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.

8176–8200 of 29123

  • SevereFDA (Devices)·Z-1539-2021·2021-06-16

    COVID-19 Self-Test Kit Distributed Without Clinical Investigation Authorization

    Innova Medical Group recalled COVID-19 self-test kits distributed to customers outside of clinical investigation requirements. About 1,206 tests in 402 boxes were distributed across the U.S., Canada, India, and the United Kingdom.

    Product
    COVID-19 Self-Test Kit *** INNOVA *** 3T
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1834-2021·2021-06-16

    Surgical procedure pack anesthetic mislabeled with wrong drug and strength

    DeRoyal Angio Cath Removal Tray contains mislabeled anesthetic; the label indicates 1% Lidocaine but the tray actually contains 0.5% Bupivacaine. This FDA Class I recall affects 60 trays distributed in MS, VA, LA, and NY.

    Product
    DeRoyal Angio Cath Removal Tray, REF 89-9936.02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0674-2021·2021-06-16

    BC Foods Celery Stalk and Leaf Dice Recalled for Salmonella

    BC Foods is recalling Celery Stalk and Leaf Dice due to an ingredient testing positive for Salmonella. The product was distributed to food manufacturers and distributors across eight states.

    Product
    BC Foods Celery Stalk and Leaf Dice 3/8, AD Sulfites, 11 lb. Poly lined bulk fiber carton. Item code: VCE1-D38-AXG-AB-AR
    Category
    Food
    Distribution
    8 states
  • SevereNHTSA·21E051000·2021-06-14

    Wallace Forge recalls medium duty adjustable mount couplers

    Wallace Forge is recalling specific medium duty adjustable mount couplers that may uncouple due to excessive play, increasing crash risk.

    Product
    EQUIPMENT recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V445000·2021-06-11

    Host Campers Recalls 2019-2021 Trailers Due to Gas Leak Risk

    Host Industries is recalling 2019-2021 Cascade, Rainier, Tahoe, and Mammoth trailers because a stove bolt may damage the seal, causing a gas leak and fire risk.

    Product
    HOST CAMPERS — HOST CAMPERS RAINIER, TAHOE, MAMMOTH, CASCADE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·21150·2021-06-09

    Klein Tools Non-Contact Voltage Tester Recalled for Shock Hazard

    Klein Tools non-contact voltage testers (model NCVT-1) are recalled because the on/off button can fail to disengage, causing the tester to malfunction and potentially fail to detect live voltage. One shock injury has been reported.

    Product
    Klein Tools Non-Contact Voltage Tester Model NCVT-1
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V437000·2021-06-09

    Karavan Recalls 2021 Move I 1500 Long Trailers Due to Axle Weld Defect

    Karavan is recalling 2021 Move I 1500 Long trailers because improperly welded wheel spindles can break, causing the wheel to detach and increasing crash risk.

    Product
    KARAVAN — KARAVAN MOVE I 1500 LONG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0646-2021·2021-06-09

    Giant Eagle Chicken Street Taco Kit recalled for undeclared egg allergen

    Giant Eagle is recalling Chicken Street Taco Kit packages due to undeclared egg allergen. The affected product was distributed to stores in PA, WV, OH, and IN.

    Product
    Giant Eagle Chicken Street Taco Kit; 20 oz (1 lbs 4 oz) Individual Units, PLU Code beginning 256598 00000
    Category
    Food
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0626-2021·2021-06-09

    Bupivacaine and Lidocaine Injection Vials Recalled for Label Mix-Up

    Pfizer is recalling 163,957 vials of 0.5% Bupivacaine Hydrochloride Injection due to a label mix-up where some vials labeled as bupivacaine may contain lidocaine, and vials labeled as lidocaine may contain bupivacaine. The mix-up could lead to patients receiving the wrong local anesthetic.

    Product
    BUPIVACAINE HYDROCHLORIDE — BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1619-2021·2021-06-09

    Leccurate COVID-19 Antibody Test Kit Recalled for Unauthorized U.S. Distribution

    LEPU Medical has recalled the Leccurate SARS-CoV-2 Antibody Rapid Test Kit because it is not authorized, cleared, or approved for marketing in the U.S. Approximately 8.4 million units have been distributed worldwide.

    Product
    Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adapti
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Food)·F-0645-2021·2021-06-09

    Peppa Pig Chocolate Chip Cookies Recalled for Undeclared Egg Allergen

    PRIMARY COLORS DESIGN CORP is recalling Peppa Pig brand chocolate chip cookies due to undeclared egg allergen on the packaging. The recall affects 294 boxes distributed in Georgia, lot number 091820.

    Product
    Peppa Pig brand chocolate chip cookies. One 7 oz bag per box- 6 boxes per case
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Food)·F-0633-2021·2021-06-09

    Mahayograj Guggulu Dietary Supplement Recalled for High Lead Contamination

    Garry N Sun USA Inc. is recalling Mahayograj Guggulu dietary supplement capsules and powder due to high lead levels detected in a consumer sample. The product was distributed across multiple U.S. states and Canada.

    Product
    Mahayograj Guggulu; 120 Vegetarian Capsules, 1/2 lb. bags of powder Dietary Supplement, 1030 Matley Lane, Unit A Reno, NV 89502 Serving size: 2 capsule Servings per container: 60 Proprietary Blend - 500 mg Certified Organic Distributed by Garry N Sun USA
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-1620-2021·2021-06-09

    Leccurate SARS-CoV-2 Antigen Test Kit Recalled: Not FDA-Approved for U.S. Distribution

    The Leccurate SARS-CoV-2 Antigen Rapid Test Kit is being recalled because it was not authorized, cleared, or approved for marketing in the United States. Approximately 8.4 million units were distributed worldwide, including to U.S. states and territories.

    Product
    Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab).
    Category
    Medical Device
    Distribution
    5 states
  • SevereNHTSA·21V426000·2021-06-04

    KZRV Sidewinder Recalled for Propane Regulator Fire Risk

    KZRV is recalling 2018-2019 Sidewinder RVs because a propane regulator may fail, increasing pressure and fire risk.

    Product
    KZRV — KZRV SIDEWINDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V430000·2021-06-04

    Highland Ridge RV Recalls Trailers with Propane Regulator Defect

    Highland Ridge RV is recalling certain 2019-2021 fifth wheel and travel trailers because a propane regulator may fail, increasing fire risk.

    Product
    HIGHLAND RIDGE FW — HIGHLAND RIDGE FW, HIGHLAND RIDGE TT OPEN RANGE, SILVERSTAR, MESA RIDGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V424000·2021-06-03

    Land Rover Defender Recall for Engine Stall Risk

    Land Rover is recalling 2020-2021 Defender vehicles with 6-cylinder engines because the powertrain control module may unexpectedly switch off, causing an engine stall.

    Product
    LAND ROVER — LAND ROVER DEFENDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V423000·2021-06-03

    GM Recalls 2019 Silverado and Sierra 1500 for Tire Sidewall Defect

    General Motors is recalling 2019 Chevrolet Silverado 1500 and GMC Sierra 1500 vehicles because over-cured tires may develop sidewall breaks, risking sudden air loss and loss of vehicle control.

    Product
    GMC — GMC, CHEVROLET SIERRA 1500, SILVERADO 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V422000·2021-06-03

    2021 GMC Acadia Fuel Supply Line Recall Due to Fire Risk

    General Motors is recalling certain 2021 GMC Acadia vehicles due to improperly attached fuel supply lines. The lines may loosen or separate, causing fuel leaks and increasing the risk of fire.

    Product
    CADILLAC — CADILLAC, GMC XT5, XT6, ACADIA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V420000·2021-06-03

    Sea-Doo Move I Extended 1500 Trailer Recalled for Wheel Spindle Weld Defect

    Bombardier is recalling 2021 Sea-Doo Move I Extended 1500 trailers because improperly welded wheel spindles can break, causing the wheel to detach and increasing crash risk.

    Product
    SEA-DOO — SEA-DOO MOVE I EXTENDED 1500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1630-2021·2021-06-02

    Philips Respironics BiPAP A40 Ventilator Recall for Material Defects

    Philips Respironics is recalling four BiPAP A40 ventilators because non-conforming plastic in the motor assembly may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0632-2021·2021-06-02

    Sara Lee and Chef Pierre Pecan Pies Recalled for Undeclared Peanut

    Sara Lee Frozen Foods is recalling specific pecan pie products due to potentially undeclared peanut. Consumers should check labels and stop using the affected items.

    Product
    Sara Lee Pecan Pie 4oz. retail packaged UPC 032100051118, 24 and 48 count wholesale case; Chef Pierre Southern Pecan Pie, 10 slices, 36oz. retail packaged UPC 032100092739, 6 pies per wholesale case; Chef Pierre Pecan Pie, 10 slices, 36oz. retail packaged UPC 032100093750, 6 pies
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V418000·2021-06-02

    Stonebrooke RAM 5500 Recalled for Rear Brake Fluid Leak Risk

    Stonebrooke is recalling one 2019 RAM 5500 because the rear brake line can wear and leak, increasing crash risk.

    Product
    STONEBROOKE EQUIPMENT — STONEBROOKE EQUIPMENT RAM 5500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V414000·2021-06-02

    Volvo Recalls 2019-2020 Models for Fuel Pump Fuse Failure Risk

    Volvo is recalling 2019-2020 models because a fuel pump fuse can fail, causing the vehicle to stall and increasing crash risk.

    Product
    VOLVO — VOLVO V90, XC60, V90CC, V60CC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1625-2021·2021-06-02

    Philips Respironics BiPAP V30 Auto Recall for Non-Conforming Plastic Material

    Philips Respironics is recalling 22 BiPAP V30 Auto ventilators because non-conforming plastic in motor assemblies may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0567-2021·2021-06-02

    Indianapolis Fruit Company Recalls Organic Coleslaw Due to Plastic Foreign Material

    Indianapolis Fruit Company is recalling Garden Cut Coleslaw W/ Carrot Organic due to the presence of plastic foreign material. The product was distributed to retailers in six states.

    Product
    Garden Cut Coleslaw W/ Carrot Organic, 1lb plastic clamshell, UPC 053495081016, 4 1lb retail units per wholesale case. Item number: CACO41L / 17671
    Category
    Food
    Distribution
    6 states