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.

9801–9825 of 29157

  • SevereNHTSA·20V203000·2020-04-08

    Spartan Gladiator and MetroStar Recalled for Park Brake Line Defect

    Marion Body Works is recalling 2019-2020 Spartan Gladiator and MetroStar vehicles because the park brake control line may loosen, potentially causing sudden deceleration and increasing crash risk.

    Product
    SPARTAN — SPARTAN METROSTAR, GLADIATOR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0863-2020·2020-04-08

    Tiffany Food Corp. Recalls Dried Mushroom for Undeclared Sulfites

    Tiffany Food Corp. is recalling 1,500 units of Huangfushanzhen Dried Mushroom because the product contains undeclared sulfites.

    Product
    HUANGFUSHANZHEN; Dried Mushroom; Net Weight: 170G/6 OZ; Ingredient: Dried Mushroom; PRODUCT OF CHINA; SOLE AGENT: TIFFANY FOOD CORP; UPC: 6 943153 804047
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Drugs)·D-1074-2020·2020-04-08

    Medical Center Pharmacy Recalls Vancomycin Opthal Drops Due to Sterility Concerns

    Medical Center Pharmacy is recalling Vancomycin Opthal 14 mg drops because production processes could not assure sterility. The product was distributed to patients in Tennessee.

    Product
    C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 67457-0340-01.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1076-2020·2020-04-08

    Medical Center Pharmacy Recalls Gentamicin Bladder Irrigation Bags

    Medical Center Pharmacy is recalling 250 mL bags of Gentamicin/Bacitracin Bladder Irrigation due to concerns that production processes cannot assure sterility.

    Product
    C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 63323-0010-02.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1073-2020·2020-04-08

    Medical Center Pharmacy Recalls C-Albumin Eye Drops Due to Sterility Concerns

    Medical Center Pharmacy is recalling specific lots of C-Albumin Eye Drop 10% S because production processes cannot assure sterility. Patients in Tennessee who received these prescriptions should contact their healthcare provider.

    Product
    C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center Pharmacy, 2401 Ocoee Street, Cleveland, TN 37311, NDC 44206-0251-05.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1075-2020·2020-04-08

    Morphine 2 mg/mL CADD Cassettes Recalled for Sterility Concerns

    Medical Center Pharmacy is recalling Morphine 2 mg/mL CADD Cassettes because production processes cannot assure sterility. Patients in Tennessee who received specific prescriptions should contact their healthcare provider.

    Product
    *Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pharmacy, 2401 N. Ocoee Street, Cleveland, TN 37311, NDC 00409-1134-03.
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1602-2020·2020-04-08

    Stryker Recalls Ceiling Mounted Surgical Light Systems Due to Fall Risk

    Stryker is recalling 1,415 Berchtold Chromophare Ceiling Mounted Surgical Light Systems because a missing snap ring or spanner nut may cause the light to fall.

    Product
    Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereCPSC·20107·2020-04-08

    Continuum Recalls Lenox Tea Kettles Due to Burn Hazard

    Continuum is recalling Lenox 2.5 Quart Tea Kettles because they can expel hot water, posing a burn hazard. Consumers should stop using the kettles and contact the company for a refund.

    Product
    Lenox 2.5 Quart Tea Kettles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V198000·2020-04-06

    KTM Recalls 2019-2020 790 Adventure Models Due to Rear Brake Hose Overheating

    KTM is recalling 2019-2020 790 Adventure and 790 Adventure R motorcycles because the rear brake hose may overheat, potentially causing brake failure and increasing crash risk.

    Product
    KTM — KTM 790 ADVENTURE R, 790 ADVENTURE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V193000·2020-04-03

    Isuzu Recalls 2019 NPR Vehicles Due to Brake Line Clip Defect

    Isuzu is recalling 2019 NPR and Chevrolet 4500 vehicles because incorrectly installed brake line clips may cause rear driver-side brake failure.

    Product
    ISUZU — ISUZU NPR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·20V190000·2020-04-02

    Setra S417TC Coaches Recalled for Front Door Detachment Risk

    Daimler Coaches is recalling 2017-2020 Setra S417TC coaches because the front entrance door support frame may be the wrong size, allowing the door to detach while moving.

    Product
    SETRA — SETRA S417 TC
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0887-2020·2020-04-01

    International Sprout Holding Recalls Clover Seed for E. Coli Contamination

    International Sprout Holding Inc. is recalling 13,455 lbs of clover seed due to possible E. Coli contamination. The product was distributed to multiple US states, territories, and countries.

    Product
    Clover seed in 55 lb. multi-layered white paper bags, 40 bags to a pallet.
    Category
    Food
    Distribution
    19 states
  • SevereFDA (Devices)·Z-1527-2020·2020-04-01

    ev3 Pipeline Flex Embolization Device Recalled for Potential Fracture

    Micro Therapeutics Inc is recalling 1,050 ev3 Pipeline Flex Embolization Devices because the delivery system may fracture during implantation, potentially leaving a part in the patient.

    Product
    ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0890-2020·2020-04-01

    Hong Bin Foods Recalls Enoki Mushrooms Due to Listeria Risk

    Hong Bin Foods LLC is recalling Enoki Mushrooms after testing by the State of Michigan found Listeria monocytogenes. The product was distributed in six states.

    Product
    Enoki Mushroom; Product of Korea; Net Wt. 7.05 oz., (200 g) UPC: 7 426852 625810 The Enoki is packaged in a clear film, bottom portion will be a green back group. With Enoki Mushroom in Orange letters, under that will be Product of Korea, 7.05 oz / 200g Sun Hong Foods,
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Devices)·Z-1589-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pumps Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 38 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522K
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1054-2020·2020-04-01

    Thrive Pharmacy Recalls Subpotent Buprenorphine Troches in Florida

    Thrive Pharmacy is recalling 89 Buprenorphine Black Cherry 2 mg troches in Florida because the medication was found to be subpotent.

    Product
    Buprenorphine Black Cherry 2 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1053-2020·2020-04-01

    Thrive Pharmacy Recalls Subpotent Buprenorphine Troches in Florida

    Thrive Pharmacy is recalling 403 buprenorphine troches in Florida because they contain less active ingredient than labeled.

    Product
    Buprenorphine Watermelon 8 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1587-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pumps Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 88,243 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-522
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0857-2020·2020-04-01

    WinCo Foods Recalls Frozen Berry Medley Due to Norovirus Contamination

    WinCo Foods is recalling 21,264 bags of frozen Berry Medley because the product was found to be adulterated with Norovirus.

    Product
    WinCo Foods frozen Berry Medley (Strawberries, Blackberries, Raspberries and Blueberries), item# 107412, packaged in polyethylene bags. Product is distributed by WinCo Foods, LLC, Boise, ID 83704. Net weight 16 oz (1 lb or 454 g). UPC 70552 30522. Net weight 32 oz (2 lb or
    Category
    Food
    Distribution
    10 states
  • SevereFDA (Devices)·Z-1591-2020·2020-04-01

    Medtronic MiniMed Paradigm Insulin Pump Recalled for Cybersecurity Vulnerabilities

    Medtronic MiniMed is recalling 23,221 Paradigm insulin pumps due to cybersecurity vulnerabilities that could allow unauthorized wireless control of insulin delivery.

    Product
    Medtronic MiniMed Paradigm Insulin pump, model number MMT-523
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1052-2020·2020-04-01

    Thrive Pharmacy Recalls Subpotent Buprenorphine Troches in Florida

    Thrive Pharmacy is voluntarily recalling 71 Buprenorphine troches in Florida because the medication was found to be subpotent.

    Product
    Buprexone Banana cream 6-0.6 mg Troche, supplied in plastic troche molds with cardboard outer sleeve, Thrive Pharmacy 2863 St Johns Bluff RD. South # 135 Jacksonville, Florida
    Category
    Drug
    Distribution
    1 state
  • SevereNHTSA·20E018000·2020-03-31

    Cummins Recalls B6.7 Diesel Engines Due to Fuel Heater Fire Risk

    Cummins is recalling specific B6.7 diesel engines used in school buses, trucks, and emergency vehicles because the fuel heater may overheat, melt, or cause a fire.

    Product
    FUEL SYSTEM, DIESEL: PRE-HEATER recall
    Category
    Vehicle
    Distribution
    Distributed nationwide