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.

8451–8475 of 29123

  • SevereNHTSA·21V213000·2021-03-25

    GM Recalls 2015 Chevrolet Colorado and GMC Canyon for Steering Defect

    General Motors is recalling 2015 Chevrolet Colorado and GMC Canyon vehicles because a poor electrical connection may cause loss of power steering, increasing crash risk.

    Product
    CHEVROLET — CHEVROLET, GMC COLORADO, CANYON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V204000·2021-03-24

    Jayco Recalls 2019-2020 Motorhomes Due to Gas Leak Risk

    Jayco is recalling 2,144 motorhomes because a stove component may cause a gas leak, increasing the risk of fire.

    Product
    ENTEGRA — ENTEGRA, JAYCO ESTEEM, ODYSSEY, REDHAWK, GREYHAWK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·010-2021·2021-03-24

    BC Food LA Recalls Ineligible Chinese Beef Hot Pot Base Products

    BC Food LA, LLC is recalling approximately 1,643 pounds of Chinese-style hot pot base products containing beef tallow imported from China, a country ineligible to export beef to the U.S.

    Product
    BC Food LA, LLC Recalls Ineligible Beef Products Imported From China
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Food)·F-0342-2021·2021-03-24

    Alqosh Sesame Oil Tahin Recalled Due to Salmonella Contamination

    Mediterranean Food, Inc. is recalling Alqosh Sesame Oil Tahin in 2lb jars because the product tested positive for Salmonella.

    Product
    Alqosh Sesame Oil "Tahin" packaged in 2lb plastic jars
    Category
    Food
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1262-2021·2021-03-24

    Merit Medical Recalls HeartSpan Transseptal Needles Due to Tip Curvature Mismatch

    Merit Medical Systems is recalling 587 HeartSpan Transseptal Needles because the labeled tip curvature may not match the actual curvature, posing a risk of unintended anatomy puncture.

    Product
    HeartSpan Transseptal Needles Catalog No. FND-019-01, Lot No. E1913644 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a soli
    Category
    Medical Device
    Distribution
    18 states
  • SevereFDA (Devices)·Z-1196-2021·2021-03-24

    Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin

    Medtronic is recalling 70 units of Affinity Pixie Cardiotomy/Venous Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Custom Perfusion System (CUSTOM PACK BB10H89R4 ECLR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, and defoamed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V206000·2021-03-24

    Western Star 4700 and 5700 Ground Harness Wiring Defect

    DTNA is recalling 2019-2021 Western Star 4700 and 5700 vehicles with undersized ground harness wiring that may cause connector melting and engine stall, increasing crash risk. Owners should contact DTNA for free replacement.

    Product
    WESTERN STAR — WESTERN STAR 5700, 4700
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V205000·2021-03-24

    Tracker Recalls 2021 Trailers Due to Tire Fender Rubbing

    Tracker Marine is recalling 2021 Ranger Trail and Trailstar trailers because tires may rub against fenders, causing premature wear and increasing the risk of a tire blowout.

    Product
    TRAILSTAR — TRAILSTAR, RANGER TRAIL NZ18, ZV21, NZ21, NZ19
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V203000·2021-03-24

    Starcraft RV Recalls 2019-2020 Travel Trailers Due to Gas Leak Risk

    Starcraft RV is recalling 2019-2020 travel trailers because an overtightened bolt may damage a seal, causing a gas leak that increases fire risk.

    Product
    STARCRAFT RV TT — STARCRAFT RV TT MOSSY OAK LITE, GPS, AUTUMN RIDGE, LAUNCH OUTFITTER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V200000·2021-03-24

    Porsche Recalls 2021 Models Due to Engine Connecting Rod Defect

    Porsche is recalling 2021 Cayman, Boxster, and 718 Spyder vehicles because engine connecting rods may crack and loosen, increasing the risk of a crash or fire.

    Product
    PORSCHE — PORSCHE redundant CAYMAN, redundant BOXSTER, 718 SPYDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V202000·2021-03-24

    2020-2021 Ford F-53 and F-59 Motorhome Rear Bearing and Axle Defect

    Ford is recalling certain 2020-2021 F-53 and F-59 motorhome and commercial chassis vehicles due to inadequate rear axle lubricant. The defect may cause rear wheel bearing damage, rear axle failure, and loss of motive power and brake function.

    Product
    FORD — FORD F-59, F-53
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0305-2021·2021-03-24

    Sagent Recalls Phenylephrine Hydrochloride Injection Due to Sterility Concerns

    Sagent Pharmaceuticals is recalling specific lots of Phenylephrine Hydrochloride Injection due to customer complaints of loose vial overseals that may compromise sterility.

    Product
    PHENYLEPHRINE HYDROCHLORIDE — PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1192-2021·2021-03-24

    Medtronic Recalls Custom Perfusion System Due to Endotoxin Risk

    Medtronic Perfusion Systems is recalling three units of its Custom Perfusion System because they may contain elevated levels of bacterial endotoxins. Patients exposed to these devices could develop an acute inflammatory response.

    Product
    Custom Perfusion System (CUSTOM PACK HY10J00R6 ECC SMALL CAR). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is collected, filtered, an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1197-2021·2021-03-24

    Medtronic Affinity Pixie Cardiotomy Reservoir Recalled for Bacterial Endotoxin

    Medtronic is recalling 5 units of Affinity Pixie Cardiotomy Reservoirs due to potentially elevated bacterial endotoxin levels that may cause acute inflammatory responses.

    Product
    Medtronic Custom Pack CP Kinderset 1/4-1/4 MIT Pixie 1/B (PERFUSION M490817B 1/B). The Affinity Pixie Cardiotomy/Venous Reservoir (CVR) with Balance Biosurface is a single-use device designed to collect and store blood during extracorporeal circulation. Cardiotomy blood is coll
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0303-2021·2021-03-24

    Spironolactone Tablets Recalled Due to Potential Labeling Error

    Bryant Ranch Prepack is recalling 35 bottles of Spironolactone 25 mg tablets because they may contain 50 mg tablets.

    Product
    Spironolactone Tablets, USP, 25 mg, packaged in: a) 30-count bottles (NDC 63629-1064-01), b) 60-count bottles (NDC 63629-1064-02), c) 90-count bottles (NDC 63629-1064-03), Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch P
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1264-2021·2021-03-24

    Imactis NaviKit Stereotaxic Accessory Recalled for Mechanical Defect

    Imactis is recalling 105 NaviKit-stereotaxic accessories due to a mechanical defect in the needle holder that may cause inaccurate needle positioning during use.

    Product
    Impactis NaviKit-stereotaxic accessory for Computed Tomography systems Reference # I10100
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1263-2021·2021-03-24

    Heartspan Transseptal Needle Recall Due to Tip Curvature Mismatch

    Merit Medical Systems is recalling Heartspan Transseptal Needles because the labeled tip curvature may not match the actual curvature, posing a risk of unintended anatomy puncture.

    Product
    Heartspan Transseptal Needles, Catalog No. FND-019-02, Lot No. E1913645 consisting of an outer needle cannula and an inner stylet. The needle is comprised of flexible thin walled tubing with an ergonomic hub and stopcock attached to the proximal end. The stylet consists of a soli
    Category
    Medical Device
    Distribution
    18 states
  • SevereFDA (Food)·F-0339-2021·2021-03-24

    Frozen Tuna Steaks Recalled Due to Salmonella Contamination

    Seafood Imports Distributors Inc. is recalling 10 oz. frozen tuna steaks because FDA samples tested positive for Salmonella.

    Product
    Java Frozen Tuna Steaks - 10 oz. Net Wt. 10 lb. - Approximately 15-18 pieces individually vacuum packed. Product of Indonesia - Wild Caught.
    Category
    Food
    Distribution
    5 states
  • SevereUSDA FSIS·009-2021·2021-03-20

    Avanza Pasta Recalls Beef and Poultry Products Lacking Federal Inspection

    Avanza Pasta, LLC is recalling approximately 9,847 pounds of beef and poultry ravioli and tortellini produced without federal inspection. No adverse reactions have been reported.

    Product
    Avanza Pasta, LLC Recalls Beef and Poultry Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V197000·2021-03-19

    Mercedes-Benz Recalls Vehicles with Potential Front Roof Panel Bonding Defect

    Mercedes-Benz is recalling specific 2014-2020 models equipped with panoramic sunroofs because the front roof panel may not have been bonded correctly during a prior repair.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ C 300, S 450, C 350 E, CLA 250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V194000·2021-03-19

    Isuzu and Chevrolet Trucks Recalled for Rear Axle U-Bolt Nut Defect

    Isuzu is recalling 2015-2021 Isuzu, Chevrolet, and International trucks because rear axle U-bolt nuts may loosen, causing axle misalignment and potential loss of power.

    Product
    CHEVROLET — CHEVROLET, INTERNATIONAL MOTORS, ISUZU 5500HD, 4500XD, CHEVY 5500HD, CHEVY 4500HD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·21V196000·2021-03-19

    Mercedes-Benz Recalls 2006-2007 Models for Sunroof Glass Detachment Risk

    Mercedes-Benz is recalling 11,356 vehicles because the sunroof glass may detach, creating a road hazard and increasing crash risk.

    Product
    MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ CLK500, C280, E500, C230
    Category
    Vehicle
    Distribution
    Distributed nationwide