summitt Labs Recalls KORE Organic CBD Oil Due to Lead Contamination

    Summitt Labs is recalling 236 bottles of KORE Organic CBD Oil Watermelon 15mg due to elevated lead levels. The product was distributed nationwide in the USA.

    Product
    KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREORGANIC.com 833.810.KORE.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1458-2020·2020-08-12

    BC Hemp Co. CBD Oil Recalled for Undeclared Lead Contamination

    Michigan Herbal Remedies is recalling 72 bottles of BC Hemp Co. CBD Oil due to elevated levels of undeclared lead.

    Product
    BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural 500MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1459-2020·2020-08-12

    BC Hemp Co. CBD Oil Recalled for Undeclared Lead Contamination

    Michigan Herbal Remedies is recalling BC Hemp Co. CBD Oil bottles due to elevated levels of undeclared lead.

    Product
    BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Spearmint, 500mg CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1470-2020·2020-08-12

    Tasty Drops CBD Oil Recalled for Undeclared Lead Contamination

    Michigan Herbal Remedies is recalling Tasty Drops CBD oil bottles due to elevated levels of undeclared lead.

    Product
    Tasty Drops, Hemp Oil Extract, Berry, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29083 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1451-2020·2020-08-12

    Michigan Herbal Remedies Recalls Hemp Extract Due to Lead Contamination

    Michigan Herbal Remedies is recalling 495 bottles of Made by Hemp 1000MG Hemp Extract because the product contains elevated levels of undeclared lead.

    Product
    Made by Hemp 1000MG Hemp Extract, French Vanilla, 1 OZ (30 ML) bottles, Dist by: MHR Brands, Jenison, MI, UPC 8 02991 76553 7
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1481-2020·2020-08-12

    Michigan Herbal Remedies Recalls Goodness Gurus Hemp Drops for Lead Contamination

    Michigan Herbal Remedies is recalling Goodness Gurus Healthy Hemp Drops due to elevated levels of undeclared lead. The product was sold nationwide via internet and retail channels.

    Product
    Goodness Gurus, Healthy Hemp Drops, 1500 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6 53341 99411 0
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2750-2020·2020-08-12

    GE Healthcare Recalls CARESCAPE ONE Monitors Due to Alarm Failure Risk

    GE Healthcare is recalling 8,414 CARESCAPE ONE patient monitors because they may fail to provide visual and audible alarms for Ventricular Fibrillation when docked to specific host monitors.

    Product
    CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1465-2020·2020-08-12

    Michigan Herbal Remedies Recalls CBD Hemp Oil Due to Lead Contamination

    Michigan Herbal Remedies is recalling 25 bottles of SP Berry CBD hemp oil because the product contains elevated levels of undeclared lead.

    Product
    SP, hemp oil, Berry, 300MG CBD,1 FL. OZ (30 ML) bottles, Distributed by: The Spiffy Piff
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1479-2020·2020-08-12

    BC Hemp Co. CBD Oil Recalled for Undeclared Lead Contamination

    Michigan Herbal Remedies is recalling 25 bottles of BC Hemp Co. CBD Oil due to elevated levels of undeclared lead.

    Product
    BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural, 1000MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, Eau Claire, MI 49111
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2758-2020·2020-08-12

    Siemens Ysio Max X-Ray System Recalled for Software Defects

    Siemens Medical Solutions is recalling 512 Ysio Max X-ray systems due to software issues that may cause collisions or incorrect diagnostic images.

    Product
    SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1469-2020·2020-08-12

    Acadia Farms Serenity Hemp Oil Recalled for Undeclared Lead Contamination

    Michigan Herbal Remedies is recalling Acadia Farms Serenity Hemp Oil bottles due to elevated levels of undeclared lead.

    Product
    Acadia Farms, Serenity, soothing mint, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles, Distributed by: Acadia Farms, Rehobeth, Massachusetts
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1463-2020·2020-08-12

    Javan CBD Oil Recalled for Undeclared Lead Contamination

    Michigan Herbal Remedies is recalling Javan CBD Oil bottles due to elevated levels of undeclared lead. The product was sold nationwide via internet and retail.

    Product
    Javan Anti Aging and Wellness Institute, CBD Oil, Full Spectrum Hemp Oil, Spearmint, 300MG CBD, 1 FL. OZ (30 ML) bottles, Dist by: Javan Wellness LLC, 1445 Church St NW Unit 24, Washington, DC 20005
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2769-2020·2020-08-12

    Beacon EUS Access System Needle Recalled Due to Cannula Detachment

    Covidien is voluntarily recalling 269 Beacon EUS Access System needles because the cannula detached during procedures in three reported cases.

    Product
    Beacon EUS Access System Preloaded Access 135degree Needle sterile, single-use, endoscopic ultrasound device consisting of a sharp stylet and an 18.5-gauge, echo-enhanced, tip-shaped, nitinol cannula intended to pierce tissue and then act as an access channel to facilitate guide
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1480-2020·2020-08-12

    Michigan Herbal Remedies Recalls Goodness Gurus Hemp Drops for Lead Contamination

    Michigan Herbal Remedies is recalling 50 bottles of Goodness Gurus Healthy Hemp Drops due to elevated levels of undeclared lead.

    Product
    Goodness Gurus, Healthy Hemp Drops Full Strength, 1000 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 53341 99311 3
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1462-2020·2020-08-12

    Herbzeedy Hemp Oil Recalled for Undeclared Lead Contamination

    Michigan Herbal Remedies is recalling Herbzeedy Hemp Oil Full Spectrum bottles due to elevated levels of undeclared lead.

    Product
    Herbzeedy, Hemp Oil Full Spectrum, Natural, 500 MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Herbzeedy, Statesboro, GA
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2716-2020·2020-08-12

    CareFusion Alaris System PC Unit Model 8000 Recall for Cleaning Agent Damage

    CareFusion 303, Inc. is recalling Alaris System PC Unit Model 8000 infusion pumps because cleaning agents may damage connectors, causing therapy interruptions.

    Product
    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1448-2020·2020-08-12

    Tasty Drops Hemp Oil Extract Recalled for Undeclared Lead

    Michigan Herbal Remedies is recalling Tasty Drops Hemp Oil Extract due to elevated levels of undeclared lead.

    Product
    Tasty Drops Hemp Oil Extract, Berry, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76469 1
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1457-2020·2020-08-12

    BC Hemp Co. CBD Oil Recalled for Undeclared Lead Contamination

    Michigan Herbal Remedies is recalling 25 bottles of BC Hemp Co. CBD Oil due to elevated levels of undeclared lead.

    Product
    BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Berry Blast, 500mg CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 146, Eau Claire, MI 49111
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·019-2020·2020-08-10

    Mr. Wok Foods Recalls Meat and Poultry for Undeclared Allergens

    Mr. Wok Foods is recalling approximately 242,640 pounds of frozen meat and poultry products due to misbranding and undeclared allergens.

    Product
    Mr Wok Foods Inc. dba Maxfield Foods — Mr. Wok Foods, Inc. Recalls Multiple Meat and Poultry Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V467000·2020-08-10

    Ford Recalls 2020 F-150 Trucks Due to Starter Motor Fire Risk

    Ford is recalling 2020 F-150 vehicles because an incorrect attachment nut on the starter motor may cause electrical arcing and increase the risk of a fire.

    Product
    FORD — FORD F-150
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20T015000·2020-08-10

    Linglong Americas Recalls Venezia Crusade HT Tires Due to Sidewall Separation

    Linglong Americas Inc. is recalling specific Venezia Crusade HT tires because they may experience lower sidewall separation, which can lead to sudden tire failure and increase the risk of a crash.

    Product
    TIRES:SIDEWALL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V471000·2020-08-10

    BMW Recalls Motorcycles Due to Fuel Pump Flange Crack Risk

    BMW is recalling specific motorcycles because a fuel pump flange may crack, causing a fuel leak that increases fire risk.

    Product
    BMW — BMW K1200 GT, HP2 SPORT, K1200 S, K1200 R SPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide