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.

8326–8350 of 29123

  • SevereCPSC·21124·2021-05-05

    Scott Fetzer Recalls Wayne WaterBUG GLOW Pumps Due to Fire and Shock Hazards

    Scott Fetzer Consumer Brands is recalling Wayne WaterBUG GLOW pumps because water exposure can cause short circuits, posing fire, burn, and electrical shock risks.

    Product
    WAYNE WaterBUG GLOW Multi-Use Submersible Water Removal Pumps
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0353-2021·2021-05-05

    FDA Recalls PremierZen Platinum 5000 for Unapproved Active Ingredients

    Na Na Collection is recalling PremierZen Platinum 5000 capsules because FDA analysis detected unapproved active ingredients tadalafil and/or sildenafil.

    Product
    PremierZen Platinum 5000, Packaged in paper packaging with a pill blister, 1 capsule per box, Distributed by New Premier Group Los Angeles CA 90006
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0352-2021·2021-05-05

    Imperial Extreme 2000 Capsules Recalled for Unapproved Active Ingredients

    S & B Story LLC is recalling Imperial Extreme 2000 Capsules because FDA analysis found unapproved ingredients tadalafil and sildenafil.

    Product
    Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0346-2021·2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Due to Fungal Contamination

    CareFusion is recalling ChloraPrep antiseptic applicators because fungal growth breached package integrity. The product is non-sterile, but the breach compromises the sterility of the applicators.

    Product
    ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0348-2021·2021-05-05

    ChloraPrep One-Step Recalled for Potential Fungal Growth and Package Breach

    CareFusion 213, LLC is recalling ChloraPrep One-Step applicators due to a lack of assurance of sterility. The product may allow fungal growth at labeled storage conditions, potentially breaching package integrity.

    Product
    CHLORAPREP ONE-STEP — CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0351-2021·2021-05-05

    Namoo Enterprise Recalls PremierZen Black 5000 Capsules for Unapproved Ingredients

    Namoo Enterprise LLC is recalling PremierZen Black 5000 capsules because FDA analysis found unapproved ingredients tadalafil and sildenafil.

    Product
    PremierZen Black 5000 capsules, 1 capsule per card/24 capsules per box, Distributed by New Premier Group Los Angeles CA 90006 UPC 7 2817542189 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0354-2021·2021-05-05

    Triple SupremeZen Gold 3500 Recalled for Unapproved Active Ingredients

    Na Na Collection is recalling Triple SupremeZen Gold 3500 capsules because FDA analysis found unapproved active ingredients tadalafil and/or sildenafil.

    Product
    Triple SupremeZen Gold 3500, Packaged in paper packaging with a pill blister,1 capsule per box, Distributed by VIEW LIFE Distributors Los Angeles CA 90005 UPC 7 15122 05089 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0345-2021·2021-05-05

    CareFusion Recalls ChloraPrep Antiseptic Applicators Due to Fungal Contamination

    CareFusion 213, LLC is recalling ChloraPrep One-Step antiseptic applicators because fungal growth breached package integrity under labeled storage conditions.

    Product
    ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 26040
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·017-2021·2021-05-04

    Bellisio Recalls Spaghetti with Meat Sauce for Undeclared Soy Allergen

    Bellisio Foods is recalling approximately 3,927 pounds of Michelina's Spaghetti with Meat Sauce due to misbranding and an undeclared soy allergen.

    Product
    Bellisio Foods, Inc. — Bellisio Foods, Inc. Recalls Beef Pasta Products Due to Misbranding and an Undeclared Allergen
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V315000·2021-05-04

    Ducati Recalls Motorcycles Due to Rear Brake System Air Ingress

    Ducati is recalling specific 2016-2020 models because air may enter the rear brake system, reducing braking effectiveness and increasing crash risk.

    Product
    DUCATI — DUCATI XDIAVEL, MONSTER 1200, MONSTER 797, MONSTER 821
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V309000·2021-05-04

    2020 Alfa Romeo Stelvio Braking System Defect Increases Crash Risk

    Chrysler is recalling the 2020 Alfa Romeo Stelvio due to a defect in the anti-lock braking system. Hard braking can cause the ABS hydraulic control unit rotor shaft to separate, reducing braking performance and increasing crash risk.

    Product
    ALFA ROMEO — ALFA ROMEO STELVIO, GIULIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V313000·2021-05-04

    Blue Bird Recalls 2018-2022 All American Buses for Fuel Leak Risk

    Blue Bird is recalling 2018-2022 All American buses because a fuel rail leak could cause a fire. Owners should contact dealers for free repairs.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN TRANSIT BUS, ALL AMERICAN
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V308000·2021-05-03

    2021 Hyundai Santa Fe Fuel Pipe Connection Defect Recall

    Hyundai is recalling 2021 Santa Fe vehicles with 2.5-litre Turbo engines due to improperly tightened fuel pipe connections that may leak fuel and increase fire risk. The affected vehicles have already been repaired at dealerships at no cost to owners.

    Product
    HYUNDAI — HYUNDAI SANTA FE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V307000·2021-05-03

    Arcimoto Electric Motorcycles Recalled for Steering Angle Sensor Failure

    Arcimoto is recalling multiple 2019-2021 motorcycle models due to faulty steering angle sensors that may cause oversteer and increase crash risk. The company will update firmware and replace the idler arm at no cost.

    Product
    ARCIMOTO — ARCIMOTO FUV, DELIVERATOR, RAPID RESPONDER, ROADSTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E039000·2021-04-30

    Mando Recalls ABS Modules for Brake Fluid Leak and Fire Risk

    Mando America Corporation is recalling certain Anti-lock Brake System (ABS) modules that may leak brake fluid and cause a short circuit, increasing the risk of an engine compartment fire.

    Product
    SERVICE BRAKES, HYDRAULIC:ANTILOCK/TRACTION CONTROL/ELECTRONIC LIMITED SLIP:CONTROL UNIT/MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E038000·2021-04-30

    Mando Recalls ABS Modules Due to Electrical Short Circuit Fire Risk

    Mando America Corporation is recalling specific Anti-lock Brake System (ABS) modules that may malfunction and short circuit, increasing the risk of an engine compartment fire.

    Product
    SERVICE BRAKES, HYDRAULIC:ANTILOCK/TRACTION CONTROL/ELECTRONIC LIMITED SLIP:CONTROL UNIT/MODULE recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1468-2021·2021-04-28

    Trinity Sterile Recalls Midline Catheter Dressing Change Kits Due to Seal Defects

    Trinity Sterile, Inc. is recalling 2,970 Midline Catheter Dressing Change Kits with Statlock because evidence of foreign material in the seal caused improper sealing and compromised sterility.

    Product
    Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1460-2021·2021-04-28

    Biotronik Inventa 7 Defibrillators Recalled for Premature Battery Depletion

    Biotronik Inc is recalling 285 Inventa 7 defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, VR-T DX DF-1, REF 399437, UDI: 04035479136321 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1448-2021·2021-04-28

    BIOTRONIK Iforia 7 Defibrillators Recalled for Premature Battery Depletion

    BIOTRONIK is recalling 490 Iforia 7 implantable defibrillators due to a potential for premature battery depletion. The devices are distributed nationwide and worldwide.

    Product
    BIOTRONIK Iforia 7,DR-T, DF-1,REF 390064, UDI: 04035479126926 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2021·2021-04-28

    Teligent Pharma Recalls Flurandrenolide Ointment Due to Impurity Failures

    Teligent Pharma is recalling 3,432 tubes of Flurandrenolide Ointment 0.05% because the product failed impurity and degradation specifications.

    Product
    Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1467-2021·2021-04-28

    AngioDynamics Safe Sheath Ultralite Recalled for Potential Sterility Compromise

    AngioDynamics is recalling specific Safe Sheath Ultralite kits due to potential sterility compromise. The recall affects 337 units distributed nationwide.

    Product
    AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1437-2021·2021-04-28

    Stryker Recalls Tritanium X TL Spinal Instruments Due to Failure Risk

    Stryker Spine is recalling 169 sets of Tritanium X TL instruments because non-conforming components could lead to device failure during surgery.

    Product
    Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0435-2021·2021-04-28

    Glutenull Goji Berries & Chocolate Cookies Recalled for Undeclared Milk

    Amra Services Ltd. is recalling Glutenull Goji Berries & Chocolate Cookies in Oregon and Washington due to undeclared milk.

    Product
    Glutenull Goji Berries & Chocolate Cookies, packaged in a clear plastic clamshell container, net wt. 11 oz. (320g). UPC 628451529132. The label also states "Non-GMO * Gluten Free Certified * Vegan * GluteNull Bakery Port Coquitlam, BC V3C 6P8 ***".
    Category
    Food
    Distribution
    2 states