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.

8351–8375 of 29123

  • 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 (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
  • SevereFDA (Devices)·Z-1459-2021·2021-04-28

    Biotronik Inventa 7 ICDs Recalled for Premature Battery Depletion

    Biotronik is recalling Inventa 7 ICDs and CRT-Ds due to a potential for premature battery depletion. The recall covers devices distributed nationwide and worldwide.

    Product
    BIOTRONIK INVENTRA 7, VR-T DX DF-1 ProMRI, REF 399436, UDI: 04035479136314 - 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-1474-2021·2021-04-28

    Smiths Medical Recalls Medex High Pressure Adaptors and LogiCal Kits

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Adaptors and LogiCal Kits due to insufficient or incomplete welds.

    Product
    Gang Cath Lab Set, Model Number M20858R1.for the administration of IV fluids. Stopcocks and manifolds are used to control the direction of IV fluid flow.
    Category
    Medical Device
    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-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 (Devices)·Z-1445-2021·2021-04-28

    BIOTRONIK Ilestro 7 VR-T DX Defibrillators Recalled for Battery Depletion

    BIOTRONIK Inc is recalling 3,664 Ilestro 7 VR-T DX implantable defibrillators due to a potential for premature battery depletion.

    Product
    BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - 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 (Food)·F-0472-2021·2021-04-28

    Quirch Foods Recalls Frozen Yellowfin Tuna Portions Due to Histamines

    Quirch Foods is recalling 55 cases of frozen yellowfin tuna portions due to fish decomposition and histamines. The product was distributed domestically in Puerto Rico.

    Product
    Yellowfin Tuna portions Frozen IVP-CO Treated, Net WT 20 LBS, Size 1 LB.
    Category
    Food
    Distribution
    0 states
  • 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 (Devices)·Z-1476-2021·2021-04-28

    Smiths Medical Recalls Manifold Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of manifold rotators and related components because they may have insufficient or incomplete welds.

    Product
    Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1232MR b. 250 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Model Number MX1233MR c. 550 2 GANG MANIFOLD ROTATOR, OPEN HANDLE, Model Number MX1322MR d. 550 3 GANG MANIFOLD ROTATOR, OFF HANDLE, Mod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1479-2021·2021-04-28

    Smiths Medical Recalls High Pressure Rotators Due to Incomplete Welds

    Smiths Medical ASD Inc. is recalling specific lots of Medex High Pressure Rotators because they may have insufficient or incomplete welds.

    Product
    HIGH PRESSURE ROTATOR (Component) a. WITH MALE LUER LOCK, Model Number MX496HP b. WITH FEMALE LUER LOCK, Model Number MX497HP. component of extravascular blood-pressure Transducer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V297000·2021-04-27

    Mitsubishi Fuso Recalls FEC7T Trucks for Rear Leaf Spring Defect

    Mitsubishi Fuso is recalling 2019-2021 FEC7T trucks because the rear leaf spring may break, creating a road hazard and increasing crash risk.

    Product
    MITSUBISHI FUSO — MITSUBISHI FUSO FEC7T
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V295000·2021-04-26

    Multiple Audi vehicles recalled for defective rear axle suspension lock nuts

    Audi is recalling certain 2019-2021 vehicles for rear axle lock nuts that may break from stress corrosion. A broken lock nut can cause axle misalignment, loss of control, and increased crash risk.

    Product
    AUDI — AUDI S5 CABRIOLET, S5, S4, RS 7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V292000·2021-04-26

    Keystone Recalls 2021 Passport Trailers Due to Underrated Safety Chains

    Keystone is recalling specific 2021 Passport trailers because the installed safety chains are underrated for the vehicle's weight rating, which could allow the trailer to detach from the tow vehicle.

    Product
    KEYSTONE — KEYSTONE PASSPORT
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V288000·2021-04-23

    Mercedes-Benz Recalls 2020-2021 GLE and GLS Models for Fire Risk

    Mercedes-Benz is recalling certain 2020-2021 GLE and GLS vehicles because incorrectly installed air conditioner drain hoses may cause water intrusion, leading to electrical short circuits and fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLE 350, GLE 450, GLS 450, GLS 580 4MATIC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·014-2021·2021-04-23

    Super World Trading Recalls Ineligible Imported Ready-to-Eat Fish Chips

    Super World Trading Inc. is recalling approximately 26,270 pounds of ready-to-eat fish chips imported from China because the country is ineligible to export processed products to the U.S.

    Product
    Super World Trading Inc. Recalls Ineligible Ready-To-Eat Siluriformes Products Imported From China
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V285000·2021-04-22

    Blue Bird Recalls 2022 Transit Buses Due to Air Brake Defect

    Blue Bird is recalling 96 2022 Vision and All American transit buses because a check valve defect may cause unintended spring brake application, increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN TRANSIT BUS, VISION TRANSIT BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V284000·2021-04-22

    Blue Bird Recalls 2020-2022 School Buses Due to Brake Valve Defect

    Blue Bird is recalling 2020-2022 Vision and All American school buses because a check valve may fail to isolate air, potentially causing unintended spring brake application and increasing crash risk.

    Product
    BLUE BIRD — BLUE BIRD ALL AMERICAN SCHOOL BUS, VISION SCHOOL BUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0612-2021·2021-04-21

    Novo Nordisk Recalls Fiasp Insulin Due to Temperature Abuse

    Novo Nordisk is recalling Fiasp insulin cartridges stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    FIASP — FIASP (INSULIN ASPART INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1410-2021·2021-04-21

    K2M Chesapeake Cervical Drill Guide Inserter Recalled for Interference Defect

    K2M, Inc. is recalling the Chesapeake Cervical-Ti 10mm Drill Guide Inserter due to an interference condition that may cause spinal cord injury or screw misalignment.

    Product
    Chesapeake Cervical-Ti 10mm Drill Guide Inserter- a multi-screw construct providing stability to the anterior column (cervical spine) Catalog number: 3608-90033
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0621-2021·2021-04-21

    Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling specific lots of TRESIBA insulin pens because they were stored below 32°F, which may reduce efficacy and damage the device.

    Product
    TRESIBA — TRESIBA (INSULIN DEGLUDEC)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1385-2021·2021-04-21

    Recall of Covidien Signia Stapler Reloads Due to Safety Interlock Failure

    FDA is recalling specific lots of Covidien Signia stapler reloads because a safety interlock may fail, allowing empty reloads to be fired.

    Product
    Covidien Signia Small Diameter Curved Tip Intelligent Reload 30 mm Vascular/Thin 8 mm - Short Item Code:SIGSDS30CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide