The Recall Desk

Severity 4 of 5

Severe recalls

The hazard poses a serious risk of illness, injury, or structural failure. 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.

19526–19550 of 32115

  • SevereNHTSA·16V572000·2016-08-02

    Aluma/KLM Recalls 2011-2015 Trailers Due to Missing Welds

    Aluma/KLM is recalling 2011-2015 5410T and 5410WD trailers because missing welds may cause the tongue to separate, increasing crash risk.

    Product
    ALUMA KLM — ALUMA KLM 5410T, 5410WD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V566000·2016-08-01

    Heartland Recalls Travel Trailers Due to Fire Risk from LED Light

    Heartland is recalling specific 2015-2017 travel trailers and fifth wheels because an LED light may short circuit and overheat, increasing fire risk.

    Product
    HEARTLAND — HEARTLAND MALLARD, ELKRIDGE, SUNDANCE, WILDERNESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·059-2016 EXP·2016-08-01

    Michael Angelo's Recalls Frozen Shrimp Scampi and Meat Lasagna for Allergens

    Michael Angelo's Gourmet Foods is recalling 5,677 pounds of frozen shrimp scampi and meat lasagna due to misbranding and undeclared allergens like chicken, egg, soy, and shrimp.

    Product
    Michael Angelo's Gourmet Foods Inc. — Michael Angelo's Gourmet Foods, Inc. Recalls Shrimp Scampi and Meat Lasagna Products Due To Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V564000·2016-07-29

    Keystone Recalls 2017 Dutchmen Voltage Trailers Due to Hitch Defect

    Keystone is recalling 2017 Dutchmen Voltage toy haulers because they were built with an incorrect hitch rating. This defect could cause the trailer to separate from the tow vehicle.

    Product
    DUTCHMEN — DUTCHMEN VOLTAGE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V565000·2016-07-29

    Cruiser RV Recalls 2017 Trailers Due to Front Cap Light Fire Risk

    Cruiser RV is recalling 649 model year 2017 recreational trailers because an LED light on the front cap may short circuit and overheat, increasing the risk of fire.

    Product
    CRUISER RV — CRUISER RV SHADOW CRUISER, FUN FINDER, RADIANCE, STRYKER TOY
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereUSDA FSIS·068-2016·2016-07-29

    Santana's Black Label Beef Jerky Recalled for Unauthorized Inspection Mark

    Santana's Black Label Gourmet Beef Jerky is recalling 295 pounds of beef jerky produced without federal inspection and using an unauthorized USDA mark.

    Product
    Santana's Black Label Gourmet Beef Jerky Recalls Beef Jerky Products Produced Without Benefit of Inspection
    Category
    Food
    Distribution
    1 state
  • SevereUSDA FSIS·067-2016·2016-07-28

    Casa Di Trevi Recalls Meat Pasta Products for Undeclared Allergens and Misbranding

    Casa Di Trevi is recalling approximately 845 pounds of meat pasta products that were produced without federal inspection, misbranded, and contain undeclared allergens.

    Product
    DAIRY MAID RAVIOLI MFG. CORP. — Casa Di Trevi Recalls Meat Pasta Products Produced Without Benefit Of Inspection And Due To Misbranding And Undeclared Allergens
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereCPSC·16234·2016-07-28

    Lekker Recalls Patriot Power Generators Due to Fire Hazard

    Lekker LLC is recalling Patriot Power 1500-watt generators because the battery can catch fire. Consumers should stop using the units and contact 4Patriots for a free replacement.

    Product
    Patriot Power 1500-watt Generator
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereNHTSA·16V562000·2016-07-28

    Tiffin Recalls 2016-2017 Breeze Motorhomes for Air Compressor Defect

    Tiffin is recalling 2016-2017 Breeze motorhomes because air compressor debris may cause the parking brake to set unexpectedly, increasing crash risk.

    Product
    TIFFIN — TIFFIN BREEZE, ALLEGRO BREEZE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereCPSC·16235·2016-07-28

    Loot Crate Recalls Marvel Thanos Oven Mitts Due to Burn Hazard

    Loot Crate is recalling Marvel Thanos Infinity Gauntlet oven mitts because they lack thermal protection and have caused burn injuries.

    Product
    Marvel Thanos Infinity Gauntlet oven mitts
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1400-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

    PharMEDium Services, LLC is recalling 480 bags of compounded fentanyl and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    2 mcg/mL Fentanyl Citrate and 0.167% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 200 mL in 250 mL Baxter Intravia Bag, Service Code 2K9276, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-276-98
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1444-2016·2016-07-27

    GlaxoSmithKline Recalls Bactroban Nasal Ointment Due to Penicillin Contamination

    GlaxoSmithKline is recalling Bactroban Nasal ointment tubes due to penicillin cross-contamination. The recall covers 153,119 units distributed nationwide and in Puerto Rico.

    Product
    Bactroban Nasal, (Mupirocin Calcium Ointment 2%), 1 gram Single Use Tubes, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 0029-1526-11.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1411-2016·2016-07-27

    FDA Recalls Hydrocodone and Bupivacaine Cassettes Due to Glass Particulates

    Pharmedium Services is recalling 212 cassettes of compounded hydrocodone and bupivacaine injectable solution because the active ingredient was contaminated with glass particulate matter.

    Product
    20 mcg/mL HYDROmorphone HCl and 0.1% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 ml in 100 mL Yellow Smiths Medical Cassette, flow stop free-flow protection, Service Code 2T8216, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2238-2016·2016-07-27

    Stryker 2.3mm Tapered Routers Recalled Due to Breakage Risk

    Stryker is recalling 2.3mm Tapered Routers because a variation in flute depth may cause breakage, posing a risk of injury to critical soft tissue.

    Product
    2.3MM Tapered Router, Product Number 5407-FA2-023 A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otology /Neurotology/ Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1373-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Infusions Due to Glass Particulates

    PharMEDium Services is recalling specific lots of compounded fentanyl and bupivacaine infusions because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.

    Product
    1 mcg/mL Fentanyl Citrate and 0.08% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Yellow Smiths Medical Cassettes, Service Code 2T8175 Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-175-48
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1424-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

    Pharmedium Services, LLC is recalling 562 bags of sterile injectable fentanyl and bupivacaine due to the presence of glass particulate matter.

    Product
    5 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Hospira LifeCare Bag, Service Code 2H8287 (NDC 61553-287-50), 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8287 (NDC 61553-287-02), Rx Only, Compounded by…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1443-2016·2016-07-27

    GlaxoSmithKline Recalls Bactroban Cream Due to Penicillin Cross Contamination

    GlaxoSmithKline is recalling Bactroban Cream (Mupirocin Calcium Cream 2%) due to penicillin cross-contamination. The recall covers 7,480 tubes distributed nationwide and in Puerto Rico.

    Product
    Bactroban Cream, (Mupirocin Calcium Cream 2%), 30 gram tube, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709, Made in England, NDC 0029-1527-25,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1417-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Bags Due to Glass Particulate

    Pharmedium Services, LLC is recalling 1,015 bags of compounded fentanyl and bupivacaine injectable solutions because the active ingredient was contaminated with glass particulate matter.

    Product
    3.5 mcg/mL Fentanyl Citrate and 0.0625%Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 125 mL in 150 mL Baxter Intravia Bag, Service Code 2K8470, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-470-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1695-2016·2016-07-27

    Clif Bar Mojo Mountain Mix trail bars recalled for Listeria risk

    Clif Bar and Company is recalling Mojo Mountain Mix trail bars because a supplier notified them that sunflower kernels may be contaminated with Listeria monocytogenes.

    Product
    CLIF BAR Mojo Mountain Mix trail bar, 45 g bar UPC: 7-22252-10561-5; 12 count packages; INGREDIENTS: Organic Brown Rice Syrup, Soy Rice Crisps (Soy Protein Isolate, Organic Rice Flour, Calcium Carbonate), Organic Peanuts, Organic Raisins, Almonds, Organic Chocolate Chips…
    Category
    Food
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1387-2016·2016-07-27

    PharMEDium Recalls Sterile Injectable Drugs Contaminated with Glass Particulate Matter

    PharMEDium Services, LLC is recalling 1,277 bags of sterile injectable drugs containing hydromorphone and bupivacaine due to the presence of glass particulate matter.

    Product
    10 mcg/mL HYDROmorphone HCl and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; 250 mL in 250 mL Baxter Intravia Bag, Service Code 2K8908, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-908-02 ,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2213-2016·2016-07-27

    AMD-RITMED Conforming Stretch Gauze Bandages Recalled for Sterility Failure

    AMD-RITMED is recalling specific lots of sterile conforming stretch gauze bandages because FDA testing showed they did not meet sterility requirements.

    Product
    AMD-RITMED brand Conforming Stretch Gauze Bandages, Sterile, 6 in x 4/1 yds./15 cm x 3.7 cm, Reorder Number/Code D606, Bar code 6 86864 04230 3, Made in China -- Manufactured for & distributed by: AMD-RITMED INC. Montreal Quebec H8T 3J8 -- US Distribution: AMD-RITMED INC.…
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Drugs)·D-1396-2016·2016-07-27

    FDA Recalls Fentanyl and Bupivacaine Injectable Bags Due to Glass Particulates

    Pharmedium Services is recalling 97,716 bags of sterile injectable fentanyl and bupivacaine because they were produced using an active pharmaceutical ingredient contaminated with glass particulate matter.

    Product
    2 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride; Service Code 2H8125 , NDC 61553-125-52 , 100 ml in 100 ml Hospira LifeCare Bag ; Service Code 2H8204 , NDC 61553-204-54 , 200 ml in 250 ml Hospira LifeCare Bag ; Service Code…
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1433-2016·2016-07-27

    PharMEDium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulate

    PharMEDium Services, LLC is recalling 79 syringes of compounded Fentanyl Citrate and Bupivacaine HCl due to the presence of glass particulate matter in the active pharmaceutical ingredient.

    Product
    6.66 mcg/mL Fentanyl Citrate and 0.22% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 15 mL in 20 mL BD Syringe, Service Code 2T6156, Rx Only, Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-156-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1426-2016·2016-07-27

    Pharmedium Recalls Fentanyl and Bupivacaine Syringes Due to Glass Particulates

    Pharmedium Services, LLC is recalling 3,927 syringes of compounded fentanyl and bupivacaine because glass particulates were found in the active pharmaceutical ingredient.

    Product
    5 mcg/mL Fentanyl Citrate and 0.125% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride 50 mL in 60 mL BD Syringe, Service Code 2T6140 (NDC 61553-140-20) , 60 mL in 60 mL BD Syringe, Service Code 2T6222 (NDC 61553-222-31), Rx Only, Compounded by PharMEDium Services…
    Category
    Drug
    Distribution
    Distributed nationwide