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.

7376–7400 of 29119

  • SevereFDA (Devices)·Z-0347-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Assembly Defect

    Covidien LLC is recalling 278 units of the Puritan Bennett 980 Series Ventilator due to a manufacturing defect that may cause the device to become inoperable during clinical use.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1ENDIUU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0266-2022·2021-12-15

    AmericanScreening Hand Sanitizer Recalled for Misleading Bottle Resemblance

    AmericanScreening Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ bottles, is being recalled nationwide because the containers resemble drinking water bottles, posing a risk of accidental ingestion.

    Product
    AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0343-2022·2021-12-15

    Puritan Bennett 980 Ventilator Recalled for Capacitor Assembly Error

    Covidien is recalling the Puritan Bennett 980 Series Ventilator due to incorrect capacitor assembly that may cause the device to become inoperable during patient use.

    Product
    Puritan Bennett 980 Series Ventilator, 980U1ESDIUC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0243-2022·2021-12-15

    Aqua Nova and Tony's Smoke House Smoked Salmon Recalled for Listeria

    Oregon Lox Company is recalling Aqua Nova and Tony's Smoke House smoked salmon products due to potential Listeria monocytogenes contamination. The recall affects products distributed in Alaska, California, Oregon, and Washington.

    Product
    Aqua Nova - Sliced Nova Lox, Oregon Cold Smoked Salmon, net wt. 3 oz. UPC 008603001608. Aqua Nova -Sliced Nova Lox, Oregon Cold Smoked Salmon, net wt. 1 lb. UPC 008603001400. Aqua Nova - Premium Oregon Nova Lox (Sliced), cold smoked salmon, various net wt 2-3 lbs per side. UPC
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Food)·F-0244-2022·2021-12-15

    North Coast Traditional Nova Lox Recall for Listeria monocytogenes

    Oregon Lox Company is recalling North Coast Traditional Nova Lox (cold smoked salmon) due to potential Listeria monocytogenes contamination. The product was distributed in Alaska, California, Oregon, and Washington.

    Product
    North Coast Traditional Nova Lox, cold smoked salmon, various net wt. 2-3lb average per side. UPC 008603005200. The Ingredients statement on the label are read in parts: "***INGREDIENTS: Wild Pacific salmon, corn oil, salt, brown sugar, sodium nitrite, FD&C Yellow 6/Red 40, natu
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0351-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Assembly Error Risk

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor that may cause the device to become inoperable during use. This recall affects units worldwide and in the US.

    Product
    Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0353-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recall Due to Assembly Error

    Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators due to a capacitor assembly error that may cause the device to become inoperable during use. Affected devices were distributed worldwide with specific serial numbers targeted.

    Product
    Puritan Bennett 980 Series Ventilator, 980X3JADIJJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0350-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recall Due to Assembly Defect

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to an assembly error where a capacitor was incorrectly installed, potentially causing the device to become inoperable during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1PLDIPC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0340-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Defect

    Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing assembly error where a capacitor may have been installed incorrectly, potentially causing device inoperability during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980S1ENDICU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0338-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator recalled for capacitor assembly error

    The Puritan Bennett 980 Series Ventilator is being recalled because a capacitor may be assembled incorrectly, which could cause the ventilator to stop working during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980A1ENNISB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0349-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator recalled for assembly defect

    Puritan Bennett 980 Series Ventilators are recalled due to a capacitor assembly error that may cause the device to become inoperable during use. The recall affects 278 units distributed worldwide.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1JADIJJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0342-2022·2021-12-15

    Puritan Bennett 980 Ventilator Recalled for Capacitor Assembly Error

    Puritan Bennett 980 Series Ventilators are recalled due to an assembly error in a capacitor that may cause the device to become inoperable during use. The recall affects 278 units.

    Product
    Puritan Bennett 980 Series Ventilator, 980U1ENASAA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0352-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recall - Capacitor Assembly Error

    Covidien is recalling 278 Puritan Bennett 980 Series ventilators (model 980X3ENDIUU) due to a capacitor assembly error that may cause the device to become inoperable during patient use.

    Product
    Puritan Bennett 980 Series Ventilator, 980X3ENDIUU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0339-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Assembly Defect

    Covidien is recalling Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor. The defect may cause the ventilator to become inoperable during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980A3ENNISB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0245-2022·2021-12-15

    North Coast Smoked Salmon Trim Recalled for Listeria Contamination

    Oregon Lox Company is recalling North Coast Smoked Salmon Trim (3 lb packages, UPC 008603002551) due to potential Listeria monocytogenes contamination. The product was distributed in Alaska, California, Oregon, and Washington.

    Product
    North Coast Smoked Salmon Trim - Partial Slices of Cold Smoked Salmon, net wt. 3 lb. UPC 008603002551. The Ingredients statement on the label are read in parts: "***INGREDIENTS: Salmon, salt, brown sugar, sodium nitrite, FD&C Yellow 6/Red 40, natural hardwood smoke ***CONTAINS:
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Devices)·Z-0348-2022·2021-12-15

    Puritan Bennett 980 Ventilator recalled for capacitor assembly defect

    The Puritan Bennett 980 Series Ventilator may become inoperable due to a manufacturing defect in the internal capacitor assembly. A total of 278 units worldwide have been affected.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1ENNISB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·047-2021·2021-12-14

    Margherita Pepperoni Recalled for Possible Bacillus Cereus Contamination

    Smithfield Packaged Meats is recalling approximately 10,990 pounds of Margherita pepperoni due to possible Bacillus cereus contamination. No illnesses have been reported.

    Product
    Smithfield Packaged Meats Corp. Dba Margherita Meats Inc. Recalls Pepperoni Products Due to Possible Bacillus Cereus Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V961000·2021-12-13

    Mercedes-Benz Recalls Vehicles Due to Fuel Leak Fire Risk

    Mercedes-Benz is recalling specific gasoline-engine vehicles because trapped particles may cause a fuel leak, increasing the risk of a fire.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ AMG G63, GLB 250, AMG A35, AMG C63
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V962000·2021-12-13

    Sutphen Recalls 2016-2020 Fire Trucks Due to Fuel Leak Risk

    Sutphen is recalling 2016-2020 fire trucks because fuel tubes may crack, causing high-pressure leaks that increase fire risk.

    Product
    SUTPHEN — SUTPHEN FIRE TRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V960000·2021-12-10

    KME Predator Fire Risk Recall Due to Fuel Tube Cracking

    KME is recalling 2020-2022 Predator and Severe Service vehicles because fuel tubes may crack, causing high-pressure leaks that increase fire risk.

    Product
    KME — KME PREDATOR SS, PREDATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V953000·2021-12-09

    Mack Trucks Recalls TerraPro Models Due to Parking Brake Release Risk

    Mack Trucks is recalling certain TerraPro vehicles because a brake control valve air leak can cause the parking brake to release unexpectedly, increasing the risk of a crash.

    Product
    MACK — MACK TERRAPRO (MRU), TE, MRU, TERRAPRO (TE)
    Category
    Vehicle
    Distribution
    Distributed nationwide