The Recall Desk

Severity 5 of 5

Critical recalls

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

What “critical” means here

Severity 5 (Critical) covers recalls where deaths or serious injuries have been reported, or where the agency itself classified the action as the highest severity (FDA Class I, NHTSA 'death/serious injury reported'). These are the recalls you should treat as urgent — stop using the product immediately and follow the agency's guidance. Common Severity-5 categories are pathogen-contaminated ready-to-eat foods (Listeria, E. coli O157, Salmonella), drug products with confirmed adverse-event reports, and vehicle defects with documented fatal crashes.

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.

1926–1950 of 7439

  • CriticalFDA (Drugs)·D-1879-2019·2019-09-18

    Plastikon Recalls Milk of Magnesia Unit Dose Cups for Microbial Contamination

    Plastikon Healthcare LLC is recalling specific lots of Milk of Magnesia unit dose cups because they failed bioburden testing for Total Aerobic Microbial Count.

    Product
    Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2452-2019·2019-09-18

    Allergan Recalls Textured Breast Implants Due to Lymphoma Risk

    Allergan is recalling 4 million textured breast implants worldwide after FDA safety updates linked them to a higher incidence of anaplastic large cell lymphoma.

    Product
    Natrelle 410, Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implant Biocell Low Height Low Projection, Sterile, for the following style numbers: Syle LL: LL-410135,LL-410180,LL-410210,LL-410240,LL-410300; Style LM: LM-410140, LM-410190, LM-410220, LM-410250, LM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2457-2019·2019-09-18

    Allergan Natrelle Tissue Expanders Recalled for Lymphoma Risk

    Allergan is recalling Natrelle 133 tissue expanders due to FDA safety information regarding a higher incidence of anaplastic large cell lymphoma in patients with textured breast implants.

    Product
    Natrelle 133 Tissue Expanders w/Suture Tabs BIOCELL Full Height Variable Projection with MAGNA-FINDEr Xact & 21G Needle Infusion Set STYLE 133FV-T: 133FV-11-T, 133FV-12-T, 133FV-13-T, 133FV-14-T, 133FV-15-T, 133FV-16-T; STYLE 133MV-T: 133MV-11-T, 133MV-12-T, 133MV-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-2093-2019·2019-09-04

    FDA Recalls Fresh Basil Tested Positive for Salmonella

    Harvest Sensations, LLC is recalling fresh basil that tested positive for Salmonella. The product was imported from Mexico and distributed in New York.

    Product
    Fresh basil packaged in plastic bags, each weighing one pound. (No label)
    Category
    Food
    Distribution
    1 state
  • CriticalFDA (Food)·F-2076-2019·2019-08-28

    Kroger Private Selection Frozen Blackberries Recalled for Hepatitis A Risk

    The Kroger Co is recalling 16 oz packages of Private Selection Frozen Blackberries due to possible Hepatitis A contamination. The product was distributed to retail locations in 30 states.

    Product
    PRIVATE SELECTION FROZEN BLACKBERRIES, 16 oz
    Category
    Food
    Distribution
    30 states
  • CriticalFDA (Food)·F-2074-2019·2019-08-28

    Kroger Frozen Triple Berry Medley Recalled for Possible Hepatitis A

    The Kroger Co is recalling Private Selection Frozen Triple Berry Medley due to possible Hepatitis A contamination. Consumers should discard the product.

    Product
    PRIVATE SELECTION FROZEN TRIPLE BERRY MEDLEY, 48 oz
    Category
    Food
    Distribution
    30 states
  • CriticalFDA (Food)·F-2090-2019·2019-08-28

    Dole Baby Spinach Recalled Due to Positive Salmonella Test

    Dole Fresh Vegetables is recalling specific lots of Dole Baby Spinach after a Michigan state test detected Salmonella.

    Product
    Dole Baby Spinach: 6 oz. (170 g) plastic bag, UPC 0-71430-00964-2, SKU 320; 10 oz. (283 g) clamshell, UPC 0-71430-00016-8, SKU 2337 Distributed by: Dole Fresh Vegetables, Inc., Monterey, CA 93940.
    Category
    Food
    Distribution
    10 states
  • CriticalFDA (Food)·F-2070-2019·2019-08-28

    Elevation Foods Recalls Archer Farms Egg Salad Due to Listeria

    Elevation Foods is recalling Archer Farms egg salad because Listeria monocytogenes was found in the product. The recall covers 572 cases distributed to multiple states.

    Product
    Archer Farms egg salad packaged in 12oz plastic cup with lid, 6 cups per case, refrigerated
    Category
    Food
    Distribution
    9 states
  • CriticalFDA (Devices)·Z-2226-2019·2019-08-28

    Edwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons

    Edwards Lifesciences is recalling SAPIEN 3 Ultra Transcatheter Heart Valve Systems due to reports of burst balloons that caused difficulty retrieving the device during procedures.

    Product
    Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253
    Category
    Medical Device
    Distribution
    12 states
  • CriticalFDA (Food)·F-2077-2019·2019-08-28

    Kirkland Signature Three Berry Blend Recalled for Hepatitis A Risk

    Townsend Farms Inc. is recalling Kirkland Signature Three Berry Blend frozen berries due to potential Hepatitis A virus contamination.

    Product
    Kirkland Signature Three Berry Blend product, frozen, package in a plastic bag. Net wt. 4 lbs. UPC 0 96619 10105 4. The product label is read in parts: "*** KIRKLAND Signature *** Three Berry Blend *** Raspberries***Blueberries***Blackberries*** PRODUCT OF USA *** Distributed
    Category
    Food
    Distribution
    5 states
  • CriticalFDA (Food)·F-2075-2019·2019-08-28

    Kroger Frozen Triple Berry Medley Recalled for Possible Hepatitis A

    The Kroger Co is recalling Private Selection Frozen Triple Berry Medley due to possible Hepatitis A contamination. Consumers should check their freezers for the affected product.

    Product
    PRIVATE SELECTION FROZEN TRIPLE BERRY MEDLEY, 16 oz
    Category
    Food
    Distribution
    30 states
  • CriticalUSDA FSIS·086-2019·2019-08-24

    Olympia Meats Recalls Pork Sausage for Undeclared Pistachio Allergen

    Olympia Meats is recalling ready-to-eat pork sausage products because they contain undeclared pistachios, a known tree nut allergen.

    Product
    Olympia Provisions — Olympia Meats Recalls Ready-To-Eat Pork Sausage Products due to Misbranding and Undeclared Allergens
    Category
    Food
    Distribution
    3 states
  • CriticalFDA (Food)·F-1995-2019·2019-08-21

    The Cookie Dough Cafe Recalls Chocolate Chip Edible Cookie Dough Bars

    The Cookie Dough Cafe is recalling 16,080 bars of chocolate chip edible cookie dough due to undeclared peanuts. The product was distributed in Illinois, Michigan, Pennsylvania, and South Carolina.

    Product
    The Cookie Dough Cafe - Chocolate chip chilled gourmet edible cookie dough; 1.6 oz bars, packaged in plastic wrappers, 16 bars per wholesale case. UPC: 850947006418
    Category
    Food
    Distribution
    4 states
  • CriticalFDA (Food)·F-1989-2019·2019-08-21

    Golden Macadamia Nuts Recalled Due to Salmonella Contamination

    Golden Peanut and Tree Nuts LLC is recalling 25 lb. boxes of Golden Macadamia Nuts because a customer found Salmonella during testing.

    Product
    Golden Macadamia Nuts Dry Roasted Style 4R-DM; 25 lb. cardboard box Product of Kenya Manufactured by Golden Peanut Company, LLC-Lodi 1230 S. Fairmont Ave. Lodi, Ca 95240
    Category
    Food
    Distribution
    1 state
  • CriticalUSDA FSIS·085-2019·2019-08-20

    Tip Top Poultry Recalls Fully Cooked Chicken Due to Listeria Risk

    Tip Top Poultry is recalling approximately 135,810 pounds of fully cooked diced chicken products due to possible Listeria monocytogenes contamination.

    Product
    Silver Comet Foods, LLC (FKA Tip Top Poultry Inc.) distributed by Tip Top — Tip Top Poultry, Inc. Recalls Fully Cooked Poultry Products due to Possible Listeria Contamination
    Category
    Food
    Distribution
    Distributed nationwide
  • CriticalFDA (Food)·F-1978-2019·2019-08-14

    Shirakiku Fish Cake Age Balls Recalled for Undeclared Allergens

    Wismettac Asian Foods is recalling Shirakiku Fish Cake Age Balls because they may contain undeclared egg, milk, and shellfish.

    Product
    Shirakiku FISH CAKE AGE BALL SK F; 20/ 150G; Net Wt. 5.29 oz. Keep Frozen, 15 pcs. UPC 074410925574 Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA
    Category
    Food
    Distribution
    38 states
  • CriticalFDA (Food)·F-1974-2019·2019-08-14

    Shirakuku Fish Cake Minch Balls Recalled for Undeclared Allergens

    Wismettac Asian Foods is recalling Shirakuku Fish Cake Minch Balls because they may contain undeclared egg, milk, and shellfish.

    Product
    Shirakuku FISH CAKE MINCH BALL SK F; 20/ 150G; Net Wt. 5.29 oz. Keep Frozen, 9 pcs. Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA UPC 074410925260
    Category
    Food
    Distribution
    38 states
  • CriticalFDA (Food)·F-1977-2019·2019-08-14

    Shirakiku Fish Cake Recalled for Undeclared Egg, Milk, and Shellfish

    Wismettac Asian Foods is recalling Shirakiku Fish Cake Ika Maki due to possible undeclared egg, milk, and shellfish.

    Product
    Shirakiku FISH CAKE IKA MAKI SK F; 20/ 150G, Net Wt. 5.29 oz. Keep Frozen, 4 pcs. UPC 074410925567 Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA
    Category
    Food
    Distribution
    38 states
  • CriticalFDA (Food)·F-1979-2019·2019-08-14

    Shirakiku Fish Cake Recalled for Undeclared Allergens

    Wismettac Asian Foods is recalling Shirakiku Fish Cake Satsuma Age due to possible undeclared egg, milk, and shellfish.

    Product
    Shirakiku FISH CAKE SATSUMA AGE SK F; 20/ 150G; Net Wt. 5.29 oz. Keep Frozen, 4 pcs. UPC 0744109925598 Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA
    Category
    Food
    Distribution
    38 states
  • CriticalFDA (Food)·F-1976-2019·2019-08-14

    Shirakiku Fish Cake Recalled for Undeclared Egg, Milk, and Shellfish

    Wismettac Asian Foods is recalling Shirakiku Fish Cake Gobo Maki due to possible undeclared egg, milk, and shellfish.

    Product
    Shirakiku FISH CAKE GOBO MAKI SK F: 20/ 150G, Net Wt. 5.29 oz. Keep Frozen, 5 pcs. UPC 07441092550 Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA
    Category
    Food
    Distribution
    38 states
  • CriticalFDA (Food)·F-1972-2019·2019-08-14

    Shirakiku Fish Cake Recalled for Undeclared Milk and Shellfish

    Wismettac Asian Foods is recalling Shirakiku Fish Cake due to possible undeclared milk and shellfish allergens.

    Product
    Shirakiku FISH CAKE IWASHI TEN SK F 20/150 g; Net WT. 5.29 oz. Keep frozen, 7 pcs. UPC 074410925246 Distributed by Wismettac Asian Foods, Inc. Santa Fe Springs, CA
    Category
    Food
    Distribution
    38 states
  • CriticalFDA (Food)·F-1970-2019·2019-08-14

    Tainy Vostoka Assorted Dry Fruits Recalled for Undeclared Sulfites

    Euphoria Fancy Food, Inc. is recalling Tainy Vostoka Assorted Dry Fruits-Apple due to elevated levels of undeclared sulfites.

    Product
    Tainy Vostoka brand Assorted Dry Fruits-Apple, net wt. 17.63 oz. (500gram) in clear plastic package marked with container code #21 01 19 SS and UPC #4605932006197.
    Category
    Food
    Distribution
    3 states
  • CriticalCPSC·19767·2019-08-13

    SunSetter Recalls Vinyl Covers for Motorized Awnings Due to Fall Hazards

    SunSetter is recalling vinyl covers for motorized awnings because they can cause unexpected opening and falls. One death and six injuries have been reported.

    Product
    Vinyl covers for SunSetter Motorized Awnings
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalUSDA FSIS·083-2019·2019-08-09

    Taylor Farms Recalls Breaded Chicken Products Due to Possible Undercooking

    Taylor Farms Illinois is recalling approximately 342 pounds of breaded chicken products due to a processing defect that may have led to undercooking.

    Product
    Taylor Farms Illinois, Inc — Taylor Farms Illinois Inc. Recalls Chicken Products due to Possible Processing Defect
    Category
    Food
    Distribution
    7 states