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.

8376–8400 of 29123

  • SevereNHTSA·21V271000·2021-04-21

    2021 Porsche Cayenne recalled for rear axle suspension defect

    Porsche is recalling certain 2021 Cayenne models because lock nuts on the rear axle may break due to stress corrosion, potentially causing loss of control and crash risk.

    Product
    PORSCHE — PORSCHE CAYENNE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1414-2021·2021-04-21

    Roche cobas Liat Analyzer Respiratory Virus Panel Recall

    Roche is recalling the cobas Liat Analyzer respiratory virus panel due to invalid or false positive results for SARS-CoV-2 and Influenza A/B.

    Product
    cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0623-2021·2021-04-21

    Novo Nordisk Recalls Xultophy 100/3.6 Due to Temperature Abuse

    Novo Nordisk is recalling Xultophy 100/3.6 samples stored below 32°F. The temperature abuse may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    XULTOPHY 100/3.6 — XULTOPHY 100/3.6 (INSULIN DEGLUDEC AND LIRAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1384-2021·2021-04-21

    Recall of Covidien Signia Vascular Stapler Reloads Due to Safety Interlock Failure

    FDA recalls 11,391 units of Covidien Signia vascular stapler reloads because a safety interlock may fail, allowing empty reloads to fire and cause tissue injury.

    Product
    Covidien Signia Grey Small Diameter Curved Tip Intelligent Reload 30 mm Vascular 8 mm - Short Item Code: SIGSDS30CTV
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0611-2021·2021-04-21

    Novo Nordisk Recalls Fiasp Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling Fiasp insulin pen samples stored below 32°F. The temperature abuse 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 (Drugs)·D-0613-2021·2021-04-21

    Novo Nordisk Recalls Fiasp Insulin Samples Due to Temperature Abuse

    Novo Nordisk is recalling Fiasp (insulin aspart injection) samples 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 (Drugs)·D-0620-2021·2021-04-21

    Novo Nordisk Recalls TRESIBA Insulin Samples Due to Temperature Abuse

    Novo Nordisk is recalling TRESIBA (insulin degludec) samples stored below 32°F, which may cause lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    TRESIBA — TRESIBA (INSULIN DEGLUDEC)
    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-0615-2021·2021-04-21

    Novo Nordisk Recalls Insulin Diluting Medium Due to Temperature Abuse

    Novo Nordisk is recalling specific samples of Insulin Diluting Medium for NovoLog because they were stored below 32°F, potentially causing lack of efficacy and damage to the cartridge and pen-injectors.

    Product
    INSULIN DILUTING MEDIUM FOR NOVOLOG — INSULIN DILUTING MEDIUM FOR NOVOLOG (WATER INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1383-2021·2021-04-21

    FDA Recalls 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 and causing tissue injury.

    Product
    Covidien Signia Small Diameter Curved Tip Intelligent Reload 45 mm Vascular/Thin 8 mm - Long Item Code: SIGSDL45CTVT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0361-2021·2021-04-21

    Spartan Chemical Recalls Antiseptic Hand Cleaner Due to Manufacturing Deviations

    Spartan Chemical Co Inc is recalling 400 gallons of Antiseptic Hand Cleaner due to CGMP deviations. The product was distributed nationwide in the US, Puerto Rico, and Mexico.

    Product
    ANTISEPTIC HAND CLEANER — ANTISEPTIC HAND CLEANER (CHLOROXYLENOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0619-2021·2021-04-21

    Novo Nordisk Recalls TRESIBA Insulin Pens Due to Temperature Abuse

    Novo Nordisk is recalling TRESIBA (insulin degludec) prefilled 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 (Drugs)·D-0332-2021·2021-04-21

    Lupin Recalls Cefprozil Oral Suspension Due to Superpotent Drug Concerns

    Lupin Pharmaceuticals is recalling specific lots of Cefprozil for Oral Suspension because the drug may be superpotent. The recall covers bottles distributed nationwide in the USA and Puerto Rico.

    Product
    CEFPROZIL — CEFPROZIL (CEFPROZIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E032000·2021-04-20

    Cummins Diesel Engine Fuel Rail Recall for Fire Risk

    Cummins is recalling specific L9 and ISX12 diesel engines because a sealing washer defect may cause fuel leaks, increasing the risk of fire.

    Product
    FUEL SYSTEM, DIESEL:FUEL INJECTION SYSTEM:FUEL RAIL recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E029000·2021-04-16

    Daimler Trucks Recalls Detroit Axles Due to Steering Bolt Defect

    Daimler Trucks North America is recalling Detroit Model 2 and 3 axles because steering arm and tie rod bolts may fracture, potentially causing a loss of steering.

    Product
    STEERING:CRITICAL FASTENERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21E030000·2021-04-16

    TSE Brakes Recalls Omni Tandem Brake Chambers Due to Spring Defect

    TSE Brakes is recalling certain Omni Tandem Brake Chambers because incorrect springs may cause the pressure plate to shift, potentially leading to a loss of air pressure and increased crash risk.

    Product
    PARKING BRAKE:CRITICAL FASTENERS recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·012-2021·2021-04-15

    Olymel Recalls Ready-to-Eat Ham Due to Salmonella Enteritidis Contamination

    Olymel S.E.C./L.P. is recalling approximately 6,804 pounds of ready-to-eat ham products due to possible Salmonella Enteritidis contamination. The products were shipped to distributors in California for institutional use.

    Product
    Olymel S.E.C./L.P. Recalls Ready-to-Eat Ham Products Due to Possible Salmonella Enteritidis Contamination
    Category
    Food
    Distribution
    1 state
  • SevereNHTSA·21V266000·2021-04-15

    2022 Thomas Built Buses Minotour Recalled for Electrical Fire Risk

    Daimler Trucks North America is recalling 2022 Thomas Built Buses Minotour vehicles because battery cable terminals may contact a fuse block, causing an electrical short circuit and increasing fire risk.

    Product
    THOMAS BUILT BUSES — THOMAS BUILT BUSES MINOTOUR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0320-2021·2021-04-14

    Sun Pharmaceutical Recalls Ganirelix Acetate Injection Due to Impurities

    Sun Pharmaceutical Industries is recalling 91,211 syringes of Ganirelix Acetate Injection because the product failed impurities and degradation specifications.

    Product
    Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Food)·F-0383-2021·2021-04-14

    Bobo's Maple Pecan Oat Bars Recalled for Peanut Complaints

    Simply Delicious Inc. is recalling Bobo's Maple Pecan Oat Bars due to consumer complaints regarding the presence of peanuts.

    Product
    Bobo's Maple Pecan Oat Bars, 3 oz., UPC 8 2926200021 0, Best By 7/30/21 or 7/31/21.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0396-2021·2021-04-14

    MG Foods Recalls Fresh To You Deluxe Triple Decker Club Sandwiches

    Canteen Inc. dba MG Foods, Inc. is recalling 379 Fresh To You Deluxe Triple Decker Club sandwiches due to positive Listeria monocytogenes test results.

    Product
    FRESH TO YOU Deluxe Triple Decker Club, Net Wt. 12.17 oz (345g), MG Foods Charlotte, NC 28208, UPC MGF9719
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0390-2021·2021-04-14

    Whole Foods Market Cranberry Biscotti Recalled for Undeclared Pistachios

    Whole Foods Market is recalling Cranberry Biscotti (PLU 41712) because the product contains undeclared pistachios, a major tree nut allergen.

    Product
    Whole Foods Market Cranberry Biscotti PLU 41712 packaged in a clear plastic clam shell container
    Category
    Food
    Distribution
    3 states