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.

4251–4275 of 4878

  • SevereCPSC·22712·2021-12-16

    Northern Lights Alaura Two-Tone Jar Candles Recall Due to Laceration and Fire Hazards

    Northern Lights is recalling Alaura Two-Tone Jar Candles sold at Costco because the glass containers can shatter, crack, or break while burning, posing laceration and fire hazards. The company has received 138 reports of breakage, including three reports of laceration injuries.

    Product
    Alaura Two-Tone Jar Candles
    Category
    Consumer Product
    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-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 (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-0346-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Capacitor Assembly Defect

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators (Model 980X1ENDIPC) due to incorrect capacitor assembly that may cause the device to malfunction during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
    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 (Food)·F-0269-2022·2021-12-15

    ELLENOS Mango Real Greek Yogurt Recall for Undeclared Egg Allergen

    ELLENOS Real Greek Yogurt in Mango flavor is recalled because the product contains egg but the label does not declare it. The recall affects 3,912 units distributed in Oregon and Washington.

    Product
    Mango Real Greek Yogurt, 16 oz., refrigerated item and packaged in a clear plastic container with a blue foil seal and can be identified by the blue lettering on front panel display. UPC on 16 oz. CUP is 8 57290 00612 6. The Mango Real Greek Yogurt label is read in parts: "*
    Category
    Food
    Distribution
    2 states
  • 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 (Food)·F-0268-2022·2021-12-15

    TaDah! Falafel Street Wrap recalled for undeclared milk allergen

    The Fillo Factory Inc. is recalling TaDah! Falafel Street Wrap with Spicy Brown Sugar Harissa Hummus (7.5 oz) due to undeclared milk allergen. The product was distributed to retailers across multiple states.

    Product
    TaDah! FALAFEL STREET WRAP WITH SPICY BROWN SUGAR HARISSA HUMMUS NET WT. 7.5 OZ. UPC Code:8-5019800307-5
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-0335-2022·2021-12-15

    OsteoMed Surgical Consoles Recalled for Electrical Safety Violations

    OsteoMed OsteoPower Power Consoles and footswitches are being recalled due to non-compliance with electrical safety standard IEC 60601. The product has shocked a patient, creating a significant electrical hazard.

    Product
    OsteoMed OsteoPower Power Console: -OsteoMed OsteoPower Power Console 2 REF 450-0021-00 -OsteoMed D-Power Control Console 2 REF 450-0021-01 -Power Control Console 2 REF ECOS-450-0021-00 -OsteoMed OsteoPower Power Console 2i REF 450-0005-00 -OsteoMed D-Power Control Conso
    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-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 (Devices)·Z-0341-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recall Due to Manufacturing Defect

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing error where a capacitor was assembled incorrectly, which may cause the device to become inoperable during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980S3ENDICU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-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 (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 (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
  • SevereNHTSA·21V878000·2021-12-11

    Alfa Romeo Stelvio and Giulia fuel line sensor housing cracks

    The fuel line sensor housing in certain 2020-2021 Alfa Romeo Stelvio and Giulia vehicles may crack and leak fuel, causing engine stalls and increasing fire risk.

    Product
    ALFA ROMEO — 2020 ALFA ROMEO STELVIO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V876000·2021-12-11

    2021-2022 Continental Cargo and Cargo Mate Trailers: Welding Defect in Coupler

    Forest River is recalling certain 2021-2022 Continental and Cargo Mate cargo trailers due to an improperly welded coupler. The defect may cause the trailer to separate from the tow vehicle, increasing crash risk.

    Product
    CONTINENTAL CARGO — 2021 CONTINENTAL CARGO CARGO TRAILER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0265-2022·2021-12-08

    Pfizer 5% Dextrose Injection Recalled for Potential Bag Leakage

    Pfizer is recalling one lot of 5% Dextrose Injection (50 mL ADD-Vantage Units) due to lack of sterility assurance; the bags have the potential to leak. This is a Class II recall affecting 765 bags distributed nationwide.

    Product
    DEXTROSE — DEXTROSE (DEXTROSE MONOHYDRATE)
    Category
    Drug
    Distribution
    Distributed nationwide